Narcolepsy

Active Ingredient: Pitolisant

Indication for Pitolisant

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Pitolisant is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy.

For this indication, competent medicine agencies globally authorize below treatments:

9 mg once daily at week 1, that may be increased to 18 mg once daily at week 2 and 30 mg once daily at week 3

For:

Dosage regimens

Oral, 9 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 18 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 36 milligrams pitolisant, once daily to breakfast.

Detailed description

Pitolisant should be used at the lowest effective dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day:

  • Week 1: initial dose of 9 mg (two 4.5 mg tablets) per day.
  • Week 2: the dose may be increased to 18 mg (one 18 mg tablet) per day or decreased to 4.5 mg (one 4.5 mg tablet) per day.
  • Week 3: the dose may be increased to 36 mg (two 18 mg tablets) per day.

At any time the dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day) according to the physician assessment and the patient's response.

The total daily dose should be administered as a single dose in the morning during breakfast.

Maintenance of efficacy

As long-term efficacy data are limited, the continued efficacy of treatment should be regularly evaluated by the physician.

Poor metabolizers

By comparison to CYP2D6 extensive metabolisers, higher systemic exposure (up to 3 fold) is observed in CYP2D6 poor metabolisers. In the up-titration scheme, dose increment should take into account this higher exposure.

4.5 mg once daily at week 1 up-titrated to 18 mg/day in children weighing <40 kg and to 36 mg/day in children weighing ≥40 kg

For:

Dosage regimens

Regimen A, in case that patient age in years is ≥ 6 and patient weight is < 40 kg

Oral, 4.5 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 9 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 18 milligrams pitolisant, once daily to breakfast, over the duration of 1 week.

Regimen B, in case that patient age in years is ≥ 6 and patient weight is ≥ 40 kg

Oral, 4.5 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 9 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 18 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 36 milligrams pitolisant, once daily to breakfast.

Detailed description

Pitolisant should be used at the optimal dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day (18 mg/day in children weighing less than 40 kg).

  • Week 1: initial dose of 4.5 mg per day.
  • Week 2: the dose may be increased to 9 mg per day.
  • Week 3: the dose may be increased to 18 mg per day.
  • Week 4: in children weighing 40 kg and above, the dose may be increased to 36 mg per day.

At any time, the dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day in children weighing 40 kg and above or 18 mg per day in children weighing less than 40 kg) according to the physician assessment and the patient's response. The total daily dose should be administered as a single dose in the morning during breakfast.

Poor metabolizers

By comparison to CYP2D6 extensive metabolisers, higher systemic exposure (up to 3 fold) is observed in CYP2D6 poor metabolisers. In the up-titration scheme, dose increment should take into account this higher exposure.

Active ingredient

Pitolisant

Pitolisant is a potent, orally active histamine H3-receptor antagonist/inverse agonist which, via its blockade of histamine auto-receptors enhances the activity of brain histaminergic neurons, a major arousal system with widespread projections to the whole brain. Pitolisant also modulates various neurotransmitter systems, increasing acetylcholine, noradrenaline and dopamine release in the brain.

Read more about Pitolisant

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