Asfotase Alfa, Injection

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KEY POINTS

• This medicine is given by injection to treat hypophosphatasia.
• Keep all appointments for eye exams and tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: tissue nonspecific alkaline phosphatase; enzyme replacement therapy

Generic and brand names: asfotase alfa, injection; Strensiq

What is this medicine used for?

This medicine is given by injection (shot) to treat hypophosphatasia, a genetic disorder that affects the development of bones and teeth.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had an allergic reaction to any medicine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

The shots are given just under the skin. Your healthcare provider will determine the exact dosage. If your healthcare provider is giving you the shots, keep all your appointments.

If you give yourself these shots or have someone at home give them to you, your provider will teach you how to use this medicine. Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions in the medicine package for preparing and using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

If you miss a shot, skip the missed shot and give the next one as directed. Do not give double doses. If you are not sure of what to do if you miss a shot, or if you miss more than one shot, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may increase the risk for calcium building up in your eyes or kidneys. You will need to have eye exams, kidney exams, and blood tests regularly to see how this medicine affects you. Keep all appointments.

The injections of this medicine may cause lumps or dents in the skin at the injection site. Choose a different injection site with each shot so lumps do not develop. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Vomiting; fever; chills; flushing; irritability; headache; numbness in the mouth; blood in the urine; trouble urinating or painful urination; severe pain in the belly, back, or groin.

Other: Itching, injection site reactions (redness, rash, pain, lumps, dents).

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in a refrigerator. Do not freeze or shake the medicine. After removing from the refrigerator, you must inject the medicine within 1 hour. Discard any unused medicine in the vial.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.