Consumer medicine information

Strensiq

Asfotase alfa

BRAND INFORMATION

Brand name

Strensiq

Active ingredient

Asfotase alfa

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Strensiq.

SUMMARY CMI

Strensiq®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Strensiq?

Strensiq contains the active ingredient asfotase alfa rch. Strensiq is an enzyme replacement therapy for patients with paediatric-onset hypophosphatasia or HPP.

For more information, see Section 1. Why am I using Strensiq? in the full CMI.

2. What should I know before I use Strensiq?

Do not use if you have ever had an allergic reaction to Strensiq or any of the ingredients listed at the end of the CMI.

Patients receiving Strensiq have had allergic reactions including life-threatening allergic reactions requiring medical treatment. These may occur within minutes of receiving Strensiq or after a longer period of time on therapy.

Talk to your doctor if you have any other medical conditions, take any other medicines, are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Strensiq? in the full CMI.

3. What if I am taking other medicines?

The effect of Strensiq with other medicines has not been studied. Ask your doctor or nurse if you have any questions.

For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Strensiq?

Your doctor will tell you how much of this medicine (number of milligrams) you need to inject based on your body weight.

If you are injecting this medicine yourself, you will be shown how to prepare and give the injection by your doctor, pharmacist, or nurse. Do not inject this medicine yourself unless you have received training and you understand the procedure.

Allow unopened Strensiq vial(s) to reach room temperature before injecting and administer injections within 3 hours. Follow the instructions in this leaflet carefully regarding the use of sterile disposable needles to withdraw and inject the medicine.

More instructions on injection technique can be found in Section 4. How do I use Strensiq? in the full CMI

5. What should I know while using Strensiq?

Things you should do
  • If you are having any blood tests, tell your doctor that you are using this medicine.
  • Keep all your doctor's appointments so that your progress can be checked.
Things you should not do
  • Do not stop taking your medicine or lower the dosage without checking with your doctor.
Looking after your medicine
  • Keep your medicine in the packaging until it is time to use it.
  • Keep your medicine in the refrigerator (2°C to 8°C).
  • Do not use after the EXP date and talk to your pharmacist about disposing of unwanted medicine

For more information, see Section 5. What should I know while using Strensiq? in the full CMI.

6. Are there any side effects?

The common side effects of Strensiq treatment are reactions at the injection site. These can include fatty lumps under the surface of the skin or localised loss of fat tissue, and allergic reactions.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Strensiq®

Active ingredient(s): [asfotase alfa rch]

Consumer Medicine Information (CMI)

This leaflet provides important information about using Strensiq.

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Strensiq.

Where to find information in this leaflet:

1. Why am I using Strensiq?
2. What should I know before I use Strensiq?
3. What if I am taking other medicines?
4. How do I use Strensiq?
5. What should I know while using Strensiq?
6. Are there any side effects?
7. Product details

1. Why am I using Strensiq?

Strensiq contains the active ingredient asfotase alfa rch. Strensiq is an enzyme replacement therapy for patients with paediatric-onset hypophosphatasia or HPP.

Patients with HPP have low levels of an enzyme called alkaline phosphatase, which is naturally present in the body and necessary for the proper hardening of bones and teeth. Patients have problems with bone growth and strength, which can lead to broken bones, bone pain, and difficulty walking, as well as difficulties with breathing and a risk of seizures (fits).

Strensiq has been shown to benefit patients' mineralization of the skeleton and growth.

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

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

2. What should I know before I use Strensiq?

Warnings

Do not use Strensiq if:

  • you are allergic to Strensiq, or any of the ingredients listed at the end of this leaflet.

Patients receiving Strensiq have had allergic reactions including life threatening allergic reactions requiring medical treatment like anaphylaxis. Patients who experienced anaphylaxis-like symptoms had difficulty breathing, choking sensation, nausea, swelling around the eyes, and dizziness. The reactions occurred within minutes after taking Strensiq and can occur in patients who were taking Strensiq for more than one year. If you experience any of these symptoms, discontinue Strensiq and seek medical help immediately.

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

  • take any medicines for any other condition
  • you are not sure whether you should be treated with Strensiq
  • have previously had an allergic reaction to Strensiq, your doctor will discuss with you the next steps and the possibility to restart Strensiq under medical supervision.
  • if you have allergies to any other medicines, foods, preservatives, or dyes.
  • notice any change in the shape of your infant's head. Early fusion of the bones of the head in children below 5 years of age has been reported in clinical studies of infants with hypophosphatasia, with and without use of Strensiq.
  • have problems with your vision, some eye-related side-effects have been reported in clinical studies both in patients using Strensiq and those who were not, probably associated with hypophosphatasia.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Your doctor can discuss with you the risks and benefits involved.

Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known whether Strensiq passes into breast milk. You should not breast feed while using Strensiq unless you have discussed it with your doctor.

3. What if I am taking other medicines?

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

The effect of Strensiq on other medicines has not been studied. Ask your doctor or nurse if you have any questions.

4. How do I use Strensiq?

How much to use

  • Your doctor will tell you how much of this medicine (in number of milligrams) you need to inject based on your body weight.
  • The correct dose will be calculated by your doctor based on a total of 6 milligrams of Strensiq, per kg of body weight, per week.
  • Your doctor may adjust your dose as your weight changes.
  • The maximum amount of Strensiq to be injected is 1 mL. If more than 1 mL is required, split the volume equally between two or more syringes, and administer each injection using a separate site.

When to use

  • You will inject either 3 or 6 times a week, depending on the recommendation of your doctor.

