Consumer medicine information

NeoRecormon

Epoetin beta

BRAND INFORMATION

Brand name

NeoRecormon

Active ingredient

Epoetin beta

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using NeoRecormon.

What is in this leaflet

This leaflet answers some common questions about NeoRecormon. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using NeoRecormon against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What NeoRecormon is used for

NeoRecormon is used to treat anaemia caused by chronic kidney disease.

Anaemia is caused by a lack of red blood cells or haemoglobin which transport oxygen in the blood. If you have anaemia, your body's tissues might not receive enough oxygen. Symptoms may include tiredness, weakness and shortness of breath.

NeoRecormon may also be used:

  • If you are planning to have major surgery and you are going to have your own blood collected for use during the surgery.
  • To prevent anaemia in premature babies.
  • If you have anaemia after being treated with chemotherapy for cancer and you can't have a blood transfusion.
    In some studies, people with cancer treated with medicines like NeoRecormon for anaemia did not live as long as people not receiving these medicines.

NeoRecormon contains the active ingredient epoetin beta (pronounced ee-poe-tin bee-ta). Epoetin beta is also known as recombinant human erythropoietin (pronounced ee-rithroe-poy-tin).

NeoRecormon belongs to a group of medicines known as hormones. The kidneys produce the natural hormone erythropoietin, which stimulates the production of red blood cells in the bone marrow and spleen.

Like erythropoietin, NeoRecormon works by increasing the number of red blood cells and the haemoglobin level in your blood.

Your doctor, however, may have prescribed NeoRecormon for another reason.

Ask your doctor if you have any questions about why NeoRecormon has been prescribed for you.

NeoRecormon is not addictive.

This medicine is available only with a doctor's prescription.

Before you use NeoRecormon

When you must not use it

Do not use NeoRecormon if:

  • You have had an allergic reaction to epoetin beta or any ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction include swelling, itching, rash or breathing difficulties.
  • You have high blood pressure that is not well controlled.
  • You or your baby has phenylketonuria (a genetic metabolic disease).
    NeoRecormon contains phenylalanine as an inactive ingredient and you should consult your doctor about the risks.
  • You are donating your own blood before surgery, and:
    - you have had a heart attack or stroke in the month before your treatment, or
    - you have new or increasing chest pain, or
    - you are at risk of blood clots in the veins (deep vein thrombosis) or if you have had clots before.
    If any of these apply or might apply to you, tell your doctor at once.
  • The package is torn or shows signs of tampering.
  • The expiry date (EXP) printed on the pack has passed.
    If you use this medicine after the expiry date has passed it may have no effect at all, or worse, may have an unexpected effect.

If you are not sure if you should be using NeoRecormon, talk to your doctor.

Use in children

NeoRecormon may be used to treat anaemia due to kidney disease in children who are at least 2 years of age.

NeoRecormon is also approved for treating anaemia in premature babies born before 34 weeks and weighing between 750 and 1500 grams.

Before you start to use it

Your doctor must know about all the following before you start to use NeoRecormon.

Tell your doctor if:

  • You are allergic to any other medicines, foods, dyes or preservatives.
  • You have any other health problems especially the following:
    - blood clotting diseases
    - high blood pressure - it is important to follow all your doctor's instructions to control your blood pressure, including any changes to your diet
    - cancer
    - epilepsy
    - excess levels of aluminium in the blood as a result of kidney disease treatment
    - folic acid or vitamin B12 deficiencies
    - you have had problems with another erythropoietin-type medicine
    - liver disease
    - any other illness or health problems.
  • You are using NeoRecormon for donating your own blood before surgery and you weigh less than 50kg.
  • You are pregnant or plan to become pregnant.
    NeoRecormon is not generally recommended for use in pregnant women unless the benefits of treatment outweigh the risks to the unborn baby.
  • You are breast-feeding or plan to breast-feed.
    Because epoetin beta occurs naturally in the body, it has not been possible to determine whether NeoRecormon passes into the breast milk following injection. Your doctor will discuss the risks and benefits of using NeoRecormon if you are breast-feeding.

Do not misuse NeoRecormon. Misuse by healthy people may lead to an excessive increase in the number of red blood cells in the blood. Such an increase may cause life-threatening effects on the heart and blood vessels.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food shop. Some medicines may interfere with NeoRecormon and may affect how well it works. Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking NeoRecormon.

Ask your doctor or pharmacist if you are not sure about any medicine.

How to use NeoRecormon

NeoRecormon can be given by your doctor or nurse. Alternatively your doctor, nurse or pharmacist may teach you or your carer how to inject NeoRecormon. Do not inject yourself with NeoRecormon unless you have received training.

Follow all directions given to you by your doctor, nurse or pharmacist carefully. Those directions may differ from the information contained in this leaflet.

A NeoRecormon patient support kit is available. For more information contact your doctor, healthcare professional or Roche Medical Information service on 1800 233 950 (Australia) or 0800 656 464 (New Zealand).

How much to inject

The dosage of NeoRecormon is expressed in international units (IU). Your doctor will tell you how much and how often to inject NeoRecormon according to your individual needs.

If necessary, depending on your response to treatment, your dose may be changed by your doctor.

Your doctor will keep track of your response to NeoRecormon by asking questions and doing tests such as taking your blood pressure or taking blood.

Do not exceed or change the dose recommended by your doctor.

How to inject it

NeoRecormon can be administered by subcutaneous (under the skin) or intravenous (into the vein) injection. Your doctor will decide which way is right for you.

Intravenous administration
Only a health professional should administer NeoRecormon intravenously.

Subcutaneous administration
It is recommended that the first dose of NeoRecormon be administered by a doctor or nurse.

Your doctor may discuss whether it would be more convenient for you to receive your injections at home, in which case you or a family member would be instructed on how to give the injection properly. This is a simple procedure and many patients prefer it.

If your doctor has directed you to use NeoRecormon by subcutaneous injection, please follow the instructions below.

