This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Pasireotide subcutaneous

Updated 2 Feb 2023 | Somatostatin analogues


Solution for subcutaneous injection containing pasireotide.

Drugs List

  • pasireotide 300microgram/1ml injection solution
  • pasireotide 600microgram/1ml injection solution
  • pasireotide 900microgram/1ml injection solution
  • SIGNIFOR 300microgram/1ml injection solution
  • SIGNIFOR 600microgram/1ml injection solution
  • SIGNIFOR 900microgram/1ml injection solution
  • Therapeutic Indications


    Cushing's syndrome - treatment



    The recommended initial dose of pasireotide is 600micrograms by subcutaneous injection twice a day.

    Two months after the start of pasireotide therapy, patients should be evaluated for clinical benefit. Patients who experience a significant reduction in urinary free cortisol levels should continue to receive pasireotide as long as benefit is derived.

    A dose increase to 900micrograms may be considered based on the response to the treatment, as long as the 600micrograms dose is well tolerated by the patient.

    Patients who have not responded to pasireotide after two months of treatment should be considered for discontinuation.

    Management of suspected adverse reactions at any time during the treatment may require temporary dose reduction of pasireotide. Dose reduction by decrements of 300micrograms twice a day is suggested.

    Patients with Hepatic Impairment

    Moderate hepatic impairment (Child Pugh B)
    The recommended initial dose of 300micrograms twice a day. The maximum recommended dose for these patients is 600micrograms twice a day.

    Additional Dosage Information

    Switching formulations
    If switching from intramuscular injection to subcutaneous injection, maintain at least a 28 day interval from last intramuscular injection to first subcutaneous injection. Dose adjustments may be required, monitor patient for response and tolerability.

    Missed dose
    If dose is missed, next injection should be administered at the scheduled time. The dose should not be doubled to make up for missed dose.


    Pasireotide is to be administered subcutaneously by self injection.

    Patients should receive instructions from the physician or a healthcare professional on how to inject pasireotide subcutaneously.

    Preferred injection sites for subcutaneous injections are the top of the thighs and the abdomen (excluding the navel or waistline).


    Children under 18 years
    Long QT syndrome
    Severe hepatic impairment
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Cardiac disorder
    Diabetes mellitus
    Electrolyte imbalance
    End stage renal disease
    History of torsade de pointes
    Moderate hepatic impairment
    New York Heart Association class III failure
    New York Heart Association class IV failure
    Non paced second/third degree AV block
    QTc interval greater than or equal to 500 msec
    Recent myocardial infarction
    Severe renal impairment
    Unstable angina
    Ventricular fibrillation
    Ventricular tachycardia

    Patients with diabetes may experience fluctuations in blood glucose
    Advise ability to drive/operate machinery may be affected by side effects
    Vary injection site during prolonged therapy
    Correct hypokalaemia before or during treatment
    Correct hypomagnesaemia prior to administration
    Monitor blood glucose and HbA1c before treatment
    Monitor gallbladder ultrasonically before treatment then every 6-12 months
    Monitor hepatic function before treatment and regularly during treatment
    Perform ECG before treatment
    Advise diabetics to increase self-monitoring of glucose at start of therapy
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor adrenocortical function
    Monitor blood glucose 4 weeks after treatment complete
    Monitor blood glucose for 2 to 4 weeks after any dose increase
    Monitor blood glucose weekly for 8 to 12 weeks then as indicated
    Monitor closely patient with a history of congestive cardiac failure
    Monitor ECG after 1 week and then as clinically indicated
    Monitor HbA1c 3 months after end of treatment
    Monitor hepatic function after 1, 2, 4, 8 and 12 weeks of treatment
    Monitor patients with cardiac disorders
    Monitor pituitary function as clinically indicated
    Monitor serum electrolytes
    Advise patient to report signs of hypocortisolism
    If hypocortisolism occurs, reduce dose and/or institute steroid therapy
    Discontinue if AST or ALT level > 3x ULN and bilirubin > 2x ULN
    Discontinue if AST or ALT level exceeds 5x ULN and persists
    Discontinue if jaundice or other evidence of hepatic impairment occurs
    Discontinue if no response after 2 months
    Do not restart following significant hepatic dysfunction
    Reduce dose or discontinue if persistent uncontrolled hyperglycaemia occurs
    Female: Ensure adequate contraception during treatment

    Treatment with pasireotide leads to rapid suppression of ACTH (adrenocorticotropic hormone) secretion in Cushing's disease patients. Rapid, complete or near-complete suppression of ACTH may lead to a decrease in circulating levels of cortisol and potentially to transient hypocortisolism/hypoadrenalism.

    Pregnancy and Lactation


    Pasireotide is contraindicated in pregnancy.

    Animal studies have shown reproductive toxicity, although the risk to humans is not known.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Pasireotide is contraindicated in breastfeeding.

    It is not known whether pasireotide is secreted in the human milk, but animal studies show that it is found in the milk of rats.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Acute adrenal insufficiency
    Alanine aminotransferase increased
    Aspartate aminotransferase increased
    Decreased appetite
    Decreased glucose tolerance
    Diabetes mellitus
    Elevated amylase levels
    Elevated serum lipase
    Gamma glutamyl transferase (GGT) increased
    Increase in serum glucose
    Increased glycated haemoglobin (HbA1c) levels
    Injection site reactions
    Prolongation of QT interval
    Prothrombin time increased
    Sinus bradycardia
    Upper abdominal pain


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2018.

    Reference Sources

    Summary of Product Characteristics: Signifor solution for injection 0.3mg, 0.6mg, 0.9mg. Novartis Pharmaceuticals. Revised September 2017.

    NICE Evidence Services Available at: Last accessed: 06 April 2018.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.