How to inject Strensiq

  • Follow all directions given to you by your doctor, nurse, or pharmacist carefully. They may differ from the information contained in this leaflet.
  • “How to inject Strensiq” will be explained to you by a healthcare professional. After being trained by the doctor or specialised nurse, you can inject Strensiq yourself at home.
  • Strensiq must not be injected into a vein or muscle. Strensiq is intended for subcutaneous (under the skin) injection.
  • If you do not understand these instructions, ask your doctor, nurse, or pharmacist for help.
  • When injecting, it is important to change the injection site to different areas of the body, to help reduce potential pain and irritation and lipodystrophy (clumping or loss of fat under the skin).
  • Areas with a good amount of fat below the skin (thigh, upper arm, abdomen, or buttocks) are the most suitable areas to inject.

Injection technique:

1) Before you begin, take your vial(s) of Strensiq out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature.

Do not warm Strensiq in any other way (for example in a microwave or in hot water).

It is recommended to administer the medicine within 3 hours after removing the vial (s) from the refrigerator.

Always use a new vial. Each vial is for single use and should only be punctured once.

2) Wash your hands thoroughly with soap and water.

3) Place all the items you will need on a clean surface where you will not be disturbed. These should include:

  • vial(s) of Strensiq
  • syringes (small enough to withdraw the correct volume accurately)
  • needles (25 G and 29 G)
  • alcohol swabs
  • gauze or cotton wool
  • wool
  • sharps container
  • adhesive bandage
  • injection diary (or other recording means e.g. paper or notebook).

4) Visually check the vial before use. Strensiq should be clear, colourless to slightly yellow and may have a few small translucent or white particles in it. Do not use it if the liquid is discolored or contains any lumps or large particles in it and get a new vial.

5) Remove the protective cap from the Strensiq vial to reveal the sterile rubber seal.

6) Place a drawing up needle (e.g.25G) on an empty syringe and with the protective cap on, push down and turn clockwise the needle onto the syringe until it is tight. Remove the plastic cap covering the syringe needle and place it on a flat surface, you will need this later to recap your needle. Pull the plunger back to draw air into the syringe, equal to the volume of medicine to be injected. The volume per injection should not exceed 1mL. If this is the case, multiple injections should be done at different sites.

7) Holding the syringe and vial at 45° angle, insert the needle through the sterile rubber top. Push the plunger in completely to inject air into the vial.

8) Turn the vial and syringe upside down. With the needle in the solution, pull the plunger to withdraw the volume of the correct dose into the syringe.

9) Before removing the needle from the vial check that the appropriate volume has been withdrawn and check the syringe for air bubbles.

If bubbles are present, hold the syringe with the needle pointing upwards and gently tap the side of the syringe until the bubbles float to the top.

Once all the bubbles are at the top of the syringe, gently push on the plunger to force the bubbles out of the syringe and back into the vial.

After removing the bubbles, recheck the dose of medicine in the syringe to be sure you have drawn up the correct amount. You may need to use several vials to withdraw the complete amount needed to reach the correct dose.

Remove the larger drawing up needle from the vial. Recap with one hand by sliding the exposed needle into the cap on a flat surface, lift it up in a scooping motion and snap it on securely by grasping the cap at its base. Carefully remove the recapped drawing up needle by pushing down and turning counterclockwise. Dispose the needle with the protective cap in your sharps container.

Place a smaller injecting needle (e.g.29 G) on the filled syringe and with the protective cap on, push down and turn clockwise the needle onto the syringe until it is tight. Pull the cap straight off the needle and dispose of it in your sharps container, you will not recap the injecting needle.

Hold the syringe with the needle pointing up and tap the barrel of the syringe with your finger to remove any air bubbles. After removing the bubbles, check the volume of medication in the syringe to be sure you have drawn up the correct amount,

You are now ready to inject the correct dose.

10) Choose an injection site. Strensiq should be administered as a subcutaneous injection into the fatty layer just below the skin. This is called the subcutaneous layer and it is just above the muscle. Areas with a substantial amount of fat below the skin (as shown in the diagram) are the most suitable areas to inject. Your doctor will advise you on the possible injection sites.

It is important to rotate injection sites, as this may help reduce pain and irritation. Do not inject into areas that are reddened, inflamed, swollen or into any areas in which you feel lumps, firm knots, or pain.

11) Using an alcohol-based (isopropyl alcohol or ethanol) solution wipe or clean the site.

12) If injecting an infant or child, hold your infant or child firmly in a comfortable position. Gently pinch the skin of the chosen injection area between your thumb and index finger.

13) Holding the syringe like a pencil or a dart, insert the needle into the raised skin so it is at an angle of between 45° and 90° to the skin surface.

For children, or patients who have little subcutaneous fat or thin skin, a 45° angle may be preferable.

14) While continuing to hold the skin, push the syringe plunger to inject the medicine slowly and steadily all the way in.

15) Remove the needle, release the skin fold and gently place a piece of cotton wool or gauze over the injection site for a few seconds. This will help seal the punctured tissue and prevent any leakage.

Do not rub the injection site after injection.

16) Dispose of the syringe, needle cap and used vial into your sharps container.

17) Place a small adhesive bandage over the injection site if necessary.

18) If you need a second injection for your prescribed dose, get another Strensiq vial and repeat steps 4 through 17.

19) Record all details of the injection in your injection diary or using another means. It is recommended that you note:

  • where you injected
  • the dose injected
  • date and time of injection
  • any injection reactions

If you have any concerns about injection reactions, preparing or administering your injection, discuss them with your doctor or pharmacist.

If you forget to use Strensiq

Strensiq should be used regularly at the same time each day. If you miss your dose at the usual time, do not take a double dose to make up for a forgotten dose. Contact your doctor for advice.

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

Do not take a double dose to make up for the dose you missed.

If you use too much Strensiq

If you think that you have used too much Strensiq, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Strensiq?

Things you should do

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Discuss traveling with your medicine with your doctor or pharmacist.

You will need to calculate how many vials you will need for your trip. Take extra in case you are away longer than expected.

