Posology : מינונים

4.2    Posology and method of administration

Posology

Acromegaly
The recommended initial dose for the treatment of acromegaly is 40 mg of pasireotide every 4 weeks.
The dose may be increased to a maximum of 60 mg for patients whose growth hormone (GH) and/or insulin-like growth factor-1 (IGF-1) levels are not fully controlled after 3 months of treatment with Signifor LAR at 40 mg.


Management of suspected adverse reactions or over-response to treatment (IGF-1 < lower limit of normal) may require temporary dose reduction of Signifor LAR. The dose may be decreased either temporarily or permanently.

Cushing’s disease
The recommended initial dose for the treatment of Cushing’s disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks.

The patient should be evaluated for clinical benefit after the first month of treatment and periodically thereafter. The dose may be titrated every 2 to 4 months based on response and tolerability. The maximum dose of Signifor in Cushing’s disease is 40 mg every 4 weeks. If no clinical benefit is observed, the patient should be considered for discontinuation.

Management of suspected adverse reactions or over-response to treatment (cortisol levels < lower limit of normal) may require dose reduction, interruption or discontinuation of Signifor.

Switch from subcutaneous to intramuscular formulation in Cushing’s disease There are no clinical data available on switching from the subcutaneous to the intramuscular pasireotide formulation. If such a switch should be required, the recommended initial dose for the treatment of Cushing’s disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks.
The patient should be monitored for response and tolerability and further dose adjustments may be needed.

Missed dose
If a dose of Signifor LAR is missed the missed injection should be administered as soon as possible.
The next dose should then be planned for 4 weeks after the injection is administered in order to resume the normal schedule of one dose every 4 weeks.

Special populations

Elderly patients (≥65 years)
Data on the use of Signifor LAR in patients older than 65 years are limited, but there is no evidence to suggest that dose adjustment is required in these patients (see section 5.2).

Renal impairment
No dose adjustment is required in patients with impaired renal function (see section 5.2).

Hepatic impairment
Dose adjustment is not required in patients with mildly impaired hepatic function (Child Pugh A).
Acromegaly: the recommended initial dose for acromegaly patients with moderate hepatic impairment (Child Pugh B) is 20 mg every 4 weeks, and the maximum recommended dose for these patients is 40 mg every 4 weeks (see section 5.2).

Cushing's disease: the recommended initial dose for Cushing’s disease patients with moderate hepatic impairment (Child Pugh B) is 10 mg every 4 weeks, and the maximum recommended dose for these patients is 20 mg every 4 weeks (see section 5.2).

Signifor LAR should not be used in patients with severe hepatic impairment (Child Pugh C) (see sections 4.3 and 4.4).

Paediatric population
The safety and efficacy of Signifor LAR in children and adolescents aged 0 to 18 years have not been established. No data are available.


Method of administration
Signifor LAR is to be administered by deep intramuscular injection by a trained healthcare professional. Signifor LAR suspension must only be prepared immediately before administration.

The site of repeat intramuscular injections should be alternated between the left and right gluteal muscle.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.