Fosdenopterin Injection

What is this medication?

FOSDENOPTERIN (FOS den OP ter in) is cyclic pyranopterin monophosphate (cPMP). It is used to decrease the risk of death in patients with molybdenum cofactor deficiency type A. It is not a cure for molybdenum cofactor deficiency type A.

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

COMMON BRAND NAME(S): Nulibry

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

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

• an unusual or allergic reaction to fosdenopterin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is injected into a vein. It is usually given by a health care provider in a hospital or clinic setting. It may also be given at home. If you get this medicine at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label at the same time every day. Keep taking it unless your health care provider tells you to stop.

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 health care provider to get one.

This medicine comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medicine. Read the information carefully. Talk to your pharmacist or health care provider if you have questions.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as newborns 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 get this medicine at the hospital or clinic: It is important not to miss your dose. Call your health care provider if you are unable to keep an appointment.

If you give yourself this medicine at home: If you miss a dose, take it as soon as you can. Then administer the next scheduled dose at least 6 hours after taking the missed dose. Do not take double or extra doses. Call your health care provider with questions.

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 health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths.

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 (skin rash, itching, or hives; swelling of the face, lips, or tongue)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• pain, redness, or irritation at site where injected

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

• diarrhea
• stomach pain
• vomiting

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 and pets.

Store unopened vials in the freezer between -25 and -10 degrees C (-13 and 14 degrees F). Keep it in the original carton until you are ready to use it. Protect from light. Remove the dose from the carton about 30 minutes before it is time for you to use it.

After mixing store at room temperature between 15 and 25 degrees C (59 and 77 degrees F) or in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F) until you are ready to take the dose. Use it within 4 hours of mixing.

Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, ask your pharmacist or health care provider how to get rid of this medicine safely.

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.