asfotase alfa

What is the most important information I should know about asfotase alfa?

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 is 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.

What should I discuss with my healthcare provider before using 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 this medicine.

How should I use asfotase alfa?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Asfotase alfa is usually given 3 to 6 times per week. Follow your doctor's dosing instructions very carefully.

Asfotase alfa is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You may need to use 2 vials and 2 separate syringes to make up a single dose of this medicine. Follow your doctor's dosing instructions very carefully.

Your care provider will show you where on your body to inject asfotase alfa. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Asfotase alfa doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

You may need frequent eye examinations.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using asfotase alfa.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using asfotase alfa?

What are the possible side effects of asfotase alfa?

• 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 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.

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.

Where can I get more information?

Your pharmacist can provide more information about asfotase alfa.