pasireotide (Rx)

Brand and Other Names:Signifor, Signifor LAR
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

SC injection solution (Signifor)

  • 0.3mg/mL
  • 0.6mg/mL
  • 0.9mg/mL

IM injection, powder for reconstitution (Signifor LAR)

  • 20mg/vial
  • 40mg/vial
  • 60mg/vial

Cushing Disease

Indicated for treatment of adults with Cushing disease in whom pituitary surgery is not an option or has not been curative

Also see Administration

Signifor

  • 0.6-0.9 mg SC BID initially; titrate dose based on response and tolerability
  • If started on 0.6 mg BID, a dosage increase to 0.9 mg BID may be considered if treatment tolerated; dosage range: 0.3-0.9 mg SC BID

Signifor LAR

  • 10 mg IM q4Week initially
  • After 4 months of treatment, the dose may be increased for patients who have not normalized 24-hr urinary free cortisol (UFC) and who tolerate this dose, up to a maximum dose of 40 mg IM q4Week

Acromegaly

Indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option

Also see Administration

Signifor LAR

  • 40 mg IM q4Week initially
  • If tolerated, may increase dose to up to 60 mg IM q4Week for patients who have not normalized growth hormone (GH) and/or age and sex adjusted insulin-like growth factor-1 (IGF-1) levels after 3 months of treatment with 40 mg

Dosage Modifications

Adverse reactions or over-response

  • Cushing disease
    • Adverse effects or over-response to treatment (eg, cortisol levels
    • Signifor: May require temporary dose reduction; dose reduction by 0.3 mg decrements per injection is suggested
    • Signifor LAR: If dose is 10 mg IM q4Weeks, the dose may be either interrupted or discontinued
  • Acromegaly (Signifor LAR)
    • Adverse reactions or over-response to treatment (age and sex adjusted IGF-1
    • Decreased dose, either temporarily or permanently, by 20-mg decrements

Hepatic impairment

  • Cushing disease
    • Mild (Child-Pugh A): No dose adjustment required
    • Moderate (Child-Pugh B), Signifor: 0.3 mg SC BID; not to exceed 0.6 mg SC BID
    • Moderate (Child-Pugh B), Signifor LAR: 10 mg IM q4Week; not to exceed 20 mg q4Week
    • Severe (Child-Pugh C): Avoid use
  • Acromegaly (Signifor LAR)
    • Mild (Child-Pugh A): No dose adjustment required
    • Moderate (Child-Pugh B): 20 mg IM q4Week; not to exceed 40 mg q4Week
    • Severe (Child-Pugh C): Avoid use

Dosing Considerations

Evaluation for treatment response is based on reduction in 24-hr urinary free cortisol levels and/or improvement in disease signs and symptoms

Maximum urinary free cortisol reduction typically seen by 2 months of treatment

Continue treatment as long as benefit is derived

Intensively optimize antidiabetic therapy (if blood glucose poorly controlled) before initiating pasireotide

Baseline tests

  • Obtain the following before initiating:
  • Fasting plasma glucose
  • Hemoglobin A1c
  • Liver tests
  • Electrocardiogram
  • Gallbladder ultrasound

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and pasireotide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (3)

            • dronedarone

              dronedarone and pasireotide both increase QTc interval. Contraindicated.

            • pimozide

              pimozide and pasireotide both increase QTc interval. Contraindicated.

            • thioridazine

              thioridazine and pasireotide both increase QTc interval. Contraindicated.

            Serious - Use Alternative (18)

            • artemether

              artemether and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.

            • entrectinib

              pasireotide and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and pasireotide both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.

            • glasdegib

              pasireotide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.

            • inotuzumab

              inotuzumab and pasireotide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

            • ivosidenib

              ivosidenib and pasireotide both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

            • lefamulin

              lefamulin and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.

            • macimorelin

              macimorelin and pasireotide both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

              pasireotide, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin. .

            • panobinostat

              pasireotide and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.

