Drug Interaction:
Drug interactions- summary-
Betablockers + Lanreotide -
coadmin of drugs such as beta-blockers may have additional effect on the reduction of heart rate
associated with lanreotide . Dosage adjustments may be necessary
Lantrotide + bromocriptine-
coadmin may increase availability of bromocriptine.
Lanreotide + cyclosporine-
coadmin of cyclosporine with lanreotide may decrease relative availability of cyclosporine
and may necessiate dose adjustment of cyclosporine to maintain theapeutic levels
Lanreotide + CYP3A4 metabolism eg quinidine, terfenadine-
lanreotide may decrease metabolic clearance of drugs known to be metabolised by CYP-450
enzymes eg quinidine, terfenadine. Use with caution and consider dose reduction of coadministered
medications
Indication:
SOMATULINE® DEPOT (lanreotide) INJECTION
Initial U.S. Approval: 2007
RECENT MAJOR CHANGES
Indications and Usage
Gastroenteropancreatic Neuroendocrine Tumors (1.2) 12/2014
Dosage and Administration
Gastroenteropancreatic Neuroendocrine Tumors (2.2) 12/2014
Warnings and Precautions:
Cardiovascular Abnormalities (5.4) 12/2014
Proprietary Name- SOMATULIONE DEPOT INJECTION*
Established Name- Lanreotide
Applicant- ISPEN PHARMA
Indication- For the treatment of Patients with Unresectable, well or moderately
differentiated, locally Advanced or Metastatic gastroenteropancreatic
Neuroendocrine Tumors (GEP-NETs) to improve Progression-free
survival
Approval Date- 16/12/2014
Approved by U.S.FDA (Ref- FDA approved List- 2014)
Acromegaly
Acromegaly-
When growth hormones- secreting tumors develop after puberty , acromegaly results. The disorder
occurs equally in men and women. Approximately 10 to 15 perecent of all large pitutiary tumors
secrete growth hormone and cause acromegaly.
Because of the slow progression of the disease the changes in physical features, which often
begin between second and fourth decade are frrqeuntly not recongnized for 10 to 20 years
Acromegaly
Acromegaly-
When growth hormones- secreting tumors develop after puberty , acromegaly results. The disorder
occurs equally in men and women. Approximately 10 to 15 perecent of all large pitutiary tumors
secrete growth hormone and cause acromegaly.
Because of the slow progression of the disease the changes in physical features, which often
begin between second and fourth decade are frrqeuntly not recongnized for 10 to 20 years
Adverse Reaction:
Cardiovascular- 13% bradycardia 12%
GI - 56% abdominal pain 15% diarrhea 45% flatulence 7%
Hematologic - 8% anemia 8%
Hepatic- 19% choleithiasis 13%
Local 14%
Metabolic /nutrional - 20% weight decrease 8%
Contra-Indications:
Special precautions-
Cholelithiasis and gall bladder sludge- lanreotide may reduce gall bladder motility and
lead to gallstone formation. Therfore patients treated with lanreotide should be monitored
regularly.
Hyperglycemia and hypoglycemia- monitor blood levels when lanreotide treatment is initiated
and when the dose is altered and adjust anti-diabetic treatment accordingly.
Thyroid function abnormalities- thyroid function tests are recommended when clicinally indicated
Cardiovascular anbormalities - take care when initiating treatment in patients with bradycardia
Renal function impairment- patients with moderate to severe renal function impairment,
begin treatment with lanreotide 60mg
Hepatic function impairment- for patients with moderate to severe hepatic function impairment
begin treatment with lanreotide 60mg
Pregnancy- use lanreotide in pregnancy only if required
Lactation- decide whether to disconitinue nursing or the drug depending on the importance
of the drug to the mother
Children- safety and efficacy in children have not been established
Elderly -no overal differences noticed between elderly patients and younger patients.
However greater sensitivity in elderly patients cannot be ruled
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
SOMATULINE DEPOT (lanreotide) Injection is a somatostatin analog indicated for:
the long-term treatment of acromegalic patients who have had aninadequate
response to or cannot be treated with surgery and/orradiotherapy
the treatment of patients with unresectable, well-or moderately-differentiated,
locally advanced or metastatic gastroenteropancreaticneuroendocrine tumors
(GEP-NETs) to improve progression-free survival
DOSAGE AND ADMINISTRATION
Injected in the superior external quadrant of the buttock. Injection site
should be alternated
Acromegaly
Dose range is 60 mg to 120 mg every 4 weeks. Recommended starting
dose is 90 mg every 4 weeks for 3 months. Adjust thereafter based on
GH and/or IGF-1 levels
Moderate and Severe Renal and Hepatic Impairment: Initial dose is 60 mg
every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1
levels.
GEP-NET
Recommended dose is 120 mg every 4 weeks (2.2)
DOSAGE FORMS AND STRENGTHS
Injection:
60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL single-useprefilled syringes
Indication-
Acromegaly
Dosage-
Begin ttreatment with lanreotide 90mg via the deep subcutaneous route at 4-week intervals
for 3 months
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients to inform their doctor or pharmacist if they develop any unusual
symptoms, or if any known symptom persists or worsens.
Advise patients with acromegaly that response to SOMATULINE DEPOT should
be monitored by periodic measurements of GH and IGF-1 levels, with a goal
of decreasing these levels to the normal range.
Advise patients experiencing dizziness not to drive or operate machinery.
Manufactured by: Distributed by:
Ipsen Pharma Biotech
83870 Signes, France
Ipsen Biopharmaceuticals, Inc.
Basking Ridge, NJ 07920
1. Advice patients to inform their health care provider or the pharmacist if they develop
unusual symptoms or if any unknown symptoms persists
2. Advice patients that respone to lanreotide be monitored by periodic measurements of
GH and IGH -1 levels with a goal of decreasing these levels to normal range
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Lanreotide, the active component of SOMATULINE DEPOT is an octapeptide
analog of natural somatostatin. The mechanism of action of lanreotide
is believed to be similar to that of natural somatostatin.
2 Pharmacokinetics
SOMATULINE DEPOT is thought to form a drug depot at the injection site due
to the interaction of the formulation with physiological fluids. The most likely
mechanism of drug release is a passive diffusion of the precipitated dru
from the depot towards the surrounding tissues, followed by the absorption
to the bloodstream.
After a single, deep subcutaneous administration, the mean absolut
e bioavailability of SOMATULINE DEPOT in healthy subjects was
73.4, 69.0, and 78.4% for the 60 mg, 90 mg, and 120 mg doses, respectively.
Mean C max values ranged from 4.3 to 8.4 ng/mL during the first day.
Single-dose linearity was demonstrated with respect to AUC and Cmax ,
and showed high inter-subject variability.
SOMATULINE DEPOT showed sustained release of lanreotide with a half-life
of 23 to 30 days. Mean serum concentrations were > 1 ng/mL throughout
28 days at 90 mg and 120 mg and > 0.9 ng/mL at 60 mg.
Pregnancy and lactation:
Pregnancy-
Use lanreotide in pregnancy only if required
Lactation-
Decide whether to disconitinue nursing or the drug depending on the importance
of the drug to the mother
Children-
Safety and efficacy in children have not been established
Elderly -
No overal differences noticed between elderly patients and younger patients.
However greater sensitivity in elderly patients cannot be ruled
Manufacturer Details