Call your doctor straight away if you:

  • If you become pregnant while using Strensiq, tell your doctor immediately.
Your doctor will discuss the benefits and risks of continuing treatment with Strensiq during pregnancy, including participation in a monitoring program.
  • If you intend to breastfeed whilst using Strensiq, consult your doctor.
Your doctor will discuss the benefits and risks of continuing treatment with Strensiq whilst breastfeeding, including participation in a monitoring program.

Remind any doctor, dentist, or pharmacist you visit that you are using Strensiq.

Things you should not do

  • Do not stop taking your medicine or lower the dosage without checking with your doctor.

Looking after your medicine

  • Keep your medicine in the packaging until it is time to use it. If you take the medicine out of the packaging it may not keep well.
  • Keep your medicine in the refrigerator (2°C to 8°C).
    Do not put Strensiq in, or near the freezer compartment, and never inject Strensiq that you know, or suspect, has been frozen.
  • Take the unopened Strensiq vial(s) out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature.
  • Do not warm Strensiq in any other way (for example, do not warm it in a microwave or in hot water). Upon removal of the vial(s) from refrigeration, Strensiq should be used within 3 hours maximum.

Follow the instructions in the carton on how to take care of your medicine properly.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Reactions at injection site
During the injection of the medicine or during the hours following the injection including,
  • redness, itching, pain and/or swelling
  • loose skin, discolouration of the skin, skin darkening, bleeding under the skin, bruising, scarring
  • fatty lumps under the surface of the skin or localised loss of fat tissue
  • small dent or depression of the injection site
  • infection of the skin at injection site
  • skin peeling or rash
Others
  • kidney stones
  • low blood calcium levels
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Allergic reactions
Signs and symptoms may include
  • fever
  • chills
  • redness or flushing
  • numbness of mouth
  • headache
  • increased heart rate
  • cough
  • nausea and vomiting
  • rash
  • irritability
Anaphylaxis (Serious allergic reaction)
Signs and symptoms may include,
  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin
  • low blood pressure
  • vomiting
  • fast heart rate
  • choking sensation
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side affects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What Strensiq contains

Active ingredient
(main ingredient)		asfotase alfa rch
Other ingredients
(inactive ingredients)		Sodium chloride
monobasic sodium phosphate monohydrate
dibasic sodium phosphate heptahydrate
Water for Injection
Potential allergensProteins of Chinese hamster origin

Do not take this medicine if you are allergic to any of these ingredients.

What Strensiq looks like

Strensiq is a clear, slightly opalescent or opalescent, colourless to slightly yellow, aqueous solution contained in a glass vial. A few small translucent or white particles may be present.

It is available in packs of 12 vials in the following strengths:

40 milligrams (mg) per mL

Volume (mL)
per vial		Milligrams (mg)
per vial		Aust R
0.3 mL12 mg266984
0.45 mL18 mg266985
0.7 mL28 mg266986
1.0 mL40 mg232546

100 milligrams (mg) per mL

Volume (mL)
per vial		Milligrams (mg)
per vial		Aust R
0.8 mL80 mg232545

*Not all vials listed above may be available

Who distributes Strensiq

In Australia, this product is registered by:

Alexion Pharmaceuticals Australasia Pty Ltd
Level 4,
66 Talavera Road,
Macquarie Park NSW 2113

Medical enquiries: 1800 788 189

This leaflet was prepared in December 2022

Published by MIMS February 2023

BRAND INFORMATION

Brand name

Strensiq

Active ingredient

Asfotase alfa

Schedule

S4

 

1 Name of Medicine

Asfotase alfa rch.

2 Qualitative and Quantitative Composition

Strensiq is supplied as a single-use vial containing 40 or 100 mg/mL of asfotase alfa rch.
Asfotase alfa rch is a human recombinant tissue nonspecific alkaline phosphatase (TNSALP)-Fc-deca-aspartate fusion protein with enzymatic activity, produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection. Strensiq is a sterile, preservative-free, non-pyrogenic, clear, slightly opalescent or opalescent, colourless to slightly yellow aqueous solution; few small translucent or white particles may be present. For subcutaneous injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Strensiq (asfotase alfa rch) is indicated as enzyme replacement therapy in patients with paediatric onset hypophosphatasia.

4.2 Dose and Method of Administration

Strensiq treatment should be initiated by a physician experienced in the management of patients with metabolic or bone disorders.

Patient monitoring program.

Physicians should enrol consenting patients receiving Strensiq in a monitoring program.

Recommended dose.

The recommended dosage regimen is 2 mg/kg of body weight, administered subcutaneously 3 times per week, or 1 mg/kg of body weight administered 6 times per week. Also see dosing chart (Table 1).
The maximum volume of subcutaneous injection is 1 mL per injection site. If more than 1 mL is required, split the volume equally between two or more syringes and administer each injection using a separate site.
Patients should be regularly reviewed for their response to treatment and appropriate dose, including patients who have progressed to adolescence and adulthood.

Method of administration.

Patients can self-inject only if they have been appropriately trained on administration procedures.
Take the unopened Strensiq vial(s) out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. Do not warm Strensiq in any other way (for example, do not warm it in a microwave or in hot water).
Strensiq should be administered using sterile disposable syringes and injection needles. The use of two different gauge needles is recommended, a larger bore needle (e.g. 25 gauge) for withdrawal of the medication and a smaller bore needle (e.g. 29 gauge) for the injection. An aseptic technique should be used. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Do not administer intravenously or intramuscularly. Strensiq must be administered as subcutaneous injection.
Do not administer injections in areas that are reddened, inflamed, or swollen. Injection sites should be rotated and carefully monitored for signs of potential reactions. Rotate the injection from among the following sites to reduce the risk of lipodystrophy: abdominal area, thigh, deltoid or buttocks (see Section 4.4 Special Warnings and Precautions for Use).

Special populations.

Patients with renal and hepatic impairment.

The safety and efficacy of Strensiq have not been studied in patients with renal or hepatic impairment, and no specific dose regimen can be recommended for these patients.