            • pitolisant

              pasireotide and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • ponesimod

              ponesimod, pasireotide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Coadministration of ponesimod with drugs that decrease HR may have additive effects on decreasing HR and should generally not be initiated in these patients.

            • ribociclib

              ribociclib increases toxicity of pasireotide by QTc interval. Avoid or Use Alternate Drug.

            • tacrolimus

              tacrolimus and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.

            • toremifene

              toremifene and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.

            • umeclidinium bromide/vilanterol inhaled

              pasireotide increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vilanterol/fluticasone furoate inhaled

              pasireotide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vorinostat

              vorinostat and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.

            Monitor Closely (124)

            • albuterol

              albuterol and pasireotide both increase QTc interval. Use Caution/Monitor.

            • alfuzosin

              alfuzosin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

              pasireotide and alfuzosin both increase QTc interval. Use Caution/Monitor.

            • amiodarone

              amiodarone and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • amitriptyline

              amitriptyline and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • amoxapine

              amoxapine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • apomorphine

              apomorphine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • arformoterol

              arformoterol and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • aripiprazole

              aripiprazole and pasireotide both increase QTc interval. Use Caution/Monitor.

            • arsenic trioxide

              arsenic trioxide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • artemether/lumefantrine

              artemether/lumefantrine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • asenapine

              asenapine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • atomoxetine

              atomoxetine and pasireotide both increase QTc interval. Use Caution/Monitor.

            • azithromycin

              azithromycin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • bedaquiline

              pasireotide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely

            • bromocriptine

              pasireotide increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Somatropin may increase CYP450 enzymes and, therefore, suppression of growth hormone secretion by somatostatin analogs including pasireotide may decrease the metabolic clearance of compounds metabolized by CYP450 enzymes.

            • chlorpromazine

              chlorpromazine and pasireotide both decrease QTc interval. Modify Therapy/Monitor Closely.

            • ciprofloxacin

              ciprofloxacin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • citalopram

              citalopram and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • clarithromycin

              clarithromycin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • clomipramine

              clomipramine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • clozapine

              clozapine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • copper CU 64 dotatate

              pasireotide decreases effects of copper CU 64 dotatate by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as CU 64 dotatate and may affect imaging. Image patients just prior to dosing with somatostatin analogs. Washout period of 28 days recommended for patients on long-acting somatostatin analogs before imaging; whereas, 2 days washout recommended for short-acting somatostatin analogs.

            • crizotinib

              crizotinib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • cyclosporine

              pasireotide decreases levels of cyclosporine by unspecified interaction mechanism. Use Caution/Monitor. Coadministration may decrease bioavailability of oral cyclosporine.

            • dasatinib

              dasatinib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • degarelix

              degarelix and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • desipramine

              desipramine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • dichlorphenamide

              dichlorphenamide and pasireotide both decrease serum potassium. Use Caution/Monitor.

            • disopyramide

              disopyramide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • dofetilide

              dofetilide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • dolasetron

              dolasetron and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • droperidol

              droperidol and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin base

              erythromycin base and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin lactobionate

              erythromycin lactobionate and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin stearate

              erythromycin stearate and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • escitalopram

              escitalopram and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • ezogabine

              ezogabine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • flecainide

              flecainide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluconazole

              fluconazole and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluoxetine

              fluoxetine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluphenazine

              fluphenazine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • formoterol

              formoterol and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • foscarnet

              foscarnet and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • fostemsavir

              pasireotide and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • gallium Ga 68 dotatate

              pasireotide decreases effects of gallium Ga 68 dotatate by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatate and may affect imaging. Image patients with Ga 68 dotatate PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatate.

            • gallium Ga 68 dotatoc

              pasireotide decreases effects of gallium Ga 68 dotatoc by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatoc and may affect imaging. Image patients with Ga 68 dotatoc PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatoc.

