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Asfotase alfa Side Effects

In Summary

Commonly reported side effects of asfotase alfa 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

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

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]

Renal

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: Nephrocalcinosis[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]

References

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

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

Not all side effects for asfotase alfa may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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