afamelanotide (Rx)

Brand and Other Names:Scenesse
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

subcutaneous implant

  • 16mg/implant

Phototoxicity/Anaphylaxis & Erythropoietic Protoporphyria

Indicated for prevention of phototoxicity and anaphylactoid reactions in adults with erythropoietic protoporphyria (EPP)

16 mg implanted SC q2Months

Safety and efficacy not established

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Adverse Effects

>10%

Implant site reaction (21%)

Nausea (19%)

1-10%

Oropharyngeal pain (7%)

Fatigue (6%)

Skin hyperpigmentation (4%)

Dizziness (4%)

Melanocytic nevus (4%)

Respiratory tract infection (4%)

Somnolence (2%)

Nonacute porphyria (2%)

Skin irritation (2%)

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Warnings

Contraindications

None

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 recommended to monitor preexisting and new skin pigmentary lesions

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Pregnancy & Lactation

Pregnancy

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

Animal data

In animal reproductive and development toxicity studies, no adverse developmental effects were observed with administration during organogenesis to pregnant rats at SC doses up to 12 times the maximum recommended human dose (MRHD)

Lactation

No data are available on the presence of afamelanotide or any of its metabolites in human or animal milk, effects on the breastfed infant, or on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Erythropoietic protoporphyria is a rare disorder caused by mutations leading to impaired activity of ferrochelatase, an enzyme involved in heme production; decreased ferrochelatase activity leads to protoporphyrin IX (PPIX) accumulation in the body; light reaching the skin can react with PPIX, causing intense skin pain and skin changes (eg, redness, thickening)

Afamelanotide, a melanocortin-1 receptor (MC1-R) agonist, increases production of eumelanin (the most common type of melanin) in the skin independent of exposure to sunlight or artificial light sources

Absorption

Peak plasma time: 36 hr

Peak plasma concentration: 3.7 ng/mL

AUC: 42.6 hr⋅ng/mL

Metabolism

Not fully characterized; may undergo hydrolysis

Elimination

Half-life: 15 hr

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Administration

SC Implant Preparation

Equipment required

  • Afamelanotide implant
  • SFM implantation cannula (contact manufacturer for other suitable implantation devices)
  • Sterile gloves
  • Local anesthetic, needle, and syringe
  • Blunt forceps suitable for removing implant from vial
  • Sterile gauze, adhesive bandage, pressure bandage

SC Implant Administration

Also see prescribing information for instructions and diagrams

Step 1

  • Remove implant from refrigerator and allow to gradually warm up to ambient temperature
  • Remove the seal and stopper from the glass vial containing implant; remove implant from vial using the blunt forceps under aseptic conditions and place on sterile gauze

Step 2

  • Position patient in a comfortable reclined supine position
  • Identify the insertion site 3-4 cm above the anterior suprailiac crest and disinfect the skin surface

Step 3 (optional)

  • Anesthetize insertion area if deemed necessary and in consultation with the patient

Step 4

  • While pinching skin at insertion site, insert the cannula with the bevel facing upwards (away from the abdomen) at a 30-45º angle into the SC layer
  • Advance the cannula 2 cm into the SC layer

Step 5

  • Remove stylet (obturator) from the cannula, maintaining aseptic precautions
  • Load the implant into the cannula
  • Using the stylet (obturator), gently push the implant down the full length of the cannula’s shaft

Step 6

  • Apply pressure to implant site while removing the stylet (obturator) and cannula
  • Verify that no implant or implant portion remains in the cannula

Step 7

  • Verify the correct insertion and placement of the implant by palpating the skin overlying the implant

Step 8

  • Apply dressing to the insertion site
  • Leave dressing in place for 24 hr

Step 9

  • Monitor the patient for 30 minutes after implant administration

Storage

Refrigerate at 2-8ºC (36-46ºF)

Protect from light

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.