Strensiq

Generic name: Asfotase Alfa
Drug class: Miscellaneous metabolic agents

Usage of Strensiq

Strensiq is an enzyme replacement medicine that is used to treat hypophosphatasia (HYE-poe-FOS-fa-TAY-zha).

Hypophosphatasia is a rare genetic disorder in which there is a deficiency of an enzyme that helps the body process calcium and phosphorus. This leads to abnormal growth and development of the bones and teeth, including soft or brittle bones, growth problems, and tooth loss.

Strensiq may also be used for purposes not listed in this medication guide.

Strensiq side effects

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

Call your doctor at once if you have:

vision changes;

urinating more or less than usual;

painful or difficult urination;

pink, red, or brown urine; or

severe pain in your side or lower back.

Common Strensiq 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. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Strensiq

You should not use Strensiq if you are allergic to asfotase alfa.

Before you use Strensiq, tell your doctor about all your medical conditions or allergies.

Your name may be listed on a patient registry while you are using Strensiq. This is to track and evaluate any long-term effects of using this medicine.

It is not known whether Strensiq will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether asfotase alfa passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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How to use Strensiq

Usual Adult Dose of Strensiq for Hypophosphatasia:

Usual dose: 2 mg/kg suBCutaneously 3 times per week OR 1 mg/kg subcutaneously 6 times per week Maximum dose: 9 mg/kg per week Comments: -For patients with perinatal/infantile-onset hypophosphatasia (HPP), an increase to 3 mg/kg three times per week may be necessary for insufficient efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings). -Injection site reactions may limit the tolerability of the 6 times per week dosing regimens. Use: For the treatment of patients with perinatal/infantile and juvenile onset HPP.

Usual Pediatric Dose of Strensiq for Hypophosphatasia:

Usual dose: 2 mg/kg subcutaneously 3 times per week OR 1 mg/kg subcutaneously 6 times per week Maximum dose: 9 mg/kg per week Comments: -For patients with perinatal/infantile-onset hypophosphatasia (HPP), an increase to 3 mg/kg three times per week may be necessary for insufficient efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings). -Injection site reactions may limit the tolerability of the 6 times per week dosing regimens. Use: For the treatment of patients with perinatal/infantile and juvenile onset HPP.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What other drugs will affect Strensiq

Other drugs may interact with asfotase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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