INTRODUCTION
BUFATAS contains Busulfan which belongs to the group of medicines called Anti-cancer agents. It is used as a preparative medicine prior to bone marrow or stem cell transplantation to suppress immune functions and to prevent graft rejection among patients with chronic myelogenous leukemia (cancer of white blood cells in the blood).
It is generally used in combination with other anticancer medicines (such as cyclophosphamide, fludarabine, or melphalan) and can be used in both adults and in children (including newborns).
Before receiving BUFATAS inform your doctor if you have a history of seizures, or any lung, liver, or kidney problems. BUFATAS should not be used in pregnant or breastfeeding women as it may cause serious harm to the growing fetus or nursing infant.
Men receiving BUFATAS must not father a child during treatment with BUFATAS and up to six months after stopping the therapy. Both men and women receiving BUFATAS must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with BUFATAS.
The use of BUFATAS may cause abnormal decrease in white blood cells (WBC) and platelet count in the blood. To avoid this, your doctor will closely monitor your blood count periodically before and during treatment with BUFATAS. It may also precipitate fits and/or nausea, and so your doctor will pre-treat you with few anticonvulsants and anti-emetic medicines to prevent them.
Other common side effects of receiving BUFATAS are mouth sores, diarrhea, hair loss, infections, problems in sleeping, confusion, weight gain and difficulty in urination. Consult your doctor if any of these side effects worsen.
USES OF BUFATAS
It is used among patients (adults and children) with chronic myelogenous leukemia as a pre-treatment prior to bone marrow/stem cell transplantation to:
Prevent transplant (bone marrow/stem cell) rejection
HOW BUFATAS WORKS
BUFATAS is an anticancer medicine with immune suppressing properties. When used prior to stem cell/bone marrow transplantation, BUFATAS can suppress the functions of immune cells (white blood cells) and prevent the risk of transplant rejection among patients having high WBC count or leukemia.
DIRECTIONS FOR USE
BUFATAS will be given to you only by a doctor or a nurse into the vein as an intravenous infusion. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF BUFATAS
COMMON
Low blood counts (WBC, RBC, and platelets)
Signs of infections, sore throat, cough
Difficulty in sleeping, anxiety, dizziness, confusion, and depression
Loss of appetite, low magnesium, sodium, and potassium levels in the blood
Fast heart rate, changes in blood pressure, blood clots
Difficulty in breathing, nasal secretion (rhinitis), hiccup, nasal bleeds, abnormal breath sounds
Increased blood sugar levels
Nausea, vomiting, stomach pain, diarrhea, constipation, heart burn
Mouth ulcers (oral sores)
Jaundice (yellowing of skin or whites of eye)
Inflammation at injected site
Hair loss
Skin rash, itching or redness, skin discoloration
Back pain, joint pain, and muscle pain
Bloody urine or difficulty in urination
Fever, chills, pain
Headache
Feeling weak, edema
Weight gain
UNCOMMON
Problems in thinking, nervousness, hallucination
Fits (seizure)
Bleeding in the brain or in the gut
RARE
Contact your doctor immediately if you experience any of the following side effects after receiving BUFATAS:
Any signs of fever or infection (chills, sore throat, mouth sores, cough, urinary problems) caused due to sudden decrease in WBC counts
Abnormal bleeding and bruising caused due to sudden decrease in platelet counts
Pale skin and tiredness caused due to low RBC counts
Sudden feeling of unwellness
Blockade of liver vein
Graft versus host disease (reaction between the transplanted graft and the host)
Lung problems causing shortness of breath and chest pain
HOW TO MANAGE SIDE EFFECTS
Diarrhoea:
Drink plenty of fluids such as water, fruit juices or electrolytes to avoid dehydration in your body. Consult your doctor if your symptom worsens.
Mouth ulcers:
Use soft toothbrush to brush your teeth. Avoid eating spicy and acidic foods such as beverages, sodas, and processed foods. Also, you may can use over-the-counter pain-relieving oral gel to get some relief.
