Usual Adult Dose for Acromegaly

Initial dose: 90 mg, by deep subcutaneous injection, every 4 weeks for 3 months

Comments:

• The goal of treatment is to reduce growth hormone (GH) and insulin-like growth factor (IGF-1) levels to normal.
• Adjust dose after initial 3 months.
• No dose adjustment is required for elderly patients.

Usual Adult Dose for Neuroendocrine Carcinoma

120 mg, by deep subcutaneous injection, every 4 weeks

Comments: No dose adjustment is required for elderly patients.

Use: Treatment of patients with unresectable, well or moderately-differentiated, locally advanced, or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

Usual Adult Dose for Carcinoid Syndrome

120 mg by deep subcutaneous injection every 4 weeks

Comments: If patients are already being treated for GEP-NETs, do not administer an additional dose for the treatment of carcinoid syndrome.

Use: For the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Renal Dose Adjustments

Acromegaly:

• Moderate to severe renal impairment: Initial dose: 60 mg, by deep subcutaneous injection, every 4 weeks for 3 months, followed by dose adjustments as described for non-renally impaired patients.
• Use caution when considering an extended dosing interval (120 mg every 6 or 8 weeks) in moderate or severe renal impairment.

• No adjustment recommended for mild to moderate renal impairment
• Data not available for severe renal impairment

Liver Dose Adjustments

Acromegaly:

• Moderate to severe hepatic impairment: Initial dose: 60 mg, by deep subcutaneous injection, every 4 weeks for 3 months, followed by dose adjustments as described for non-hepatically impaired patients.

• Data not available for any level of hepatic impairment

Dose Adjustments

Acromegaly:
After the initial 3 month dosing, adjust dose based on growth hormone (GH) and insulin-like growth factor (IGF-1) levels:

• GH over 1 and up to 2.5 ng/mL, IGF-1 normal, and symptoms controlled: 90 mg, by deep subcutaneous (SC) injection, every 4 weeks
• GH over 2.5 ng/mL, IGF-1 elevated, and/or symptoms uncontrolled: 120 mg, by deep SC injection, every 4 weeks
• GH less than 1 ng/mL, IGF-1 normal, symptoms controlled: 60 mg, by deep SC injection, every 4 weeks

• Adjust dose according to patient response, as judged by a reduction in GH and/or IGF-1 levels, and/or changes in acromegaly symptoms.
• Patients controlled on 60 mg or 90 mg may be considered for an extended dosing interval of 120 mg every 6 or 8 weeks; obtain GH and IGF-1 levels 6 weeks after this change to evaluate persistence of patient response.
• Continued monitoring of patient response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.
• No dose adjustment is required for elderly patients.
• No difference in safety and effectiveness was seen in elderly patients, however greater sensitivity cannot be ruled out.
• In general, dose selection for elderly patient should be cautious, starting at the low end of the dosing range.

• No dose adjustment is required for elderly patients.

Precautions

CONTRAINDICATIONS: Hypersensitivity to lanreotide; allergic reactions (including angioedema and anaphylaxis) have occurred

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Healthcare providers should administer this drug.
• Administer in the superior external quadrant of the buttock; alternate between right and left sides with each injection.
• Remove from refrigerator 30 minutes before administration, but keep pouch sealed until ready to administer.