Drug Detail:Pasireotide (Pasireotide [ pas-i-ree-oh-tide ])
Drug Class: Somatostatin and somatostatin analogs
Usual Adult Dose for Cushing's Syndrome
Intramuscular formulation:
Initial dose: 10 mg intramuscularly every 4 weeks (28 days)
Maximum dose: 40 mg intramuscularly every 4 weeks (28 days), after 4 months of treatment with 10 mg for patients without normalized 24-hour urinary free cortisol (UFC) levels after 4 months treatment who tolerated the 10 mg dose
Subcutaneous formulation:
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.
- Perform baseline evaluations of fasting plasma glucose, hemoglobin A1c, liver tests, electrocardiogram, serum potassium, and serum magnesium prior to initiating therapy.
- Optimize glucose control in poorly controlled diabetics prior to initiating therapy.
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
Intramuscular formulation:
Initial dose: 40 mg, IM, every 28 days
Maximum dose: 60 mg, IM, every 28 days for patients without normalized growth hormone (GH) and/or age and sex adjusted insulin-like growth factor (IGF-1) levels after 3 months treatment who tolerated the 40 mg dose
Comments:
- Titrate dose based on response and tolerability.
- 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:
Subcutaneous formulation:
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
Intramuscular formulation:
Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate liver dysfunction (Child-Pugh B): Initial dose is 10 mg once every 4 weeks. Maximum dose is 20 mg once every 4 weeks.
Severe liver dysfunction (Child-Pugh C): Avoid use
Acromegaly:
Intramuscular formulation:
Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate liver dysfunction (Child-Pugh B): Initial dose is 20 mg once every 4 weeks. Maximum dose is 40 mg once every 4 weeks.
Severe liver dysfunction (Child-Pugh C): Avoid use
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for dosing related precautions.
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.