            • gemifloxacin

              gemifloxacin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • gemtuzumab

              pasireotide and gemtuzumab both increase QTc interval. Use Caution/Monitor.

            • goserelin

              goserelin increases toxicity of pasireotide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • haloperidol

              haloperidol and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • histrelin

              histrelin increases toxicity of pasireotide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • ibutilide

              ibutilide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • iloperidone

              iloperidone and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • indapamide

              indapamide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • insulin aspart

              pasireotide increases effects of insulin aspart by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin aspart protamine/insulin aspart

              pasireotide increases effects of insulin aspart protamine/insulin aspart by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin degludec

              pasireotide, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.

              pasireotide increases effects of insulin degludec by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin degludec/insulin aspart

              pasireotide, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.

            • insulin detemir

              pasireotide increases effects of insulin detemir by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin glargine

              pasireotide increases effects of insulin glargine by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin glulisine

              pasireotide increases effects of insulin glulisine by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin inhaled

              pasireotide, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.

              pasireotide increases effects of insulin inhaled by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin isophane human/insulin regular human

              pasireotide increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin lispro

              pasireotide increases effects of insulin lispro by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin lispro protamine/insulin lispro

              pasireotide increases effects of insulin lispro protamine/insulin lispro by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin NPH

              pasireotide increases effects of insulin NPH by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin regular human

              pasireotide increases effects of insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • isradipine

              isradipine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • lapatinib

              lapatinib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • lenvatinib

              pasireotide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.

            • leuprolide

              leuprolide increases toxicity of pasireotide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • levofloxacin

              levofloxacin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • lopinavir

              lopinavir and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • lumefantrine

              lumefantrine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • lutetium Lu 177-dota-tate

              pasireotide decreases effects of lutetium Lu 177-dota-tate by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as lutetium Lu 177-dota-tate and may affect its efficacy. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hr prior to each lutetium Lu 177-dota-tate dose. Administer short- and long-acting octreotide during treatment as recommended.

            • maprotiline

              maprotiline and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • mefloquine

              mefloquine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • metformin

              pasireotide decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.

            • methadone

              methadone and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • mifepristone

              mifepristone and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • moxifloxacin

              moxifloxacin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • nilotinib

              nilotinib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • nortriptyline

              nortriptyline and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • octreotide

              octreotide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • ofloxacin

              ofloxacin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • olanzapine

              olanzapine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • ondansetron

              ondansetron and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • osilodrostat

              osilodrostat and pasireotide both increase QTc interval. Use Caution/Monitor.

            • osimertinib

              osimertinib and pasireotide both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.

            • oxaliplatin

              oxaliplatin will increase the level or effect of pasireotide by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

            • ozanimod

              ozanimod and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • paliperidone

              paliperidone and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • pazopanib

              pazopanib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • pentamidine

              pentamidine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • perphenazine

              perphenazine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • posaconazole

              posaconazole and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • procainamide

              procainamide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • propafenone

              propafenone and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • protriptyline

              protriptyline and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • quetiapine

              quetiapine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • quinidine

              quinidine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • quinine

              quinine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • ranolazine

              ranolazine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • risperidone

              risperidone and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • romidepsin

              romidepsin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • saquinavir

              saquinavir and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • selpercatinib

              selpercatinib increases toxicity of pasireotide by QTc interval. Use Caution/Monitor.

            • sertraline

              sertraline and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • solifenacin

              solifenacin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • sorafenib

              sorafenib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • sotalol

              sotalol and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • sunitinib

              sunitinib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • telavancin

              telavancin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • thiothixene

              thiothixene and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • triclabendazole

              triclabendazole and pasireotide both increase QTc interval. Use Caution/Monitor.

            • trimipramine

              trimipramine and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • triptorelin

              triptorelin increases toxicity of pasireotide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • vandetanib

              vandetanib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • vardenafil

              vardenafil and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • vemurafenib

              vemurafenib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • voclosporin

              voclosporin, pasireotide. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            • voriconazole

              voriconazole and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • ziprasidone

              ziprasidone and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            Minor (1)

            • chloroquine

              chloroquine increases toxicity of pasireotide by QTc interval. Minor/Significance Unknown.

