Consumer medicine information

Ferrum H Injection

Iron polymaltose complex

BRAND INFORMATION

Brand name

Ferrum H Injection

Active ingredient

Iron polymaltose complex

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ferrum H Injection.

What is in this leaflet

This leaflet answers some of the common questions about FERRUM H. 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 using FERRUM H against the benefits this medicine is expected to have for you.

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

Keep this leaflet with your medicine.

You may need to read it again.

What FERRUM H is used for

FERRUM H provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency.

FERRUM H is used when dosage by mouth is impractical or contraindicated and when disturbances in the gastrointestinal tract make absorption difficult or uncertain.

Before you are given FERRUM H

When you must not be given it

Do not use FERRUM H if:

  • You are known to be sensitive (allergic) to any of the ingredients of FERRUM H
  • Your anaemia is not due to a shortage of iron
  • You have a condition known as haemochromatosis (an excess of iron in the body)
  • You have any medical conditions or health problems including arthritis, bronchial asthma, hepatitis
  • You are in the 1st trimester of a pregnancy

FERRUM H should not be used after the expiry date printed on the label.

If you are not sure whether you should be given FERRUM H please talk to your doctor.

Before you are given it

You should be aware that:

  • A blood test should have been carried out to ensure treatment with this medicine is appropriate
  • If you have a history of asthma, eczema or other atopic allergies you are more susceptible to experience allergic reactions

You must tell your doctor if:

  • You are pregnant or breastfeeding
  • You or a blood relative have the condition haemochromatosis
  • You have a history of liver disease

If you have not told your doctor about any of the above, please do so before you are given FERRUM H.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with FERRUM H.

These include:

  • Drugs that are used to treat heart disease and high blood pressure known as ACE inhibitors (e.g. captopril, enalapril, fosinopril, lisinopril or quinalapril)
  • Iron preparations taken by mouth

Your doctor or pharmacist has more information on medicines to avoid while taking FERRUM H.

How FERRUM H is given

FERRUM H is given in a prescribed manner into the muscle. The injection technique is well defined and must be adhered to.

Failure to inject as recommended could result in persistent staining of the skin.

FERRUM H should never be injected into the arm or other exposed areas.

Your doctor has detailed information on the correct injection technique.

Your doctor will decide what dose and how long you will receive FERRUM H.

FERRUM H will be administered in a setting where possible allergic reactions can receive appropriate and prompt treatment.

You will be observed for about 30 minutes by your doctor or nurse after each administration.

If you are given too much (overdose)

As FERRUM H is given to you under the supervision of your doctor, it is very unlikely that you will be given an overdose. However, if you experience several side effects, tell your doctor immediately. The symptoms of an overdose may include the side effects listed in the side effects section but are usually of a more severe nature.

Side effects

Tell your doctor, nurse or pharmacist if you do not feel well while you are using FERRUM H.

FERRUM H helps most people with low iron levels 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.

Ask your doctor to answer any question you may have.

Side effects that have been reported by people using FERRUM H include:

  • Flushing, sweating, chills and fever
  • Chest and back pain
  • Pain at site of injection
  • Local redness or swelling at the injection site
  • Abdominal pain
  • Nausea, vomiting
  • Headache, dizziness
  • Joint and muscle pains
  • Sensation of stiffening of the arms, legs or face
  • Fainting
  • Hypotension
  • Difficulty in breathing
  • Rash

Adverse reactions can be delayed by 1-2 days after treatment with FERRUM H.

Incorrect injection technique could result in staining of the skin.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After using Ferrum H

Storage

FERRUM H will be stored in the pharmacy or on the ward.

The ampoules should be stored below 25°C in the original cartons. The product should not be frozen. Protect from light. Once the ampoules have been opened they should be used immediately. FERRUM H is to be kept out of the reach and sight of children.