You should read these directions from beginning to end before starting your injection. Follow these instructions carefully. Consult your doctor if you require further instructions.

Remember that cleanliness is vital so be sure to wash your hands!

Preparing to self-inject

Before you begin

  1. Find a clean, comfortable area.
  2. Gather all the medicinal supplies you will need:
    - an alcohol swab.
    - some cotton wool or a dry sterile pad.
    - a sharps disposal bin.
  3. Remove the NeoRecormon pre-filled syringe from the fridge. Leave it out of the fridge for 30 minutes before use or gently warm the syringe in the palms of your hands for about 1 minute. Be careful not to shake it.
  4. Check the expiry date (EXP). Do not use NeoRecormon after the expiry date shown on the pre-filled syringe label.
  5. Check that the liquid has no discolouration, cloudiness or particles. The liquid should look clear and colourless.

Preparing the syringe and needle

  1. Wash your hands thoroughly.
  2. Remove the protective covering from the needle packaging.
  3. Remove the rubber cap from the end of the syringe.
  4. Push the needle firmly onto the syringe while gently twisting.
  5. Pull the needle shield straight off the needle.
  6. If you notice any air bubbles in the syringe, hold the syringe with the needle facing upwards, lightly tap the syringe to bring the air bubbles to the top. You may need to gently push the plunger in slightly to push air out of the syringe.
  7. Check the dose of medication your doctor has prescribed. You may need to gently push the plunger to push out some medication to get the dose your doctor has prescribed.
  8. If you need to put the syringe (with the needle attached) down, make sure the plastic guard covers the needle and place on a clean flat surface.
  9. The syringe is now ready for use.

Choosing the injection site

  1. Choose an injection site in your stomach area or the top of your thigh.
  2. Avoid your navel and waistline.
  3. Change injection sites with each injection to prevent soreness in one spot.
  4. Never inject into a red or swollen area.
  5. Never inject NeoRecormon into a muscle.

Preparing the injection site

  1. Clean the injection site with an alcohol swab and let the skin dry (10 seconds).
  2. Remove the protective needle guard from the end of the syringe and hold the syringe with the needle facing upwards.
  3. Grab your skin at the injection site firmly between your thumb and forefinger to elevate your skin.

Injecting the medicine

  1. Hold the syringe at a 45 degree angle to your skin.
  2. Insert the needle in one quick motion with the bevel (flat edge) facing upwards.
  3. Slowly push the plunger all the way down.
  4. Once all the liquid has left the syringe, pull out the needle at the same angle at which you put it in.
  5. Do not recap the needle.
  6. If you notice slight bleeding, gently press over the injection site with some cotton wool or a dry sterile pad.

Remember: Most people can learn to give themselves a subcutaneous injection, but if you experience difficulty, please do not be afraid to ask for help and advice from your doctor, nurse or pharmacist.

Cleaning up after your injection

  1. The needle and syringe must be used ONCE only.
  2. Dispose of the needle and syringe into a sharps container immediately after injection.
  3. Do not replace the needle cover.
  4. NEVER place used needles and syringes into your normal household waste bin.
If you are not sure how to dispose of the needles and syringes, consult your doctor, nurse or pharmacist on how to properly dispose of the syringes and needles.

When to inject NeoRecormon

Your doctor will tell you how often to use this medicine.

Injecting NeoRecormon at the same time of the day will have the best effect. It will also help you remember your injections.

Follow your doctor's instructions exactly on when to inject NeoRecormon.

How long to use NeoRecormon

Your treatment period could range from a few weeks up to a lifetime, depending on your illness.

Continue using NeoRecormon until your doctor tells you to stop. Your doctor will decide when your treatment should be stopped. It is important to keep using NeoRecormon even if you feel well.

If you forget to use NeoRecormon

If it is almost time for your injection, skip the injection you missed and have your next injection when you are meant to.

Otherwise, inject it as soon as you remember, and then go back to using NeoRecormon as you would normally.

Do not have a double dose to make up for the injection that you missed. Because NeoRecormon is administered over prolonged periods, occasional missed doses are not expected to have a significant effect on your treatment.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

If you use too much NeoRecormon (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26 in Australia or 0800 764 766 [0800 POISON] in New Zealand) for advice or go to your nearest Accident and Emergency if you think that you or anyone else may have used too much NeoRecormon. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep these telephone numbers handy.

While you are using NeoRecormon

Things you must do

Use NeoRecormon exactly as your doctor has prescribed.

Tell all doctors, dentists and pharmacists who are treating you that you are using NeoRecormon.

Do not take any other medicines, whether they require a prescription or not, without first telling your doctor or pharmacist that you are using NeoRecormon.

If you have blood pressure problems, it is important to follow all your doctor's instructions to control your blood pressure, including any changes to your diet, while using NeoRecormon.

Most people's blood iron levels decrease when using NeoRecormon. Almost all patients will need to be treated with iron supplements.

Tell your doctor if you become pregnant while using NeoRecormon.

Tell your doctor if, for any reason, you have not used NeoRecormon exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Be sure to keep all of your appointments with your doctor so that your progress can be checked. Your doctor will keep track of your response to NeoRecormon by asking questions and doing tests such as taking your blood pressure or taking blood.

Things you must not do

Do not stop using NeoRecormon or change the dose without first checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Do not give NeoRecormon to anyone else even if they have the same condition as you.

Do not use NeoRecormon to treat other complaints unless your doctor says to.

