Drugs List

Therapeutic Indications

Uses

Erythropoietic protoporphyria

Administration

For subcutaneous injection.

Contraindications

Children under 18 years
Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment
Severe hepatic disorder

Precautions and Warnings

Females of childbearing potential
Patients over 70 years
Risk factors for skin cancer
Addison's disease
Cardiovascular disorder
Cushing's disease
Endocrine disease
Gastrointestinal disorder
Haematological disorder
History of skin cancer
Neurological disorder
Peutz-Jeghers syndrome
Pre-malignant skin lesions
Respiratory disease

Advise ability to drive/operate machinery may be affected by side effects
Treatment to be prescribed and administered by a specialist
Evaluate benefit/risk in long term use >2 years
Perform skin examination every 6 months during treatment
Advise patient to immediately report new skin lesions
Monitor for hypersensitivity reactions for 30 minutes after administration
Female: Contraception required during and for 3 months after treatment
Advise patient on appropriate sun protection methods

The safety of afamelanotide implant has not been evaluated for a duration of longer than 2 years.

Monitor for vital signs, routine haematology and biochemistry after administration of every implant in patients over 70 years of age and those with clinically significant disorders of the gastrointestinal, cardiovascular, respiratory, endocrine (including diabetes), neurological (including seizures) and haematological systems (especially anaemia). A careful decision must be made whether to treat patients with any of these conditions with afamelanotide.

Afamelanotide may induce darkening of pre-existing pigmentary lesions. Monitor changes in pigmentary lesions and other skin abnormalities during the two full body examinations per year. Dermatology specialist advice should be sought with any skin changes that are consistent with skin cancer or its precursors. Special precaution is required in patients with an individual or family history of melanoma (including in-situ melanoma, e.g. lentigo maligna) or suspected or confirmed susceptibility to cutaneous melanoma and/or an individual history of basal cell carcinoma, squamous cell carcinoma (including carcinoma in situ, e.g. Bowen's disease), Merkel cell carcinoma, or other malignant or premalignant skin lesions.

Pregnancy and Lactation

Pregnancy

Afamelanotide is contraindicated during pregnancy.

The use of afamelanotide during pregnancy and in women of childbearing potential not using effective contraception is contraindicated by the manufacturer. At the time of writing, human data is limited and animal studies are insufficient with respect to developmental toxicity. The potential risks in human pregnancy are unknown.

Lactation

Afamelanotide is contraindicated during breastfeeding.

Use of afamelanotide when breastfeeding is contraindicated by the manufacturer. It is unknown if afamelanotide or any of its metabolites are excreted in human milk. A risk to neonates cannot be excluded.

Side Effects

Abdominal distension
Abdominal pain
Acne
Alanine aminotransferase increased
Arthralgia
Aspartate aminotransferase increased
Asthenia
Back pain
Burning sensation
Candidiasis
Cheilitis
Creatine phosphokinase increased
Cystitis
Depressed mood
Depression
Diarrhoea
Discolouration (injection site)
Discolouration of hair
Disturbances of appetite
Dizziness
Dysgeusia
Dyspepsia
Eczema
Erythema
Erythema at application site
Erythematous rash
Extrusion of implant
Eye disorder
Fatigue
Feeling hot
Flatulence
Flushing
Folliculitis
Gastritis
Gastroesophageal reflux disease
Gastrointestinal disorder
Haemangioma
Haematoma
Haematoma (injection site)
Haematuria
Hangover
Headache
Hyperaesthesia
Hypercholesterolaemia
Hyperhidrosis
Hypertension
Hypertrophy (injection site)
Hypoaesthesia
Increase in plasma cholesterol
Increase in serum glucose
Increase of liver transaminases
Influenza-like symptoms
Insomnia
Irritation (injection site)
Irritation at application site
Lethargy
Leukopenia
Lichen planus
Liver function disturbances
Melanocytic naevus
Menstrual disturbances
Migraine
Mouth discolouration
Muscle pain
Myalgia
Naso-sinus congestion
Nasopharyngitis
Nausea
Oedema (injection site)
Oedema of the lips
Pain at application site
Palpitations
Papular eruption
Peripheral oedema
Presyncope
Pruritic rash
Pruritus
Pyrexia
Reduced libido
Restless legs
Rhinitis
Seborrhoea
Sensation of heaviness
Serum iron decrease
Skin exfoliation
Skin pigmentation changes
Sleep disturbances
Somnolence
Sore gums
Syncope
Tachycardia
Tinnitus
Tooth ache
Transferrin saturation decreased
Upper respiratory tract infection
Vaginal discharge
Vitiligo
Vomiting
Wound complication

Presentation

Implants containing afamelanotide.

Drugs List

Therapeutic Indications

Uses

Erythropoietic protoporphyria

Dosage

The implant is administered prior to expected and during increased sunlight exposure, e.g. from spring to early autumn. The number of implants depends on the length of protection required.

Adults

Administration

For subcutaneous injection.

Contraindications

Children under 18 years
Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment
Severe hepatic disorder

Precautions and Warnings

Females of childbearing potential
Patients over 70 years
Risk factors for skin cancer
Addison's disease
Cardiovascular disorder
Cushing's disease
Endocrine disease
Gastrointestinal disorder
Haematological disorder
History of skin cancer
Neurological disorder
Peutz-Jeghers syndrome
Pre-malignant skin lesions
Respiratory disease

Advise ability to drive/operate machinery may be affected by side effects
Treatment to be prescribed and administered by a specialist
Evaluate benefit/risk in long term use >2 years
Perform skin examination every 6 months during treatment
Advise patient to immediately report new skin lesions
Monitor for hypersensitivity reactions for 30 minutes after administration
Female: Contraception required during and for 3 months after treatment
Advise patient on appropriate sun protection methods

The safety of afamelanotide implant has not been evaluated for a duration of longer than 2 years.

Monitor for vital signs, routine haematology and biochemistry after administration of every implant in patients over 70 years of age and those with clinically significant disorders of the gastrointestinal, cardiovascular, respiratory, endocrine (including diabetes), neurological (including seizures) and haematological systems (especially anaemia). A careful decision must be made whether to treat patients with any of these conditions with afamelanotide.

Afamelanotide may induce darkening of pre-existing pigmentary lesions. Monitor changes in pigmentary lesions and other skin abnormalities during the two full body examinations per year. Dermatology specialist advice should be sought with any skin changes that are consistent with skin cancer or its precursors. Special precaution is required in patients with an individual or family history of melanoma (including in-situ melanoma, e.g. lentigo maligna) or suspected or confirmed susceptibility to cutaneous melanoma and/or an individual history of basal cell carcinoma, squamous cell carcinoma (including carcinoma in situ, e.g. Bowen's disease), Merkel cell carcinoma, or other malignant or premalignant skin lesions.

Pregnancy and Lactation

Pregnancy

Afamelanotide is contraindicated during pregnancy.

The use of afamelanotide during pregnancy and in women of childbearing potential not using effective contraception is contraindicated by the manufacturer. At the time of writing, human data is limited and animal studies are insufficient with respect to developmental toxicity. The potential risks in human pregnancy are unknown.

Lactation

Afamelanotide is contraindicated during breastfeeding.

Use of afamelanotide when breastfeeding is contraindicated by the manufacturer. It is unknown if afamelanotide or any of its metabolites are excreted in human milk. A risk to neonates cannot be excluded.

Side Effects

Abdominal distension
Abdominal pain
Acne
Alanine aminotransferase increased
Arthralgia
Aspartate aminotransferase increased
Asthenia
Back pain
Burning sensation
Candidiasis
Cheilitis
Creatine phosphokinase increased
Cystitis
Depressed mood
Depression
Diarrhoea
Discolouration (injection site)
Discolouration of hair
Disturbances of appetite
Dizziness
Dysgeusia
Dyspepsia
Eczema
Erythema
Erythema at application site
Erythematous rash
Extrusion of implant
Eye disorder
Fatigue
Feeling hot
Flatulence
Flushing
Folliculitis
Gastritis
Gastroesophageal reflux disease
Gastrointestinal disorder
Haemangioma
Haematoma
Haematoma (injection site)
Haematuria
Hangover
Headache
Hyperaesthesia
Hypercholesterolaemia
Hyperhidrosis
Hypertension
Hypertrophy (injection site)
Hypoaesthesia
Increase in plasma cholesterol
Increase in serum glucose
Increase of liver transaminases
Influenza-like symptoms
Insomnia
Irritation (injection site)
Irritation at application site
Lethargy
Leukopenia
Lichen planus
Liver function disturbances
Melanocytic naevus
Menstrual disturbances
Migraine
Mouth discolouration
Muscle pain
Myalgia
Naso-sinus congestion
Nasopharyngitis
Nausea
Oedema (injection site)
Oedema of the lips
Pain at application site
Palpitations
Papular eruption
Peripheral oedema
Presyncope
Pruritic rash
Pruritus
Pyrexia
Reduced libido
Restless legs
Rhinitis
Seborrhoea
Sensation of heaviness
Serum iron decrease
Skin exfoliation
Skin pigmentation changes
Sleep disturbances
Somnolence
Sore gums
Syncope
Tachycardia
Tinnitus
Tooth ache
Transferrin saturation decreased
Upper respiratory tract infection
Vaginal discharge
Vitiligo
Vomiting
Wound complication

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: September 2020

Reference Sources

Summary of Product Characteristics: Scenesse 16mg implant. Clinuvel Europe Limited. Revised November 2019.