TM Owner Alexion / AstraZeneca
Strensiq 80mg/0.8mL Injection
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Indications & Clinical Uses
- Strensiq 80 mg/0.8 mL is a subcutaneous injection containing asfotase alfa, a recombinant human tissue-nonspecific alkaline phosphatase enzyme-replacement therapy manufactured by Alexion Pharmaceuticals, Inc. (part of AstraZeneca).
- It is approved in the US and EU for long-term treatment of perinatal-, infantile- and juvenile-onset hypophosphatasia (HPP), a rare inherited bone-mineralisation disorder caused by low alkaline phosphatase activity that leads to soft, fragile bones, respiratory failure in infants, and fractures or dental problems in children.
- Strensiq is given by subcutaneous injection, and the 80 mg/0.8 mL strength is reserved for patients weighing 40 kg or more; smaller vial strengths (18 mg, 28 mg, 40 mg) are used for lower body weights with more frequent dosing.
- Treatment is usually started and monitored by a specialist in metabolic bone disease, and patients or caregivers can be trained to give injections at home once stabilised.
Side Effects
- Injection site reactions are very common with Strensiq, affecting more than half of patients, and include redness, pain, itching, swelling, bruising, or a lump under the skin; some patients develop lipodystrophy, a thinning or loss of fat tissue at repeated injection sites, after months of treatment.
- Strensiq carries a boxed warning for life-threatening hypersensitivity reactions, including anaphylaxis, which have occurred both early in treatment and after months or years of use; patients and caregivers are trained to recognise symptoms such as difficulty breathing, swelling of the face or throat, and severe rash, and to seek emergency care immediately if these occur.
- Ectopic (abnormal) calcium deposits can form in the eyes and kidneys, so regular eye and kidney monitoring is part of routine care.
- Rotate injection sites each time to reduce skin changes.
Precautions & Warnings
- Because Strensiq can cause anaphylaxis, the first doses are usually given under healthcare provider supervision with access to appropriate medical support, and patients may be shown how to use emergency allergy treatment if prescribed.
- Regular monitoring includes eye examinations for ectopic calcification, kidney function tests and renal ultrasound, injection-site checks for lipodystrophy, and craniosynostosis (early skull-bone fusion) monitoring in infants and young children, which can raise pressure inside the skull and may need neurosurgical review.
- Standard serum alkaline phosphatase blood tests are not reliable for monitoring HPP control while on treatment, because asfotase alfa itself has alkaline phosphatase activity and interferes with the assay.
- Use in pregnancy and breastfeeding should be discussed individually with a specialist, as data are limited; there are no formal contraindications listed on the label.
Avoid Interactions
- Strensiq has few classic drug-drug interactions, but its most important interaction is with laboratory testing rather than other medicines: because the enzyme itself has alkaline phosphatase activity, routine serum alkaline phosphatase tests will read artificially high and cannot be used to judge disease control or dosing while on Strensiq.
- Patients should tell their healthcare provider about all other medicines, supplements, and vaccines they are using, particularly around the time of any planned surgery, contrast imaging, or new medication affecting calcium or kidney function, since Strensiq is already associated with ectopic calcification and renal changes.
- There is no specific advice to avoid alcohol, grapefruit, or live vaccines with Strensiq, but any new sign of allergy, breathing difficulty, or rash after a dose should be reported promptly given the risk of hypersensitivity.
References
Frequently Asked Questions
Strensiq (asfotase alfa) treats hypophosphatasia (HPP), a rare inherited disease causing weak, poorly mineralised bones. It is approved for perinatal, infantile and juvenile-onset HPP. Long-term enzyme-replacement therapy helps improve bone growth and mineralisation, breathing, and mobility in affected infants, children and adults.
Strensiq is given as a subcutaneous (under-the-skin) injection, not intravenously. The 80 mg/0.8 mL strength is for patients weighing 40 kg or more; smaller strengths are given more often in lighter patients. A specialist supervises the first doses, then trained caregivers can inject at home, rotating sites.
Most people get injection-site reactions such as redness, pain, or a lump, and some develop fat loss (lipodystrophy) at repeated sites. Strensiq carries a boxed warning for anaphylaxis, a severe allergic reaction that can occur early or after months of treatment. Get emergency help for breathing trouble or facial swelling.
There are no specific foods or drugs to avoid, but tell your healthcare provider about every medicine and supplement you take. Do not rely on standard alkaline phosphatase blood tests to judge how well Strensiq is working, since the drug itself raises this reading and makes it unreliable.
Strensiq treatment includes regular eye checks for calcium deposits, kidney function tests and ultrasound, and skin checks at injection sites. Infants and young children are also monitored for craniosynostosis, early fusion of skull bones, which can raise pressure in the skull and sometimes needs surgery.
Strensiq is approved for infants, children, adolescents and adults with hypophosphatasia; the 80 mg/0.8 mL strength is only for those weighing 40 kg or more. Data on use in pregnancy and breastfeeding are limited, so this should be discussed individually with the treating specialist.
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