Belinostat Injection
Belinostat (Beleodaq) is a cancer medicine given by intravenous infusion to treat adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) — a type of blood cancer that has come back or stopped responding to prior treatment.
🧬 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 1 clinical label set 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 →
📖 Belinostat Injection: Patient Information Guide
A plain-language walkthrough of Belinostat 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▾
Belinostat injection (brand: Beleodaq) is approved for one specific use in adults:
- Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) — a type of aggressive blood cancer that has either returned after prior treatment or never fully responded to it. This approval was granted under the FDA's accelerated approval pathway based on tumor response rates, not yet on proven survival benefit.
⚙️How it works▾
Belinostat is an HDAC (histone deacetylase) inhibitor. HDACs are enzymes that normally help regulate how genes are read inside cells — including cancer cells. By blocking these enzymes, belinostat causes a build-up of acetylated (chemically modified) proteins that disrupts the cancer cell's normal cycle, forcing it to stop growing or undergo apoptosis (programmed cell death). Belinostat shows a preference for killing tumor cells over normal cells.
💊How it's taken▾
Beleodaq is given exclusively as an intravenous (IV) infusion in a clinical setting — it is not taken by mouth or self-administered at home. It is infused over 30 minutes, once daily, on 5 consecutive days, followed by about 16 days off — this makes one 21-day cycle. Cycles continue as long as the cancer is responding and side effects are tolerable.
- Blood counts must meet minimum thresholds before each cycle begins
- Liver and kidney function tests are done before the first dose of each cycle
- The dose may be reduced or treatment temporarily stopped if serious side effects occur
- Patients with moderate liver or kidney impairment require a lower dose; those with severe impairment should not use Beleodaq
🤒Side effects — in detail▾
The most common side effects seen with Beleodaq include:
- Nausea and vomiting
- Fatigue
- Fever (pyrexia)
- Anemia (low red blood cells)
- Constipation or diarrhea
- Shortness of breath (dyspnea)
- Rash or itching (pruritus)
- Swelling in the lower limbs (peripheral edema)
- Low platelet count (thrombocytopenia)
- Headache, dizziness, or chills
- Pain at the infusion site
Serious reactions — including fatal infections (pneumonia, sepsis), severe liver damage, tumor lysis syndrome, and multi-organ failure — have occurred. Contact your care team immediately if you develop high fever, signs of infection, yellowing of the skin or eyes, or unusual bleeding.
⚠️Warnings & precautions▾
- Low blood cell counts: Beleodaq can dangerously lower platelets, white blood cells, and red blood cells. Weekly blood count monitoring is required, and doses may need to be adjusted.
- Serious infections: Fatal infections including pneumonia and sepsis have occurred. Beleodaq must not be started during an active infection. Patients with a history of intensive chemotherapy are at higher risk.
- Liver toxicity (hepatotoxicity): Beleodaq can cause serious — and potentially fatal — liver damage. Liver function is tested before each treatment cycle. Treatment may need to be paused, reduced, or stopped depending on severity.
- Tumor lysis syndrome: Dying cancer cells can release harmful levels of substances into the bloodstream, leading to serious complications. Patients with advanced disease or large tumors need close monitoring.
- Embryo-fetal toxicity: Beleodaq can harm an unborn baby. Females must use effective contraception during treatment and for 6 months after; males must do so for 3 months after the last dose. Pregnancy testing is recommended before starting treatment.
- Nausea, vomiting, and diarrhea: These are common and may require anti-nausea or anti-diarrheal medications to manage.
🔀What it interacts with▾
Belinostat has one key drug interaction category to be aware of:
- UGT1A1 inhibitors — These are drugs that block the liver enzyme (UGT1A1) primarily responsible for breaking down belinostat. When taken together, they raise belinostat levels in the blood, increasing the risk of serious side effects. Avoid combining Beleodaq with UGT1A1 inhibitors if possible; if the combination is unavoidable, your doctor will reduce the Beleodaq dose. Ask your oncology pharmacist or doctor whether any of your current medications are UGT1A1 inhibitors.
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▾
- Liver problems: The dose must be lowered for moderate liver impairment; Beleodaq should be avoided entirely in severe liver impairment.
- Kidney problems: A dose reduction is needed for moderate kidney impairment; Beleodaq should be avoided in severe kidney impairment.
- Active infection: Do not start Beleodaq if you currently have an active infection.
- Prior heavy chemotherapy: Increases the risk of life-threatening infections with Beleodaq.
- Pregnancy: Beleodaq can cause serious harm to a developing baby. Pregnancy testing is recommended before starting, and effective contraception is required during treatment and for 6 months after (females) or 3 months after (males).
- Breastfeeding: Breastfeeding is not recommended during treatment or for 2 weeks after the last dose, due to potential harm to the infant.
- Male fertility: Animal studies suggest Beleodaq may impair male fertility; whether this is reversible is not yet known.
- UGT1A1*28 genetic variant: Patients with this inherited gene change process belinostat more slowly; the dose may need to be adjusted.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults (65+): Beleodaq has been used in patients 65 and older without a meaningful difference in serious side effects compared to younger patients; no dose adjustment is specifically required based on age alone.
🚑If you take too much▾
There is no specific antidote for a Beleodaq overdose, and it is not known whether the drug can be removed by dialysis. If an overdose occurs, supportive care measures will be used as determined by the treating medical team. Belinostat clears from the body relatively quickly, with a half-life of about 1.1 hours.
📡Pharmacodynamics — effects in the body▾
Belinostat's precise exposure-response relationships are not fully characterized. Studies across multiple clinical trials showed that Beleodaq does not have a meaningful effect on the heart's electrical activity — specifically, it did not cause significant changes in heart rate, cardiac conduction, or QT interval (a measure of heart rhythm) at the doses studied, and no cases of a dangerous arrhythmia called Torsades de Pointes were reported.
🔬Pharmacokinetics — how your body processes it▾
Belinostat is distributed broadly throughout the body and is highly protein-bound (about 93–96%). It is cleared from the bloodstream quickly, with a half-life of only about 1.1 hours. The drug is primarily broken down in the liver by an enzyme called UGT1A1, with additional metabolism by CYP2A6, CYP2C9, and CYP3A4 enzymes. Most of the drug is eliminated through the urine. Patients with moderate or severe liver impairment clear belinostat more slowly, leading to higher drug exposure, which is why dose adjustments or avoidance are necessary in those patients.
📦How to store it▾
Store Beleodaq (belinostat) for injection at room temperature 20°C to 25°C (68°F to 77°F).
📄 Written from Belinostat 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 Belinostat Injection
83 supplements and herbal products have documented interactions with Belinostat 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 · 4
- Moderate · 73
- Minor · 6
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 Belinostat Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Beleodaq being used to treat? ▾
How is this medication given, and what should I expect during treatment? ▾
What side effects are most likely, and when should I call my doctor? ▾
Are there any medications I should avoid while on Beleodaq? ▾
Is it safe to get pregnant or father a child while on this medication? ▾
Can I breastfeed while taking Beleodaq? ▾
Is Belinostat Injection available over the counter? ▾
When was Belinostat Injection first available? ▾
Who makes Belinostat Injection? ▾
💬 Answers drafted from Belinostat 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 Belinostat Injection comes
Belinostat 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.
Injection
How this form is used
- Beleodaq is used intravenously to treat adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) — cancer that has returned or did not respond to prior treatment
- Beleodaq's approval is based on tumor response rate and duration of response; an improvement in survival has not yet been established
- Beleodaq is given as a 30-minute IV infusion once daily on days 1 through 5 of a 21-day cycle
- Beleodaq cycles are repeated every 21 days until the disease progresses or side effects become unacceptable
- Beleodaq dose may be reduced or treatment paused based on blood counts, liver function, kidney function, or other side effects — follow your oncology team's guidance closely
- Beleodaq requires preparation by a healthcare professional; it is administered in a clinical setting, not at home
📊 Belinostat Injection across the U.S. market
How Belinostat 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Belinostat Injection is used
A general measure of how commonly Belinostat Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Belinostat Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Belinostat Injection prescribed? Of the 1,597 medications we measure, Belinostat Injection ranks #1,454 by Medicaid prescriptions — more than 9% of them.
Utilization by Belinostat Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
belinostat 500 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1543547
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Belinostat Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Belinostat Injection NDCs with Medicaid activity.
🔍 Compare Belinostat Injection products
A representative set of FDA-listed product records for Belinostat 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 | ||||
| 500 mg/10 mL | Intravenous | Acrotech Biopharma Inc × 2 listings | NDA | View NDC → |
| 500 mg/10 mL | Intravenous | Acrotech Biopharma LLC × 2 listings | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Belinostat 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 Belinostat 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 Belinostat 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 Belinostat 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 1543543 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1804980In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 1543547
Look up RxCUI 1543543 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 Belinostat 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
Belinostat Injection belongs to the Histone Deacetylase Inhibitor 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 1 FDA-filed SPL label set 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. Acrotech Biopharma 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.