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            Adverse Effects

            >10% (Signifor)

            Diarrhea (58-59%)

            Nausea (46-58%)

            Hyperglycemia (38-43%)

            Cholelithiasis (30%)

            Headache (28-29%)

            Abdominal pain (23-25%)

            Fatigue (15-24%)

            Diabetes mellitus (16-20%)

            Injection site reactions (17-18%)

            Asthenia (6-16%)

            Nasopharyngitis (12-14%)

            Increased alanine aminotransferase (ALT) (8-13%)

            Increased A1c (10-12%)

            >10% (Signifor LAR)

            Diarrhea (39%)

            Hyperglycemia (29%)

            Diabetes mellitus (26%)

            Cholelithiasis (26%)

            Headache (19%)

            Alopecia (18%)

            Abdominal pain (18%)

            Nasopharyngitis (16%)

            Nausea (14%)

            Increased creatinine phosphokinase (13-16%)

            Hypoglycemia (4-15%)

            Insomnia (4-14%)

            Abdominal distension (12%)

            Increased gamma-glutamyl transferase (9-12%)

            Upper abdominal pain (8-12%)

            Type 2 diabetes mellitus (6-12%)

            Myalgia (5-12%)

            Anxiety (6-11%)

            Influenza (6-11%)

            Peripheral edema (10-11%)

            Decreased appetite (9-11%)

            Hypercholesterolemia (9-11%)

            1-10% (Signifor)

            Hypertension (10%)

            Dizziness (9-10%)

            Arthralgia (5-10%)

            Vomiting (4-10%)

            Sinus bradycardia (3-10%)

            Pruritus (7-9%)

            ncreased lipase (6-9%)

            Constipation (5-9%)

            Hypotension (6-8%)

            Back pain (5-8%)

            Hypokalemia (5-7%)

            Pain in extremity (5-7%)

            Increased AST (4-7%)

            Increased blood glucose (4-7%)

            Dry skin (6%)

            Prolonged QT interval (6%)

            Vertigo (5-8%)

            Abdominal distension (5-6%)

            Adrenal insufficiency (5-6%)

            ncreased AST (6%)

            Increased blood glucose (6%)

            Anemia (4%)

            Increased amylase (2%)

            Prolonged PTT (2%)

            1-10% (Signifor LAR)

            Arthralgia (10%)

            Fatigue (10%)

            Dizziness (10%)

            Increased blood glucose (8%)

            Influenza (8%)

            Vomiting (8%)

            Hypertension (8%)

            Increased ALT (8%)

            Back pain (8%)

            Pain in extremity (7%)

            Upper respiratory infection (7%)

            Injection site reactions (7%)

            Increased glycosylated hemoglobin (6%)

            Upper abdominal pain (6%)

            Increased aspartate aminotransferase (AST) (6%)

            Decreased weight (5%)

            Cough (5%)

            Hypoglycemia (5%)

            Postmarketing Reports

            Ketoacidosis

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            Warnings

            Contraindications

            None

            Cautions

            Suppresses ACTH, which may lead to decreased cortisol and potential hypocortisolism

            Can cause increased blood glucose levels, which are sometimes severe; patients with poor baseline glycemic control are at higher risk of developing severe hyperglycemia; access fasting blood glucose and HgA1c before initiating and monitor blood glucose the first 3 months after initiating an for 4-6 weeks after a dose increase

            May cause bradycardia and QT prolongation; obtain baseline and periodic ECG, and potassium and magnesium levels; correct/supplement potassium and /or magnesium if clinically warranted

            Increased liver enzymes may occur and may require dose interruption and reduction

            Cholelithiasis reported; perform gallbladder ultrasound at baseline and at 6- to 12-months; if complications of cholelithiasis suspected, discontinue therapy and treat appropriately

