INDICATION & IMPORTANT SAFETY INFORMATION for STRENSIQ® (asfotase alfa) 40mg/mL vial
What is STRENSIQ?
Strensiq is a prescription medicine used to treat people with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
IMPORTANT SAFETY INFORMATION
What are the possible side effects of STRENSIQ?
STRENSIQ may cause serious side effects, including
- Serious allergic (hypersensitivity) reactions happened in some people who use STRENSIQ. Stop using STRENSIQ and go to the nearest hospital emergency room right away if you or your loved one have any of the signs and symptoms of a serious allergic reaction, including
- Difficulty breathing
- Swelling of your eyes, lips, or tongue
- Feeling faint
- Nausea or vomiting
- Itching of your lips, tongue, or throat
- Choking sensation
- Skin thickening or pits at the injection site (lipodystrophy) has happened several months after using STRENSIQ.
- Calcium buildup in the eyes and kidneys can occur if you or your loved one have HPP. Your healthcare provider should check the eyes and kidneys while you or your loved one use STRENSIQ.
- Decreased efficacy. Contact your healthcare provider if you or your loved one notice STRENSIQ is no longer working or experience worsening symptoms of HPP (e.g., increased respiratory support, increased difficulty walking, new fractures).
The most common side effects of STRENSIQ include local skin injection-site reactions (red skin patches, bruising, color change, pain, itching, thinning, swelling, pits, and bumps) and calcium buildup in your eyes and kidneys.
Strensiq may affect other lab test results, therefore it is important that you present your Medical Alert Card to your healthcare team so they are aware that you are being treated with an alkaline phosphatase (ALP) replacement therapy which may cause incorrect results on certain laboratory tests.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.
These are not all the possible side effects of STRENSIQ. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
Please see STRENSIQ full Prescribing Information, including Patient Information and Instructions for Use.