Somatuline Depot
(lanreotide)Dosage & Administration
Administration :
Recommended Dosage
Dosage Adjustment:
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Somatuline Depot Prescribing Information
Acromegaly
SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.
Gastroenteropancreatic Neuroendocrine Tumors
SOMATULINE DEPOT is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
Carcinoid Syndrome
SOMATULINE DEPOT is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
Important Administration Instructions
- For deep subcutaneous injection only.
- SOMATULINE DEPOT is intended for administration by a healthcare provider.
- Refer to the Instructions For Use (IFU) for complete administration instructions with illustrations.
Preparation
- Remove SOMATULINE DEPOT from the refrigerator 30 minutes prior to administration and allow to come to room temperature.
- Keep pouch sealed until just prior to injection.
- Product left in its sealed pouch at room temperature (not to exceed 104°F or 40°C) for up to 72 hours may be returned to the refrigerator for continued storage and use at a later time.
- Prior to administration, inspect the SOMATULINE DEPOT syringe visually for particulate matter and discoloration. Do not administer if particulate matter or discoloration is observed. The content of the prefilled syringe is a semi-solid phase having a gel-like appearance, with viscous characteristics and a color varying from white to pale yellow. The supersaturated solution can also contain micro bubbles that can clear up during injection. These differences are normal and do not interfere with the quality of the product.
Administration
- Slowly administer for 20 seconds as a deep subcutaneous injection in the superior external quadrant of the buttock.
- Alternate the injection site between the right and left sides from one injection to the next.
Recommended Dosage
Acromegaly
The recommended starting dosage of SOMATULINE DEPOT is 90 mg given via the deep subcutaneous route, at 4-week intervals for 3 months.
After 3 months, the dosage may be adjusted as follows:
- GH greater than 1 ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain SOMATULINE DEPOT dosage at 90 mg every 4 weeks.
- GH greater than 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: increase SOMATULINE DEPOT dosage to 120 mg every 4 weeks.
- GH less than or equal to 1 ng/mL, IGF-1 normal, and clinical symptoms controlled: reduce SOMATULINE DEPOT dosage to 60 mg every 4 weeks.
Thereafter, the dosage should be adjusted according to the response of the patient as judged by a reduction in serum GH and/or IGF-1 levels; and/or changes in symptoms of acromegaly.
Patients who are controlled on SOMATULINE DEPOT 60 or 90 mg may be considered for an extended dosing interval of SOMATULINE DEPOT 120 mg every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response.
Continued monitoring of patient response with dosage adjustments for biochemical and clinical symptom control, as necessary, is recommended.
Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
The recommended dosage of SOMATULINE DEPOT is 120 mg administered every 4 weeks by deep subcutaneous injection.
Carcinoid Syndrome
The recommended dosage of SOMATULINE DEPOT is 120 mg administered every 4 weeks by deep subcutaneous injection.
If patients are already being treated with SOMATULINE DEPOT for GEP-NETs, do not administer an additional dose for the treatment of carcinoid syndrome.
Dosage Adjustment in Renal Impairment
Acromegaly
The recommended starting dosage of SOMATULINE DEPOT in acromegalic patients with moderate or severe renal impairment (creatinine clearance less than 60 mL/min) is 60 mg via the deep subcutaneous route at 4-week intervals for 3 months followed by dosage adjustment [see Dosage and Administration (2.2), Use in Specific Populations (8.6)].
Dosage Adjustment in Hepatic Impairment
Acromegaly
The recommended starting dosage of SOMATULINE DEPOT in acromegalic patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) is 60 mg via the deep subcutaneous route at 4-week intervals for 3 months followed by dosage adjustment [see Dosage and Administration (2.2), Use in Specific Populations (8.7)].
Injection: 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL sterile, single-dose, prefilled syringes fitted with an automatic safety system (attached retractable needle and needle guard). The prefilled syringes contain a white to pale yellow, semi-solid formulation.
Pregnancy
Risk Summary
Limited available data based on postmarketing case reports with SOMATULINE DEPOT use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, decreased embryo/fetal survival was observed in pregnant rats and rabbits at subcutaneous doses 5- and 2-times the maximum recommended human dose (MRHD) of 120 mg, respectively (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal Data
A reproductive study in pregnant rats given 30 mg/kg of lanreotide by subcutaneous injection every 2 weeks (5 times the human dose, based on body surface area comparisons) resulted in decreased embryo/fetal survival. A study in pregnant rabbits given subcutaneous injections of 0.45 mg/kg/day (2 times the human therapeutic exposures at the maximum recommended dose of 120 mg, based on comparisons of relative body surface area) shows decreased fetal survival and increased fetal skeletal/soft tissue abnormalities.
