Myleran (Busulfan)
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Description
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Fact Table
| Fact Table | |
|---|---|
| Formula | C6H14O6S2 |
| License | US FDA, EU EMA, US DailyMed |
| Bioavailability | 60–80% |
| Legal status | Rx-Only |
| Chemical Name | Busulfan |
| Elimination half-life | 2.5 hours |
| Dosage (Strength) | 2mg |
| Pregnancy | Contraindicated |
| Brands | Myleran |
| Protein binding | 32.4% |
| PubChem CID | 2478 |
| MedlinePlus | a682248 |
| ChEBI | 28901 |
| ATC code | L01AB01 |
| DrugBank | DB01008 |
| KEGG | D00248 |
| Routes of administration | By mouth |
Myleran (Busulfan) is an oral alkylating agent used primarily in the treatment of chronic myeloid leukemia (CML). It functions by interfering with the replication of DNA, thereby inhibiting the proliferation of malignant cells. Myleran is typically employed as part of a conditioning regimen prior to bone marrow or stem cell transplantation in both adult and pediatric patients. Due to its cytotoxic properties, the use of Myleran is restricted to situations where alternative therapies are inadequate or not tolerated.
Directions
Apply a thin layer of Noritate Cream to the affected areas of the face once daily, typically in the evening or as directed by a healthcare provider. The area should be gently cleansed and dried before application. Care should be taken to avoid contact with the eyes, mouth, and mucous membranes. Hands should be washed thoroughly after applying the cream.
Ingredients
The active ingredient in Noritate Cream is metronidazole 1%. Inactive ingredients include benzyl alcohol, cetyl alcohol, methylparaben, propylene glycol, purified water, stearyl alcohol, and other emulsifiers and stabilizers designed for topical administration.
Cautions
Extreme care must be taken in dosing Myleran due to its narrow therapeutic index and risk of prolonged bone marrow suppression. Frequent monitoring of hematologic parameters is essential. The drug may cause pulmonary toxicity, including interstitial fibrosis, particularly with long-term use. Hepatic veno-occlusive disease has been reported, especially when used in high-dose regimens before transplant. Myleran has been associated with increased risk of secondary malignancies. Adequate contraception is advised during and following treatment due to potential genotoxic effects.
Contraindications
Myleran is contraindicated in individuals with a known hypersensitivity to busulfan or any of the excipients. It should not be used in patients with severely impaired hepatic or renal function unless the benefits outweigh the risks. The drug is also contraindicated during pregnancy unless clearly necessary, due to its potential for teratogenicity and fetal toxicity.
Side Effects
Common and serious side effects of Myleran include:
- Bone marrow suppression (e.g., leukopenia, thrombocytopenia, anemia)
- Pulmonary fibrosis or interstitial lung disease
- Nausea, vomiting, and gastrointestinal discomfort
- Hepatic veno-occlusive disease
- Seizures (particularly with high doses)
- Hyperpigmentation or skin rashes
- Increased risk of secondary cancers
- Fatigue and weakness
Patients should report any signs of infection, unusual bleeding, or respiratory symptoms immediately.
Frequently Asked Questions about Myleran (Busulfan)
What is Myleran used for?
Myleran (busulfan) is a chemotherapy medication primarily used to treat chronic myelogenous leukemia (CML). It may also be used as part of a conditioning regimen before a bone marrow or stem cell transplant in certain blood cancers.
How does Myleran work?
Busulfan is an alkylating agent that works by interfering with the DNA of cancer cells, preventing them from dividing and multiplying. This action slows or stops the growth of abnormal blood cells in conditions like leukemia.
How is Myleran administered?
Myleran is typically taken orally in tablet form, but intravenous formulations of busulfan are also available. The dosing schedule and duration depend on the patient’s condition, treatment goals, and overall response, and must be determined by a specialist.
What are the common side effects of Myleran?
Common side effects may include bone marrow suppression (leading to low blood counts), nausea, vomiting, diarrhea, fatigue, and mouth sores. Long-term use can increase the risk of secondary cancers and pulmonary fibrosis.
Can Myleran affect fertility?
Yes, busulfan can impair fertility in both men and women. It may cause temporary or permanent infertility. Patients planning to have children should discuss fertility preservation options with their healthcare provider before starting treatment.
Is Myleran safe during pregnancy or breastfeeding?
Myleran can cause harm to an unborn baby and is not recommended during pregnancy. It should also not be used while breastfeeding, as it may pass into breast milk. Effective contraception is advised during treatment and for some time after.
What monitoring is required while taking Myleran?
Regular blood tests are essential to monitor blood counts, liver function, and drug levels (if IV busulfan is used). Patients should be closely monitored for signs of toxicity, especially bone marrow suppression and lung complications.
Can Myleran interact with other medications?
Yes, busulfan may interact with several medications, including acetaminophen, phenytoin, antifungals, and chemotherapy drugs. These interactions can affect how the drug is metabolized or increase the risk of toxicity.
What precautions should I take while on Myleran?
Avoid contact with people who have infections, as Myleran weakens the immune system. Report any signs of infection, unusual bruising, bleeding, or persistent cough to your doctor. Alcohol should be limited, and live vaccines should be avoided.
How long is Myleran treatment typically continued?
The duration of Myleran treatment varies depending on the disease being treated and the patient’s response. In CML, it may be taken for weeks or months, while in transplant settings, it's usually given for a few days. Treatment plans are individualized by oncology specialists.
