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Strensiq Side Effects

Generic Name: asfotase alfa

Note: This page contains side effects data for the generic drug asfotase alfa. It is possible that some of the dosage forms included below may not apply to the brand name Strensiq.

For the Consumer

Applies to asfotase alfa: subcutaneous solution

Get emergency medical help if you have signs of an allergic reaction: hives; dizziness, nausea, vomiting; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • pain, itching, swelling, redness, bruising, hardening, pitting, or other skin changes where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

It is possible that some side effects of Strensiq may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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