Pasireotide Injection
Pasireotide is a long-acting somatostatin analog injection used to treat acromegaly and Cushing's disease when surgery has not worked or is not an option.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Pasireotide Injection: Patient Information Guide
A plain-language walkthrough of Pasireotide Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Pasireotide injection is used for two hormone conditions. The label evidence is for Signifor LAR.
- Signifor LAR treats acromegaly in people who had an inadequate response to surgery and/or cannot have surgery.
- Signifor LAR treats Cushing's disease when pituitary surgery is not an option or has not cured it.
⚙️How it works▾
Pasireotide is a somatostatin analog. It binds to somatostatin receptors on cells, including those on pituitary tumors.
In Cushing's disease, it lowers ACTH release, which lowers cortisol. In acromegaly, it lowers growth hormone and IGF-1.
💊How it's taken▾
Signifor LAR is given by a trained health care professional as an injection into the buttock muscle, usually once every 4 weeks. It is mixed just before use and is never given into a vein.
- Food does not affect it.
- Your doctor may raise or lower the dose based on your response and side effects.
- Baseline tests include blood sugar, liver tests, ECG, potassium, and magnesium.
🤒Side effects — in detail▾
Common side effects seen in studies include:
- Diarrhea
- Gallstones
- High blood sugar and diabetes
- Nausea and abdominal pain
- Headache
- Fatigue
- Hair loss
- Slow heart rate
Call your doctor about severe high blood sugar, fainting or heart rhythm changes, liver problems, gallbladder pain, or symptoms of low cortisol.
⚠️Warnings & precautions▾
- High blood sugar and diabetes, sometimes severe, including ketoacidosis.
- Slow heart rate and QT prolongation.
- Liver enzyme increases, with monitoring before and during treatment.
- Gallstones and complications such as cholecystitis or cholangitis.
- Lower pituitary hormones, including adrenal insufficiency.
- Fat malabsorption causing loose, greasy stools and weight loss.
🔀What it interacts with▾
Tell your care team about all medicines you take, especially:
- QT-prolonging drugs, because the effects can add up.
- Beta-blockers and calcium channel blockers, which also slow the heart.
- Cyclosporine, which may become less available in the body.
- Bromocriptine, whose levels may rise.
- Diabetes medicines, which may need adjusting.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- No contraindications are listed.
- Tell your doctor about diabetes, heart rhythm problems, low potassium or magnesium, and liver disease.
- Pregnancy data are limited, and breastfeeding effects are unknown.
- Not established in children.
- Older adults should be dosed cautiously.
- No dose change is needed for kidney impairment.
🚑If you take too much▾
Overdose with Signifor LAR has not been described. In healthy volunteers receiving high subcutaneous pasireotide doses, diarrhea was common. Supportive treatment is advised. Call Poison Control at 1-800-222-1222.
📡Pharmacodynamics — effects in the body▾
Pasireotide lowers GH and IGF-1 in acromegaly. In Cushing's disease it lowers ACTH and cortisol. Studies showed it can lengthen the QT interval and slow the heart rate.
🔬Pharmacokinetics — how your body processes it▾
Signifor LAR is a long-acting depot. Drug levels rise at first, dip in the first week, peak around day 21, then slowly decline. Steady state is reached after about 3 monthly doses. It is cleared mainly through the liver and bile, with a small kidney role. Moderate and severe liver impairment raise drug levels.
📦How to store it▾
Store at 2°C to 8°C (36°F-46°F). Do not freeze. stored at refrigerated temperatures between 2°C to 8°C (36°F-46°F) until the time of use.
📄 Written from Pasireotide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Pasireotide Injection
13 supplements and herbal products have documented interactions with Pasireotide Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 7
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Pasireotide Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is this injection for? ▾
How is it given? ▾
What side effects should I expect? ▾
When should I call my doctor? ▾
Will it affect my diabetes? ▾
Can I use it if I'm pregnant? ▾
Is Pasireotide Injection available over the counter? ▾
When was Pasireotide Injection first available? ▾
Who makes Pasireotide Injection? ▾
💬 Answers drafted from Pasireotide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Pasireotide Injection comes
Pasireotide Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
📊 Pasireotide Injection across the U.S. market
How Pasireotide Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Pasireotide Injection products
A representative set of FDA-listed product records for Pasireotide Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 0.3 mg/mL | Subcutaneous | Recordati Rare Diseases, Inc. × 3 listings | NDA | View NDC → |
| 0.6 mg/mL | Subcutaneous | Recordati Rare Diseases, Inc. × 3 listings | NDA | View NDC → |
| 0.9 mg/mL | Subcutaneous | Recordati Rare Diseases, Inc. × 3 listings | NDA | View NDC → |
| 5 mg/mL | — | Synergy Health AST, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg/mL | — | Synergy Health AST, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 15 mg/mL | — | Synergy Health AST, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 20 mg/mL | — | Synergy Health AST, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 30 mg/mL | — | Synergy Health AST, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Kits | ||||
| — | Intramuscular | Recordati Rare Diseases Inc. | NDA | View NDC → |
Showing 15 of 15 products — FDA National Drug Code Directory. See every product, package size and price: browse all 15 Pasireotide Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Pasireotide Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Pasireotide Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Pasireotide Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1364105 1 dose form · 8 strengths
-
Dose form (SCDF) Injection RxCUI 1655405In current FDA listingsClinical drug / strength (SCD) 1 ML pasireotide 0.3 MG/MLRxCUI 13641091 ML pasireotide 0.6 MG/MLRxCUI 13641161 ML pasireotide 0.9 MG/MLRxCUI 136412010 MGRxCUI 204973420 MGRxCUI 159759630 MGRxCUI 204973040 MGRxCUI 159760160 MGRxCUI 1597820
Look up RxCUI 1364105 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Pasireotide Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Pasireotide Injection belongs to the Somatostatin Analog class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Recordati Rare Diseases, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.