Dosing & Uses
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
- Adverse effects or over-response to treatment (eg, cortisol levels
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
- Adverse reactions or over-response to treatment (age and sex adjusted IGF-1
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (35)
- adagrasib
adagrasib, pasireotide. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Each drug prolongs the QTc interval, which may increased the risk of Torsade de pointes, other serious arryhthmias, and sudden death. If coadministration unavoidable, more frequent monitoring is recommended for such patients.
- amisulpride
amisulpride and pasireotide both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- anagrelide
anagrelide and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- artemether
artemether and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine
buprenorphine and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine buccal
buprenorphine buccal and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine subdermal implant
buprenorphine subdermal implant and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine transdermal
buprenorphine transdermal and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine, long-acting injection
buprenorphine, long-acting injection and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- ceritinib
ceritinib and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- desflurane
desflurane and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- encorafenib
encorafenib and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- entrectinib
pasireotide and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.
- eribulin
eribulin and pasireotide 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.
- isoflurane
isoflurane and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- 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. . - mobocertinib
mobocertinib and pasireotide both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.
- oxaliplatin
oxaliplatin and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- 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.
- sevoflurane
sevoflurane and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- siponimod
siponimod and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- tacrolimus
tacrolimus and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- tetrabenazine
tetrabenazine 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.
Monitor Closely (140)
- 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.
- asenapine transdermal
asenapine transdermal 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.
- deutetrabenazine
deutetrabenazine and pasireotide both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- 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.
- donepezil
donepezil and pasireotide both increase QTc interval. Use Caution/Monitor.
- doxepin
doxepin and pasireotide both increase QTc interval. Use Caution/Monitor.
- droperidol
droperidol and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.
- efavirenz
efavirenz and pasireotide both increase QTc interval. Use Caution/Monitor.
- eliglustat
eliglustat and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
- fingolimod
fingolimod and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
- gilteritinib
gilteritinib and pasireotide 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.
- granisetron
granisetron and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
- hydroxyzine
hydroxyzine and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
- itraconazole
itraconazole and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
- lithium
lithium and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
- mirtazapine
mirtazapine and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
- primaquine
primaquine and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
- valbenazine
valbenazine and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
- vorinostat
vorinostat and pasireotide both increase QTc interval. Use Caution/Monitor.
- 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.
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
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
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.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)
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
Images
Patient Handout
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 last or get worse, 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.Lab and/or medical tests (such as blood sugar tests, hemoglobin A1c, liver function, hormone levels including cortisol and thyroid, EKG, gallbladder ultrasound) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. 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 December 2022. Copyright(c) 2023 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.
Formulary
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