Adult patients.

Safety and efficacy data in patients > 18 years old are limited.

4.3 Contraindications

Strensiq is contraindicated in patients with known hypersensitivity to asfotase alfa rch, Chinese hamster ovary cell proteins or to any of the excipients of this product.
Severe and life-threatening hypersensitivity to the active substance or to any of the excipients if hypersensitivity is not controllable (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Limited data.

Due to HPP being an ultra-rare (orphan) disease, only limited, Phase II data have been provided in support of the safety and efficacy of Strensiq in the treatment of HPP.

Hypersensitivity.

Hypersensitivity reactions have been reported in Strensiq-treated patients including signs and symptoms consistent with anaphylaxis. Signs and symptoms included difficulty breathing, choking sensation, periorbital oedema and dizziness. The reactions have occurred within minutes after subcutaneous administration of Strensiq. Hypersensitivity reactions have been observed as late as more than one year after treatment initiation. Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, erythema, rash, pruritus and oral hypoesthesia (see Section 4.8 Adverse Effects (Undesirable Effects)).
Other severe allergic type hypersensitivity reactions are possible, including urticaria, difficulty breathing and/or cardiovascular collapse. If severe hypersensitivity reaction occurs, immediate discontinuation of Strensiq treatment is recommended and appropriate medical treatment should be initiated. The current medical standards for emergency treatment should be observed.
Consider the risks and benefits of re-administering Strensiq to individual patients following a severe reaction, taking other factors into account that may contribute to the risk of a hypersensitivity reaction, such as concurrent infection and/ or use of antibiotics. If the decision is made to re-administer the product, the re-challenge should be made under medical supervision and consideration may be given to use of appropriate pre-medication. Patients should be monitored for recurrence of signs and symptoms of a severe hypersensitivity reaction.
Severe or life-threatening hypersensitivity to the active substance or to any of the excipients if hypersensitivity is not controllable (see Section 4.3 Contraindications).

Injection site reactions.

Administration of Strensiq may result in local injection site reactions (including, but not limited to, erythema, rash, discolouration, pruritus, pain, papule, nodule or atrophy) defined as any related adverse event occurring during the injection, or until the end of the injection day (see Section 4.8 Adverse Effects (Undesirable Effects)). These have been generally assessed as non-serious, mild to moderate in severity and self-limiting. Rotation of injection sites may help to minimise these reactions. One patient treated in clinical trials experienced a severe ISR of injection site discolouration which led to the discontinuation of Strensiq.
Strensiq administration should be interrupted in any patient experiencing severe injection reactions and appropriate medical therapy administered.

Lipodystrophy.

Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with Strensiq in clinical trials. Patients should be advised to follow proper injection technique and to rotate injection sites (see Section 4.2 Dose and Method of Administration).

Craniosynostosis.

In Strensiq clinical studies, adverse events of craniosynostosis (associated with increased intracranial pressure), including worsening of pre-existing craniosynostosis have been reported in HPP patients < 5 years of age. There are insufficient data to establish a causal relationship between exposure to Strensiq and progression of craniosynostosis. Craniosynostosis as a manifestation of HPP is documented in published literature and occurred in 61.3% of patients between birth and 5 years of age in a natural history study of untreated infantile onset HPP patients. Craniosynostosis can lead to increased intracranial pressure. Periodic monitoring (including fundoscopy for signs of papilloedema) and prompt intervention for increased intracranial pressure is recommended in infantile onset HPP patients below 5 years of age.

Ectopic calcification.

Patients with HPP are at increased risk for developing ectopic calcifications.
Ophthalmology examinations and renal ultrasounds are recommended at baseline and periodically during treatment with Strensiq to monitor for signs and symptoms of ophthalmic and renal ectopic calcifications and for changes in vision or renal function.
In clinical trials, events of ectopic calcification including opthalmic (corneal and conjunctival) calcification and nephrocalcinosis have been reported to be at least possibly related to Strensiq. There was insufficient information to determine whether or not the reported events were consistent with the disease or due to Strensiq. No visual changes or changes in renal function were reported resulting from the occurrence of ectopic calcifications.

Serum parathyroid hormone and calcium.

Serum parathyroid hormone concentrations may increase in HPP patients administered Strensiq, most notably during the first 12 weeks of treatment. It is recommended that serum parathyroid hormone and calcium be monitored in patients treated with Strensiq. Supplements of calcium and oral vitamin D may be required.

Disproportionate weight gain.

Patients may display disproportionate weight increase. Dietary supervision is recommended.

Use in hepatic impairment.

Safety and efficacy of Strensiq have not been studied in patients with hepatic impairment.

Use in renal impairment.

Safety and efficacy of Strensiq have not been studied in patients with renal impairment.

Use in the elderly.

Safety and efficacy of Strensiq in patients older than 65 years have not been established. Therefore, there is no information available to determine whether patients aged 65 years and over respond differently from younger patients.

Paediatric use.

The safety and efficacy of Strensiq have been studied in paediatric patients aged between 0-18 years. The posology of Strensiq is based on body weight.

Effects on laboratory tests.

Serum alkaline phosphatase.

High serum ALP measurements detected through clinical laboratory testing are expected in patients receiving Strensiq and reflect circulating concentrations of asfotase alfa rch.
Do not rely on serum ALP measurements for clinical decision making in patients treated with Strensiq.

Laboratory tests utilizing alkaline phosphatase as a detection reagent.

