Pronunciation:

fos-den-OP-ter-in

Brand Names:

• Nulibry

Dosage Forms:

• Powder for Solution

Uses of This Medicine:

Fosdenopterin injection is used to help reduce the risk of death caused by molybdenum cofactor deficiency (MoCD) type A.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fosdenopterin injection in the pediatric population. Safety and efficacy have been established.

Older adults—

No information is available on the relationship of age to the effects of fosdenopterin injection in geriatric patients. MoCD is usually a disease of young children.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. You or your child's caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your child's progress closely while your child is receiving this medicine to make sure that the medicine is working properly.

This medicine may cause photosensitivity. Check with your doctor right away if your child has increased sensitivity of the skin to sunlight, itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Use sunscreen or sunblock lotions with a sun protection factor (SPF) on a regular basis when you are outdoors. Wear protective clothing and hats and avoid sunlamps and tanning beds.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Chills

cold flu-like symptoms

cough or hoarseness

fever

increased sensitivity of the skin to sunlight

itching

redness or other discoloration of the skin

severe sunburn

skin rash

Less common

Agitation

body aches or pain

chest pain or tightness

cough

diarrhea

earache

ear congestion

headache

loss of appetite

loss of voice

nausea

pale skin

rash with flat lesions or small raised lesions on the skin

redness or swelling in the ear

runny or stuffy nose

seizures

sneezing

sore throat

stomach pain

swelling of the eye

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.