Headache:
Try to take rest. Apply a pain-relieving balm on your forehead. If the symptom does not improve, consult with your doctor.
Dizziness:
Lie down until dizziness passes away and then move slowly and carefully. Take plenty amount of rest and drink plenty of fluids. If your symptom does not improve consult your doctor.
WARNING & PRECAUTIONS
PREGNANCY
BUFATAS is not recommended for use in pregnant women. Women of childbearing age must use a suitable contraceptive before and during treatment with BUFATAS to avoid pregnancy and up to 6 months after discontinuation. If you became pregnant while undergoing therapy with BUFATAS, stop taking the medicine and contact your doctor immediately.
BREASTFEEDING
BUFATAS is not recommended for use in breastfeeding women. However, consult your doctor before receiving it.
DRIVING AND USING MACHINES
BUFATAS does not cause any side effects that affects your ability to drive or operate any machines. If you experience any side effects that impairs your ability to concentrate, avoid driving and operating machines.
ALCOHOL
Consumption of alcohol is not recommended during treatment with BUFATAS.
KIDNEY
BUFATAS should be used with caution in patients with kidney problems. Therefore, consult your doctor before receiving it.
LIVER
BUFATAS should be used with caution in patients with liver problems. Therefore, consult your doctor before receiving it.
ALLERGY
Do not receive BUFATAS if you are allergic to Busulfan.
LUNGS
BUFATAS should be used with caution in patients with lung problems. Therefore, consult your doctor before receiving it.
OTHERS
Before receiving BUFATAS inform your doctor if you have:
History of seizures
Are a man wishing to father a child
Use in pediatrics:
BUFATAS should be used in infants, children and adolescents (aged between 0-18 years) only if prescribed by a physician. Therefore, consult your doctor before administration.
Use in geriatrics:
BUFATAS should be used with caution in elderly patients. Therefore, consult your doctor before receiving it.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving BUFATAS inform your doctor, if you are receiving any of the following medicines such as:
Other chemotherapy medicines (used to treat cancer) such as cyclophosphamide, cisplatin, carboplatin, methotrexate etc
Itraconazole (a medicine used to treat fungal infections)
Metronidazole (a medicine used to treat bacterial and protozoal infections)
Ketobemidone (a medicine used for pain relief)
Deferasirox (a medicine used to remove excess iron from the body)
Paracetamol (used to treat fever and pain)
Overdosage:
BUFATAS will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms.
SYNOPSIS
Drug :?? Busulfan????????
Pharmacological Category :??
Alkylating agents
Therapeutic Indication :??
Prevents Transplant Rejection
Dosage Forms :?? Tablet, Injection???????????????????
MORE INFORMATION
Keep BUFATAS out of reach of children
Store in a refrigerator between 2-8?C
FAQs ABOUT BUFATAS
What is the use of BUFATAS?
BUFATAS is an anticancer medicine with immune suppressing properties. It is used as a preparative medicine prior to bone marrow/stem cell transplantation to suppress immune functions and to prevent graft rejection among patients with chronic myelogenous leukemia (cancer of white blood cells in the blood).
Is BUFATAS a chemotherapy?
Yes. BUFATAS is a chemotherapeutic agent with immune suppressing properties. When used prior to stem cell/bone marrow transplantation, BUFATAS can suppress the functions of immune cells (white blood cells) and prevent the risk of transplant rejection among patients having high WBC count or leukemia.
Is the use of BUFATAS safe?
BUFATAS is safe when used under proper medical supervision and at the prescribed doses.
What are the side effects of BUFATAS?
BUFATAS may cause abnormal decrease in WBC and platelet counts. It may also cause nausea, vomiting, seizures, diarrhea, mouth sores and difficulty in urination. Therefore, consult your doctor for advice if they trouble you.
How BUFATAS works?
BUFATAS works by suppressing your immune system. When used prior to stem cell/bone marrow transplantation, BUFATAS can suppress the functions of immune cells (white blood cells) and prevent the risk of transplant rejection among patients having high WBC count or leukemia.
Can the use of BUFATAS cause hair loss?
