Pasireotide Dosage

Usual Adult Dose for Cushing's Syndrome

Initial dose: 0.6 mg or 0.9 mg subcutaneously twice daily.
Maintenance dose: 0.3 to 0.9 mg subcutaneously twice daily.
Maximum dose: 0.9 mg subcutaneously twice daily
Duration of therapy: Treatment should be continued as long as benefit is derived.

Comments: Titrate dose based on response and tolerability.

Use: The treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

Usual Adult Dose for Acromegaly

Singifor(R) LAR

Initial dose: 40 mg, IM, every 28 days
Maximum dose: 60 mg, IM, every 28 days

Comments:
-Evaluate fasting plasma glucose, HbA1c, liver enzymes, electrocardiogram, and serum magnesium and potassium prior to therapy.
-Optimize glucose control in poorly controlled diabetes prior to therapy.

Use: Treatment of patients with acromegaly with an inadequate response to surgery and/or for whom surgery is not an option.

Renal Dose Adjustments

No dosage adjustment is required in patients with impaired renal function.

Liver Dose Adjustments

Cushing's:
Mild liver dysfunction (Child-Pugh A): No adjustment recommended
Moderate liver dysfunction (Child-Pugh B): Initial dose is 0.3 mg twice daily. Maximum dose is 0.6 mg twice daily.
Severe liver dysfunction (Child-Pugh C): Avoid use

Acromegaly:
Mild liver dysfunction (Child-Pugh A): No adjustment recommended
Moderate Hepatic Impairment (Child Pugh B): Initial dose: 20 mg IM every 28 days; maximum dose: 40 mg every 28 days
Severe Hepatic Impairment (Child Pugh C): Avoid use

Dose Adjustments

Cushing's:
-Evaluate patients for a treatment response (clinically meaningful reduction in 24-hour urinary free cortisol levels and/or improvement in signs or symptoms of the disease) and continue therapy as long as benefit is derived.
-Maximum urinary free cortisol reduction is typically seen by two months of treatment.
-For patients started on 0.6 mg twice a day, a dose increase to 0.9 mg twice a day may be considered based on treatment response, as long as the 0.6 mg dosage is well tolerated.
-Adverse reactions may require temporary dose reduction; reduction by 0.3 mg decrements per injection is suggested.

Acromegaly:
-Adjust dose after 3 months based on biochemical response and tolerability.
-Reduce dose by 20 mg increments, temporarily or permanently, as needed for adverse reactions or over response to treatment.

Precautions

Consult WARNINGS section for dosing related precautions.

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

Dialysis

Data not available

Other Comments

Administration advice:
-Refer to the manufacturers product information for detailed administration instructions.

Reconstitution/preparation techniques:
-Refer to the manufacturers product information for detailed preparation instructions.