Scenesse

— THERAPEUTIC CATEGORIES —
  • Inborn errors of metabolism

Scenesse Generic Name & Formulations

General Description

Afamelanotide 16mg; per implant; for SC use.

Pharmacological Class

Melanocortin receptor agonist.

How Supplied

Implant (in vial)—1

Generic Availability

NO

Scenesse Indications

Indications

To increase pain free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria.

Scenesse Dosage and Administration

Adult

See full labeling. Use an SFM implantation cannula or other suitable devices. ≥18yrs: Insert 1 implant subcutaneously above the anterior supra-iliac crest every 2 months.

Children

<18yrs: not established.

Scenesse Contraindications

Not Applicable

Scenesse Boxed Warnings

Not Applicable

Scenesse Warnings/Precautions

Warnings/Precautions

Should be administered by an experienced health care provider. Pre-existing nevi and ephelides. Monitor skin pigmentary lesions; perform full body skin exam twice yearly. Advise patients to maintain sun and light protection measures during treatment to prevent phototoxic reactions. Pregnancy. Nursing mothers.

Scenesse Pharmacokinetics

See Literature

Scenesse Interactions

Not Applicable

Scenesse Adverse Reactions

Adverse Reactions

Implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, skin irritation; skin pigmentation/darkening.

Scenesse Clinical Trials

See Literature

Scenesse Note

Not Applicable

Scenesse Patient Counseling

See Literature