Product description

What it looks like

FERRUM H comes in a glass ampoule containing 2 mL of solution. The product is supplied in cardboard boxes each containing 5 ampoules.

Ingredients

Active ingredient:

  • Iron polymaltose complex

Inactive ingredients:

  • Water for injections
  • Sodium hydroxide
  • Hydrochloric acid

Medicine classification

Prescription Only Medicine

Sponsor

FERRUM H is supplied in Australia by:

Vifor Pharma Pty Ltd
Level 8, 80 Dorcas Street
South Bank, Melbourne VIC 3006
Australia

Exclusive New Zealand distributor:

Pharmacy Retailing (NZ) Limited
trading as Healthcare Logistics
Auckland, New Zealand

Australian Registration Number
AUST R 68110

This leaflet was prepared in June 2015.

BRAND INFORMATION

Brand name

Ferrum H Injection

Active ingredient

Iron polymaltose complex

Schedule

S4

 

Name of the medicine

Iron polymaltose.

Excipients

Water for injections, hydrochloric acid and sodium hydroxide (for pH adjustment).

Description

MW: 462,000. Ferrum H contains a macromolecular spherocolloidal complex of iron(III)-hydroxide and the carbohydrate polymaltose.

Pharmacology

Ferrum H is an aqueous, approximately isotonic solution for intramuscular injection.
When injected intramuscularly the iron polymaltose evokes a local inflammatory response and is transported via the lymphatics to the regional lymph nodes without being broken down (reactive absorption). It then enters the blood, reaching its maximum concentration in about 24 hours. The circulating iron polymaltose is taken up by the cells of the reticuloendothelial system, which slowly ionise it to Fe3+ and polymaltose. The majority of Fe3+ is bound to transferrin and transported to the bone marrow where it is incorporated into haemoglobin, the remainder is contained within the storage forms haemosiderin and ferritin or incorporated into myoglobin or haem containing enzymes. Only very small amounts of iron are excreted. The conservation of body iron and the lack of an excretory mechanism for excess iron may lead to iron overload if iron intake is excessive. Polymaltose is either metabolised or excreted.

Clinical Trials

A study was conducted on 12 anaemic women aged from 20-45 years. After an intravenous infusion of 100 mg elemental iron, comprising 2 mL of Ferrum H diluted in 48 mL 0.9% sodium chloride, at a rate of 1.7 mL/min (i.e. 50 mL per 30 minutes) a mean Cmax (in serum) of 25.1 microgram/mL iron was observed. The mean Tmax was 0.75 hours and the mean terminal half-life 22.4 hours. The mean residence time (MRT) was 20.2 hours.

Indications

For the treatment of iron deficiency anaemia in the following circumstances.
When oral therapy is contraindicated.
When enteric absorption of iron is defective.
When patient noncompliance or persistent gastrointestinal intolerance makes oral therapy impractical.

Contraindications

Ferrum H should not be given to patients presenting with any of the following conditions:
hypersensitivity to iron(III)-hydroxide polymaltose complex;
anaemia not caused by simple iron deficiency (e.g. haemolytic anaemia, megaloblastic anaemia caused by vitamin B12 deficiency, disturbances in erythropoiesis, hypoplasia of the marrow);
iron overload (e.g. haemochromatosis, haemosiderosis);
Osler-Rendu-Weber syndrome;
chronic polyarthritis;
bronchial asthma;
infectious renal complaints in acute phase;
uncontrolled hyperparathyroidism;
decompensated hepatic cirrhosis;
infectious hepatitis;
during the first trimester of pregnancy.
As elemental iron tends to accumulate in inflamed tissues, parenteral iron should not be given to patients with severe inflammation or infection of the kidney or liver.

