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INTRODUCTION
SPNIB 50 TABLET contains Dasatinib which belongs to the group of medicines called Tyrosine Kinase Inhibitor. It is used to treat cancers of blood and bone marrow (such as chronic myeloid leukaemia (CML) or Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia) in adults, adolescents and in children (aged 1 year or above).
It is primarily used in patients when treatment with conventional therapies is not suitable or fails to provide adequate response.
Leukaemia is the cancer of blood cells. It is caused due to abnormal growth and multiplication of blood cells within the bone marrow. It is characterized by severe tiredness, breathlessness, increased bleeding tendency, tiredness, anemia, night sweats, fever, chills, frequent infections and weight loss.
During treatment with SPNIB 50 TABLET your doctor will closely monitor your health condition through several blood tests to avoid the risk of unwanted side effects. Avoid eating grapefruit or drinking grapefruit juice while taking SPNIB 50 TABLET as it may increase the risk of side effects.
Before taking SPNIB 50 TABLET inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have or at risk of developing hepatitis C infection as a precaution.
Avoid concomitant use of antacids or any stomach medicines along with SPNIB 50 TABLET. Leave a time gap of at least 2 hours between the medicines. SPNIB 50 TABLET is not recommended for use in pregnant or breastfeeding women.
Men and women taking SPNIB 50 TABLET must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with SPNIB 50 TABLET.
The most common side effects of taking SPNIB 50 TABLET are increased bleeding tendency, increased infections, feeling tired or weak, nausea, vomiting, hair loss, mouth ulcers, changes in taste, inflammation of the food pipe or stomach, muscle pain or spasm, skin rashes, headache, dizziness and weight loss. Contact your doctor if any of these side effect worsens.
USES OF SPNIB 50 TABLET
It is used in adults, adolescents and in children (aged 1 year or above) to treat:
- Cancers of blood and Bone marrow (such as chronic myeloid leukaemia or (Ph+) acute lymphoblastic leukaemia)
HOW SPNIB 50 TABLET WORKS
SPNIB 50 TABLET is an anti-cancer medicine. It works by blocking the actions of certain proteins (such as BCR-ABL, Src kinase, etc.) in the body that triggers cancer formation. As a result, it reduces abnormal growth and multiplication of cancer cells in the body.
DIRECTIONS FOR USE
Take SPNIB 50 TABLET as advised by your physician. It can be taken with or without meals. Swallow the medicine with a glass of water. Do not crush or chew the medicine.
Try to take SPNIB 50 TABLET at the same time each day. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition. Do not stop taking SPNIB 50 TABLET unless advised by your doctor.
SIDE EFFECTS OF SPNIB 50 TABLET
COMMON
- increased infections
- nausea, vomiting
- diarrhea, stomach pain, bloating, constipation, heartburn
- lack of appetite, changes in taste
- mouth ulcers, hair loss
- weight loss or weight gain
- headache, tiredness, weakness
- dizziness
- skin rash, itching, dry skin, acne
- increased bleeding tendency
- joint pain, muscle pain or spasms
- increased sweating, flushing
- blurred vision, dry eyes
- depression, sleeplessness
- oedema (swelling of body parts)
UNCOMMON
- irregular heartbeat, chest pain, breathing difficulties
- stomach ulcers, inflammation of the food pipe
- swollen tummy, anal tears
- anxiety, confusion, mood swings, memory loss
- low sexual drive
- loss of hearing, sensitivity to light
- skin inflammation, nail disorder
- problems in passing urine
- breast enlargement in men, menstrual disorder
- high blood cholesterol levels
- swollen lymph nodes
- increased protein in the urine
RARE
Stop taking SPNIB 50 TABLET and contact your doctor immediately if you experience any of the following side effects such as:
- signs of allergic reactions (such as skin rash, swelling of the face, lips, mouth or throat which can lead to difficulty in breathing or swallowing)
- chest pain, cough, breathing difficulties and fainting (signs of fluid retention in lungs)
- unusual bleeding or bruising with fever, tiredness and confusion (signs of blood vessel damage)
- bloody stools/urine/vomit or black tarry stools
- blistering or peeling of skin and mucous membranes with fever and sore throat, mouth ulcers
HOW TO MANAGE SIDE EFFECTS
Skin rash:
Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if your skin rash worsens.
Headache:
Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Consult your doctor if your headache worsens.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Consult your doctor if your dizziness worsens.
Nausea and Vomiting:
Stick to simple meals. Avoid eating oil rich or spicy foods. If your nausea worsens, consult your doctor for advice.
Mouth ulcers:
Avoid eating spicy foods. Drink plenty of water. Apply a pain-relieving gel on the affected areas of the mouth if required. Consult your doctor if the symptom did not improve.
Diarrhoea:
Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhoea and consult your doctor if the symptom gets worse.
Constipation:
Try to eat more high-fibre foods such as fresh fruit, vegetables, cereals and drink plenty of water. Try doing exercise regularly (going for a daily walk or run). If this does not help, inform your doctor for receiving alternate treatments for constipation.
