Setmelanotide parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of setmelanotide.
Drugs List
Therapeutic Indications
Uses
Appetite control in the treatment of obesity
Treatment of obesity and appetite control associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin, including PCSK1, deficiency or biallelic leptin receptor deficiency in adults and children aged 6 years and above.
Dosage
Adults
Initial
1mg once daily for 2 weeks.
Maintenance
If setmelanotide is well tolerated after 2 weeks, the dose can be increased to 2mg once daily. If a dose increase is not tolerated, a dose of 1mg once daily can be maintained.
If additional weight loss is desired, the dose can be increased to 2.5mg once daily. If this dose increase is well tolerated, the dose can be increased to 3mg once daily.
Children
Children aged 12 to 18 years
Initial
1mg once daily for 2 weeks.
Maintenance
If setmelanotide is well tolerated after 2 weeks, the dose can be increased to 2mg once daily. If a dose increase is not tolerated, a dose of 1mg once daily can be maintained.
If the patients weight remains above the 90th percentile with the 2mg once daily dose and additional weight loss is desired, dose can be increased to 2.5mg once daily with a maximum dose of 3mg once daily.
Children aged 6 to 12 years
Initial
0.5mg once daily for 2 weeks.
Maintenance
If setmelanotide is well tolerated after 2 weeks, the dose can be increased to 1mg once daily. If a dose increase is not tolerated, a dose of 0.5mg once daily can be maintained. If the dose increase of 1mg once daily is tolerated after 2 weeks, the dose may be increased to 2mg once daily.
If the patients weight remains above the 90th percentile with the 2mg once daily dose and additional weight loss is desired, dose can be increased to 2.5mg once daily.
Patients with Renal Impairment
Patients aged 12 years and over with mild renal impairment
Initial dose is 0.5mg once daily for 2 weeks. If well tolerated after 2 weeks, the dose may be increased to 1mg once daily. If the 1mg once daily dose is tolerated after 2 weeks, the dose may be increased to 2mg once daily. If additional weight loss is desired, the dose may be increased to 2.5mg once daily. If the dose increase of 2.5mg once daily is well tolerated, the dose may be increased to 3mg once daily.
Children aged 6 to 12 years with mild renal impairment
Initial dose is 0.5mg once daily for 2 weeks. If well tolerated after 2 weeks, the dose may be increased to 1mg once daily. If the 1mg once daily dose is tolerated after 2 weeks, the dose may be increased to 2mg once daily. Maximum dose is 2mg once daily.
Additional Dosage Information
Missed dose
In the event of a missed dose, the once daily regimen should be resumed at the dose prescribed.
Administration
For subcutaneous injection into the abdomen. Injection site in the abdomen should alternate each day.
Contraindications
Children under 6 years
Breastfeeding
Hepatic impairment
Moderate renal impairment
Pregnancy
Precautions and Warnings
Depression
Mild renal impairment
Reduce dose in patients with renal impairment
Monitor growth of children during treatment
Treatment to be initiated and supervised by a specialist
Contains benzyl alcohol
Rotate the injection site
Monitor for depressive disorders/suicidal ideation-consider discontinuation
Monitor heart rate and blood pressure regularly
Reassess need for continued treatment at regular intervals
Advise patient to report any erection lasting more than 4 hours
Generalised increased skin pigmentation and darkening of pre-existing nevi may result from treatment with setmelanotide. Full body skin monitoring should be conducted at least annually to monitor pre-existing and new skin pigmentary lesions before and during setmelanotide treatment.
Pregnancy and Lactation
Pregnancy
Setmelanotide is contraindicated during pregnancy.
Use of setmelanotide during pregnancy or while attempting to become pregnant is contraindicated by the manufacturer. Animal studies have reported decreased maternal food consumption leading to embryo-foetal effect. Human data is limited and as such a potential risk cannot be ruled out.
In the event of a patient becoming pregnant whilst at a stable weight, consideration should be given to maintaining treatment. In the event of a patient who is still losing weight becoming pregnant, setmelanotide should either be discontinued, or the dose reduced whilst carefully monitoring the patients weight during treatment with setmelanotide.
Pregnant patients should be advised of the potential risk from the excipient benzyl alcohol, which might accumulate over time and cause metabolic acidosis.
Lactation
Setmelanotide is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues setmelanotide or discontinues breastfeeding. Animal data reports levels of setmelanotide in the breast milk, however presence in human breast milk is unknown. Effects on exposed infants are unknown.
Counselling
Inject setmelanotide at the beginning of the day to help maximise hunger reduction during awake period, without regard to the timing of meals.
Advise patient to rotate injection site regularly.
Advise patient to report any erection lasting more than 4 hours.
Side Effects
Abdominal discomfort
Abdominal distension
Abdominal pain
Alopecia
Arthralgia
Asthenia
Back pain
Changes in libido
Chest pain
Chills
Constipation
Depression
Dermatitis
Diarrhoea
Dizziness
Dry mouth
Dry skin
Dyspepsia
Dysplastic nevus
Ejaculation disorders
Erectile disturbance
Erythema
Eye nevus
Fatigue
Flatulence
Genital discomfort
Genital hyperaesthesia
Gingival discolouration
Headache
Hot flushes
Hyperaesthesia
Hyperhidrosis
Hyperpigmentation of skin
Insomnia
Local reaction at injection site
Melanocytic naevus
Migraine
Muscle spasm
Musculoskeletal chest pain
Myalgia
Nail disorders
Nausea
Pain
Parosmia
Pruritus
Rash
Salivary hypersecretion
Scleral discolouration
Scleral icterus
Sexual disturbances
Skin cysts
Sleep disorders
Somnolence
Spontaneous penile erection
Taste disturbances
Temperature disturbances
Vertigo
Vomiting
Yawning
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: October 2022
Reference Sources
Summary of Product Characteristics: Imcivree 10mg/ml solution for injection. Rhythm Pharmaceutical UK Ltd. Revised April 2022.
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