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?
You should not use asfotase alfa if you are allergic to it.
Before you use asfotase alfa, tell your doctor about all your medical conditions or allergies.
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.
It is not known whether this medicine 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.
How should I use asfotase alfa?
Asfotase alfa is usually given 3 to 6 times per week. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Asfotase alfa is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
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 the best places 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.
Do not use asfotase alfa if it has changed colors or has particles in it. Call your pharmacist for new medication.
Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
While using asfotase alfa, you may need frequent eye examinations.
Tell your doctor if you have any changes in weight. Asfotase alfa doses are based on weight (especially in children), and any changes may affect the dose.
Store vials in the original container in a refrigerator, protected from light. Do not freeze or shake this medicine.
You may take the medicine out of the refrigerator and allow it to reach room temperature before preparing a dose. Do not leave the medicine at room temperature for longer than 1 hour.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose of asfotase alfa.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using asfotase alfa?
Do not inject this medicine into skin areas that are red or swollen.
What are the possible side effects of asfotase alfa?
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.
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 interact with asfotase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about asfotase alfa.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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