Setmelanotide

Generic name
Setmelanotide
Brand name
ATC Code
A08AA12
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Setmelanotide

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Simulations of population PK analyses indicate slightly higher exposure in younger patients (who also have lower body weight). [SmPC]

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Obesity and hunger control caused by deficiency of leptin receptors (LEPR) or pro-opiomelanocortin (POMC), including PCSK-1 deficiency
  • Subcutaneous
    • 6 years up to 12 years
      • Titrate dose if needed based on effect and tolerability
        Week 1 and 2 0,5 mg/day in 1 dose
        Week 3 and 4 1 mg/day in 1 dose
        Week 5 and further
        		 2 mg/day in 1 dose
        If the clinical response is insufficient and dose of 2 mg/day is well tolerated 2,5 mg/day in 1 dose

         

    • 12 years up to 18 years
      • Titrate dose if needed based on effect and tolerability
        Week 1 en 2 1 mg/day in 1 dose
        Week 3 and further 2 mg/day in 1 dose
        If the clinical response is insufficient and the dose of 2 mg/day is well tolerated 2,5 mg/day in 1 dose
        If the clinical response is insufficient and the dose of 2,5  mg/day is well tolerated 3 mg/day in 1 dose

         

    • 2 years up to 6 years and 30 up to 40 kg
      • Titrate dose if needed based on effect and tolerability
        Week 1 and 2 0,5 mg/day in 1 dose. 
        Week 3 and 4 1 mg/day in 1 dose
        Week 5 and further  1,5 mg/day in 1 dose

         

    • 2 years up to 6 years and 30 up to 40 kg
      [1]
      • Titrate dose if needed based on effect and tolerability
        Week 1 and 2 0,5 mg/day in 1 dose. 
        Week 3 and 4 1 mg/day in 1 dose
        Week 5 and further  1,5 mg/day in 1 dose

         
Bardet-Biedl syndrome
  • Subcutaneous
    • 2 years up to 6 years and 20 up to 30 kg
      • Titrate dose if needed based on effect and tolerability
        Week 1 and 2 0,5 mg/day in 1 dose. Decrease if needed to 0,25 mg/day
        Week 3 and further  1 mg/day in 1 dose

         

    • 2 years up to 6 years and ≥ 40 kg
      • Titrate dose if needed based on effect and tolerability
        Week 1 and 2 0,5 mg/day in 1 dose. Decrease if needed to 0,25 mg/day
        Week 3 and 4 1 mg/day in 1 dose
        Week 5 and 6 1,5 mg/day in 1 dose
        Week 7 and 8 2 mg/day in 1 dose
        Week 9 and further 2,5 mg/day in 1 dose

         

    • 2 years up to 6 years and < 20 kg
      • 0.5 mg/day in 1 dose If needed decrease dose to 0,25 mg/day.
    • 6 years up to 16 years
      • Week 1 1 mg/day in 1 dose
        Week 2 (if 1 mg is well tolerated) 2 mg/day in 1 dose
        Week 3 and further (if 2 mg is well tolerated) 3 mg/day in 1 dose

         

      • Dose titration based on effect and tolerability

    • ≥ 16 years
      • Week 1 and 2 2 mg/day in 1 dose
        Week 3 and further (if 2 mg is well tolerated) 3 mg/day in 1 dose

         

      • Dose titration based on effect and tolerability

    • 2 years up to 6 years and < 20 kg
      • 0.5 mg/day in 1 dose If needed decrease dose to 0,25 mg/day.
    • 2 years up to 6 years and 20 up to 30 kg
      • Titrate dose if needed based on effect and tolerability
        Week 1 and 2 0,5 mg/day in 1 dose. Decrease if needed to 0,25 mg/day
        Week 3 and further  1 mg/day in 1 dose

         

    • 2 years up to 6 years and ≥ 40 kg
      • Titrate dose if needed based on effect and tolerability
        Week 1 and 2 0,5 mg/day in 1 dose. Decrease if needed to 0,25 mg/day
        Week 3 and 4 1 mg/day in 1 dose
        Week 5 and 6 1,5 mg/day in 1 dose
        Week 7 and 8 2 mg/day in 1 dose
        Week 9 and further 2,5 mg/day in 1 dose

         

Renal impaiment in children > 3 months

According to the manufacturer in severe renal impairment:

POMC, including PCSK1, deficiency and LEPR deficiency

  • children 6-11 years initially 0.25 mg 1x per day for weeks 1 and 2, if not tolerating the starting dose discontinue treatment, if well tolerated increase to 0.5 mg 1x per day for weeks 3-5, then increase to 1 mg 1x per day from week 6, if additional weight loss is desired increase to max. 2 mg 1x per day;
  • children 12 years and older initially 0.5 mg 1x daily for weeks 1 and 2, if not tolerated decrease to 0.25 mg 1x daily, if treatment is well tolerated increase to 1 mg 1x daily from week 3; if additional weight loss is desired increase to 2 mg 1x daily and thereafter to 2.5 mg 1x daily, if dose increase is well tolerated further increase to max. 3 mg 1x daily if necessary;

Bardet-Biedl Syndrome

  • children 6-15 years initially 0.25 mg 1x per day for weeks 1 and 2, if not tolerating the starting dose discontinue treatment, if well tolerated increase to 0.5 mg 1x per day for weeks 3-5, then increase to 1 mg 1x per day from week 6, if additional weight loss is desired increase to max. 2 mg 1x per day;
  • children 16 years and older initially 0.5 mg 1x daily for weeks 1 and 2, if not tolerated decrease to 0.25 mg 1x daily, if treatment is well tolerated increase to 1 mg 1x daily from week 3; if additional weight loss is desired increase to 2 mg 1x daily and thereafter to 2.5 mg 1x daily, if dose increase is well tolerated further increase to max. 3 mg 1x daily if necessary;

if after the initial dose a subsequent dose level is not tolerated, the dose should be reduced back to the previous dose level. If the reduced dose is tolerated, dosing should be followed again.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The frequency, type type and severity of adverse events in the adult and pediatric populations are similar

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In growing children, periodically assess the impact of weight loss on growth and maturation. Monitor height and weight using appropriate growth curves based on age and gender.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Reference

  1. Rhythm Pharmaceuticals Netherlands B.V, SmPC Imcivree (EU/1/21/1564/0001) Rev 11, 30-09-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose