Nulibry

Nulibry is used to lower 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 newborns that impacts brain function and worsens over time. Babies with MoCD usually start to show symptoms within a week after birth, and this condition can cause serious developmental delays and dangerous health issues.

Nulibry may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your medicine label and packaging. Inform all of your child's healthcare providers about all of your child's medical conditions, allergies, and medications.

Your doctor will do a genetic test to confirm if your baby has MoCD.

Nulibry is sometimes given before the results of the genetic test are ready. Treatment will be stopped if the test shows that your baby does not have MoCD.

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

Call your doctor right away if your child has:

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

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 of Nulibry may include:

• issues with the catheter or IV line;
• fever;
• vomiting, diarrhea; or
• cold symptoms like a stuffy nose, sneezing, cough.

This is not a complete list of side effects, and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

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.

Nulibry 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.

Nulibry 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.

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

Store unmixed Nulibry 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.

Give the medicine as soon as possible, then give the next injection at least 6 hours later and return to the usual daily injection schedule. Do not give two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Nulibry may cause your child to get sunburned more easily. Avoid sunlight and tanning beds. Make sure the child wears protective clothing, a hat, and sunglasses when outside. Also, apply sunscreen (SPF 30 or higher) if your child is at least 6 months old.

Other drugs may affect Nulibry, 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.