Active Ingredient and Strength	PASIREOTIDE PAMOATE 82.26 MG EQV PASIREOTIDE - 60 MG
Dosage Form	INJECTION, POWDER, FOR SUSPENSION
Manufacturer and Country	RECORDATI AG RARE DISEASES BRANCH (MANUFACTURE OF BULK POWDER) - SWITZERLAND NOVARTIS PHARMACEUTICAL MANUFACTURING GMBH (PRIMARY PACKAGER) - AUSTRIA ABBOTT BIOLOGICALS B.V. (MANUFACTURE, PRIMARY AND SECONDARY PACKAGER FOR SOLVENT) - NETHERLANDS SYNERGY HEALTH DANIKEN AG (STERILIZATION SITE) - SWITZERLAND
Registration Number	SIN15170P
Licence Holder	PHARM-D SINGAPORE PRIVATE LIMITED
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	H01CB05

INDICATIONS

Signifor LAR is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.

DOSAGE REGIMEN AND ADMINISTRATION

Dosage regimen

General target population

The recommended initial dose of Signifor LAR is 40 mg administered by deep intramuscular injection every 4 weeks (q28d).

The dose may be increased to a maximum of 60 mg for patients whose GH and/or 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 dose reduction of Signifor LAR. The dose may be decreased, either temporarily or permanently, by 20 mg decrements.

Missed dose

If a dose of Signifor LAR is missed, the injection should be administered as soon as possible and the next injection should be planned 4 weeks thereafter to resume normal schedule every 4 weeks.

Special populations

Renal impairment

No dose adjustment is required in patients with impaired renal function (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

Dose adjustment is not required in patients with mildly impaired hepatic function (Child-Pugh A). For patients with moderately impaired hepatic function (Child-Pugh B) the recommended initial dose is 20 mg every 4 weeks and the maximum recommended dose is 40 mg every 4 weeks (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Signifor LAR should not be used in patients with severe hepatic impairment (Child-Pugh C) (see section CONTRAINDICATIONS).

Pediatric patients

Signifor LAR is not recommended for use in pediatric patients with acromegaly as there are no clinical data available in patients under 18 years of age.

Geriatric patients (65 years of age or older)

There are limited data on the use of Signifor LAR in patients older than 65 years but there is no evidence suggesting that a dose adjustment is required in elderly patients (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

Signifor LAR should only be administered by deep intramuscular injection by a trained health care 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 (see section INSTRUCTIONS FOR USE AND HANDLING – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CONTRAINDICATIONS

Severe hepatic impairment (Child-Pugh C).