Yes. Hair loss is one of the common side effects of receiving BUFATAS. Consult your doctor if it bothers you.
Will the use of BUFATAS affect fertility?
Yes. The use of BUFATAS may affect fertility in both men and women. It may cause lack of periods, delayed puberty, early menopause in women and decreased sperm production in men. Consult your doctor if they trouble you.
Can I stop therapy with BUFATAS without consulting your doctor?
No, you should not stop therapy with BUFATAS without consulting your doctor because it may lead to reversal of symptoms. If you feel better after using BUFATAS, consult your doctor for advice. Your doctor might would reduce the dose gradually before discontinuation of therapy.
Can the use of BUFATAS cause seizure?
Yes. BUFATAS may cause seizure in some individuals. To avoid this, your doctor will treat you with few anticonvulsant medicines such as phenytoin or benzodiazepines (Ex. diazepam, clonazepam, lorazepam, alprazolam, midazolam) prior to the treatment with BUFATAS. However, if you still experience any unpleasant reactions contact your doctor for advice.
Can the use of BUFATAS cause vomiting?
Yes. BUFATAS may cause vomiting in some individuals. To avoid this, your doctor will treat you with few medicines that can help in prevent vomiting. However, if you still experience any unpleasant reactions contact your doctor for advice.
REFERENCES
1. KD. Tripathi. Chemotherapy of Neoplastic Diseases. Essentials of medical pharmacology. Seventh edition. 2013. Page ? 861.
2.?Partow Kebriaei,?Claudio Anasetti,?Mei-Jie Zhang,?Hai-Lin Wang,?Ibrahim Aldoss,?Marcos de Lima,?H Jean Khoury,?Brenda M. Sandmaier,?Mary M. Horowitz,?Andrew Artz,?Nelli Bejanyan,?Stefan Ciurea,?Hillard M. Lazarus,?Robert Peter Gale,?Mark Litzow,?Christopher Bredeson,?Matthew D. Seftel,?Michael A. Pulsipher,?Jaap-Jan Boelens,?Joseph Alvarnas,?Richard Champlin,?Stephen Forman,?Vinod Pullarkat,?Daniel Weisdorf,?David I. Marks. Intravenous busulfan compared to total body irradiation pre-transplant conditioning for adults with acute lymphoblastic leukaemia. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. April 2019. [Accessed on 3rd September 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5902420/
3. MD ANDERSON. Q&A: Intravenous busulfan before stem cell transplant. MD Anderson Cancer Center. The University of Texas. May 2010. [Accessed on 3rd September 2022]?https://www.mdanderson.org/cancerwise/qa-intravenous-busulfan-before-stem-cell-transplant.h00-158592945.html#:~:text=Busulfan%20acts%20directly%20on%20the,before%20a%20stem%20cell%20transplant.
4.?Donna A. Wall MD, Ka Wah Chan MD, Michael L. Nieder MD, Robert J. Hayashi MD, Andrew M. Yeager MD, Richard Kadota MD, Donna Przepiorka MD, Khaled Mezzi MD, Morris Kletzel MD. Safety, efficacy, and pharmacokinetics of intravenous busulfan in children undergoing allogeneic hematopoietic stem cell transplantation. Paediatric Blood and Cancer. Wiley Online Library. September 2009. [Accessed on 3rd September 2022]?https://onlinelibrary.wiley.com/doi/10.1002/pbc.22227
5. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in July 2020] [Accessed on 3rd September 2022]?https://www.medicines.org.uk/emc/files/pil.2160.pdf
6. Gland Pharma Limited. Pfizer Ltd. [Revised in August 2020]. [Accessed on 3rd September 2022]?https://labeling.pfizer.com/ShowLabeling.aspx?format=PDF&id=11523
USEFUL DIAGNOSTIC TESTS
Bcr-Abl Gene Translocation
Complete Blood Count
Kidney Function Test
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PRODUCT DETAILS
Net Qty
1 N
Ingredient
Busulphan 6 MG
Hsn Code
30049099
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