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Strensiq Side Effects

Generic Name: asfotase alfa

Note: This document contains side effect information about asfotase alfa. Some of the dosage forms listed on this page may not apply to the brand name Strensiq.

In Summary

Common side effects of Strensiq include: anaphylaxis, ectopic calcification, nausea, calcium nephrolithiasis, fever, headache, hypersensitivity reaction, lipodystrophy, vomiting, chills, erythema, flushing, and irritability. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to asfotase alfa: parenteral injection

Side effects include:

Injection site reactions, ectopic calcifications, lipodystrophy, hypersensitivity reactions.

For Healthcare Professionals

Applies to asfotase alfa: subcutaneous solution

General

The most common adverse reactions include injection site reactions, lipodystrophy, ectopic calcifications, and hypersensitivity reactions.[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity reactions (12%)

Uncommon (0.1% to 1%): Anaphylaxis symptoms[Ref]

In clinical trials 1 treated-patient (n=99; 1%) experienced signs and symptoms consistent with anaphylaxis. This patient had been receiving this drug for 3.5 years before this reaction occurred. The reaction (difficulty breathing, nausea, periorbital edema, and dizziness) occurred approximately 1 minute after injection and resolved without medical treatment. This patient continued on therapy with premedication and eventually continued treatment without premedication.

Hypersensitivity reactions including nausea/vomiting, fever, headache, flushing, irritability, rigor/chills, skin erythema, rash, pruritus, and oral hypoesthesia have been reported.[Ref]

Local

Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported after several months. The frequency of injection site reactions and lipodystrophy were higher in patients with juvenile-onset hypophosphatasia (HPP) as compared to perinatal/infantile onset HPP patients.

Injection site reactions included erythema, discoloration/hyperpigmentation, pain/tenderness, pruritus/itching, swelling, induration, macule, bruising, nodule, injection site rash, inflammation, papules, hemorrhage, hematoma, urticaria, warmth, calcification, mass, scar, and cellulitis. The majority of injection site reactions resolved within 1 week. One patient experienced a severe injection site reaction of injection site discoloration and withdrew from the clinical trial.[Ref]

Very common (10% or more): Injection site reactions (63%), lipodystrophy (28%)[Ref]

Renal

Frequency not reported: Nephrocalcinosis, renal stones[Ref]

In clinical trials, there were 14 cases (14%) of ectopic calcification of the eye (including the cornea and conjunctiva) and the kidneys (nephrocalcinosis). No visual changes or changes in renal function were reported as a result of these ectopic calcifications. The frequency of ectopic calcifications was higher in patients with juvenile-onset hypophosphatasia (HPP) as compared to perinatal/infantile onset HPP patients.

Renal stones have been reported in less than 1% of patients.[Ref]

Ocular

In clinical trials, there were 14 cases (14%) of ectopic calcification of the eye (including the cornea and conjunctiva) and the kidneys (nephrocalcinosis). No visual changes or changes in renal function were reported as a result of these ectopic calcifications. The frequency of ectopic calcifications was higher in patients with juvenile-onset hypophosphatasia (HPP) as compared to perinatal/infantile onset HPP patients.[Ref]

Frequency not reported: Ectopic calcifications of eye[Ref]

Hepatic

Frequency not reported: Chronic hepatitis

Chronic hepatitis has been reported in less than 1% of patients.

Immunologic

Frequency not reported: Anti-drug antibodies

In clinical trials, 78% (76/98) of patients tested positive for anti-drug antibodies at some point after receiving treatment. Of these patients, 45% (34/76) had neutralizing antibodies. No correlation was observed between anti-drug antibody titer and neutralizing antibody (% inhibition) values. Formation of anti-drug antibody resulted in a reduced systemic exposure.

Metabolic

Frequency not reported: Hypocalcemia, decreased vitamin B6

Hypocalcemia and decreased vitamin B6 have been reported in less than 1% of patients

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Strensiq (asfotase alfa)." Alexion Pharmaceuticals Inc, Cheshire, CT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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