Precautions

Since parenteral use of complexes of iron and carbohydrates has resulted in fatal anaphylactoid reactions, iron polymaltose should be used only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate laboratory tests. In the case of a mild allergic reaction, antihistamines should be administered immediately.
There is a risk of hypersensitivity and anaphylactoid reactions with each dose given. Anaphylactoid reactions occur most frequently within the first several minutes of administration and are generally characterised by sudden onset of respiratory difficulties, tachycardia and hypotension. A test dose is not required as a test dose without incident does not indicate that subsequent doses will also be reaction free.
Ferrum H should only be administered when personnel trained to evaluate and manage anaphylactic reactions, and resuscitative interventions, are immediately available. Each patient should be monitored for signs and symptoms of hypersensitivity during and after each administration of intravenous iron for at least 30 minutes. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately.
Patients with bronchial asthma, with low iron binding capacity and/or folic acid deficiency are particularly at risk of an allergic or anaphylactoid reaction. Caution is also recommended in patients with allergies, hepatic and renal insufficiency or cardiovascular disease.
Patients with rheumatoid arthritis and possibly other inflammatory diseases (e.g. ankylosing spondylitis, lupus erythematosus) may be at particular risk of delayed reactions, including fever and exacerbation or reactivation of joint pain.
Iron may increase the pathogenicity of certain microorganisms. The use of intramuscular iron in neonates has been associated with an increased incidence of Gram negative sepsis, principally infections caused by E. coli.
Unwarranted administration of parenteral iron preparations may cause excess storage of iron and a syndrome similar to haemosiderosis in patients whose anaemia is not attributable to iron deficiency, e.g. those with haemoglobulinopathies.

Use in pregnancy.

(Category B3)
Ferrum H should not be administered in the first trimester of pregnancy. No controlled studies are available on animals or on pregnant women. Embryofetal toxicity was observed in animals dosed with IV iron products.
Ferrum H should only be administered in the second and third trimester of pregnancy if the benefits of treatment outweigh the potential risk to the foetus.

Interactions

As with all parenteral iron preparations, Ferrum H should not be administered concomitantly with oral iron preparations as the absorption of oral iron is reduced. Oral iron therapy should not commence until at least one week after the last iron injection.
Concomitant administration of angiotensin converting enzyme (ACE) inhibitors may increase the incidence of adverse effects associated with parenteral iron preparations, e.g. erythema, abdominal cramps, nausea, vomiting and hypotension.

Adverse Effects

Adverse reactions to parenteral Ferrum H have only been reported infrequently. However the following reactions are known to have occurred after parenteral iron therapy.

General.

Flushing, sweating, chills and fever; chest and back pain.

Injection site reactions.

Pain at injection site; local inflammation with inguinal lymphadenopathy; lower quadrant abdominal pain.

Hypersensitivity.

Anaphylaxis.

Gastrointestinal.

Nausea and vomiting.

Central nervous system.

Headache; dizziness.

Musculoskeletal.

Joint and muscle pain; arthralgia; sensation of stiffening of the arms, legs or face.

Cardiovascular.

Fainting; syncope; tachycardia; hypotension; circulatory collapse.

Respiratory.

Bronchospasm with dyspnoea.

Haematological.

Generalised lymphadenopathy.

Dermatological.

Rash; urticaria; angioneurotic oedema.
Adverse reactions may be delayed by 1-2 days after treatment with Ferrum H injection.

Laboratory test interferences.

Large intravenous doses (250 mg or more of iron) of Ferrum H may cause serum from blood samples obtained 4 hours after administration of the drug to have a brown colour.
The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Serum iron determinations (especially colorimetric assays) may not be meaningful for 3 weeks following the administration of the drug. Results of serum iron measurements obtained within 1-2 weeks of administration of large doses of the drug should be interpreted with caution.
Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following treatment as Ferrum H may remain in the reticuloendothelial cells.
Bone scans with technetium Tc-99m diphosphonate, taken 1-6 days after intramuscular injection of the drug may show dense areas of activity in the buttock, following the contour of the iliac crest. Bone scans using imaging agents labelled with technetium Tc-99m, in the presence of high serum ferritin concentrations or following intravenous infusions of the drug, may show reduced bone uptake, marked renal activity and excessive blood pool and soft tissue accumulation.
The drug may cause a decrease in Ga-67 gallium citrate uptake during tumor and/or abscess imaging with Ga-67 gallium citrate due to competition for the same binding sites.
The presence of iron may give false positive orthotolidine test results.