Do not switch to any other brands of epoetin without consulting your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how NeoRecormon affects you. NeoRecormon is not expected to affect your ability to drive a car or operate machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using NeoRecormon. NeoRecormon helps most people with anaemia but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • feeling tired or lacking energy, looking pale; this may be due to changes in your blood iron levels. Your doctor may prescribe an iron supplement for you
  • headache
  • bleeding or bruising more easily
  • swelling of the arms, feet or legs
  • stinging or swelling around the injection area
  • chest or throat infection, difficulty breathing, cough
  • weakness
  • nausea and vomiting
  • pain with urination or increased urgency and/or frequency of urination.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice the following:

  • stabbing, migraine-like headache
  • cardiac (heart) symptoms such as chest pain, shortness of breath, double vision, dizziness, feeling lightheaded or tingling of extremities (fingers and toes)
  • swelling, pain, tenderness, warmth or discolouration of one leg or arm or along a vein in your leg or arm
  • sudden shortness of breath, chest pain, palpitations or coughing up blood
  • sudden trouble walking, speaking, seeing or understanding what someone is saying
  • sudden onset of wheezing or difficulty breathing, swollen tongue, face or throat
  • severe skin reactions, hives, blisters or rash that may cover your whole body
    A severe allergic reaction (very rare) can occur, especially just after an injection. This must be treated at once.

You may experience flu-like symptoms (very rare) particularly when starting treatment. These include fever, chills, headaches, pain in the limbs, bone pain and/or generally feeling unwell. These reactions are usually mild to moderate and go away within a few hours or days.

This is not a complete list of all possible side effects. Your doctor or pharmacist has a more complete list. Other side effects may occur in some people and there may be some not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on the above list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using NeoRecormon

Storage

Store NeoRecormon pre-filled syringes in the fridge at 2 to 8°C. Do not freeze.

Always keep NeoRecormon in its carton, in the fridge, until it is time to use it. This will protect NeoRecormon from being affected by light. If you take the pre-filled syringes out of the pack they may not keep well.

You can use NeoRecormon if it has been left out of the fridge for no longer than 3 days (a single period only) at room temperature (up to 25°C).

Do not store NeoRecormon or any other medicine in a bathroom or near a sink or any other place where there is high humidity.

Do not leave NeoRecormon in the car or on window sills. Heat and dampness can destroy some medicines.

Keep NeoRecormon where young children cannot reach it. An appropriate container on the top shelf of a fridge is a good place to store NeoRecormon.

Disposal

The syringe is intended for single use ONLY and must be thrown away after the injection. Dispose of the syringe with the needle in a puncture proof container as instructed by your doctor, nurse or pharmacist.

Never put the used syringe/needle in your normal household garbage.

If your doctor tells you to stop using NeoRecormon, or the pre-filled syringe has passed its expiry date, ask your pharmacist what to do with any pre-filled syringes that are left over.

Product description

Availability

NeoRecormon pre-filled syringes are available in the following strengths (syringe plungers and packaging are coloured as indicated below to easily identify the strength):

  • 2000 IU/0.3 mL (orange)
  • 3000 IU/0.3 mL (blue)
  • 4000 IU/0.3 mL (red)
  • 5000 IU/0.3 mL (grey)
  • 6000 IU/0.3 mL (green)
  • 10000 IU/0.6 mL (purple)

Each pre-filled syringe pack contains 6 pre-filled syringes containing solution for injection and 6 needles.

What NeoRecormon pre-filled syringes look like

NeoRecormon solution for injection is contained in a disposable glass syringe. The solution is clear and colourless.

A stainless steel needle is also supplied with the syringe to allow for subcutaneous injection.

Ingredients

Active ingredient

  • epoetin beta (recombinant human erythropoietin)

Inactive ingredients

Each pre-filled syringe also contains:

  • urea
  • sodium chloride
  • monobasic sodium phosphate
  • dibasic sodium phosphate
  • calcium chloride
  • polysorbate 20
  • glycine
  • leucine
  • isoleucine
  • threonine
  • glutamic acid
  • phenylalanine

Distributor

Distributed in Australia by:

Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30 Hickson Road
Sydney NSW 2000
AUSTRALIA

Medical enquiries:
1800 233 950

Distributed in NZ by:

Roche Products (New Zealand) Limited
PO Box 109113 Newmarket
Auckland 1149
NEW ZEALAND

Medical enquiries:
0800 276 243

Please check with your pharmacist for the latest Consumer Medicine Information.

Australian Registration Numbers:

2000 IU/0.3 mL: AUST R 104262

3000 IU/0.3 mL: AUST R 104263

4000 IU/0.3 mL: AUST R 104264

5000 IU/0.3 mL: AUST R 104265

6000 IU/0.3 mL: AUST R 104266

10000 IU/0.6 mL: AUST R 104267

This leaflet was prepared on 14 November 2019.

Published by MIMS May 2020

BRAND INFORMATION

Brand name

NeoRecormon

Active ingredient

Epoetin beta

Schedule

S4

 

1 Name of Medicine

Epoetin beta.

2 Qualitative and Quantitative Composition

NeoRecormon 2000 IU solution for injection in pre-filled syringe.

One pre-filled syringe with 0.3 mL solution for injection contains 2000 international units (IU) epoetin beta.

NeoRecormon 3000 IU solution for injection in pre-filled syringe.

One pre-filled syringe with 0.3 mL solution for injection contains 3000 international units (IU) epoetin beta.

NeoRecormon 4000 IU solution for injection in pre-filled syringe.

One pre-filled syringe with 0.3 mL solution for injection contains 4000 international units (IU) epoetin beta.

NeoRecormon 5000 IU solution for injection in pre-filled syringe.

One pre-filled syringe with 0.3 mL solution for injection contains 5000 international units (IU) epoetin beta.

NeoRecormon 6000 IU solution for injection in pre-filled syringe.

One pre-filled syringe with 0.3 mL solution for injection contains 6000 international units (IU) epoetin beta.

NeoRecormon 10,000 IU solution for injection in pre-filled syringe.

One pre-filled syringe with 0.6 mL solution for injection contains 10,000 international units (IU) epoetin beta.
NeoRecormon (epoetin beta (rch)) is a sterile, purified, stable recombinant human erythropoietin concentrate produced from genetically engineered Chinese hamster ovary (CHO) cells containing a cloned human erythropoietin gene.
The active ingredient, epoetin beta (rch), is a highly purified glycoprotein, identical in amino acid sequence to endogenous erythropoietin, with a mean molecular weight of approximately 30 kDa. Epoetin beta (rch) is ≥ 98% pure, with no detectable cell line residues.

