Pasireotide Diaspartate: uses, dosing, side effects & brands
Pasireotide Diaspartate is a medicine sold in the U.S. under one brand, for cushing syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Cushing Syndrome
- Available as
- Injectable
- Sold as
- Signifor
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How pasireotide diaspartate is dosed
From the FDA label for Signifor (application NDA200677). Other pasireotide diaspartate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended initial dosage is either 0.6 mg or 0.9 mg by subcutaneous injection twice a day; recommended dosage range is 0.3 mg to 0.9 mg twice a day ( 2.1 ) Titrate dosage based on treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) and/or improvements in signs and symptoms of disease] and tolerability ( 2.1 ) Testing Prior to Dosing : fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), liver tests, electrocardiogram (ECG), gallbladder ultrasound, and serum potassium and magnesium levels ( 2.2 ) Patients With Hepatic Impairment : Child-Pugh B: Recommended initial dosage is 0.3 mg twice a day and maximum dosage is 0.6 mg twice a day ( 2.3 , 8.6 ) Child-Pugh C: Avoid use in these patients ( 2.3 , 8.6 ) 2.1 Recommended Dosage Range The recommended dosage range of SIGNIFOR is 0.3 mg to 0.9 mg by subcutaneous injection twice a day. The recommended initial dose is either 0.6 mg or 0.9 mg twice a day. Titrate dose based on response and tolerability. Patients should be evaluated for a treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) levels and/or improvement in signs or symptoms of the disease] and should continue receiving therapy with SIGNIFOR as long as benefit is derived [see Clinical Studies (14)] . Maximum UFC reduction is typically seen by two months of treatment [see Clinical Studies (14)] .…
Pasireotide Diaspartate side effects
Clinically significant adverse reactions that appear in other sections of the labeling include: Hypocortisolism [see Warnings and Precautions (5.1)] Hyperglycemia and Diabetes [see Warnings and Precautions (5.2)] Bradycardia and QT prolongation [see Warnings and Precautions (5.3)] Liver Test Elevations [see Warnings and Precautions (5.4)] Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.5)] Pituitary Hormone Deficiency [see Warnings and Precautions (5.6)] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.7) ] Most common adverse reactions occurring in ≥ 20% of patients are diarrhea, nausea, hyperglycemia, cholelithiasis, headache, abdominal pain, fatigue, and diabetes mellitus ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. A total of 162 Cushing's disease patients were exposed to SIGNIFOR in the Phase III study [see Clinical Studies (14)] . At study entry, patients were randomized to receive twice a day doses of either 0.6 mg or 0.9 mg…
Who shouldn’t take pasireotide diaspartate
None. None ( 4 )
Pasireotide Diaspartate drug interactions
Drugs that Prolong QT : Use with caution in patients who are at significant risk of developing QTc prolongation ( 5.3 , 7.1 ) Cyclosporine : Consider additional monitoring ( 7.2 ) Bromocriptine : Consider bromocriptine dose reduction ( 7.2 ) 7.1 Effects of Other Drugs on SIGNIFOR Drugs That Prolong QT Coadministration of drugs that prolong the QT interval with SIGNIFOR may have additive effects on the prolongation of the QT interval. Caution is required when coadministering SIGNIFOR with drugs that may prolong the QT interval [see Warnings and Precautions (5.3)] . 7.2 Effects of SIGNIFOR on Other Drugs Cyclosporine Concomitant administration of cyclosporine with pasireotide may decrease the relative bioavailability of cyclosporine and, therefore, dose adjustment of cyclosporine to maintain therapeutic levels may be necessary. Bromocriptine Coadministration of somatostatin analogues with bromocriptine may increase the blood levels of bromocriptine. Dose reduction of bromocriptine may be necessary.
Every pasireotide diaspartate product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Signifor.
What people report to the FDA about pasireotide diaspartate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 7 reports naming pasireotide diaspartate, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- abdominal pain4 reports
- abdominal pain lower4 reports
- abdominal pain upper4 reports
- abnormal faeces4 reports
- asthenia4 reports
- blood glucose abnormal4 reports
- dizziness4 reports
- dysphagia4 reports
Read these as a signal, not a rate. A report does not mean pasireotide diaspartate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is pasireotide diaspartate?
SIGNIFOR (pasireotide) injection is prepared as a sterile solution of pasireotide diaspartate in a tartaric acid buffer for administration by subcutaneous injection. SIGNIFOR is a somatostatin analog.
Can you take pasireotide diaspartate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run pasireotide diaspartate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does pasireotide diaspartate come in?
Across the brands we track, pasireotide diaspartate is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic pasireotide diaspartate?
We do not currently list a generic-labelled pasireotide diaspartate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Pasireotide Diaspartate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/pasireotide-diaspartate
- MLA
- “Pasireotide Diaspartate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/pasireotide-diaspartate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for pasireotide diaspartate on DailyMed (NIH) ↗.