Sandostatin Lar Depot

— THERAPEUTIC CATEGORIES —
  • Cytoprotective and supportive care agents
  • Pituitary disorders

Sandostatin Lar Depot Generic Name & Formulations

General Description

Octreotide acetate 10mg, 20mg, 30mg; susp for IM inj after dilution; contains mannitol.

Pharmacological Class

Somatostatin analogue.

See Also

How Supplied

Ampules 50mcg/mL, 100mcg/mL, 500mcg/mL (1mL)—10; LAR kit—1 (6mL vial w. supplies)

Mechanism of Action

Octreotide acetate exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of growth hormone (GH), glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide (VIP), secretin, motilin, and pancreatic polypeptide.

Sandostatin Lar Depot Indications

Indications

Long-term treatment of severe diarrhea and flushing due to metastatic carcinoid tumors; and profuse watery diarrhea due to vasoactive intestinal peptide-secreting tumors in patients whom immediate-release (IR) octreotide acetate has been shown to be effective and tolerated.

Sandostatin Lar Depot Dosage and Administration

Adult

Give by intragluteal IM inj. Not currently receiving octreotide: initiate therapy with immediate-release octreotide SC inj for at least 2 weeks. Continue immediate-release octreotide therapy for ≥2 weeks, up to 3 or 4 weeks, after initial switch to LAR. Initially 20mg every 4 weeks for 2 months. After 2 months: if symptoms are controlled, may reduce to 10mg every 4 weeks; if symptoms are not controlled, may increase to max 30mg every 4 weeks. Dialysis or cirrhosis: initially 10mg every 4 weeks. Treat exacerbations with immediate-release octreotide SC inj at same dosage prior to switch.

Children

Not recommended.

Sandostatin Lar Depot Contraindications

Not Applicable

Sandostatin Lar Depot Boxed Warnings

Not Applicable

Sandostatin Lar Depot Warnings/Precautions

Warnings/Precautions

Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Carcinoid tumors: monitor 5-HIAA, plasma serotonin, plasma Substance P. VIPomas: perform baseline and periodic total and/or free T4 measurements with chronic therapy. Monitor thyroid function, gallbladder, glucose, vitamin B12. Pregnancy. Nursing mothers.

Sandostatin Lar Depot Pharmacokinetics

Absorption

Mean peak concentration of 2.8 ng/mL (100mcg dose) was reached in 0.7 hours after SC dosing in patients with acromegaly.

Distribution

In healthy volunteers, the volume of distribution: ~13.6 L; total body clearance: 7–10 L/hr.

In patients with acromegaly, the volume of distribution: ~21.6 ± 8.5 L; total body clearance: 18 L/hr.

Metabolism

Hepatic.

Elimination

Renal, fecal. Half-life: 1.7–1.9 hours.

Sandostatin Lar Depot Interactions

Interactions

Potentiates bromocriptine, CYP450 substrates (eg, quinidine, terfenadine), bradycardia-inducing drugs (eg, β-blockers). Antagonizes cyclosporine. Not compatible with TPN solutions. May need to adjust antidiabetic agents. May interfere with efficacy of lutetium Lu 177 dotatate inj; discontinue octreotide at least 24 hours (or, octreotide LAR at least 4 weeks) prior to each lutetium Lu dose.

Sandostatin Lar Depot Adverse Reactions

Adverse Reactions

Gallbladder abnormalities (eg, gallstones, biliary sludge), sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, hypothyroidism.

Sandostatin Lar Depot Clinical Trials

See Literature

Sandostatin Lar Depot Note

Not Applicable

Sandostatin Lar Depot Patient Counseling

See Literature

Sandostatin Lar Depot Generic Name & Formulations

General Description

Octreotide acetate 10mg, 20mg, 30mg; susp for IM inj after dilution; contains mannitol.

Pharmacological Class

Somatostatin analogue.

See Also

How Supplied

Ampules 50mcg/mL, 100mcg/mL, 500mcg/mL (1mL)—10; LAR kit—1 (6mL vial w. supplies)

Mechanism of Action

Octreotide acetate exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of growth hormone (GH), glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide (VIP), secretin, motilin, and pancreatic polypeptide.

Sandostatin Lar Depot Indications

Indications

Long-term maintenance therapy of acromegaly in patients who have had an inadequate response or cannot be treated with surgery and/or radiotherapy and in whom immediate-release (IR) octreotide acetate is effective and tolerated.

Sandostatin Lar Depot Dosage and Administration

Adult

Give by intragluteal IM inj. Not currently receiving octreotide: initiate therapy with immediate-release octreotide SC inj for at least 2 weeks. Switching from octreotide IR: initially 20mg every 4 weeks for 3months. After 3months, adjust as follows: GH≤2.5ng/mL, IGF-1 normal and clinical symptoms controlled: maintain dosage at 20mg every 4 weeks; GH≤1ng/mL, IGF-1 normal and clinical symptoms controlled: reduce to 10mg every 4 weeks; GH>2.5ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled: increase to 30mg every 4 weeks; may increase to max 40mg every 4 weeks. Pituitary irradiation recipients: withdraw therapy for 8 weeks once yearly to assess disease activity; resume if GH or IGF-1 levels increase or signs/symptoms recur.

Children

Not recommended.

Sandostatin Lar Depot Contraindications

Not Applicable

Sandostatin Lar Depot Boxed Warnings

Not Applicable

Sandostatin Lar Depot Warnings/Precautions

Warnings/Precautions

Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Monitor growth hormone, IGF-1 levels, thyroid function, gallbladder, glucose, vitamin B12. Discontinue and treat if cholelithiasis complications are suspected. Pregnancy. Nursing mothers.

Sandostatin Lar Depot Pharmacokinetics

Absorption

Mean peak concentration of 2.8 ng/mL (100mcg dose) was reached in 0.7 hours after SC dosing in patients with acromegaly.

Distribution

In healthy volunteers, the volume of distribution: ~13.6 L; total body clearance: 7–10 L/hr.

In patients with acromegaly, the volume of distribution: ~21.6 ± 8.5 L; total body clearance: 18 L/hr.

Metabolism

Hepatic.

Elimination

Renal, fecal. Half-life: 1.7–1.9 hours.

Sandostatin Lar Depot Interactions

Interactions

Potentiates bromocriptine, CYP450 substrates (eg, quinidine, terfenadine), bradycardia-inducing drugs (eg, β-blockers). Antagonizes cyclosporine. Not compatible with TPN solutions. May need to adjust antidiabetic agents. May interfere with efficacy of lutetium Lu 177 dotatate inj; discontinue octreotide at least 24 hours (or, octreotide LAR at least 4 weeks) prior to each lutetium Lu dose.

Sandostatin Lar Depot Adverse Reactions

Adverse Reactions

Gallbladder abnormalities (eg, gallstones, biliary sludge), sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, hypothyroidism.

Sandostatin Lar Depot Clinical Trials

See Literature

Sandostatin Lar Depot Note

Not Applicable

Sandostatin Lar Depot Patient Counseling

See Literature