Sandostatin LAR Depot (Page 6 of 6)

14.2 Carcinoid Syndrome

A 6-month clinical trial of malignant carcinoid syndrome was performed in 93 patients who had previously been shown to be responsive to Sandostatin Injection. Sixty-seven (67) patients were randomized at baseline to receive double-blind doses of 10 mg, 20 mg, or 30 mg SANDOSTATIN LAR DEPOT every 28 days and 26 patients continued, unblinded, on their previous Sandostatin Injection regimen (100 to 300 mcg three times daily).

In any given month after steady-state levels of octreotide were reached, approximately 35% to 40% of the patients who received SANDOSTATIN LAR DEPOT required supplemental subcutaneous Sandostatin Injection therapy usually for a few days, to control exacerbation of carcinoid symptoms. In any given month, the percentage of patients randomized to subcutaneous Sandostatin Injection, who required supplemental treatment with an increased dose of Sandostatin Injection, was similar to the percentage of patients randomized to SANDOSTATIN LAR DEPOT. Over the 6-month treatment period, approximately 50% to 70% of patients who completed the trial on SANDOSTATIN LAR DEPOT required subcutaneous Sandostatin Injection supplemental therapy to control exacerbation of carcinoid symptoms although steady-state serum SANDOSTATIN LAR DEPOT levels had been reached.

Table 7 presents the average number of daily stools and flushing episodes in malignant carcinoid patients.

Table 7. Average Number of Daily Stools and Flushing Episodes in Patients With Malignant Carcinoid Syndrome
Treatment Daily Stools (Average Number) Daily Flushing Episodes (Average Number)
n Baseline Last Visit Baseline Last Visit
Sandostatin Injection S.C. 26 3.7 2.6 3.0 0.5
SANDOSTATIN LAR DEPOT
10 mg 22 4.6 2.8 3.0 0.9
20 mg 20 4.0 2.1 5.9 0.6
30 mg 24 4.9 2.8 6.1 1.0

Overall, mean daily stool frequency was as well controlled on SANDOSTATIN LAR DEPOT as on Sandostatin Injection (approximately 2 to 2.5 stools/day).

Mean daily flushing episodes were similar at all doses of SANDOSTATIN LAR DEPOT and on Sandostatin Injection (approximately 0.5 to 1 episode/day).

In a subset of patients with variable severity of disease, median 24 hour urinary 5-HIAA (5-hydroxyindole acetic acid) levels were reduced by 38% to 50% in the groups randomized to SANDOSTATIN LAR DEPOT.

The reductions are within the range reported in the published literature for patients treated with octreotide (about 10% to 50%).

Seventy-eight (78) patients with malignant carcinoid syndrome who had participated in this 6-month trial, subsequently participated in a 12-month extension study in which they received 12 injections of SANDOSTATIN LAR DEPOT at 4-week intervals. For those who remained in the extension trial, diarrhea and flushing were as well controlled as during the 6-month trial. Because malignant carcinoid disease is progressive, as expected, a number of deaths (8 patients: 10%) occurred due to disease progression or complications from the underlying disease. An additional 22% of patients prematurely discontinued SANDOSTATIN LAR DEPOT due to disease progression or worsening of carcinoid symptoms.

16 HOW SUPPLIED/STORAGE AND HANDLING

SANDOSTATIN LAR DEPOT is available in single-use kits containing a 6-mL vial of 10 mg, 20 mg or 30 mg strength, a syringe containing 2 mL of diluent, one vial adapter, and one sterile 1½” 19 gauge safety injection needle. An instruction booklet for the preparation of drug suspension for injection is also included with each kit.

Drug Product Kits

10 mg kit NDC 0078-0811-81

20 mg kit NDC 0078-0818-81

30 mg kit NDC 0078-0825-81

Demonstration kit 0078-9825-81

For prolonged storage, SANDOSTATIN LAR DEPOT should be stored at refrigerated temperatures between 2°C to 8°C (36°F to 46°F) and protected from light until the time of use. SANDOSTATIN LAR DEPOT drug product kit should remain at room temperature for 30 to 60 minutes prior to preparation of the drug suspension. However, after preparation the drug suspension must be administered immediately.

