Usual Adult Dose for Carcinoid Tumor

Initial dose: 100 to 600 mcg per day, IV or subcutaneously, in 2 to 4 divided doses

Comments:

• The median daily dose was 450 mcg; mean daily dose was 300 mcg.
• Benefits were seen in doses from 50 mcg to 1500 mcg per day.
• Experience with doses above 750 mcg per day is limited.

Long-Acting depot formulation (Establish tolerability with short acting product for at least 2 weeks before using this formulation):
Initial dose: 20 mg, IM (intragluteally), at 4 week intervals, for 2 months; continue with dose of regular octreotide for at least 2 weeks (at same dose patient was on before the switch)
After 2 months:

• If symptoms are controlled, consider reducing dose to 10 mg every 4 weeks
• If symptoms are not adequately controlled, increase to 30 mg every 4 weeks

Maximum dose: 30 mg every 4 weeks

Comments:

• Failure to continue dosing of regular octreotide during a switch to the long acting formulation may exacerbate symptoms; some patients require 3 to 4 weeks of concomitant dosing.

Use: Symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.

Usual Adult Dose for Vasoactive Intestinal Peptide Tumor

Initial dose: 200 to 300 mcg per day, IV or subcutaneously, in 2 to 4 divided doses
Maintenance dose: 150 to 750 mcg per day

• Doses above 450 mcg per day are not usually required.

Long-Acting depot formulation (Establish tolerability with short acting product for at least 2 weeks before using this formulation):
Initial dose: 20 mg, IM (intragluteally), at 4 week intervals, for 2 months; continue with dose of regular octreotide for at least 2 weeks (at same dose patient was on before the switch)
After 2 months:

• If symptoms are controlled, consider reducing dose to 10 mg every 4 weeks
• If symptoms are not adequately controlled, increase to 30 mg every 4 weeks

Comments:

• Adjust dose for therapeutic response.

Use: Long term treatment of the profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors.

Usual Adult Dose for Acromegaly

Initial dose: 50 mcg, IV or subcutaneously, 3 times a day
Maintenance dose: Usually 100 mcg, 3 times a day
Maximum dose: 500 mcg, 3 times a day

Comments:

• Starting at a low dose may help patients adapt to gastrointestinal adverse events.
• Use IGF-1 (somatomedin C) levels, every 2 weeks, to guide titration.
• Multiple growth hormone levels, zero to 8 hours after dosing, may permit more rapid dose titration.
• Doses over 300 mcg per day seldom provide additional biochemical benefit.

Long-Acting depot formulation (Establish tolerability with short acting product for at least 2 weeks before using this formulation):
Initial dose: 20 mg, IM (intragluteally), at 4 week intervals, for 3 months
After 3 months:

• If GH is 1 ng/mL or less, IGF-1 normal, and clinical symptoms controlled: 10 mg, IM, every 4 weeks
• If GH is 2.5 ng/mL or less and clinical symptoms controlled: 20 mg, IM, every 4 weeks
• If GH is higher than 2.5 ng/mL and/or clinical symptoms uncontrolled: 30 mg, IM, every 4 weeks
• If GH, IGF-1, or symptoms are not adequately controlled at 30 mg, may increase dose to 40 mg IM every 4 weeks

Maximum dose: 40 mg, every 4 weeks

Delayed release oral capsules:
Initial dose: 20 mg orally twice daily, at least 1 hour before or 2 hours after a meal
Maximum dose: 80 mg per day

• Titrate dose in increments of 20 mg daily based on IGF-1 levels and patient symptoms.
• Total daily doses of 60 mg should be given as 40 mg in the morning and 20 mg in the evening
• Total daily doses of 80 mg should be given as 40 mg twice daily.

Comments:

• The goal is growth hormone (GH) levels under 5 ng/mL, or IGF-1 levels under 1.9 U/mL (male) or 2.2 U/mL (female).
• If increased doses do not provide additional benefit, reduce dose.
• Check IGF-1 or growth hormone levels every 6 months.
• For patients who have received irradiation: withdraw medication yearly for about 4 weeks (8 weeks for long-acting formulation) to assess disease activity; if growth hormone or IGF-1 increase and symptoms recur, resume therapy.

Use: To reduce blood levels of growth hormone and IGF-1 (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection or radiotherapy.

Renal Dose Adjustments

Injectable formulations: No adjustment recommended.

Delayed release oral capsules:
End stage renal disease: Initiate dose at 20 mg orally once daily

• Titrate dose based on IGF-1 levels, patient symptoms, and tolerability.

Liver Dose Adjustments

Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution is recommended.

Long acting formulation: For cirrhotic patients, starting dose is 10 mg every 4 weeks; titrate up based on clinical response.

Dose Adjustments

Long-acting depot formulation:
Carcinoid tumor and Vasoactive Intestinal Peptide Tumor patients:

• Exacerbation of symptoms is common.
• During exacerbations, administer regular octreotide at dose they were previously receiving (before switching to long acting) for a few days.

Delayed release oral capsules: Concomitant proton pump inhibitor, H2-receptor antagonist, or antacid use may require increased octreotide doses.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.
This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution is recommended.

Long acting depot formulation: Starting dose is 10 mg every 4 weeks

Other Comments

Administration advice:

• Standard formulation may be given IV or subcutaneously.
• Subcutaneous route is usually used for control of symptoms.
• To minimize pain with subcutaneous administration, use smallest volume that will deliver the dose.
• Avoid multiple subcutaneous injections at the same site within a short period of time.
• Rotate sites systematically.
• Infuse IV over 15 to 30 minutes
• Administer IV push over 3 minutes
• Rapid bolus may be given for emergency situations.
• Delayed release capsules should be taken on an empty stomach (1 hour before or 2 hours after a meal).
• Swallow delayed release capsules whole; do not crush or chew capsules.

Storage requirements:

• Refrigerate; protect from light
• Stable for 14 days at room temperature (70 to 86F) if protected from light

Reconstitution/preparation techniques:

• Dilute in 50 to 200 mL for IV infusion

IV compatibility:

• Stable in sterile isotonic saline solutions or dextrose 5% in water (D5W) for 24 hours.
• NOT compatible with TPN (total parenteral nutrition).

Monitoring:

• Monitor IGF-1 (somatomedin C) or growth hormone levels every 6 months.