Asfotase alfa solution for injection

What is this medication?

ASFOTASE ALFA (AZ fo tase AL fa) is a drug that is used to replace an enzyme in patients with hypophosphatasia (HPP). It is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Strensiq

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• kidney stones or other kidney disease
• an unusual reaction to asfotase alfa, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine. While this drug may be prescribed for children and infants for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You may need blood work or kidney tests done while you are taking this medicine. You will also receive eye exams regularly. Tell your doctor or health care professional if you have any change in your eyesight.

You can be a part of a registry for patients with hypophosphatasia. This registry may ask for information over a long time. Ask your healthcare professional for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• blood in the urine, pain in the lower back or side, pain when urinating
• changes in vision
• fever or chills
• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• irritable
• nausea
• pain, bruising, redness, or irritation at site where injected
• skin thickening or pits in the skin due to overuse of a particular injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store unopened vials in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Do not shake. Protect from light. Keep in the original carton until time of use. Use within 1 hour upon removal of the vial(s) from refrigeration. Throw away any unused medicine in an opened vial. Throw away any unused unopened vials after the expiration date on the carton.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.