Lactation
Risk Summary
There is no information available on the presence of lanreotide in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Studies show that lanreotide acetate administered subcutaneously passes into the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk. Because of the potential for serious adverse reactions in breastfed infants from SOMATULINE DEPOT, including effects on glucose metabolism and bradycardia, advise women not to breastfeed during treatment with SOMATULINE DEPOT and for 6 months (6 half-lives) following the last dose.
Females and Males of Reproductive Potential
Infertility
Females
Based on results from animal studies conducted in female rats, SOMATULINE DEPOT may reduce fertility in females of reproductive potential [see Nonclinical Toxicology (13.1)].
Pediatric Use
The safety and effectiveness of SOMATULINE DEPOT in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients with acromegaly compared with younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Studies 3 and 4, conducted in patients with neuroendocrine tumors, did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Renal Impairment
Acromegaly
Lanreotide has been studied in patients with end-stage renal function on dialysis, but has not been studied in patients with mild, moderate, or severe renal impairment. It is recommended that patients with moderate or severe renal impairment receive a starting dose of lanreotide of 60 mg. Caution should be exercised when considering patients with moderate or severe renal impairment for an extended dosing interval of SOMATULINE DEPOT 120 mg every 6 or 8 weeks [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].
Neuroendocrine Tumors (NET) – Gastroenteropancreatic Neuroendocrine Tumors
No effect was observed in total clearance of lanreotide in patients with mild to moderate renal impairment receiving SOMATULINE DEPOT 120 mg. Patients with severe renal impairment were not studied [see Clinical Pharmacology (12.3)].
Hepatic Impairment
Acromegaly
It is recommended that patients with moderate or severe hepatic impairment receive a starting dose of lanreotide of 60 mg. Caution should be exercised when considering patients with moderate or severe hepatic impairment for an extended dosing interval of SOMATULINE DEPOT 120 mg every 6 or 8 weeks [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].
Neuroendocrine Tumors (NET) – Gastroenteropancreatic Neuroendocrine Tumors
SOMATULINE DEPOT has not been studied in patients with hepatic impairment.
SOMATULINE DEPOT is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide [see Adverse Reactions (6.3)].
Cholelithiasis and Complications of Cholelithiasis
SOMATULINE DEPOT may reduce gallbladder motility and lead to gallstone formation; therefore, patients may need to be monitored periodically [see Adverse Reactions (6.1), Clinical Pharmacology (12.2)]. There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications, including cholecystitis, cholangitis, and pancreatitis, and requiring cholecystectomy in patients taking SOMATULINE DEPOT. If complications of cholelithiasis are suspected, discontinue SOMATULINE DEPOT and treat appropriately.
Hyperglycemia and Hypoglycemia
Pharmacological studies in animals and humans show that lanreotide, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Hence, patients treated with SOMATULINE DEPOT may experience hypoglycemia or hyperglycemia. Blood glucose levels should be monitored when lanreotide treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly [see Adverse Reactions (6.1)].
Cardiovascular Abnormalities
The most common overall cardiac adverse reactions observed in three pooled SOMATULINE DEPOT cardiac studies in patients with acromegaly were sinus bradycardia (12/217, 5.5%), bradycardia (6/217, 2.8%), and hypertension (12/217, 5.5%) [see Adverse Reactions (6.1)].
In 81 patients with baseline heart rates of 60 beats per minute (bpm) or greater treated with SOMATULINE DEPOT in Study 3, the incidence of heart rate less than 60 bpm was 23% (19/81) as compared to 16% (15/94) of placebo treated patients; 10 patients (12%) had documented heart rates less than 60 bpm on more than one visit. The incidence of documented episodes of heart rate less than 50 bpm as well as the incidence of bradycardia reported as an adverse event was 1% in each treatment group. Initiate appropriate medical management in patients who develop symptomatic bradycardia.
In patients without underlying cardiac disease, SOMATULINE DEPOT may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to SOMATULINE DEPOT treatment, sinus bradycardia may occur. Care should be taken when initiating treatment with SOMATULINE DEPOT in patients with bradycardia.
Thyroid Function Abnormalities
Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients, though clinical hypothyroidism is rare (less than 1%). Thyroid function tests are recommended where clinically indicated.
Monitoring: Laboratory Tests
Acromegaly: Serum GH and IGF-1 levels are useful markers of the disease and the effectiveness of treatment [see Dosage and Administration (2.2)].
Steatorrhea and Malabsorption of Dietary Fats
New onset steatorrhea, stool discoloration and loose stools have been reported in patients receiving somatostatin analogs, including SOMATULINE DEPOT. Somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new occurrence or worsening of these symptoms are reported in patients receiving SOMATULINE DEPOT, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.