            Monitor for pituitary hormone deficiency (eg, TSH/free T4, GH/IGF-1)

            Hyperglycemia

            • Blood glucose elevations have reported with therapy
            • In clinical study, patients developed pre-diabetes and diabetes; nearly all patients in the study, including those with normal glucose status at baseline, pre-diabetes, and diabetes, developed worsening glycemia in first two weeks of treatment
            • Cushing’s disease patients with poor glycemic control (HbA1c > 8%) may be at a higher risk of developing severe hyperglycemia and associated complications, eg, ketoacidosis
            • Assess patient’s glycemic status prior to starting treatment; in patients with uncontrolled diabetes mellitus, optimize anti-diabetic therapy prior to initiation of treatment
            • Glycemic monitoring should be done every week for first two to three months and periodically thereafter, as well as over first two to four weeks after any dose increase
            • If hyperglycemia develops, initiate or adjust anti-diabetic treatment per standard of care; if uncontrolled hyperglycemia persists despite appropriate treatment, reduce dose or discontinue therapy and perform glycemic monitoring according to clinical practice
            • Patients who were initiated on anti-diabetic treatment as a result of therapy require closer monitoring after discontinuation of treatment, especially if anti-diabetic therapy has a risk of causing hypoglycemia
            • Postmarketing cases of ketoacidosis reported in patients with history of diabetes and in patients without history of diabetes
            • Assess FPG and HbA1c prior to starting treatment; in patients with poorly controlled diabetes mellitus, optimize anti-diabetic treatment before initiating therapy
            • Patients receiving anti-diabetic treatment may require more frequent blood glucose monitoring and dose adjustment to their anti-diabetic drug therapy to mitigate risk of hypoglycemia after discontinuing therapy
            • Patients who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of diabetes history
            • If ketoacidosis is suspected, discontinue therapy and promptly evaluate and treat patient
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            Pregnancy & Lactation

            Pregnancy

            Limited data with pasireotide in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage

            In embryofetal development studies in rabbits, findings indicating a developmental delay were observed with SC administration of pasireotide during organogenesis at doses less than the exposure in humans at the highest recommended dose; maternal toxicity was not observed at this dose

            Discuss the potential for unintended pregnancy with premenopausal women as the therapeutic benefits of a reduction in growth hormone (GH) levels and normalization of insulin-like growth factor (IGF-1) in acromegalic females treated with pasireotide may lead to improved fertility

            Lactation

            There is no information available on the presence of pasireotide in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production

            Studies show that pasireotide administered subcutaneously passes into the milk of lactating rats; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Cyclohexapeptide somatostatin analog; binds to human somatostatin receptors (hsst) 1, 2, 3, 4 and 5

            Absorption

            Peak plasma time: 0.25-0.5 hr

            Distribution

            Protein bound: 88%

            Vd: >100 L

            P-gp substrate (low)

            Metabolism

            Since somatropin increases CYP450 enzymes, suppression of growth hormone secretion by somatostatin analogs may decrease clearance of compounds metabolized by CYP450 enzymes

            Elimination

            Total body clearance: 3.8 L/hr

            Excretion: bile (main), renal (small)

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            Administration

            SC Administration (Signifor)

            Visually inspect solution for particulate matter and discoloration; do not use if particulates and/or discoloration observed

            Avoid injection in sites showing signs of inflammation or irritation

            Gently pinch skin at the injection site and hold the needle/syringe at an angle of approximately 45 degrees

            Administer SC by self-injection into the top of thigh or abdomen

            Rotate injection sites; use of the same injection site for 2 consecutive injections is not recommended

            Missed dose

            • If dose missed, next injection should be administered at the scheduled time; do not double doses to make up for a missed dose

            IM Preparation (Signifor LAR)

            Remove kit from refrigerator; allow kit to stand at room temperature for ≤30 minutes before starting reconstitution, but not more than 24 hr; kit may be re-refrigerated

