SOMATULINE DEPOT lanreotide acetate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

lanreotide acetate (UNII: IEU56G3J9C) (lanreotide - UNII:0G3DE8943Y)

Available from:

Beaufour Ipsen Pharma SAS

INN (International Name):

lanreotide acetate

Composition:

60 mg in 0.2 mL

Prescription type:

PRESCRIPTION DRUG

Summary of Product characteristics

SOMATULINE DEPOT- LANREOTIDE ACETATE INJECTION
BEAUFOUR IPSEN PHARMA SAS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
INDICATIONS AND USAGE
Somatuline Depot (lanreotide) Injection is a somatostatin analog
indicated for:
the long-term treatment of acromegalic patients who have had an
inadequate response to or cannot be treated with
surgery and/or radiotherapy (1)
DOSAGE AND ADMINISTRATION
Dose range of 60 mg to 120 mg every 4 weeks (2)
Recommended dose is 90 mg every 4 weeks for 3 months. Adjust
thereafter based on GH and/or IGF-1 levels (2)
Renal and Hepatic Impairment: Initial dose is 60 mg every 4 weeks for
3 months in moderate and severe renal or
hepatic impairment. Adjust thereafter based on GH and/or IGF-1 levels.
(2, 12.3)
Injected in the superior external quadrant of the buttock Injection
site should be alternated (2)
Store at 2-8°C (36-46 °F) in the original package (16.2)
DOSAGE FORMS AND STRENGTHS
Single use syringe: 60, 90 and 120 mg (3)
CONTRAINDICATIONS
None (5)
WARNINGS AND PRECAUTIONS
Gallbladder: Gallstones may occur; consider periodic monitoring (5.1)
Glucose Metabolism: Hypo- and/or hyperglycemia may occur. Glucose
monitoring is recommended and anti-diabetic
treatment adjusted accordingly (5.2)
Cardiac Function: Decrease in heart rate may occur. Use with caution
in at-risk patients (5.3)
ADVERSE REACTIONS
Most common adverse reactions are diarrhea, cholelithiasis, abdominal
pain, nausea and injection site reactions (6)
DRUG INTERACTIONS
Hypoglycemia agents: Hypo- and/or hyperglycemia may occur. Glucose
monitoring is recommended and anti-diabetic
treatment adjusted accordingly (7.1)
Cyclosporine: Somatuline may decrease the bioavailability of
cyclosporine. Cyclosporine dose may need to be adjusted
(7.2)
Drugs affecting heart rate: Somatuline may decrease heart rate. Dose
adjustment of coadministered drugs that
decrease heart rate may be necessary (7.3)
USE IN SPECIFIC POPULATIONS
Renal Impairment: Start dose is 60 mg in moderate and severe renal
impairment (2, 8.6, 12.3)
Hepatic Impairment: