SANDOSTATIN LAR DEPOT- octreotide acetate kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTREOTIDE ACETATE (UNII: 75R0U2568I) (OCTREOTIDE - UNII:RWM8CCW8GP)

Available from:

Novartis Pharmaceuticals Corporation

INN (International Name):

OCTREOTIDE ACETATE

Composition:

OCTREOTIDE 1.667 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. Long-term maintenance therapy in 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 GH and IGF-1 levels to normal [see Clinical Studies (14), Dosage and Administration (2)] . Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and SANDOSTATIN LAR DEPOT on tumor size, rate of growth and development of metastases, has not been determined. None. Risk Summary The limited data with SANDOSTATIN LAR DEPOT in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, no adverse developmental effects were observed with intravenous administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7- and 13-times, respectively the maximum recommended human dose (MRHD) of 1.5 mg/day based on body surface area (BSA). Transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post-natal study of octreotide at intravenous doses below the MRHD based on BSA (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 In embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of octreotide up to 1 mg/kg/day during the period of organogenesis. A slight reduction in body weight gain was noted in pregnant rats at 0.1 and 1 mg/kg/day. There were no maternal effects in rabbits or embryo-fetal effects in either species up to the maximum dose tested. At 1 mg/kg/day in rats and rabbits, the dose multiple was approximately 7- and 13-times, respectively, at the highest recommended human dose of 1.5 mg/day based on BSA. In a pre- and post-natal development rat study at intravenous doses of 0.02-1 mg/kg/day, a transient growth retardation of the offspring was observed at all doses which was possibly a consequence of growth hormone inhibition by octreotide. The doses attributed to the delayed growth are below the human dose of 1.5 mg/day, based on BSA. Risk Summary There is no information available on the presence of SANDOSTATIN LAR DEPOT in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Studies show that octreotide administered subcutaneously passes into the milk of lactating rats; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk (see Data) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SANDOSTATIN LAR DEPOT, and any potential adverse effects on the breastfed child from SANDOSTATIN LAR DEPOT or from the underlying maternal condition. Data Following a subcutaneous dose (1 mg/kg) of octreotide to lactating rats, transfer of octreotide into milk was observed at a low concentration compared to plasma (milk/plasma ratio of 0.009). Discuss the potential for unintended pregnancy with premenopausal women as the therapeutic benefits of a reduction in GH levels and normalization of insulin-like growth factor 1 (IGF-1) concentration in acromegalic females treated with octreotide may lead to improved fertility. Safety and efficacy of SANDOSTATIN LAR DEPOT in the pediatric population have not been demonstrated. No formal controlled clinical trials have been performed to evaluate the safety and effectiveness of SANDOSTATIN LAR DEPOT in pediatric patients under 6 years of age. In postmarketing reports, serious adverse events, including hypoxia, necrotizing enterocolitis, and death, have been reported with Sandostatin use in children, most notably in children under 2 years of age. The relationship of these events to octreotide acetate has not been established as the majority of these pediatric patients had serious underlying comorbid conditions. The efficacy and safety of SANDOSTATIN LAR DEPOT was examined in a single randomized, double-blind, placebo-controlled, 6-month pharmacokinetics study in 60 pediatric patients age 6 to 17 years with hypothalamic obesity resulting from cranial insult. The mean octreotide concentration after 6 doses of 40 mg SANDOSTATIN LAR DEPOT administered by IM injection every four weeks was approximately 3 ng/mL. Steady-state concentrations were achieved after 3 injections of a 40-mg dose. Mean BMI increased 0.1 kg/m2 in SANDOSTATIN LAR DEPOT-treated subjects compared to 0.0 kg/m2 in saline control-treated subjects. Efficacy was not demonstrated. Diarrhea occurred in 11 of 30 (37%) patients treated with SANDOSTATIN LAR DEPOT. No unexpected adverse events were observed. However, with SANDOSTATIN LAR DEPOT 40 mg once a month, the incidence of new cholelithiasis in this pediatric population (33%) was higher than that seen in other adult indications, such as acromegaly (22%) or malignant carcinoid syndrome (24%), where SANDOSTATIN LAR DEPOT was dosed at 10 mg to 30 mg once a month. Clinical studies of Sandostatin did not include sufficient numbers of subjects age 65 years and over to determine whether they respond differently from younger subjects. 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. In patients with renal failure requiring dialysis, the starting dose should be 10 mg. This dose should be up titrated based on clinical response and speed of response as deemed necessary by the physician. In patients with mild, moderate, or severe renal impairment there is no need to adjust the starting dose of Sandostatin. The maintenance dose should be adjusted thereafter based on clinical response and tolerability as in nonrenal patients [see Clinical Pharmacology (12)] . In patients with established liver cirrhosis, the starting dose should be 10 mg. This dose should be up titrated based on clinical response and speed of response as deemed necessary by the physician. Once at a higher dose, patient should be maintained or dose adjusted based on response and tolerability as in any noncirrhotic patients [see Clinical Pharmacology (12)] .

Product summary:

SANDOSTATIN LAR DEPOT is available in single-dose kits containing a 6-mL single-dose vial of 10 mg, 20 mg or 30 mg strength, a prefilled 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.

Authorization status:

New Drug Application

Summary of Product characteristics

SANDOSTATIN LAR DEPOT- OCTREOTIDE ACETATE
NOVARTIS PHARMACEUTICALS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SANDOSTATIN LAR DEPOT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SANDOSTATIN LAR DEPOT.
SANDOSTATIN LAR DEPOT (OCTREOTIDE ACETATE) FOR INJECTABLE SUSPENSION,
FOR GLUTEAL
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1988
INDICATIONS AND USAGE
SANDOSTATIN LAR DEPOT is a somatostatin analogue indicated for:
Treatment in patients who have responded to and tolerated Sandostatin
Injection subcutaneous injection
for:
Acromegaly (1.1)
Severe diarrhea/flushing episodes associated with metastatic carcinoid
tumors (1.2)
Profuse watery diarrhea associated with Vasoactive Intestinal Peptide
(VIP) secreting tumors (1.3)
DOSAGE AND ADMINISTRATION
Patients Not Currently Receiving Sandostatin Injection Subcutaneously:
_Acromegaly:_ 50 mcg three times daily Sandostatin Injection
subcutaneously for 2 weeks followed by
SANDOSTATIN LAR DEPOT 20 mg intragluteally every 4 weeks for 3 months
(2.1)
_Carcinoid Tumors and VIPomas:_ Sandostatin Injection subcutaneously
100 to 600 mcg/day in 2-4
divided doses for 2 weeks followed by SANDOSTATIN LAR DEPOT 20 mg
every 4 weeks for
2 months (2.2)
Patients Currently Receiving Sandostatin Injection Subcutaneously:
_Acromegaly:_ 20 mg every 4 weeks for 3 months (2.1)
_Carcinoid Tumors and VIPomas:_ 20 mg every 4 weeks for 2 months (2.2)
Renal Impairment, Patients on Dialysis: 10 mg every 4 weeks (2.3)
Hepatic Impairment, Patients With Cirrhosis: 10 mg every 4 weeks (2.4)
DOSAGE FORMS AND STRENGTHS
For injectable suspension: strengths 10 mg per 6 mL, 20 mg per 6 mL,
or 30 mg per 6 mL single-dose
vials (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Cholelithiasis and Complications of Cholelithiasis: Monitor
periodically. Discontinue if complications of
cholelithiasis are suspected (5.1)
Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Glucose
monitoring is recommended
and ant