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Pronunciation: FOS den OP ter in

Brand: Nulibry

What is the most important information I should know about fosdenopterin?

Follow all directions on your medicine label and package. Tell each of your child's healthcare providers about all the child's medical conditions, allergies, and medicines.

What is fosdenopterin?

Fosdenopterin is used to reduce the risk of death in children with molybdenum cofactor deficiency (MoCD) Type A.

Molybdenum (moe-LIB-den-um) cofactor deficiency is a rare condition in newborn babies that affects brain function and gets worse over time. Babies with MoCD begin to show symptoms within a week after birth, and this condition can lead to severe developmental delays and life-threatening health problems.

Fosdenopterin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using fosdenopterin?

Your doctor will perform a genetic test to make sure your baby has MoCD.

Fosdenopterin is sometimes given before genetic testing results are available. Treatment will be stopped if the test shows that your baby does not have MoCD.

How should I use fosdenopterin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your child's dose. Use the medicine exactly as directed.

Fosdenopterin is given using an infusion pump attached to a catheter placed into a vein. A healthcare provider can teach you how to properly use the infusion pump by yourself.

You may need to keep a diary of the dates and times for each dose you give to your child. You may also need to record information about the specific vials and amounts of fosdenopterin you use each time. Take this information with you every time you take your child t the doctor.

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

Fosdenopterin must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Do not shake the mixed medicine.

Prepare an injection only when you are ready to give it. Each infusion should be finished within 4 hours after you mixed the medicine with the diluent.

Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Fosdenopterin doses are based on weight. Your child's dose needs may change if the child gains or loses weight.

Store unmixed fosdenopterin in a freezer. Keep each vial in its original carton and protect from light.

Take the medicine out of the freezer and let it reach room temperature for 30 minutes before mixing with the diluent. You may also warm the medicine in your hands for 3 to 5 minutes. Do not heat the medicine.

You may store mixed medicine in the refrigerator or at room temperature. If stored in a refrigerator, allow the mixture to reach room temperature before giving the injection. Complete the injection within 4 hours after mixing the medicine.

What happens if I miss a dose?

Give the medicine as soon as you can, then give the next injection at least 6 hours later and return to the regular daily injection schedule. Do not give two doses at one time.

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 fosdenopterin?

Fosdenopterin could make your child sunburn more easily. Avoid sunlight or tanning beds. Be sure the child wears protective clothing, a hat, and sunglasses while outdoors. Also apply sunscreen (SPF 30 or higher) if your child is at least 6 months old.

What are the possible side effects of fosdenopterin?

Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has:

  • a fever;
  • severe or ongoing vomiting or diarrhea;
  • bruising, swelling, discomfort, or skin changes around the catheter;
  • cough with mucus, trouble breathing;
  • a seizure; or
  • signs of an ear infection --fever, ear pain, drainage from the ear, fussiness.

Seek emergency medical attention if your child has a skin rash or symptoms of serious sunburn such as skin redness, burning, or blisters.

Common side effects may include:

  • problems with the catheter or IV line;
  • fever;
  • vomiting, diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, cough.

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 fosdenopterin?

Other drugs may affect fosdenopterin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your child's current medicines and any medicines the child starts or stops using.

Where can I get more information?

Your pharmacist can provide more information about fosdenopterin.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 1.01. Revision date: 3/16/2021.

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