            Attach vial adapter to vial; screw on syringe onto the vial adapter

            Push the plunger all the way down to transfer diluent into vial

            Shake vial moderately in a horizontal direction for a minimum of 30 seconds until powder is completely suspended; repeat moderate shaking for another 30 seconds if the powder is not completely suspended

            Draw entire contents from vial into the syringe and attach needle

            IM Administration (Signifor LAR)

            IM administration only, do not administer IV

            Remove kit from refrigerator and let it sit for at least 30 min (but not longer than 24 hr)

            Reconstitute with supplied diluent until powder is completely suspended (see package instructions)

            Insert the needle fully into the left or right gluteus at a 90° angle to the skin

            Slowly pull back the plunger to check that no blood vessel has been penetrated (reposition if a blood vessel has been penetrated)

            Slowly depress plunger until the syringe is empty

            Withdraw needle from injection site and activate the safety guard

            Missed dose

            • If a dose is missed and the patient returns prior to the next scheduled dose, dose may be given ≤14 days prior to next dose

            Storage

            Signifor

            • Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F), protect from light

            Signifor LAR

            • Unused kits: Refrigerate between 2–8°C (36–46°F); do not freeze; may also be left at room temperature for up to 24 hr
            • Diluted suspensions: Administer immediately
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            Images

            No images available for this drug.
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            Patient Handout

            Patient Education
            pasireotide subcutaneous

            PASIREOTIDE - SUBCUTANEOUS INJECTION

            (PAS-i-REE-oh-tide)

            COMMON BRAND NAME(S): Signifor

            USES: Pasireotide is used to treat a certain condition (Cushing's disease) when surgery has not been fully successful or cannot be used to correct the condition. Cushing's disease occurs when the body makes too much of a certain hormone called cortisol. Having too much cortisol in the body may lead to high blood pressure, high blood sugar, and other problems. Pasireotide works by decreasing the amount of cortisol made in the body.

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using pasireotide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the Patient Instructions for Use.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Inject this medication under the skin as directed by your doctor, usually twice daily. Pasireotide may be injected into the top of the thigh or into the abdominal/stomach area.Before injecting each dose, clean the injection site with rubbing alcohol. Avoid areas of the skin that are red or irritated. Change the injection site each time to lessen injury under the skin. Do not rub or massage the injection site after the injection.Learn how to store and discard medical supplies safely.The dosage is based on your medical condition and response to treatment.It may take up to 2 months before you get the full benefit of this drug.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.Tell your doctor if your condition does not improve or if it worsens.

            SIDE EFFECTS: Headache, hair loss, dizziness, diarrhea, constipation, muscle pain, swelling of arms/legs, and redness/pain/swelling/itching/bleeding at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may cause changes in blood sugar, especially if you have diabetes. Symptoms of high blood sugar include increased thirst and urination. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Follow your doctor's instructions to treat low blood sugar (for example, by eating a quick source of sugar such as glucose gel/tablets, table sugar, honey, or drinking fruit juice or non-diet soda). Tell your doctor right away if you experience symptoms of high or low blood sugar while using this medication. Monitor your blood sugar levels as directed by your doctor. Your doctor may need to adjust your diabetes medications.Tell your doctor right away if you have any serious side effects, including: nausea/vomiting, weakness, unusual tiredness, weight loss, extreme drowsiness, mental/mood changes, seizures, slow heartbeat, signs of liver/gall bladder disease (such as loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before using pasireotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart problems (such as irregular heartbeat, heart block), diabetes, gallbladder problems (such as gallstones).Pasireotide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using pasireotide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using pasireotide safely.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.Treatment with this medication may improve fertility in women and may lead to unintended pregnancy. Ask your doctor for more details.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood sugar tests, hemoglobin A1c, liver tests, hormone levels including cortisol and thyroid, EKG, gallbladder ultrasound) should be performed before you start treatment, and periodically to monitor your progress or to check for side effects. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.