Asfotase alfa

Generic name: Asfotase Alfa
Brand names: Strensiq
Dosage form: subcutaneous solution (18 mg/0.45 mL; 28 mg/0.7 mL; 40 mg/mL; 80 mg/0.8 mL)
Drug class: Miscellaneous metabolic agents

Usage of Asfotase alfa

Asfotase alfa 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.

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

Asfotase alfa side effects

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

Asfotase alfa may cause serious side effects. 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 side effects of asfotase alfa 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 Asfotase alfa

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

Tell your doctor if you are pregnant or breast-feeding.

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

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How to use Asfotase alfa

Usual Adult Dose for Hypophosphatasia:

2 mg/kg subcutaneously 3 times per week OR 1 mg/kg subcutaneously 6 times per weekMaximum dose: 9 mg/kg per weekComments:-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 for Hypophosphatasia:

2 mg/kg subcutaneously 3 times per week OR 1 mg/kg subcutaneously 6 times per weekMaximum dose: 9 mg/kg per weekComments:-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).-For patients weighing less than 40 kg: Do not use the 80 mg/0.8 mL vial because the systemic exposure is lower than that achieved with the lower strength vials and may not be adequate for these patients.-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 Asfotase alfa

Other drugs may affect 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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