Fosdenopterin (Intravenous route)
- 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:
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.
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.
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.
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.
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.
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:
- More common
- cold flu-like symptoms
- cough or hoarseness
- increased sensitivity of the skin to sunlight
- redness or other discoloration of the skin
- severe sunburn
- skin rash
- Less common
- body aches or pain
- chest pain or tightness
- ear congestion
- loss of appetite
- loss of voice
- pale skin
- rash with flat lesions or small raised lesions on the skin
- redness or swelling in the ear
- runny or stuffy nose
- sore throat
- stomach pain
- swelling of the eye
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- 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
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:
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:
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.
Last Updated: 3/30/2022