WARNING & PRECAUTIONS
PREGNANCY
SPNIB 50 TABLET is not recommended for use in pregnant women unless considered necessary by the physician. Therefore, inform your doctor before taking SPNIB 50 TABLET if you are pregnant or think you may be pregnant. Women of childbearing potential must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with SPNIB 50 TABLET.
BREASTFEEDING
SPNIB 50 TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. Therefore, consult your doctor taking it.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if you feel dizzy after taking SPNIB 50 TABLET.
ALCOHOL
Avoid consumption of alcohol while taking SPNIB 50 TABLET as it could make you feel dizzier.
KIDNEY
SPNIB 50 TABLET should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.
LIVER
SPNIB 50 TABLET should be used with caution in patients with liver problems. Therefore, consult your doctor before taking it.
ALLERGY
Do not take SPNIB 50 TABLET if you are allergic to Dasatinib.
HEART DISEASE
SPNIB 50 TABLET should be used with caution in patients with heart problems. Therefore, consult your doctor before taking it.
OTHERS
SPNIB 50 TABLET is not recommended for use if you:
- have, ever had or at risk of having hepatitis B infection
Use in Paediatrics:
SPNIB 50 TABLET is not recommended for use in children (aged below 1 year). Therefore, consult your doctor before taking it.
Use in Geriatrics:
SPNIB 50 TABLET should be used with caution in elderly patients (aged 65 years or above). Therefore, consult your doctor before taking it.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking SPNIB 50 TABLET, inform your doctor, if you are taking any of the following medicines such as:
- medicines used for blood thinning (Ex. warfarin)
- ketoconazole, itraconazole (used to treat fungal infection)
- medicines used to treat bacterial infection (such as erythromycin, clarithromycin, telithromycin)
- ritonavir (a medicine used to treat HIV infection)
- medicines used to treat epilepsy (Ex. phenytoin, carbamazepine, phenobarbital)
- rifampicin (a medicine used to treat tuberculosis)
- medicines used to treat stomach ulcers (such as famotidine, omeprazole)
- St. John’s wort (an herbal preparation used to treat depression)
- antacids (used to neutralize stomach acids) Ex. aluminium hydroxide or magnesium hydroxide
B. Drug-Food Interactions:
Avoid eating grapefruit or drinking grapefruit juice while taking SPNIB 50 TABLET as it may increase the risk of side effects.
Overdosage:
If you or anyone else accidentally took more SPNIB 50 TABLET, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Dasatinib |
| Pharmacological Category | : | BCR-ABL Tyrosine Kinase Inhibitor |
| Therapeutic Indication | : | Chronic Myeloid Leukaemia, Acute Lymphoblastic Leukaemia |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep SPNIB 50 TABLET out of reach of children
- Store SPNIB 50 TABLET at room temperature
FAQs ABOUT SPNIB 50 TABLET
What SPNIB 50 TABLET is used for?
SPNIB 50 TABLET is used to treat cancers of blood and bone marrow (such as chronic myeloid leukaemia (CML) or Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia) in adults, adolescents and in children (aged 1 year or above). It is primarily used in patients when treatment with conventional therapies is not suitable or fails to provide adequate response.
How SPNIB 50 TABLET works on my body?
SPNIB 50 TABLET is an anti-cancer medicine. It works by blocking the actions of certain proteins (such as BCR-ABL, Src kinase, etc.) in the body that triggers cancer formation. As a result, it reduces abnormal growth and multiplication of cancer cells in the body.
Can SPNIB 50 TABLET cure cancer?
The cure rate of cancer depends upon the severity of the disease. However, SPNIB 50 TABLET acts by preventing the abnormal growth and multiplication of cancer cells in the body, which may help in curing cancer completely.
Can the use of SPNIB 50 TABLET cause hair loss?
Hair loss is one of the common side effects of taking SPNIB 50 TABLET. If it bothers you, consult your doctor for advice.
Can the use of SPNIB 50 TABLET cause mouth ulcers?
Mouth ulcers are one of the common side effects of taking SPNIB 50 TABLET. Avoid eating spicy foods. Drink plenty of water. Apply a pain-relieving gel on the affected areas of the mouth if required. Consult your doctor if the symptom did not improve.
Can SPNIB 50 TABLET be used in children?
SPNIB 50 TABLET can be used in children and adolescents (aged 1 year or above) if prescribed by the physician. It should not be used in children aged below 1 year due to increased risk of side effects.
Is SPNIB 50 TABLET a chemo drug?
Yes. SPNIB 50 TABLET contains a medicine called Dasatinib which is a chemotherapeutic agent. It stops abnormal growth and multiplication of cancer cells in the body.
What happens if I forgot to take a dose of SPNIB 50 TABLET?