Excipients with known effect.

Phenylalanine; sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Colourless, clear to slightly opalescent solution.

4 Clinical Particulars

4.1 Therapeutic Indications

NeoRecormon is indicated:
for the treatment of anaemia associated with chronic kidney disease (CKD) in patients on dialysis and symptomatic patients not yet undergoing dialysis;
to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood;
for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks;
for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate.

4.2 Dose and Method of Administration

Dosage.

General.

Important.

Use the lowest dose of NeoRecormon that will gradually increase the haemoglobin concentration. NeoRecormon dosing regimens are different for each of the indications described in this section.
It is recommended that the first dose of NeoRecormon be administered under the supervision of a healthcare professional.

Treatment of anaemia in patients with chronic kidney disease.

NeoRecormon may be administered by either intravenous or subcutaneous injection, however, subcutaneous should be considered where feasible since lower doses are required. Generally, the subcutaneous maintenance dose is approximately 20-35% lower than the intravenous maintenance dose. In the case of intravenous administration, the solution should be injected over approximately 2 minutes (e.g. in haemodialysis patients via the arteriovenous fistula at the end of dialysis). For non-haemodialysis patients, subcutaneous administration is preferred in order to avoid puncture of peripheral veins.
The recommended haemoglobin target is 100-120 g/L. The target haemoglobin should be determined individually in the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases. It is recommended that haemoglobin is monitored at regular intervals until stabilised and periodically thereafter (see Section 4.4 Special Warnings and Precautions for Use).
Treatment with NeoRecormon is divided into two stages:
1. Correction phase.

Subcutaneous administration.

The recommended starting dose is 60 IU/kg body weight/week, administered as a single weekly injection or in up to 7 divided doses. The dose may be increased every 4 weeks by 60 IU/kg body weight/week if the haemoglobin increase is not adequate (Hb < 1.5 g/L per week).

Intravenous administration.

The initial dose is 120 IU/kg body weight/week, administered in 3 divided doses. The dose may be raised after 4 weeks to 240 IU/kg body weight/week. If further increments are needed they should be at 60 IU/kg body weight/week, at monthly intervals.
2. Maintenance phase. To maintain haemoglobin between 100-120 g/L the dose is initially reduced to half of the previously administered amount.
In the case of subcutaneous administration, the weekly dose can be given as a single injection or in up to 7 divided doses. Patients who are stable on a once weekly dosing regimen may be switched to once every 2 weeks administration. In this case dose increases may be necessary.

Dose adjustment.

Increases in dose should not be made more frequently than once a month. The dose for each patient should be adjusted so that the haemoglobin concentration does not exceed 120 g/L. If the haemoglobin is increasing and approaching 120 g/L, the dose should be reduced by approximately 25-50%. If the haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be re-initiated at a dose approximately 25-50% below the previous dose. If the haemoglobin increases by more than 10 g/L in any 2-week period, the dose should be decreased by approximately 25-50%.
The maximum dose should not exceed 720 IU/kg body weight/week.
NeoRecormon is normally a lifelong therapy. It can, however, be interrupted if necessary, at any time. Data on the once weekly dosing schedule are based on clinical studies with a treatment duration of 24 weeks.

Special populations.

Paediatric populations.

The results of clinical studies in children and adolescents have shown that on average, the younger the patient, the higher the NeoRecormon dose required. Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted.

Treatment for increasing the amount of autologous blood.

The dose may be administered by either intravenous or subcutaneous injection. In the case of intravenous administration, the solution should be injected over approximately 2 minutes.
The dose for autologous blood donation prior to elective surgery is 400-1600 IU/kg body weight/week IV or 300-1200 IU/kg body weight/week SC, administered in 2 divided doses, for a maximum of 4 weeks.
If the patient's PCV ≥ 33% or Hb > 110 g/L, NeoRecormon may be administered at the end of the blood donation. Patients with pre-existing cardiac diseases should be monitored carefully (see Section 4.4 Special Warnings and Precautions for Use).
The dose must be determined for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve.
The required amount of pre-donated blood depends on the anticipated blood loss, the physical condition of the patient and use, if any, of blood conserving procedures. This amount should be that quantity which is expected to be sufficient to avoid homologous blood transfusions. The required amount of pre-donated blood is expressed in units whereby one unit in the nomogram is equivalent to 180 mL red cells.
The ability to donate blood depends predominantly on the patient's blood volume and baseline PCV. Both variables determine the endogenous red cell reserve, which can be calculated according to the following formula (see Equation 1):
The indication for NeoRecormon treatment and, if given, the single dose should be determined from the required amount of pre-donated blood and the endogenous red cell reserves according to Figures 1 and 2.
The single dose, as determined in Figures 1 and 2, is administered twice weekly over 4 weeks. The maximum dose should not exceed 1600 IU/kg body weight/week for IV and 1200 IU/kg body weight/week for SC administration.

Prevention of anaemia of prematurity.

The solution is administered subcutaneously at a dose of 750 IU/kg body weight/week administered in 3 divided doses.
NeoRecormon treatment should be commenced as early as possible, preferably by day 3 of life. Premature infants who have already been transfused prior to NeoRecormon treatment are not likely to benefit as much as non-transfused infants. The treatment should last for 6 weeks.

Treatment of anaemia in patients with non-myeloid malignancies.

