Busulfan is an alkylating drug sold in the U.S. under 3 brand and generic names, for polycythemia vera, bcr-abl positive chronic myelogenous leukemia and primary myelofibrosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Busulfan (application ANDA205139). Other busulfan products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Pre-medicate with anticonvulsants (e.g., benzodiazepines, phenytoin, valproic acid or levetiracetam) and antiemetic. ( 2.1 , 5.2 ) Dilute and administer as intravenous infusion. Do not administer as intravenous push or bolus. ( 2.1 , 2.3 ) Recommended adult dose: 0.8 mg per kg of ideal body weight or actual body weight, whichever is lower, administered intravenously via a central venous catheter as a two-hour infusion every six hours for four consecutive days for a total of 16 doses. ( 2.1 ) 2.1 Initial Dosing Information Administer busulfan injection in combination with cyclophosphamide as a conditioning regimen prior to bone marrow or peripheral blood progenitor cell replacement. For patients weighing more than 12 kg, the recommended doses are: Busulfan injection 0.8 mg per kg (ideal body weight or actual body weight, whichever is lower) intravenously via a central venous catheter as a two-hour infusion every six hours for four consecutive days for a total of 16 doses (Days -7, -6, -5 and -4). Cyclophosphamide 60 mg per kg intravenously as a one-hour infusion on each of two days beginning no sooner than six hours following the 16 th dose of busulfan injection (Days -3 and -2). Administer hematopoietic progenitor cells on Day 0. Premedicate patients with anticonvulsants (e.g., benzodiazepines, phenytoin, valproic acid or levetiracetam) to prevent seizures reported with the…
The following adverse reactions are discussed in more detail in other sections of the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 ) ] Seizures [see Warnings and Precautions ( 5.2 ) ] Hepatic Veno-Occlusive Disease (HVOD) [ see Warnings and Precautions ( 5.3) ] Embryo-fetal Toxicity [see Warnings and Precautions ( 5.4) ] Cardiac Tamponade [see Warnings and Precautions ( 5.5 ) ] Bronchopulmonary Dysplasia [see Warnings and Precautions ( 5.6 ) ] Cellular Dysplasia [see Warnings and Precautions ( 5.7 ) ] Most common adverse reactions (incidence > 60%) were: myelosuppression, nausea, stomatitis, vomiting, anorexia, diarrhea, insomnia, fever, hypomagnesemia, abdominal pain, anxiety, headache, hyperglycemia and hypokalemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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 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. Adverse reaction information is primarily derived from the clinical study (N=61) of busulfan and the data obtained for high-dose oral busulfan conditioning in the setting of randomized, controlled trials identified…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 70/100 | Prescription | Injectable | — | — | View → | |
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| GX;EF3;M | 2 mg | white | round | — |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
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.
Busulfan injection is contraindicated in patients with a history of hypersensitivity to any of its components. Busulfan injection is contraindicated in patients with a history of hypersensitivity to any of its components. (4)
Drugs that Decrease Busulfan Clearance: Metronidazole, itraconazole, iron chelating agents, acetaminophen. ( 7.1 ) Drugs that Increase Busulfan Clearance: Phenytoin. ( 7.2 ) 7.1 Drugs that Decrease Busulfan Clearance Itraconazole decreases busulfan clearance by up to 25%. Metronidazole decreases the clearance of busulfan to a greater extent than does itraconazole; metronidazole co-administration has been associated with increased busulfan toxicity. Fluconazole (200 mg) has been used with busulfan. Decreased clearance of busulfan was observed with concomitant use with deferasirox. The mechanism of this interaction is not fully elucidated. Discontinue iron chelating agents well in advance of administration of busulfan to avoid increased exposure to busulfan. Because busulfan is eliminated from the body via conjugation with glutathione, use of acetaminophen prior to (less than 72 hours) or concurrent with busulfan may result in reduced busulfan clearance based upon the known property of acetaminophen to decrease glutathione levels in the blood and tissues. 7.2 Drugs that Increase Busulfan Clearance Phenytoin increases the clearance of busulfan by 15% or more, possibly due to the induction of glutathione-S-transferase. Since the pharmacokinetics of busulfan was studied in patients treated with phenytoin, the clearance of busulfan at the recommended dose may be lower and exposure…
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| 3 | Not yet rated | Prescription | Tablet | — | — | View → |