Afamelanotide

Afamelanotide is a prescription medication used for the prevention of phototoxicity and anaphylactoid reactions in adults with erythropoietic protoporphyria (EPP).

• Afamelanotide is available under the following different brand names: Scenesse

Common side effects of Afamelanotide include:

• nausea
• implant site reactions (bruising, discoloration, redness, bleeding, swelling, irritation, nodule, pain, itching)
• nausea
• mouth pain/sore throat
• cough
• fatigue
• dizziness
• darkened skin (hyperpigmentation)
• drowsiness
• melanocytic nevus
• respiratory tract infection
• non-acute porphyria
• skin irritation

Serious side effects of Afamelanotide include:

• none

Rare side effects of Afamelanotide include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Subcutaneous implant

• 16 mg/implant

Phototoxicity/Anaphylaxis & Erythropoietic Protoporphyria

Adult Dosage

• 16 mg implanted SC every two months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Afamelanotide has no noted severe interactions with any other drugs.
• Afamelanotide has no noted serious interactions with any other drugs.
• Afamelanotide has no noted moderate interactions with any other drugs.
• Afamelanotide has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Afamelanotide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Afamelanotide?”

Cautions

• Owing to its pharmacologic effect, afamelanotide may lead to generalized increased skin pigmentation and darkening of preexisting nevi and ephelides; twice-yearly full-body skin examination is recommended to monitor preexisting and new skin pigmentary lesions

Pregnancy and Lactation

• No data are available regarding use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome 
• Lactation
  • No data are available on the presence of afamelanotide or any of its metabolites in human or animal milk, its effects on the breastfed infant, or milk production