17 PATIENT COUNSELING INFORMATION

Cholelithiasis and Complications of Cholelithiasis

Advise patients to contact their healthcare provider if they experience signs or symptoms of gallstones (cholelithiasis) or complications of cholelithiasis (e.g., cholecystitis, cholangitis and pancreatitis) [see Warnings and Precautions (5.1)].

Carcinoid Tumors and VIPomas

Patients with carcinoid tumors and VIPomas should be advised to adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms [see Dosage and Administration (2.2)].

Acromegaly

Patients with acromegaly should also be urged to adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels [see Dosage and Administration (2.1)].

Pregnancy

Inform female patients that treatment with SANDOSTATIN LAR DEPOT may result in unintended pregnancy [see Use in Specific Populations (8.3)].

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

© Novartis

T2021-21

PRINCIPAL DISPLAY PANEL

NDC 0078-0811-81

Sandostatin® LAR Depot

(octreotide acetate) for injectable suspension,for gluteal intramuscular use

10 mg

For Intragluteal Injection

Rx only

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0811-81
							Sandostatin® LAR Depot
							(octreotide acetate) for injectable suspension, for gluteal intramuscular use
							10 mg
							For Intragluteal Injection
							Rx only
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0818-81

Sandostatin® LAR Depot

(octreotide acetate) for injectable suspension,for gluteal intramuscular use

20 mg

For Intragluteal Injection

Rx only

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0818-81
							Sandostatin® LAR Depot
							(octreotide acetate) for injectable suspension, for gluteal intramuscular use
							20 mg
							For Intragluteal Injection
							Rx only
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0825-81

Sandostatin® LAR Depot

(octreotide acetate) for injectable suspension,for gluteal intramuscular use

30 mg

For Intragluteal Injection

Rx only

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0825-81
							Sandostatin® LAR Depot
							(octreotide acetate) for injectable suspension, for gluteal intramuscular use
							30 mg
							For Intragluteal Injection
							Rx only
							NOVARTIS
(click image for full-size original)
SANDOSTATIN LAR DEPOT octreotide acetate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0811
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0811-81 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 6 mL
Part 2 1 SYRINGE 2 mL
Part 1 of 2
SANDOSTATIN LAR DEPOT octreotide acetate injection, powder, for suspension
Product Information
Item Code (Source) NDC:0078-0790
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 1.667 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTIC ACID, DL- 31.467 mg in 1 mL
MANNITOL 6.833 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0790-61 6 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021008 07/22/2016
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM 7 mg in 1 mL
MANNITOL 6 mg in 1 mL
POLOXAMER 188 2 mg in 1 mL
WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021008 07/22/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021008 07/22/2016
SANDOSTATIN LAR DEPOT octreotide acetate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0818
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0818-81 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 6 mL
Part 2 1 SYRINGE 2 mL
Part 1 of 2
SANDOSTATIN LAR DEPOT octreotide acetate injection, powder, for suspension
Product Information
Item Code (Source) NDC:0078-0797
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 3.33 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTIC ACID, DL- 62.933 mg in 1 mL
MANNITOL 13.65 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0797-61 6 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021008 07/22/2016
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM 7 mg in 1 mL
MANNITOL 6 mg in 1 mL
POLOXAMER 188 2 mg in 1 mL
WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021008 07/22/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021008 07/22/2016
SANDOSTATIN LAR DEPOT octreotide acetate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0825
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0825-81 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 6 mL
Part 2 1 SYRINGE 2 mL
Part 1 of 2
SANDOSTATIN LAR DEPOT octreotide acetate injection, powder, for suspension
Product Information
Item Code (Source) NDC:0078-0804
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTIC ACID, DL- 94.4 mg in 1 mL
MANNITOL 20.483 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0804-61 6 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021008 07/22/2016
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM 7 mg in 1 mL
MANNITOL 6 mg in 1 mL
POLOXAMER 188 2 mg in 1 mL
WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021008 07/22/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021008 07/22/2016
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 03/2021 Novartis Pharmaceuticals Corporation

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