PALSONIFY Film-coated tablet Ref.[116552] Active ingredients: Paltusotine

Posology

For medically naïve patients, the recommended initial dose is 20 mg Palsonify by oral route once daily for 2 weeks and if well tolerated, the dose should be increased to 40 mg once daily. After 2 to 4 weeks on Palsonify 40 mg once daily, if 40 mg is well tolerated, the dose can be increased to 60 mg based on insulin-like growth factor-1 (IGF-1) levels or clinical signs and symptoms.

For non-medically naïve patients, the recommended initial dose is 40 mg Palsonify by oral route once a day. After 2 to 4 weeks on Palsonify 40 mg once daily, based on IGF-1 levels or clinical signs and symptoms, the dose can be increased to 60 mg once daily.

Based on tolerability (see section 4.8), the dose may be temporarily reduced by 20 mg. Once adverse reactions have resolved, paltusotine can be resumed at the previous dose.

Monitoring of IGF-1 levels and assessment of symptoms should be made periodically as per the clinician's discretion. Normalisation of IGF-1 levels may require a longer treatment duration in patients with high IGF-1 levels at baseline. In patients with elevated baseline IGF-1 levels (e.g. ≥2.5×upper limit of normal [ULN]), especially in medically naïve patients, a more regular re-evaluation of the benefit risk of the treatment in monotherapy should be considered.

Missed dose

If the daily dose of Palsonify is missed, the patient should be told not to take the missed dose and continue with the next scheduled dose.

Drug-drug interactions

Strong inducer of CYP3A4/5, UGT1A1, and P-gp

In case of co-administration with strong inducers (e.g. carbamazepine), based on IGF-1 levels and patient's safety, paltusotine dose should be increased up to three-fold the therapeutic dose without exceeding 120 mg daily (see section 4.5).

Moderate or weak inducer of CYP3A4/P-gp

In case of co-administration with moderate (e.g. efavirenz) or weak (e.g. prednisone) inducers, based on IGF-1 levels and patient's safety, paltusotine dose may be increased without exceeding 120 mg daily (see section 4.5).

Proton pump inhibitor (PPI)

In case of co-administration with PPIs (e.g. lansoprazole, omeprazole), dose of paltusotine may be increased up to two-fold the therapeutic dose based on IGF-1 levels and patient's safety (see section 4.5).

Special populations

Elderly (≥65 years old)

No dose adjustment is required based on age (see section 5.2).

Hepatic impairment

No dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see section 5.2).

Renal impairment

No dose adjustment is required in patients with mild, moderate or severe renal impairment (see section 5.2).

Paediatric population

The safety and efficacy of Palsonify in children aged below 18 years have not been established. No data are available.

Method of administration

Oral use.

This medicinal product should be swallowed whole with a glass of water, on an empty stomach, at least 6 hours after a meal (e.g. after overnight fast), and at least 1 hour prior to a meal.

There are no clinical data available on the effects associated with overdose and no incidents of overdose have been observed with paltusotine. Animal studies indicate that bradycardia or hypertension may result from overdose. If overdose is suspected, supportive treatment should be employed in the management of overdose with a medicinal product with potential bradycardia.

30 months.

This medicinal product does not require any special storage conditions.

A heat induction sealed, white high-density polyethylene (HDPE) bottle with a white child-resistant polypropylene (PP) closure.

Each bottle contains 60 film-coated tablets and a silica gel desiccant.

Each carton contains one bottle.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.