Bucelon 2 Tablet

Description of Bucelon 2 (Busulfan 2mg) tablet

Busulfan, a component of Bucelon 2 tablet is an antineoplastic drug which falls under the classification of alkylating agents. It is mostly used in the treatment and conditioning agent before bone marrow transplantation in the treatment of hematological malignancies. Busulfan works by cross linking the DNA strands thereby interfering with the replication and transcription of DNA. This causes cell division to be blocked, and eventually causes death of the fast dividing cancer cells. Because of its potent cytotoxic capability, it acts on the cancerous and normal fast dividing cells.

Indications of Bucelon 2 (Busulfan 2mg) tablet 

Busulfan finds application in chronic myeloid leukemia (CML), conditioning regimen before hematopoietic stem cell transplantation, and in other some hematological diseases.

Mechanism of action of Bucelon 2 (Busulfan 2 mg) tablet

Busulfan is an alkylating agent, which reacts with DNA and binds the strands of DNA. This interferes with the process of DNA replication and transcription, and does not allow the cell to divide, causing cancer cells to die by apoptosis. It is not cell cycle specific, but primarily impacts on rapidly dividing cells.

How to consume Bucelon 2 (Busulfan 2 mg) tablet

Busulfan is currently used as an oral therapy in form of tablets or as an intravenous therapy in the hospital to treat transplant diseases. The level of dosage is determined with the body weight or body surface area. It has a low therapeutic index and thus, needs strict medical supervision.

Side Effects of Bucelon 2 (Busulfan 2 mg) tablet

1. Common side effects

• Nausea
• Vomiting
• Fatigue
• Loss of appetite

2. Serious side effects

• Bone marrow suppression
• Pulmonary fibrosis
• Hepatotoxicity

3. Rare side effects

• Skin hyperpigmentation
• Secondary malignancies
• Hypersensitivity reactions

Safety Advice for Bucelon 2 (Busulfan 2 mg) tablet

Busulfan is multi-organ toxic and patients must be closely monitored with blood counts, liver functioning and lung functioning.

Breastfeeding: Contraindicated as the drug may pass on the breast milk and cause harm to the baby.

Pregnancy: It should not be conceived due to teratogenic effects.

Alcohol: This should be avoided as it may cause liver to be more toxic.

Liver: Busulfan may lead to liver veno-occlusive disease, it is also needed to watch on it regularly.

Lungs: Pulmonary fibrosis is among the important long-term complications; the symptoms, which should be reported as early as possible, are cough and shortness of breath.

Kidney: The kidney functions are to be monitored especially when the doses are high.

Driving: Patients might feel dizzy or have seizures; they should avoid driving.

Interaction of Bucelon 2 (Busulfan 2 mg) tablet

• Drug–Drug Interaction

Cyclophosphamide × Busulfan
Sequential administration can lead to an augmented danger of liver toxicity, especially veno-occlusive disease.

Phenytoin × Busulfan

Phenytoin causes enzymatic activity in the liver, and could decrease the levels of Busulfan, which makes it less effective.

Itraconazole × Busulfan

These drugs prevent metabolism of Busulfan, increasing plasma levels and exposure to toxicity.

Busulfan × Other myelosuppressive drugs.

May causes increased risk of severe bone marrow suppression.

Paracetamol × Busulfan

May has an effect on the glutathione and changes the metabolism of Busulfan, which risks toxicity.

• Drug–Food Interaction

No significant food interaction, although regular intake and hydration are significant. One should not drink alcohol.

• Drug–Disease Interaction of Bucelon 2 (Busulfan 2 mg) tablet

Bone marrow disorders:
Busulfan causes a profound bone marrow depression that can be detrimental to underlying conditions, resulting in anemia, infections and bleeding.

Liver disease:

Liver impairment patients are more likely to have veno-occlusive disease and hepatotoxicity.

Pulmonary disease:

Busulfan may lead to pulmonary fibrosis particularly when used over a long period of time. Patients who have an underlying lung disease are more susceptible.

Seizure disorders:

Busulfan can cause seizures especially when administered in high doses especially to patients with history of epilepsy.

Contraindication of Bucelon 2 (Busulfan 2 mg) tablet

Should not be used in hypersensitivity, extreme bone marrow suppression and pregnancy.

Dosage of Bucelon 2 (Busulfan 2 mg) tablet

Dosage is calculated on the body weight or surface area and the dosage is different in relation to the indication. Transplant conditioning uses high-dose regimens.

Storage of Bucelon 2 (Busulfan 2 mg) tablet

Keep at room temperature, in dry, air-free place.

Missed Dose of Bucelon 2 (Busulfan 2 mg) tablet

In case of a dose missed, administer it as soon as possible except on the eve of the next dose. Do not double dose.

Other General Information of Bucelon 2 (Busulfan 2 mg) tablet

Monitoring should be done on a regular basis to the patients. Report any symptoms like breathlessness, jaundice or fever.

FAQs of Bucelon 2 (Busulfan 2 mg) tablet

1. What is the mechanism of Busulfan leading to the fibrosis of the lungs?

Due to its ability to destroy lung tissue due to chronic toxicity and inflammation.

2. What is the rationale behind high-dose therapy of seizure prophylaxis?

Since Busulfan has the ability to penetrate the blood-brain barrier and expose people to seizures.

3. What is liver monitoring?

To identify the early signs of veno-occlusive disease which is life threatening.

4. What is the use of Busulfan in transplantation?

It assists in the destruction of already existing bone marrow cells in order to successfully aid the engraftment of donor stem cells.

5. What makes bone marrow suppression an issue of concern?

Since it causes higher risk of infection, anemia and bleeding.

Fact Box of Bucelon 2 (Busulfan 2 mg) tablet

References

• FDA Prescribing Information – Busulfan
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020954s014lbl.pdf
• European Medicines Agency (EMA) – Busulfan Product Information
  https://www.ema.europa.eu/en/documents/product-information/busilvex-epar-product-information_en.pdf
• DrugBank – Busulfan
  https://go.drugbank.com/drugs/DB01008
• National Cancer Institute (NCI) – Busulfan
  https://www.cancer.gov/about-cancer/treatment/drugs/busulfan