Alkaline phosphatase (ALP) is used as the detection reagent in many routine laboratory assays. Studies have shown that there may be analytical interference between asfotase alfa and laboratory tests that utilize an alkaline phosphatase (ALP)-conjugated test system, rendering potentially erroneous test results in patients treated with Strensiq. ALP-conjugated test systems are utilized to measure substances such as hormones, bacterial antigens and antibodies. Therefore, it is recommended that laboratory assays which do not have ALP-conjugate technology be used when testing samples from patients who are receiving Strensiq.
To avoid erroneous test results for patients treated with Strensiq, inform laboratory personnel that the patient is being treated with Strensiq and discuss the use of a testing platform which does not utilize an ALP-conjugated test system.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed with asfotase alfa rch. Based on its structure and pharmacokinetics, asfotase alfa rch is an unlikely candidate for cytochrome P450 mediated interactions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No adverse effects on fertility were observed in male and female rats given intravenous doses of asfotase alfa rch at ≤ 50 mg/kg/day, yielding exposures to asfotase alfa rch (based on plasma AUC) up to 19 times higher than that in patients at the recommended human dose of 2 mg/kg SC three times weekly.
(Category C)
There are no available data on Strensiq use in pregnant women. Pregnant and lactating women were excluded from Strensiq clinical trials. Strensiq is not recommended during pregnancy, and in women of childbearing potential not using contraception. Patients should be advised to inform their physician if they become pregnant.
Animal studies are insufficient to conclude that asfotase alfa rch has no effects on the foetal skeleton. In embryofoetal development studies, no adverse effects were observed in pregnant rats and rabbits that received intravenous doses of asfotase alfa rch during organogenesis at doses up to 50 mg/kg/day. These doses resulted in exposures (based on plasma AUC) 18 and 50 times, respectively, the estimated clinical AUC at the recommended human dose of 2 mg/kg SC three times weekly. However, the production of antibodies against asfotase alfa rch in rabbits may have affected the detection of reproductive toxicity.
 There is insufficient information on the excretion of asfotase alfa rch in human milk. A risk to the newborns/ infants cannot be excluded. Breast-feeding should not be commenced whilst on treatment with Strensiq.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Summary of the safety profile.

The data described below reflect exposure to Strensiq in 112 patients with perinatal/infantile- (n=89), juvenile-onset (n=22) and adult-onset (n=1) HPP (age at enrolment from 1 day to 66.5 years) treated with Strensiq, most for more than 2 years (range from 1 day to 391.9 weeks [7.5 years]): a majority of patients (69) received at least 120 weeks (2.3 years) of treatment of which 44 patients received 240 weeks (4.6 years) or more of treatment.
The most common adverse reactions were injection site reactions (74%). The majority of these reactions resolved within a week. One patient withdrew from the trial due to an injection site hypersensitivity.
Other common adverse reactions included lipodystrophy, ectopic calcifications and hypersensitivity reactions.
The frequency of injection site reactions, lipodystrophy and ectopic calcification were higher in patients with juvenile-onset HPP as compared to perinatal/infantile-onset HPP patients and was likely due to the increased dosing frequency in older patients.
Table 2 gives the adverse events observed from clinical trials.

Less common adverse reactions.

Adverse reactions that occurred at rates less than 10% included: hypocalcaemia; renal stones; chronic hepatitis; decreased vitamin B6; skin discolouration; skin hyperpigmentation.

Description of selected adverse reactions.

Injection site reactions (ISRs).

ISRs (including injection site atrophy, abscess, erythema, discoloration, pain, pruritus, macule, swelling, contusion, bruising, lipodystrophy (lipoatrophy or lipohypertrophy), induration, reaction, nodule, rash, papule, haematoma, inflammation, urticaria, calcification, warmth, haemorrhage, cellulitis, scar, mass, extravasation, exfoliation and vesicles) are the most common adverse reactions, observed in approximately 74% of the patients in the clinical studies.

Hypersensitivity.

Hypersensitivity reactions (including irritability, pyrexia, rash, pruritus, chills, erythema, nausea, vomiting, flushing, oral hypoesthesia, headache, tachycardia and cough) are very common adverse reactions, observed in approximately 22/112 (19.6%) of the patients in the clinical studies. A few case reports of anaphylactoid/hypersensitivity reaction have also been received and were associated with signs and symptoms of difficulty breathing, choking sensation, periorbital edema and dizziness.

Immunogenicity.

As with all therapeutic proteins, there is potential for immunogenicity. Among 109 HPP patients enrolled in the clinical trials, 97/109 (89.0%) tested positive for anti-drug antibodies at some time point after receiving Strensiq treatment. Among those 97 patients, 55 (56.7%) also showed the presence of neutralizing antibodies at some time point post-baseline. The antibody response (with or without presence of neutralizing antibodies) was time variant in nature. Formation of anti-drug antibodies resulted in reduced systemic exposure of asfotase alfa rch. In clinical trials, the development of antibodies has not been shown to affect clinical efficacy or safety.
No trends in adverse events based on antibody status were observed in completed clinical trials. Furthermore, patients confirmed positive for antibodies have not shown signs of hypersensitivity or tachyphylaxis following subcutaneous administration of Strensiq.
Cases from the post-approval setting suggest that development of inhibitory antibodies may be associated with a decreased clinical response.

Reporting suspected adverse effects.

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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

The maximum dose of Strensiq used in clinical trials is 28 mg/kg/week. No dose related toxicity or change in the safety profile has been observed in clinical studies to date; therefore no overdose level has been determined.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Hypophosphatasia (HPP) is a rare, serious, and potentially fatal, genetic disorder caused by loss-of-function mutation(s) in the gene encoding TNSALP. In patients with HPP, a deficiency in TNSALP enzymatic activity leads to elevations in several TNSALP substrates, including inorganic pyrophosphate (PPi). Elevated extracellular levels of PPi block hydroxyapatite crystal growth which inhibits bone mineralisation and causes accumulation of unmineralised bone matrix which manifests as rickets and bone deformations in infants and children and as osteomalacia (softening of bones) once growth plates close, along with muscle weakness. Replacement of the TNSALP enzyme upon Strensiq treatment reduces the enzyme substrate levels.
Asfotase alfa rch, a human recombinant TNSALP-Fc-deca-aspartate fusion protein with enzymatic activity, promotes mineralisation of the skeleton in patients with HPP.

