Strensiq Side Effects Center
- Generic Name: asfotase alfa for subcutaneous administration
- Brand Name: Strensiq
Strensiq (Asfotase Alfa for Subcutaneous Administration) side effects drug center
Strensiq Side Effects Center
Strensiq (asfotase alfa) injection is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile-and juvenile-onset hypophosphatasia (HPP). Common side effects of Strensiq include:
- injection site reactions (redness, discoloration, pain, tenderness, itching, swelling, bruising, or a hard lump),
- body fat redistribution (lipodystrophy),
- Renal stones
- Chronic hepatitis
- Decreased vitamin B6
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. During clinical trials, anti-drug antibodies have been detected in patients receiving treatment with STRENSIQ using an electrochemiluminescent (ECL) immunoassay. Antibody positive samples were tested to determine the presence of neutralizing antibodies based on in vitro inhibition of the catalytic activity of STRENSIQ. Among 98 patients with hypophosphatasia (HPP) enrolled in the clinical trials and who had post-baseline antibody data, 76 (78%) tested positive for anti-drug antibodies at some time point after receiving STRENSIQ treatment. Among those 76 patients, 34 (45%) also showed the presence of neutralizing antibodies. No correlation was observed between the anti-drug antibody titer and neutralizing antibody (% inhibition) values. Formation of anti-drug antibody resulted in a reduced systemic exposure of asfotase alfa. [see CLINICAL PHARMACOLOGY].
The detection of antibody formation is dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of the antibodies to STRENSIQ with the incidence of antibodies to other products may be misleading.
Read the entire FDA prescribing information for Strensiq (Asfotase Alfa for Subcutaneous Administration)
&Copy; Strensiq Patient Information is supplied by Cerner Multum, Inc. and Strensiq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.