Dosage and Administration

Intramuscular use.

Technique of injection.

The technique of injection is of crucial importance. Ferrum H should never be injected into the arm or other exposed areas. The wrong injection technique may result in pain and persistent discolouration of the skin.
The following method of ventrogluteal injection according to Hochstetter is recommended instead of the normal method of injection in the top outer quadrant of the gluteus maximus muscle. (See manufacturer's product information for accompanying diagrams.)
a. The length of the needle should be at least 5-6 cm. The lumen of the needle should not be too wide.
b. The site of injection is determined as follows. First point A is found, corresponding to the ventral iliac spine. If the patient lies on the right side, for instance, the middle finger of the left hand is placed on point A. The index finger is extended away from the middle finger, so that it comes to lie below the iliac crest, at point B. The triangle lying between the proximal phalanges of the middle and index fingers represents the site of injection. This is disinfected in the usual way.
c. Before the needle is inserted, the skin over the site of injection is pulled down, about 2 cm, to give an S-shaped puncture channel. This prevents the injected solution from running back into the subcutaneous tissues and discolouring the skin.
d. The needle is introduced more or less vertically to the skin surface, angled to point towards the iliac crest rather than the hip joint.
e. After the injection, the needle is slowly withdrawn and pressure from a finger applied beside the puncture site. This pressure is maintained for about one minute.
f. The patient should move about after the injection.

Calculation of required dose.

The figures in the accompanying dosage table (see Table 1) have been calculated using the following formula taken from Ganzoni (Schweiz. Med. Wschr. 1970; 100: 301-303). (See Equation 1.)

Note.

The above formula can also be used to calculate the total iron deficit.
Up to 34 kg bodyweight: target Hb = 130 g/L, iron depot = 15 mg/kg bodyweight (for a patient weighing 34 kg the iron depot is 34 x 15 = 500 mg).
Over 34 kg bodyweight: target Hb = 150 g/L, iron depot = 500 mg.

Example of calculation.

Assuming a patient weighing 60 kg, target Hb 150 g/L, actual Hb 60 g/L and the need for an iron depot of 500 mg then: iron dose (mg) = 60 x (150-60) x 0.24 + 500 mg = 1,296 mg + 500 mg ≈ 1,800 mg iron. Therefore, the patient requires iron 1,800 mg or 18 ampoules.

Dosage table.

Dosage for the determination of the total millilitres of Ferrum H injection required is shown in Table 1.
Administer 2 mL by intramuscular injection every second day until total dose is attained, or administer 4 mL at longer intervals. Regular determination of Hb level is recommended.

Maximum single daily dose by intramuscular injection.

Infants up to 5 kg bodyweight.

0.5 mL.

Children 5-10 kg bodyweight.

1 mL.

Patients weighing > 10 kg to 45 kg.

2 mL.

Adults.

4 mL.

Opening one point cut ampoules.

See manufacturer's product information for diagrams showing the method of opening one point cut ampoules.

Overdosage

Overdosage of iron causes haemosiderosis and consequent cirrhosis of the liver, diabetes and heart failure. Periodic monitoring of serum ferritin may be useful in recognising a deleterious, progressive accumulation of iron.

Presentation

Solution for injection (iron polymaltose ≡ iron 100 mg/2 mL) (aqueous, colloidal, sterile, pyrogen free, approximates the pH and tonicity of the tissues): 5's (ampoules, carton).

Storage

The ampoules should be stored below 25°C. Do not freeze. Protect from light.

Poison Schedule

S4.