Pharmacodynamics.

Perinatal/infantile-and juvenile-onset HPP patients treated with Strensiq had reductions in plasma TNSALP substrates, PPi and pyridoxal 5'-phosphate (PLP) within 6 to 12 weeks of treatment. Reductions in plasma PPi and PLP levels did not correlate with clinical outcomes. In adult patients with paediatric-onset HPP, the pharmacodynamics of Strensiq was consistent with those observed in paediatric patients with perinatal/infantile-onset or juvenile-onset HPP.
Bone biopsy data from perinatal/ infantile onset and juvenile onset HPP patients treated with Strensiq demonstrated decreases in osteoid volume and thickness indicating improved bone mineralization.

Clinical trials.

Due to HPP being an ultra-rare (orphan) disease, only limited, Phase II data have been provided in support of the safety and efficacy of Strensiq in the treatment of HPP.
Four studies were conducted in the clinical development program for Strensiq, in which a total of 111 patients with paediatric-onset HPP were enrolled. Of these 111 patients, 89 had perinatal- or infantile-onset HPP, while 22 had juvenile-onset HPP. In Studies ENB-002-08/ENB-003-08 and ENB-010-10, eligible patients had perinatal- or infantile- onset HPP and were ≤ 3 or ≤ 5 years of age at enrolment, respectively. In Study ENB-006-09/ENB-008-10, eligible patients were required to have perinatal- or infantile- or juvenile-onset disease and be aged between 5 and 12 years at enrolment, while in Study ENB-009-10, eligible patients had perinatal- or infantile- or juvenile-onset and were aged between 13 and 65 years at enrolment. Patient demographics in HPP clinical trials are summarised in Table 3.
Baseline characteristics of patients with paediatric onset HPP evaluated in clinical trials included low ALP and one or more of the following; elevated TNSALP biochemical substrates (PPi and PLP), abnormal bone structure (elevated osteoid indices, reduced bone mineral content, skeletal deformities of rickets such as bowed legs, abnormally shaped chest, below normal Z-score for height) or impaired physical function (gross motor weakness, developmental delay, impaired walking, inability to perform activities of daily living). At baseline, patients less than 5 years of age presented with additional morbidities including nephrocalcinosis, seizures, respiratory compromise (including respiratory failure requiring support) and gross motor delays. In Study ENB-002-08/ENB-003-08, most patients (9/11, 81.8%) presented with significant gross motor delays on the BSID-III (Bayley Scales of Infant and Toddler Development, Third Edition) e.g. gross motor scaled scores of 1, which is 3 SDs below the mean SD for healthy age-matched peers. In Study ENB-009-10, 18/19 (94.7%) patients experienced fractures and 18 patients had bone pain severe enough to limit activity.
Subcutaneous doses of 6 mg/kg/week of Strensiq were administered 3 times a week or 6 times a week. After completion of the initial 24-week treatment period in ENB-002-08 and ENB-006-09, most patients continued to receive Strensiq by enrolling into an extension study.

Study ENB-002-08/ ENB-003-08.

Study ENB-002-08/ENB-003-08 was a 24 week prospective single arm trial in 11 patients aged 3 weeks to 39.5 months, with severe perinatal/infantile-onset HPP; 7/11 (64%) were female and 10/11 (91%) were white. Severe perinatal/infantile-onset HPP was defined as biochemical, medical history and radiographic evidence of HPP as well as the presence of any of the following: respiratory compromise, rachitic chest deformity, vitamin B6-dependent seizures, and/or failure to thrive. Ten of 11 patients completed the 24-week trial and continued treatment in the extension phase. Nine patients have been treated with Strensiq for at least 5 years (60 months) and 4 patients have been treated for more than 7 years (84 months).

Study ENB-010-10.

Study ENB-010-10 was prospective open-label study in 69 patients, aged 1 day to 5 years with perinatal/ infantile-onset HPP; 54/69 (78%) were white. Thirty-eight patients were treated for at least 2 years (24 months) and 6 patients have been treated for at least 5 years (60 months).

Study ENB-006-09/ENB-008-10.

Study ENB-006-09/ENB-008-10 was a prospective open-label 24 week trial that enrolled 13 patients that included 5 perinatal/ infantile-onset HPP patients and 8 juvenile-onset HPP patients. Twelve of the 13 patients entered the extension study and were treated for at least 6 years (72 months).

Study ENB-009-10.

Study ENB-009-10 was an open-label, randomised study that enrolled 19 patients. Patients were randomly assigned to 1 of 2 Strensiq treatment groups (either 0.3 mg/kg/day or 0.5 mg/kg/day) or to the prospective control group for the 24-week primary treatment period. All patients received Strensiq treatment (0.5 mg/kg/day) in the extended treatment period. After 48 weeks all patients were adjusted to the recommended dose 1.0 mg/kg/day. Fourteen patients completed and 5 discontinued the study. At study completion, the median treatment period was 60 months (range, 24 to 68 months). Four patients had perinatal/infantile-onset HPP, 14 patients had juvenile-onset HPP, and 1 patient had adult-onset HPP. Age was 13 to 66 years at inclusion and was between 17 and 72 years at study completion.

Study results.

Perinatal/infantile-onset HPP.

Skeletal manifestations.

Radiographs from 81 Strensiq-treated perinatal/infantile-onset HPP patients, including 77 patients in ENB-002-08/ENB-003-08 and ENB-010-10, and 4 patients in ENB-006-09/ENB-008-10, were examined to assess HPP-related rickets using the 7-point Radiographic Global Impression of Change (RGI-C) scale. Patients with a minimum RGI-C score of +2 were defined as "responders". Radiologic improvements could be seen by Week 24; at last assessment, 63/81 [78%] treated patients were rated as RGI-C responders. No comparative data were available from historical controls. The mean time interval between the baseline and last RGI-C assessment was 35.7 months (range was 2.5 months to 89.4 months).
Radiographs were also scored using the 10-grade Rickets Severity Scale (RSS), which can be used to quantify the severity of rickets in the wrists and knees of these patients based on the degree of metaphyseal fraying and cupping and the proportion of growth plate affected. A score of 10 represents severe rickets, while a score of 0 represents an absence of rickets. Change in RSS scores were also statistically significant, with progressive improvements (at Week 24, median change in RSS score was -1.5, and at last overall assessment, the median change was -3.0).

