Defibrotide Injection
Defibrotide is an intravenous medication used to treat hepatic veno-occlusive disease (a serious liver condition) with kidney or lung complications in adults and children after stem-cell transplantation.
🧬 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 →
📖 Defibrotide Injection: Patient Information Guide
A plain-language walkthrough of Defibrotide 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▾
Defibrotide injection (brand name Defitelio) is approved for one specific and serious condition that can develop after a stem-cell transplant.
- Defitelio treats hepatic veno-occlusive disease (VOD) — also known as sinusoidal obstruction syndrome (SOS) — in adult and pediatric patients (including infants from 1 month of age) following hematopoietic stem-cell transplantation (HSCT)
- It is specifically indicated when VOD is accompanied by kidney dysfunction or pulmonary (lung) dysfunction, representing a severe, life-threatening presentation of this complication
⚙️How it works▾
Defibrotide's exact mechanism isn't completely understood, but it works in several ways to help restore healthy blood flow in the liver's small vessels. It boosts the activity of plasmin — the body's main natural clot-dissolving protein — helping to break down fibrin clots that are blocking tiny blood vessels. It also protects the endothelial cells (the cells lining blood vessels) from chemotherapy-related damage, and shifts the balance of clotting proteins so the body is more able to dissolve clots rather than form new ones.
💊How it's taken▾
Defitelio is only given in a hospital or clinical setting by trained healthcare professionals — it is not a take-home medication. It is infused into a vein (intravenously) over exactly 2 hours, four times per day, spaced 6 hours apart. Treatment continues for a minimum of 21 days; if VOD signs and symptoms haven't fully resolved by then, it may be extended up to 60 days. There are no food restrictions tied to Defitelio since it is given by IV infusion.
🤒Side effects — in detail▾
The most commonly reported side effects with Defitelio (seen in at least 10% of patients) include:
- Low blood pressure (hypotension)
- Diarrhea
- Vomiting
- Nausea
- Nosebleeds (epistaxis)
Serious reactions requiring immediate attention include bleeding in the lungs (pulmonary alveolar hemorrhage), gastrointestinal bleeding, intracranial (brain) hemorrhage, severe low blood pressure, and sepsis (a life-threatening body-wide infection). Any sign of unusual or heavy bleeding should be reported to your care team right away.
⚠️Warnings & precautions▾
- Bleeding risk: Defitelio enhances the body's clot-dissolving system and can increase bleeding risk, including life-threatening hemorrhage from the lungs, gut, or brain. It must not be started if you are actively bleeding, and cannot be given alongside blood thinners or clot-dissolving drugs. If serious bleeding develops during treatment, Defitelio will be paused or stopped.
- Allergic reactions: Hypersensitivity reactions — including rash, hives, swelling, and in rare cases, life-threatening anaphylaxis — have occurred. The risk is higher in people who have received Defitelio before. A severe allergic reaction means the drug must be permanently discontinued.
- Invasive procedures: There is no reversal agent for Defitelio's effects. If a surgical or invasive procedure is needed, Defitelio must be stopped at least 2 hours beforehand and only restarted once the bleeding risk from the procedure has passed.
🔀What it interacts with▾
Defitelio has a small number of critical drug interactions, all related to bleeding risk:
- Anticoagulants (blood thinners) such as heparin: Using these together with Defitelio is contraindicated — the combination significantly raises the risk of serious bleeding. These must be stopped before Defitelio treatment begins.
- Fibrinolytic (clot-dissolving) drugs such as alteplase: Also contraindicated with Defitelio for the same reason — the combined effect on clot dissolution can cause dangerous bleeding.
- Routine use of anticoagulants for keeping central IV lines open is covered separately by your care team, but systemic (whole-body) use is not allowed alongside Defitelio.
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▾
- Do not use Defitelio if you are currently taking a systemic anticoagulant or fibrinolytic drug — these combinations are contraindicated
- Do not use Defitelio if you have had a known allergic reaction to it or any of its ingredients in the past
- Defitelio should not be started if you have active, clinically significant bleeding or are hemodynamically unstable requiring more than one vasopressor (blood pressure-supporting drug)
- Pregnancy: Animal studies showed that defibrotide can reduce the number of viable fetuses — advise your doctor if you are pregnant or may become pregnant
- Breastfeeding: It is not recommended to breastfeed while on Defitelio due to the potential for serious bleeding in a nursing infant
- Children: Defitelio is approved and has been studied in pediatric patients from 1 month of age; outcomes were consistent with adults in clinical trials
- Older adults: Clinical trials did not include enough patients aged 65 and over to draw firm conclusions, but no differences in response from younger patients have been reported
- Kidney disease: Patients with severe kidney impairment or end-stage renal disease have higher drug exposure; your care team will be aware of this and monitor accordingly
🚑If you take too much▾
There are no known cases of overdose with Defitelio. There is no antidote, and the drug cannot be removed by dialysis. If an overdose occurs, the medical team will provide supportive care and monitoring.
📡Pharmacodynamics — effects in the body▾
Defibrotide boosts the body's ability to break down fibrin clots by enhancing the activity of plasmin, a natural clot-dissolving enzyme. It also acts on the cells lining blood vessels — increasing protective proteins like tissue plasminogen activator (t-PA) and reducing pro-clotting proteins like PAI-1 (plasminogen activator inhibitor-1). The result is reduced vessel-cell activation and a shift toward clot dissolution. At doses well above the therapeutic range, Defitelio does not cause any meaningful effect on the heart's electrical rhythm (QTc interval).
🔬Pharmacokinetics — how your body processes it▾
After each IV infusion, defibrotide reaches peak blood levels right at the end of the infusion. It is highly bound to proteins in the blood (about 93%) and has a short half-life of less than 2 hours, meaning it clears the body quickly and does not build up with repeated dosing. The drug is broken down primarily through metabolic processes and excreted in the urine. In patients with severe kidney disease or end-stage renal disease, drug exposure can be 50–60% higher than in people with normal kidney function, though the clinical team accounts for this during treatment.
📦How to store it▾
Store DEFITELIO (defibrotide sodium) injection at 20°C-25°C (68°F-77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) (see USP controlled room temperature).
📄 Written from Defibrotide 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 Defibrotide Injection
202 supplements and herbal products have documented interactions with Defibrotide 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 · 2
- Moderate · 183
- Minor · 17
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 Defibrotide Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Defitelio used for, and why does my family member need it? ▾
How is Defitelio given, and how long does treatment last? ▾
What side effects should I watch for during treatment? ▾
Are there any medications that can't be used at the same time as Defitelio? ▾
Is Defitelio safe for children? ▾
Can Defitelio be used during pregnancy or while breastfeeding? ▾
Is Defibrotide Injection available over the counter? ▾
When was Defibrotide Injection first available? ▾
Who makes Defibrotide Injection? ▾
💬 Answers drafted from Defibrotide 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 Defibrotide Injection comes
Defibrotide 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
- Defitelio is used to treat hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction in adults and children after hematopoietic stem-cell transplantation (HSCT)
- Defitelio is indicated for both adult and pediatric patients, including infants as young as 1 month of age
- Defitelio must be diluted before use and given as a 2-hour intravenous infusion every 6 hours
- Defitelio is administered through an infusion set with a 0.2-micron in-line filter; the IV line must be flushed before and after each dose
- Defitelio should not be infused in the same IV line as other intravenous medications at the same time
- Defitelio treatment lasts a minimum of 21 days and may continue up to 60 days depending on how symptoms resolve
📊 Defibrotide Injection across the U.S. market
How Defibrotide 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.
🔍 Compare Defibrotide Injection products
A representative set of FDA-listed product records for Defibrotide 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 | ||||
| 80 mg/mL | Intravenous | Jazz Pharmaceuticals, Inc. × 3 listings | NDA | View NDC → |
| 80 mg/mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Defibrotide 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 Defibrotide 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 Defibrotide 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 Defibrotide 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 1311089 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1746526In current FDA listingsClinical drug / strength (SCD) 2.5 ML defibrotide sodium 80 MG/MLRxCUI 1746527
Look up RxCUI 1311089 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 Defibrotide 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
Defibrotide Injection belongs to the Other antithrombotic agents 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. Jazz Pharmaceuticals, 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.