Defitelio
- Generic Name: defibrotide sodium for intravenous use
- Brand Name: Defitelio
- Drug Class: Thrombolytics
Defitelio (Defibrotide Sodium for Intravenous Use) side effects drug center
- Related Drugs
- low blood pressure (hypotension)
- diarrhea
- vomiting
- nausea, and
- nosebleed
- easy bruising, unusual bleeding;
- blood in your urine or stools;
- confusion, headaches;
- vision problems, slurred speech; or
- a light-headed feeling, like you might pass out.
- nausea, vomiting, diarrhea;
- dizziness; or
- nosebleeds.
- Hemorrhage [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
What Is Defitelio?
Defitelio (defibrotide sodium) injection is the first in its class of an oligonucleotide that acts as a polydeoxyribonucleotide adenosine receptor, with antithrombotic, anti-inflammatory, and anti-ischemic properties, indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).
What Are Side Effects of Defitelio?
Common side effects of Defitelio include:
Dosage for Defitelio
The dose of Defitelio is 6.25 mg/kg every 6 hours given as a 2-hour intravenous infusion. Treatment with Defitelio is for a minimum of 21 days.
What Drugs, Substances, or Supplements Interact with Defitelio?
Defitelio may interact with antithrombotic/fibrinolytic drugs such as heparin or alteplase. Tell your doctor all medications and supplements you use.
Defitelio During Pregnancy and Breastfeeding
Defitelio is not recommended for use during pregnancy; there is a potential risk of miscarriage. It is unknown if Defitelio passes into breast milk, however, breastfeeding while using Defitelio is not recommended.
Additional Information
Our Defitelio (defibrotide sodium) injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives, itching, skin rash; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Your treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Defitelio (Defibrotide Sodium for Intravenous Use)
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of DEFITELIO was determined in 176 adult and pediatric patients with hepatic VOD with pulmonary and/or renal dysfunction following HSCT who were treated with DEFITELIO 6.25 mg/kg every 6 hours [see Clinical Studies]. Patients were excluded from these trials if at time of study entry they had significant acute bleeding, active grades B-D graft-versus-host disease, or a requirement for multiple vasopressors to provide blood pressure support. For the purposes of adverse event recording in the clinical trials, events were not required to be reported if they were related to the hepatic VOD, or if they were expected to occur after hematopoietic stem-cell transplantation (HSCT), unless they were serious or Grade 4-5.
The median age of the safety population was 25 years (range, 1 month to 72 years), and 63% were ≥ 17 years of age. A total of 60% of patients were male, 78% were white, 89% had undergone allogeneic HSCT, and the underlying diagnosis was acute leukemia for 43%. At study entry, 13% were dialysis dependent and 18% were ventilator dependent. DEFITELIO was administered for a median of 21 days (range: 1 to 83 days).
Information about adverse reactions resulting in permanent discontinuation of DEFITELIO was available for 102 patients, and 35 (34 %) of these patients had an adverse reaction with permanent discontinuation. Adverse reactions leading to permanent discontinuation included pulmonary alveolar hemorrhage in 5 (5%) patients; pulmonary hemorrhage, hypotension, catheter site hemorrhage, and multi-organ failure, each in 3 (3%) patients; and cerebral hemorrhage and sepsis, each in 2 (2%) patients.
Information about adverse reactions of any grade was available for all 176 patients. The most common adverse reactions (incidence ≥ 10% and independent of causality) were hypotension, diarrhea, vomiting, nausea, and epistaxis. The most common serious adverse reactions (incidence ≥ 5% and independent of causality) were hypotension (11%) and pulmonary alveolar hemorrhage (7%). Hemorrhage events of any type and any grade were reported for 104 (59%) of the patients, and the events were grade 4-5 in 35 (20%).
Table 2 presents adverse reactions independent of causality ≥ 10% any grade or Grade 4/5 ≥ 2% reported in patients treated with DEFITELIO.
Table 2: Adverse Reactionsa ≥ 10% or Grade
4-5 Adverse Reactions ≥ 2%
| Adverse Reaction a | DEFITELIO (n=176) |
|
| Any grade | Grade 4-5b | |
| Hypotension | 65 (37%) | 12 (7%) |
| Diarrhea | 43 (24%) | 0 |
| Vomiting | 31 (18%) | 0 |
| Nausea | 28 (16%) | 0 |
| Epistaxis | 24 (14%) | 0 |
| Pulmonary alveolar hemorrhage | 15 (9%) | 12 (7%) |
| Gastrointestinal hemorrhage | 15 (9%) | 5 (3%) |
| Sepsis | 12 (7%) | 9 (5%) |
| Graft versus host disease | 11 (6%) | 7 (4%) |
| Lung infiltration | 10 (6%) | 5 (3%) |
| Pneumonia | 9 (5%) | 5 (3%) |
| Pulmonary hemorrhage | 7 (4%) | 4 (2%) |
| Infection | 6 (3%) | 4 (2%) |
| Hemorrhage intracranial | 5 (3%) | 4 (2%) |
| Hyperuricemia | 4 (2%) | 4 (2%) |
| Cerebral hemorrhagec | 3 (2%) | 3 (2%) |
| a Excludes events considered to be due to the
underlying disease: multi-organ failure, veno-occlusive disease, respiratory
failure, renal failure, and hypoxia b Adverse reactions considered life-threatening or fatal c Cerebral hemorrhage has been included in the table due to clinical relevance |
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Read the entire FDA prescribing information for Defitelio (Defibrotide Sodium for Intravenous Use)
© Defitelio Patient Information is supplied by Cerner Multum, Inc. and Defitelio Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.