Growth.

Height and weight measurements (as measured by Z-scores) were available post-treatment for 82 perinatal/infantile-onset HPP patients, including 78 patients enrolled in Studies ENB-002-08/ENB-003-08 and ENB-010-10, and 4 patients enrolled in ENB-006-09/ENB-008-10 (Table 4).

Survival and ventilation-free survival.

Survival and invasive ventilation-free survival were compared in Strensiq-treated patients with severe perinatal- or infantile-onset HPP (ENB-002-08/ENB/003-08 and ENB-010-10) with a historical cohort of untreated patients with similar clinical characteristics (ENB-011-10), all of whom had a history of rachitic chest deformity, vitamin B6-dependent seizures, and/or failure to thrive (Table 5 and Figure 1).
Overall survival was improved in the cohort of treated patients with severe perinatal- or infantile-onset HPP, compared to the matched historical control group, with 69/78 (88%) treated patients vs. 13/48 (27%) historical controls alive at last contact. In patients who required any form of respiratory support, 23/29 (79%) of the treated patients survived through their last assessment (median age at last assessment was 3.9 years), versus 1 of 20 (5%) of historical controls.

Ventilation support.

The natural history of untreated infant HPP patients suggests higher mortality if ventilation is required. In studies ENB-002-08/ENB-003-08 (11 patients) and ENB-010-10 (69 patients), both open-label, non-randomised, non-controlled studies of patients aged 0.1 to 312 weeks at baseline. 69 patients completed the studies, and 11 discontinued. 29 of 80 patients required ventilation support at baseline:
16 patients required invasive ventilation support (intubation or tracheostomy) at baseline (one had a brief period of non-invasive ventilation at baseline before transfer).
7 patients were weaned off invasive ventilation (time on ventilation from 12 to 168 weeks), 4 patients were off any ventilation support, and 3 patients were on non-invasive ventilation support. Five out of 7 patients achieved an RGI-C score ≥ 2;
5 patients continued with invasive ventilation support, 4 of them with RGI-C score < 2;
3 patients died whilst on ventilation support;
1 patient withdrew consent.
13 patients required non-invasive ventilation support at baseline.
10 patients were weaned off any ventilation support (time on ventilation from 3 to 216 weeks). 9 out of 10 patients achieved a RGI-C score ≥ 2, only 1 with RGI-C < 2;
2 patients required invasive ventilation support and 1 patient continued with non-invasive ventilation support, all 3 patients died and with RGI-C score < 2.
Juvenile-onset HPP.

Skeletal manifestations.

In study ENB-006-09/ENB-008-10, radiographs from 8 Strensiq-treated patients and 32 historical controls were compared to assess HPP-related rickets using the 7-point RGI-C (Radiographic Global Impression of Change) scale. Patients who achieved a RGI-C score of 2 or higher (corresponding to substantial healing of rickets) were classified as being responders to treatment. All 8 treated patients were rated as responders by Month 54 of treatment. The mean duration between the baseline and last RGI-C assessments for control patients was 56 months (range was 8 to 95 months). At last assessment, 2/32 (6%) of control patients were rated as responders.

Gait/mobility.

Gait was assessed using a modified Performance Oriented Mobility Assessment-Gait (MPOMA-G) scale) in 8 Strensiq-treated patients at 6 month intervals out to 36 months. Step length improved by at least 1 point in either foot in 6/8 patients compared to 1/6 (17%) control patients. Mobility was also assessed using the 6 Minute Walk Test (6MWT) in 7 of the 8 patients. At last assessment, all 7 patients had an improvement in distance walked of at least the minimal clinically important difference. The mean increase from baseline for distance walked is 222.4 meters (range from 81 to 297 meters). Mean walking distance reached the normal range after 6 months of treatment and improvements were sustained over 6 years.

Bone biopsy.

Tetracycline for bone-labelling was administered in two 3-day courses (separated by a 14-day interval) prior to acquisition of the bone biopsy. Trans-iliac crest bone biopsies were obtained by standard procedure. Histological analysis of biopsies used Osteomeasure software (Osteometrics, USA). Nomenclature, symbols and units followed recommendations of the American Society for Bone and Mineral Research.
At baseline, the mineralisation indices; osteoid thickness, osteoid volume per bone volume and mineralisation lag time were all elevated, relative to a normative sample of healthy individuals, which was consistent with osteomalacia. At Week 24, all 3 parameters had declined significantly from their pre-treatment levels, associated with improved bone mineralisation. The results for 10 patients in the per-protocol set (excludes those patients who received oral vitamin D between baseline and week 24) who underwent biopsy of the trans-iliac bone crest before and after receiving Strensiq are presented in Table 6.

Growth.

Height, weight and head circumference were plotted on growth charts (series of percentile curves that illustrate distribution) available from the Centres for Disease Control and Prevention, USA. These reference data were drawn from a representative sample of healthy children and are not specific for children with special health care needs: they have been used in the absence of growth charts for children with HPP.
For those patients who received Strensiq: 9/13 patients displayed persistent apparent catch-up height-gain as shown by movement over time to a higher percentile on CDC growth charts. Three of the 13 patients did not display apparent catch-up height-gain and 1 patient did not have enough data to permit judgement. Progress through Tanner stages appeared appropriate.
For the time period of observation of historical controls: 1/16 patients displayed apparent catch-up height-gain, 12/16 patients did not display apparent catch-up height-gain and data were inconclusive in 3/16 patients.
Some patients required oral vitamin D supplements during the study (see Section 4.4 Special Warnings and Precautions for Use, Serum parathyroid hormone and calcium).
Adolescent and adult patients with HPP.

Bone biopsy.

A histomorphometric assessment (transiliac crest bone biopsy) was conducted in ENB-009-10. Patients underwent biopsy of the trans-iliac bone crest either as part of a control group or before and after exposure to Strensiq and results are presented in Table 7.

Physical function and growth.

Physical function was evaluated in ENB-009-10 using the 6 minute walk test (ambulation). At Week 24, change from baseline in distance walked in 6 minutes (6MWT) was 35.0 (-2, 182) m for the combined treatment group and -6.5 (-46, 113) m for the control group. The difference between treated and untreated patients did not achieve statistical significance due to patient heterogeneity, low Strensiq dose and/or the small sample size of the study. During the extended treatment period, most patients had sustained or increased improvements.
There was no improvement in height in the overall study population in Study ENB-009-10; however, this was expected given that 6/19 of the patients were adolescents at the time of enrolment.

5.2 Pharmacokinetic Properties

Based on data in 38 HPP patients the pharmacokinetics of asfotase alfa rch exhibited dose proportionality across the dose range of 0.3 mg/kg to 3 mg/kg, administered three times per week, and appeared to be time-independent. Steady state exposure was achieved as early as three weeks after the administration of the first dose. The elimination half-life following subcutaneous administration was approximately 5 days. In adult patients with paediatric-onset HPP, the pharmacokinetics of asfotase alfa rch at doses of 0.5, 2 and 3 mg/kg administered three times per week was consistent with those observed in paediatric patients with paediatric-onset HPP, and thus supported the approved dose of 6 mg/kg per week in treating adult patients with paediatric-onset HPP.
Table 8 summarises the pharmacokinetic parameters following multiple doses in 20 HPP patients after subcutaneous administration of Strensiq at 2 mg/kg three times per week in Study ENB-010-10 (age of less than or equal to 5 years) and Study ENB-006-08/ENB-008-10 (age of greater than 5 to 12 years), indicating the pharmacokinetics were similar between patients in the two age groups.
Based on the results of population pharmacokinetic analysis, body weight was identified to affect asfotase alfa rch clearance and volume of distribution parameters. It is expected that pharmacokinetic exposures will increase with body weight. The impact of immunogenicity on asfotase alfa rch pharmacokinetics varied over time due to the time varying nature of immunogenicity and overall was estimated to decrease pharmacokinetic exposures by less than 20%.
Formation of anti-drug antibodies resulted in reduced systemic exposure of asfotase alfa rch.
The extrinsic factors affecting asfotase alfa rch pharmacokinetic exposures were formulation specific activity and total sialic acid content.

Absorption.

Following weekly SC administrations of Strensiq, the observed median Tmax ranged from 1 to 2 days and the absolute bioavailability ranged from 45.8-98.4%. Following once weekly administration of Strensiq 3 mg/kg IV bolus on Week 1 followed by 2 mg/kg SC on Weeks 2, 3 and 4, the Week 4 mean ± SD observed Cmax and AUCt parameters were 1020 ± 326 U/L and 284,926 ± 79,652 U.h/L, respectively.

Distribution.

Based on population PK analysis, the estimated central and peripheral volumes of distribution (mean) for a patient with body weight 70 kg were 5.66 L (95% CI: 2.76, 11.6) and 44.8 L (95% CI: 33.2, 60.5), respectively. These results indicated that asfotase alfa rch was initially distributed primarily in the intra-vascular space and then distributed to the extra-vascular space, reflecting its ability to partition into tissues, likely including skeletal tissue.

Metabolism.

In vitro or in vivo metabolism studies are not considered relevant since the expected metabolic pathway is the normal catabolic degradation into small peptides and individual amino acids.

Excretion.

The central and peripheral clearance estimates for a patient with body weight 70 kg (and 95% CI) were 15.8 (13.2, 18.9) L/day and 51.99 (44.0, 61.2) L/day respectively. The average elimination half-life of asfotase alfa rch was 2.28 ± 0.58 days with a range of 1.06 to 3.62 days.

Special populations.

Based on the population PK analysis, age and sex were not found to be significant covariates.

Renal and hepatic impairment.

The safety and efficacy of Strensiq in patients with renal or hepatic impairment have not been evaluated and no specific dose regimen can be recommended for these patients.
Significant PK-PD relationships were demonstrated based on the efficacy biomarker data and clinical endpoints in patients with paediatric onset HPP, across the range of perinatal/ infantile and juvenile onset cohorts. These relationships supported the recommendation of the 6 mg/kg/week dose, administered as either 2 mg/kg 3 times weekly or 1 mg/kg 6 times weekly.

5.3 Preclinical Safety Data

Genotoxicity.

No studies have been conducted to assess the genotoxic potential of asfotase alfa rch.

Carcinogenicity.

No studies have been conducted to assess the carcinogenic potential of asfotase alfa rch.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, dibasic sodium phosphate heptahydrate, monobasic sodium phosphate monohydrate, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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.
Do not use beyond the expiration date (EXP) stamped on the packaging.

6.4 Special Precautions for Storage

Strensiq vials must be stored in a refrigerator (2° to 8°C, Do not freeze) in the original packaging in order to protect from light.
Out of refrigeration, the product should be kept at room temperature and administered within 3 hours.

6.5 Nature and Contents of Container

Strensiq is supplied as packs of 12 single-use glass vials. See Table 9.

6.6 Special Precautions for Disposal

Product is for single use in one patient only. Discard any unused portion left in the vial, as the product contains no preservatives. Unused or expired medicine should be returned to a pharmacy for disposal.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

CAS registry number: 1174277-80-5.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes