- 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]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Obesity and hunger control caused by deficiency of leptin receptors (LEPR) or pro-opiomelanocortin (POMC), including PCSK-1 deficiency | ||||||||||||||||||||||||||||||||||||
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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.
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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
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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Reference
- Rhythm Pharmaceuticals Netherlands B.V, SmPC Imcivree (EU/1/21/1564/0001) Rev 11, 30-09-2024, www.ema.europa.eu
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Changes
Changes