NeoRecormon treatment should not be commenced unless the haemoglobin falls below 100-110 g/L. The recommended initial dose is 450 IU/kg body weight/week, administered subcutaneously as a single weekly injection or in 3 to 7 divided doses. If after 4 weeks, a patient does not show a satisfactory response in terms of haemoglobin values, then the dose should be doubled. The therapy should be continued up to 4 weeks after the end of chemotherapy. The maximum dose should not exceed 900 IU/kg body weight/week.
If haemoglobin falls by more than 10 g/L in the next cycle of chemotherapy despite concomitant NeoRecormon therapy, further administration may not be effective.
Rapid increases in haemoglobin concentrations or the use of erythropoietin in subjects with normal haemoglobin concentrations may result in an increased risk of thrombotic adverse events (see Section 4.4 Special Warnings and Precautions for Use). Therefore, a rise > 10 g/L per fortnight or haemoglobin concentration > 120 g/L should be avoided. If the haemoglobin concentration is rising by more than 10 g/L per fortnight, reduce the NeoRecormon dose by approximately 25%. If the haemoglobin concentration exceeds 120 g/L, discontinue NeoRecormon until it falls below 120 g/L and then restart NeoRecormon at a dose 25% below the previous dose. It is recommended that haemoglobin is monitored at regular intervals until stabilised and periodically thereafter (see Section 4.4 Special Warnings and Precautions for Use).

Method of administration.

Remove the cap from the syringe and affix the needle provided. Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles should be injected. NeoRecormon pre-filled syringes are sterile but do not contain preservatives.
Product is for single use in one patient only.

4.3 Contraindications

NeoRecormon is contraindicated in patients with:
poorly controlled hypertension;
known hypersensitivity to the active substance or any of the excipients.
In the indication "increasing the yield of autologous blood" NeoRecormon must not be used in patients who, in the month preceding treatment, have suffered a myocardial infarction or stroke, patients with unstable angina pectoris, or patients who are at risk of deep venous thrombosis such as those with a history of venous thromboembolic disease.

4.4 Special Warnings and Precautions for Use

General.

In order to improve the traceability of biological medicinal products, the trade name of the administered product should be clearly recorded in the patient medical record. Substitution by any other biological medicinal product requires the consent of the prescribing physician.
NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in transformation, thrombocytosis, and chronic liver failure.
NeoRecormon contains phenylalanine as an excipient therefore this should be taken into consideration in patients affected with severe forms of phenylketonuria.
Anaphylactoid reactions have been observed in isolated cases. Rarely, skin reactions such as rash, pruritus, urticaria or injection site reactions may occur, however in controlled clinical studies, no increased incidences of hypersensitivity reactions were found. It is recommended that the first dose be administered under medical supervision.
The indication of nephrosclerotic patients not yet undergoing dialysis should be defined individually as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
In dialysis patients, an increase in heparin dose is frequently required during the course of NeoRecormon therapy as a result of increased haemoglobin. Occlusion of the dialysis system is possible if heparinisation is not optimum. Shunt thrombosis may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms). Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Misuse by healthy persons may lead to an excessive increase in haemoglobin. This may be associated with life-threatening complications to the cardiovascular system (see Cardiovascular and thrombotic events/ increased mortality).

Cardiovascular and thrombotic events/ increased mortality.

Cardiovascular and thrombotic events such as myocardial ischaemia and infarction, cerebrovascular haemorrhage and infarction, transient ischaemic attacks, deep venous thrombosis, arterial thrombosis, pulmonary emboli, retinal thrombosis and haemodialysis graft occlusion have been reported in patients receiving Erythropoiesis Stimulating Agents (ESAs) such as NeoRecormon.
In controlled clinical trials ESAs increased the risk for death in oncology patients and for serious cardiovascular events in oncology and CKD patients when administered to target a haemoglobin of > 120 g/L. There was an increased risk of serious arterial and venous thromboembolic events, including myocardial infarction, stroke, congestive heart failure and haemodialysis graft occlusion. A rate of haemoglobin rise of > 10 g/L over 2 weeks may also contribute to these risks.
To reduce cardiovascular risks, use the lowest dose of NeoRecormon that will gradually increase the haemoglobin concentration. The haemoglobin concentration should not exceed 120 g/L and the rate of haemoglobin increase should not exceed 10 g/L in a 2-week period. Haemoglobin levels should be checked at regular intervals and dosages adjusted (see Section 4.2 Dose and Method of Administration).
The use of NeoRecormon during an autologous blood pre-donation programme must be balanced against the reported increased risk of thromboembolic events. Patients in an autologous blood pre-donation programme prior to surgery, including orthopaedic surgery, who have been treated with NeoRecormon, had a higher incidence of thromboembolic events (6.7%), compared with placebo-treated patients (3.4%).

Growth factor potential/ increased tumour progression.

NeoRecormon, like other ESAs, is a growth factor that primarily stimulates red blood cell production. As with all growth factors, there is a theoretical concern that ESAs could act as a growth factor for any type of malignancy. ESAs, when administered to target haemoglobin of > 120 g/L, shortened the time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy. ESAs also shortened survival in patients with metastatic breast cancer receiving chemotherapy when administered to a target haemoglobin of > 120 g/L.

Use in cancer patients.

A study comparing another ESA (epoetin alfa) with placebo in cancer patients with anaemia who were not being treated with chemotherapy demonstrated no benefit in terms of reduced transfusion requirements. In addition, there were an increased number of deaths in the active group (26% vs. 20%). NeoRecormon should only be used to treat cancer patients with anaemia where the anaemia has arisen as a result of concomitantly administered chemotherapy.

Hypertension.

Patients with uncontrolled hypertension should not be treated with NeoRecormon; blood pressure should be controlled adequately before initiation of therapy. Blood pressure may rise during treatment of anaemia with NeoRecormon. Hypertensive encephalopathy and seizures have been observed. They require the immediate attention of a physician and intensive medical care. Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning sign.
Special care should be taken to closely monitor and control blood pressure in patients treated with NeoRecormon. During NeoRecormon therapy, patients should be advised of the importance of compliance with anti-hypertensive therapy and dietary restrictions. If blood pressure is difficult to control after initiation of appropriate measures, the dose of NeoRecormon should be reduced or temporarily withheld until haemoglobin begins to decrease (see Section 4.2 Dose and Method of Administration).

Pure red cell aplasia (PRCA).

PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with ESA therapy, including NeoRecormon. These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to NeoRecormon. If anti-erythropoietin antibody-mediated PRCA develops whilst on NeoRecormon, therapy with NeoRecormon must be discontinued and patients should not be switched to another ESA.

Seizures.

ESAs should be used with caution in patients with epilepsy. Convulsions have been reported in patients with CKD receiving NeoRecormon.

Lack of effect.

The most common reasons for an incomplete response to ESAs are iron deficiency and chronic inflammation (e.g. access infections, surgical inflammation, AIDS, SLE). The following conditions may also compromise the effectiveness of ESA therapy: chronic blood loss, bone marrow fibrosis, severe aluminium overload due to treatment of renal failure, folic acid or vitamin B12 deficiencies, and haemolysis. If all the conditions mentioned are excluded and the patient has a sudden drop of haemoglobin associated with reticulocytopenia and anti-erythropoietin antibodies, examination of the bone marrow for the diagnosis of PRCA should be considered. If PRCA is diagnosed, therapy with NeoRecormon must be discontinued and patients should not be switched to another ESA (see Pure red cell aplasia (PRCA) above).

Evaluation of iron status.

In order to ensure effective erythropoiesis, iron status should be evaluated for all patients before and during treatment, as the majority of patients will eventually need supplemental iron. As per CARI (Caring for Australasians with Renal Impairment) Guidelines, supplemental iron therapy is recommended for all CKD patients whose serum ferritin falls below 100 nanogram/mL or transferrin saturation below 20%.
In premature infants, oral Fe2+ should begin as soon as possible (by day 14 of life at the latest) at a dose of 2 mg/day. If serum ferritin falls below 100 nanogram/mL or if there are other signs of iron deficiency, the Fe2+ dose should be increased to 5-10 mg/day.

Autologous pre-donation.

For the use of NeoRecormon in an autologous pre-donation programme, the official guidelines on principles of blood donation must be considered. In particular:
only patients with a PCV ≥ 33% or Hb ≥ 110 g/L should donate;
special care should be taken with patients whose weight is below 50 kg;
the single blood volume drawn should not exceed approximately 12% of the patient's estimated blood volume.
When the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males) treatment should only be given to patients with no iron deficiency and if blood conserving procedures are not available or insufficient. Treatment should be reserved for patients in whom it is considered of particular importance to avoid homologous blood transfusion taking into consideration the risk/benefit assessment for homologous transfusions.

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment. More severe cases have been observed with long acting epoetins. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, NeoRecormon should be withdrawn immediately and an alternative treatment considered. If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of NeoRecormon, treatment with NeoRecormon must not be restarted in this patient at any time.

Use in premature infants.

Prognostic factors for successful results are infant birth weight and baseline haematocrit (Hct). Infants with both a birth weight > 1100 g and baseline Hct > 45% benefited most. No success was achieved in those infants with both a birth weight < 1100 g and baseline Hct < 45%.
Lack of efficacy in terms of success rate (i.e. failure to maintain PCV permanently > 32% without blood transfusion) was observed in infants with lower birth weight, i.e. < 1100 g. Nevertheless, in this subgroup, 8 of the 33 infants on epoetin beta (rch) but only 2 of the 29 in the control group completed the study without needing transfusions.

Paediatric use.

Clinical trials have been performed in children and adolescents with anaemia due to chronic kidney disease (CKD) and in neonates for prevention of anaemia due to prematurity. For CKD, NeoRecormon should not be used in infants (i.e. below 2 years of age). NeoRecormon is not indicated for paediatric patients to increase autologous blood yield; nor for anaemic paediatric patients with non-myeloid malignancies receiving chemotherapy.

Use in the elderly.

No dedicated studies in elderly patients have been performed. A large proportion of elderly patients were included in clinical trials with NeoRecormon, however, a need for special dose adjustments in the elderly population has not been studied.

Effects on laboratory tests.

Platelet counts.

There may be a moderate dose-dependent rise in the platelet count, within the normal range, during treatment with NeoRecormon, especially after intravenous administration. This regresses during continued therapy. Development of thrombocytosis is very rare. It is recommended that the platelet count is regularly monitored during the first eight weeks of therapy. In autologous blood donation, treatment with NeoRecormon should be discontinued if platelets rise above the normal range or increase by more than 150 x 109/L.

Potassium and phosphate levels.

Serum potassium and phosphate concentrations should be monitored regularly during NeoRecormon therapy. Potassium elevation has been reported in a few uraemic patients receiving NeoRecormon although causality has not been established. If an elevated or rising potassium level is observed, then consideration should be given to ceasing NeoRecormon administration until the level has been corrected.
Transient increases in serum phosphate levels have been observed in isolated cases in CKD patients.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Clinical results to date do not indicate any interaction with other substances.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No fertility studies have been conducted in humans. However, epoetin beta (rch) at doses of up to 640 U/kg/day SC did not affect fertility in rats.
(Category B3)
Epoetin beta (rch) was not teratogenic in rats and rabbits at doses of up to 3000 IU/kg/day IV when administered during the period of organogenesis. Epoetin beta (rch) caused post-implantation loss and decreased foetal weight in animals dosed prior to mating right through gestation at doses of 160 U/kg/day SC and above. Kinked tails were observed in rat pups and foetuses (from 160 U/kg SC upwards). These effects are thought to be related to the pharmacodynamic action of the drug.
All safety information with regards to exposure of NeoRecormon during pregnancy have been gained from post marketing experience. A review of the available postmarketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/foetal development or postnatal development and treatment with NeoRecormon. However, in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.
 Postnatal observations of the live offspring (F1 generation) of female rats treated with epoetin beta (rch) during gestation and lactation revealed no effect of epoetin beta (rch) at doses up to 1280 U/kg SC. There were, however, decreases in body weight gain, eyelid opening, and delayed testicular descent and vaginal opening in the F1 foetuses at doses of 320 IU/kg SC and above.
Only limited experience in human lactation has been gained. Endogenous erythropoietin is excreted into breast milk but it is not known whether it is absorbed by the neonatal gastrointestinal tract in functional form. A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with NeoRecormon should be made taking into account the benefit of breast-feeding to the child and the benefit of NeoRecormon therapy to the woman.