If you forgot to take a dose of SPNIB 50 TABLET, take it as soon as you remember. However, if it is time for the next dose of SPNIB 50 TABLET, skip the missed dose and take the next one regularly. Do not take a double dose of SPNIB 50 TABLET to compensate the missed ones.
What precautions must be followed while taking SPNIB 50 TABLET?
Before taking SPNIB 50 TABLET inform your doctor if you have any liver, kidney or heart problems or if you have or at risk of developing hepatitis C infection as a precaution. Avoid eating grapefruit or drinking grapefruit juice while taking SPNIB 50 TABLET. Leave a time gap of at least 2 hours between SPNIB 50 TABLET and stomach medicines. Inform your doctor before taking SPNIB 50 TABLET if you are pregnant or breastfeeding women. Men and women taking SPNIB 50 TABLET must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with SPNIB 50 TABLET.
Will taking a higher dose of SPNIB 50 TABLET be more effective?
No, taking a higher dose of SPNIB 50 TABLET will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.
What happens if I stop taking SPNIB 50 TABLET?
No. Do not stop taking SPNIB 50 TABLET without consulting your doctor as it may make your symptoms reappear. Therefore, take SPNIB 50 TABLET as advised by your doctor for the stipulated duration.
Can SPNIB 50 TABLET be used during pregnancy?
SPNIB 50 TABLET is not recommended for use in pregnant women unless considered necessary by the physician. Therefore, inform your doctor before taking SPNIB 50 TABLET if you are pregnant or think you may be pregnant.
Can the use of SPNIB 50 TABLET make me feel tired?
Yes. SPNIB 50 TABLET may make you feel tired easily. This is because, it reduces the levels of red blood cells in your blood and may make you anaemic. Consult your doctor if you experience tiredness after taking SPNIB 50 TABLET. Tiredness can also occur if you have any pre-existing disease conditions such as liver or kidney impairment while taking this medicine.
Can I drive a car after taking SPNIB 50 TABLET?
SPNIB 50 TABLET may make you feel tired or dizzy. Therefore, do not drive or operate any heavy tools or machines if your ability is affected by SPNIB 50 TABLET.
How to take SPNIB 50 TABLET?
Take SPNIB 50 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. SPNIB 50 TABLET can be taken with or without food.
How to control nausea caused due to SPNIB 50 TABLET?
Generally, anticancer medicines are associated with uncontrollable nausea and vomiting. To avoid this, your doctor would prescribe a suitable medicine to control them along with SPNIB 50 TABLET. If not, consult your doctor for a suitable anti-emetic medicine. Do not self-treat nausea.
What are the side effects of taking SPNIB 50 TABLET?
The most common side effects of taking SPNIB 50 TABLET are increased bleeding tendency, increased infections, feeling tired or weak, nausea, vomiting, hair loss, mouth ulcers, changes in taste, inflammation of the food pipe or stomach, muscle pain or spasm, skin rashes, headache, dizziness and weight loss. Contact your doctor if any of these side effect worsens.
Who should avoid taking SPNIB 50 TABLET?
SPNIB 50 TABLET is not recommended for use if you are allergic to dasatinib. It is also not recommended for use in pregnant or breastfeeding women and in children (aged below 1 year).
Is SPNIB 50 TABLET safe to use in kidney disease?
SPNIB 50 TABLET should be used with caution in patients with kidney problems. Your doctor will access your health condition and suggest a suitable dose for you.
Can the use of SPNIB 50 TABLET affect the liver?
Yes. SPNIB 50 TABLET may affect the way your liver work. It can elevate the levels of certain liver enzymes in your body. Therefore, it should be used with caution in patients with liver problems. Consult your doctor before taking it.
REFERENCES
1. Laurence Brunton. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies and Cytokines. Goodman and Gillman’s: The Pharmacological Basics of Therapeutics. Twelfth Edition. 2011. Page – 1732-1734.
2. Dilek Keskin, Sevil Sadri, Ahmet Emre Eskazan. Dasatinib for the treatment of chronic myeloid leukemia: patient selection and special considerations. NIH National Library of Medicine. National Centre for Biotechnology Information. PMC PubMed Central. October 2016. [Assessed on 10th November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5066856/
3. Zentiva Pharma UK Limited. Electronic Medicines Compendium (EMC). [Revised in May 2022]. [Accessed on 10th November 2022] https://www.medicines.org.uk/emc/files/pil.10921.pdf
4. Bristol-Myers Squibb Pharma EEIG. Electronic Medicines Compendium (EMC). [Revised in March 2022]. [Accessed on 10th November 2022] https://www.medicines.org.uk/emc/files/pil.3958.pdf
5. Bristol-Myers Squibb Canada. SPRYCEL. [Revised in November 2021] [Assessed on 10th November 2022] https://www.bms.com/assets/bms/ca/documents/productmonograph/SPRYCEL_EN_PM.pdf
AUTHOR DETAILS
Written By Srilekha. R, B.Pharm
Last updated on 12 Nov 2022 | 10:44 AM(IST)
PRODUCT DETAILS
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