4.7 Effects on Ability to Drive and Use Machines

No effects on ability to drive or use machines have been observed.

4.8 Adverse Effects (Undesirable Effects)

Anaemic patients with chronic kidney disease (CKD).

The most frequent adverse drug reactions (common 1-10%), in particular during the early treatment phase with NeoRecormon are hypertensive events. Increases in blood pressure can occur in normotensive patients or can be an aggravation of existing hypertension (see Section 4.4 Special Warnings and Precautions for Use).
From controlled clinical trials in 490 patients (244 epoetin beta (rch), 246 control) the following adverse reactions were reported in > 5% of patients (see Table 1).

Cardiovascular system.

Common (> 1%): headache. Uncommon (0.1 ≤ 1%): hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures).

Blood.

Common (> 1%): decrease of ferritin values and transferrin saturation. Uncommon (0.1 ≤ 1%): vascular access thromboses in hypotensive patients or those with vascular access complications, increase in platelet count. Very rare (< 0.01%): thrombocytosis, transient increase in potassium and phosphate.

Increasing the amount of autologous blood.

From clinical trials in 458 patients (341 epoetin beta (rch), 117 control) the following adverse reactions were reported in > 5% of patients (see Table 2).

Anaemia of prematurity.

From clinical trials in 404 patients (213 epoetin beta (rch), 191 control) the following adverse reactions were reported in > 5% of patients (see Table 3).

Anaemia in patients with non-myeloid malignancies.

Hypertensive events are common (1-10%) adverse drug reactions, in particular during the early phase of treatment.
In some patients, a fall in serum iron parameters is observed.
Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with NeoRecormon compared to untreated controls or placebo. In patients treated with NeoRecormon, this incidence is 7% compared to 4% in controls (both "common"); this is not associated with any increase in thromboembolic mortality compared with controls.
From clinical trials in 335 patients (198 epoetin beta (rch), 137 control) the following adverse reactions were reported in > 5% of patients with solid tumours (see Table 4).
From clinical trials in 343 patients (170 epoetin beta (rch), 173 control) the following adverse reactions were reported in > 5% of patients with haematological tumours (MM, NHL, CLL) (see Table 5).
In general, adverse reactions reported in clinical trials of patients with cancer receiving chemotherapy were consistent with the underlying disease and the treatment with chemotherapy.

All indications.

Skin.

Rarely (0.01-0.1%): skin reactions such as rash, pruritus, urticaria, or injection site reactions.

Other.

Very rare (< 0.01%): anaphylactoid reactions.
In very rare cases (< 0.01%) particularly when starting treatment, flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported. These reactions were mild to moderate in nature and subsided after a couple of hours or days.

Post-marketing experience.

The following adverse drug reactions have been identified from postmarketing experience with NeoRecormon (Table 6). Adverse drug reactions are listed according to system organ classes in MedDRA and the corresponding frequency category estimation for each adverse drug reaction is based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), unknown (cannot be estimated from the available data).

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

The therapeutic margin of NeoRecormon is very wide. Even at very high serum levels, no symptoms of poisoning have been observed.
Overdose can result in manifestations of an exaggerated pharmacodynamic effect e.g. excessive erythropoiesis, which may be associated with life-threatening complications to the cardiovascular system. In cases of excessive haemoglobin levels, NeoRecormon should be temporarily withheld (see Section 4.2 Dose and Method of Administration). If clinically indicated, phlebotomy may be performed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: antianemic, ATC code: B03XA01.

Mechanism of action.

Epoetin beta is a glycoprotein that stimulates the proliferation and differentiation processes of the erythroid stem cell compartment and also has a stimulatory effect on the proliferation and maturation compartment of the erythron. Epoetin beta therefore leads to an increase in haemoglobin formation and an associated acceleration of cell maturation with reduction in the cell cycle time. A further effect of epoetin beta is the acceleration of reticulocyte maturation and an increase in the release of reticulocytes into the bloodstream.

Clinical trials.

The therapeutic efficacy of epoetin beta (rch) has been evaluated in renal anaemia, autologous blood donation prior to elective surgery, the prevention of renal anaemia in premature infants and the treatment of anaemia in patients with non-myeloid malignancies.

Anaemic patients with chronic kidney disease (CKD).

Adult patients with renal anaemia on haemodialysis, peritoneal dialysis or not yet undergoing dialysis (predialysis) and uraemic children were studied.
Increases in reticulocyte count and haematocrit were observed from the first and second week respectively. With the recommended dose regimens, an increase in haematocrit of approximately 0.5%-1.0% per week is to be expected. The time to reach a target haematocrit was dependent on the baseline haematocrit and on the dose of epoetin beta (rch) used. The target haematocrit was reached by most patients after 12 weeks. The need for regular transfusions was abolished much earlier, usually after 4 weeks of therapy. Considerable improvements in physical performance and well-being were reported in most patients treated with epoetin beta (rch). Overall the therapeutic effects were fairly similar, irrespective of whether patients were on haemodialysis, peritoneal dialysis or not yet undergoing dialysis (pre-dialysis patients). The maintenance doses required were approximately 25%-30% lower if epoetin beta (rch) was given subcutaneously rather than intravenously.
In children response rates were age-dependent. Younger patients required more time and higher doses to reach target haematocrit. Most children reached the target haematocrit after 3 months and transfusions were abolished after 1 month if high enough doses were given. Although the response in children was age-dependent, the recommendations for the starting doses are the same for adults and children.
A summary of pivotal trials conducted in anaemic CKD patients is shown in Table 7.
Haemoglobin levels were effectively maintained in CKD patients switched from two or three times weekly to once weekly subcutaneous epoetin beta (rch) administration, and in patients switched from once weekly to once every two weeks administration.

Autologous pre-donation.

Treatment is indicated in patients with moderate anaemia [packed cell volume (PCV) approximately 33%-39% (Hb approx. 110-130 g/L) no iron deficiency] if blood conserving procedures are not available or insufficient either:
when the scheduled major elective surgery requires a large volume of blood (4 or more units for females or 5 or more units for males); or
when the period necessary to obtain the required volume of blood is too short.
The efficacy of epoetin beta (rch) in an autologous blood donation programme was demonstrated by the gain in red cell volume available at the time of surgery. The period of anaemia after blood donation was shortened and, postoperatively, haematocrit values moved towards initial values much more rapidly in epoetin beta (rch) than in placebo patients. The effective doses ranged between 200-800 IU/kg twice weekly IV and 150-600 IU/kg twice weekly SC.
Individual dose recommendations for epoetin beta (rch) in this indication are necessary and can be calculated from the nomograms taking into account the endogenous red cell reserve, the amount of autologous blood required and the sex of the patient. The nomograms also determine if the patient could donate a sufficient amount of blood even without NeoRecormon treatment. See Table 8.

Anaemia of prematurity.

The effectiveness of epoetin beta (rch) in the prevention of anaemia of prematurity was shown with a higher percentage of infants not needing transfusions in the epoetin beta (rch) group as compared with the untreated control group. In addition, the blood volumes transfused and the number of transfusions were lower in epoetin beta (rch) treated infants.
The success rates (haematocrit permanently > 32% without transfusions) were significantly higher in the epoetin beta (rch) group than in the control group. However, there are certain prognostic factors for successful results. Whereas infants with birth weight > 1100 g and baseline haematocrit > 45% benefited most, no success was achieved in those with both a birth weight < 1100 g and a baseline haematocrit < 45%. See Table 9.

Anaemia in patients with non-myeloid malignancies.

The effectiveness of epoetin beta (rch) was established in patients with solid tumours and lymphoid malignancies. In patients with solid tumours, epoetin beta (rch) was shown to increase haemoglobin levels or reduce the development of anaemia induced by chemotherapy and significantly reduce the need for blood transfusions. In patients with lymphoid malignancies, epoetin beta (rch) was shown to increase haemoglobin levels and significantly reduce the need for blood transfusion. Response rate (defined as an increase of 20 g/L from baseline without need for transfusion in the preceding 6 weeks) was significantly greater in epoetin beta (rch) treated patients than placebo and median time to first response was significantly shorter in the epoetin beta (rch) treated groups. For the patients who showed a response to treatment, the improvement in haematological parameters was associated with a statistically significant corresponding improvement in the patients' self-assessment of their quality of life.
Clinical studies have shown the efficacy of epoetin beta (rch) administered once weekly is similar to that of the thrice weekly regimen (see Table 10).

5.2 Pharmacokinetic Properties

Absorption.

Subcutaneous administration of epoetin beta (rch) results in variable rates of absorption with average maximal concentrations being reached between 12 and 28 hours after dosing.
The bioavailability of subcutaneously administered epoetin beta (rch) is between 23% and 42% as compared with intravenous administration. Slightly higher bioavailability occurs on repeated subcutaneous administration.

Distribution.

The distribution volume of epoetin beta (rch) administered intravenously corresponds to 1-2 times the plasma volume.

Excretion.

The half-life of intravenously administered epoetin beta (rch) is between 4 and 12 hours. The protracted absorption of subcutaneously administered epoetin beta (rch) results in an apparent terminal half-life of between 13 and 28 hours.

5.3 Preclinical Safety Data

Genotoxicity.

Epoetin beta (rch) did not reveal any genotoxic potential in a series of assays for gene mutations (Ames test, Chinese hamster lung cells) or chromosomal damage (human lymphocytes in vitro, mouse micronucleus test in vivo).

Carcinogenicity.

Since epoetin beta is a human protein and as such is immunogenic for other species, conventional 2-year carcinogenicity studies have not been undertaken in rodents. A carcinogenicity study with homologous erythropoietin in mice did not reveal any signs of proliferative or tumourigenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Urea, Sodium chloride, Monobasic sodium phosphate, Dibasic sodium phosphate dodecahydrate, Calcium chloride dihydrate, Polysorbate 20, Glycine, Leucine, Isoleucine, Threonine, Glutamic acid, Phenylalanine.

6.2 Incompatibilities

In the absence of compatibility studies, NeoRecormon should not be mixed with other medicinal products.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

NeoRecormon must not be used after the expiry date.
Store continuously in the refrigerator at 2°C to 8°C. Do not freeze. Protect from light.
The pre-filled syringes are for single use in one patient only. Discard any residue. For ambulatory use, the product may be removed from refrigerated storage (2°C to 8°C) for one single period of up to a maximum of 3 days at room temperature (up to 25°C).

6.5 Nature and Contents of Container

Pre-filled syringe (Type I glass) with a tip cap and a plunger stopper.

NeoRecormon 2000 IU, NeoRecormon 3000 IU, NeoRecormon 4000 IU, NeoRecormon 5000 IU and NeoRecormon 6000 IU solution for injection in pre-filled syringe.

Each pre-filled syringe contains 0.3 mL solution and is available in a pack of 6.

NeoRecormon 10,000 IU solution for injection in pre-filled syringe.

Each pre-filled syringe contains 0.6 mL solution and is available in a pack of 6.

6.6 Special Precautions for Disposal

The release of medicines into the environment should be minimised. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided.
Unused or expired medicine should be returned to a pharmacy for disposal.

Disposal of syringes/sharps.

The following points should be strictly adhered to regarding the use and disposal of the pre-filled syringe and medicinal sharps:
needles and syringes should never be reused;
place all used needles and syringes into a sharps container (puncture-proof disposable container);
keep this container out of the reach of children;
avoid placing used sharps containers in the household waste;
dispose of the full container according to local requirements or as instructed by your healthcare provider.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

122312-54-3.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes