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INTRODUCTION
IMATIB 100MG TABLET contains Imatinib which belongs to the group of medicines called Tyrosine Kinase Inhibitors. It is used in adults, children and adolescents to treat chronic myeloid leukaemia (CML) (a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control) and philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL) (a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control).
Also, it is used in adults only to treat myelodysplastic/myeloproliferative diseases (MDS/MPD) (a group of blood diseases in which some blood cells start growing out of control), hyper eosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) (a blood diseases in which some blood cells (named eosinophils) start growing out of control), gastrointestinal stromal tumours (GIST) (cancer of the stomach and bowels) and dermatofibrosarcoma protuberans (DFSP) (cancer of the tissue beneath the skin in which some cells start growing out of control).
Before taking IMATIB 100MG TABLET, inform your doctor if you have or ever had kidney, liver or heart problems, hepatitis B infection and thrombotic microangiopathy (symptoms include bruising, bleeding, fever, fatigue and confusion).
IMATIB 100MG TABLET is generally not recommended for use in pregnant women unless advised by the doctor and it is not recommended for use in breastfeeding women. IMATIB 100MG TABLET should be used with caution in children, adolescents and elderly patients (aged 65 years and above).
The most common side effects of taking IMATIB 100MG TABLET are nausea, vomiting, diarrhea, headache, weight gain, loss of appetite, disturbed sense of taste, blurred vision and weakness. Consult your physician if any of the side effects worsen.
USES OF IMATIB 100MG TABLET
Treat adults, children and adolescents for:
- chronic myeloid leukaemia (CML)
- philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL)
Treat adults for:
- myelodysplastic/myeloproliferative diseases (MDS/MPD)
- hyper-eosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL)
- gastrointestinal stromal tumors (GIST)
- dermatofibrosarcoma protuberans (DFSP)
HOW IMATIB 100MG TABLET WORKS
IMATIB 100MG TABLET is a protein-tyrosine kinase inhibitor. Tyrosine kinases are proteins which act as chemical messengers that are used by the cancer cells to signal each other for their growth, therefore this medicine works by blocking the enzyme which stops the cancer cells from growing.
DIRECTIONS FOR USE
Take IMATIB 100MG TABLET as advised by your physician. Swallow the IMATIB 100MG TABLET with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF IMATIB 100MG TABLET
COMMON
- headache or feeling tired
- nausea, vomiting, diarrhea or indigestion
- rash
- muscle cramps, joint, muscle or bone pain
- swelling such as round ankles or puffy eyes
- weight gain
- loss of appetite, weight loss or disturbed sense of taste
- feeling dizzy or weak
- insomnia
- conjunctivitis watery eyes, or blurred vision
- nose bleeds
- pain or swelling in the abdomen, flatulence, heartburn or constipation
- itching
- unusual hair loss or thinning
- numbness of the hands or feet
- mouth ulcers
- dry mouth, dry skin or dry eye
- decreased or increased skin sensitivity
- hot flushes, chills or night sweats
RARE
Stop taking IMATIB 100MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- rapid weight gain, severe fluid retention
- infection symptoms such as fever, severe chills, sore throat or mouth ulcers, low white blood cells
- unexpected bleeding or bruising
- sign of heart problems like chest pain or irregular heart rhythm
- sign of lung problems like cough, difficulty in breathing or painful breathing
- signs of low blood pressure like feeling light-headed, dizzy or fainting
- sign of liver problems like nausea, loss of appetite, dark-colored urine, yellow skin or eyes
- sign of skin problems like rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, a pustular eruption and sudden swelling and redness of the skin (cellulitis)
- sign of gastrointestinal disorders like severe abdominal pain, blood in vomit, stools or urine, black stools
- signs of kidney problems like severely decreased urine output and feeling thirsty
- signs of bowel problems like nausea with diarrhea and vomiting, abdominal pain or fever
- signs of nervous system problems like severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness, bleeding or swelling in skull/brain
- signs of low levels of red blood cells like pale skin, feeling tired and breathlessness and having dark urine
- signs of raynaud’s syndrome like numb or cold toes and fingers
- signs of muscle problems like muscle spasms with a fever, red-brown urine, pain or weakness in your muscles
- eye pain or deterioration in vision, bleeding in the eyes
- pain in hips or difficulty walking
- difficulty in hearing
- signs of problems with ovaries or womb like pelvic pain with unexpected vaginal bleeding
- thrombotic microangiopathy (blood clots in small blood vessels)
HOW TO MANAGE SIDE EFFECTS
Nausea or vomiting:
Try to take IMATIB 100MG TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich, fried or spicy foods. Consult your doctor if the symptom does not improve.
Diarrhoea:
Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom does not improve.
Headache:
Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom does not improve.
Dry mouth:
Sip water regularly and other sugar free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.
Tiredness:
Drink plenty of fluid and eat balanced diet and frequent meals. Do regular minimal exercise and follow regular sleep schedule. Consult your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
IMATIB 100MG TABLET is generally not recommended for use in pregnant women unless considered clearly necessary. Women who might become pregnant are advised to use effective contraceptive measures during treatment and for 15 days after ending the treatment. Consult your doctor before taking IMATIB 100MG TABLET.
BREASTFEEDING
IMATIB 100MG TABLET is not recommended for use during breastfeeding and for 15 days after ending the treatment as it may harm the baby. Consult your doctor before taking IMATIB 100MG TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you experience dizziness, drowsiness or blurred vision after taking IMATIB 100MG TABLET.
KIDNEY
IMATIB 100MG TABLET should be used with caution in patients with kidney problem. Consult your doctor before taking IMATIB 100MG TABLET.
LIVER
IMATIB 100MG TABLET should be used with caution in patients with liver problems and hepatitis B infection. Consult your doctor before taking IMATIB 100MG TABLET.
ALLERGY
Do not take IMATIB 100MG TABLET if you are allergic to imatinib or any other ingredients of this medicine.
HEART DISEASE
IMATIB 100MG TABLET should be used with caution in patients with heart problem. Consult your doctor before taking IMATIB 100MG TABLET.
OTHERS
Before taking IMATIB 100MG TABLET, inform your doctor if you have:
- thrombotic microangiopathy symptoms such as bruising, bleeding, fever, fatigue and confusion
Use in pediatrics:
IMATIB 100MG TABLET should be used with caution in children and adolescents. Consult your child’s doctor for advice.
Use in geriatrics:
IMATIB 100MG TABLET should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking IMATIB 100MG TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking IMATIB 100MG TABLET, inform your doctor if you are taking any of the following medicines:
- medicines used to treat fever and pain (Ex. paracetamol)
- st. john’s wort (used to treat depression)
- medicines used to prevent blood clots (Ex. clopidogrel)
- medicine used to treat thyroid (levothyroxine)
Overdosage:
If you or anyone else accidentally take too much of IMATIB 100MG TABLET, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Imatinib |
| Pharmacological Category | : | Tyrosine kinase inhibitor |
| Therapeutic Indication | : | Chronic myeloid leukaemia, Philadelphia chromosome positive acute lymphoblastic leukaemia, myelodysplastic/myeloproliferative diseases hyper eosinophilic syndrome or chronic eosinophilic leukaemia, Gastrointestinal stromal tumors, dermatofibrosarcoma protuberans |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep IMATIB 100MG TABLET out of reach of children
- Store IMATIB 100MG TABLET at room temperature
FAQs ABOUT IMATIB 100MG TABLET
What happens if I stop taking IMATIB 100MG TABLET on my own?
Do not stop taking IMATIB 100MG TABLET unless your doctor tells you to stop even if the condition improves. If you are not able to take the IMATIB 100MG TABLET as your doctor prescribed or feel you do not need it anymore, contact your doctor immediately.
It is safe to drive after taking IMATIB 100MG TABLET?
In some patients IMATIB 100MG TABLET may cause dizziness, drowsiness or blurred vision. So, it is better to avoid driving or operating any machine after taking IMATIB 100MG TABLET. Consult your doctor for advice before taking it.
Can I take IMATIB 100MG TABLET during pregnancy?
IMATIB 100MG TABLET is generally not recommended for use in pregnant women unless advised by the doctor. Women who might become pregnant are advised to use effective contraceptive measures during treatment and for 15 days after ending the treatment. Consult your doctor before taking this medicine.
How does IMATIB 100MG TABLET work?
IMATIB 100MG TABLET is a protein-tyrosine kinase inhibitor. Tyrosine kinases are proteins which act as chemical messengers that are used by the cancer cells to signal each other for their growth, therefore this medicine works by blocking the enzyme which stops the cancer cells from growing.
Can IMATIB 100MG TABLET be used in patients with liver problems?
IMATIB 100MG TABLET should be used with caution in patients with liver problems and hepatitis B infection. Your doctor may monitor your liver function during and after treatment with this medicine to prevent the risk of any unusual effects. Consult your doctor before taking it.
REFERENCES
1. Anton Wellstein, Giuseppe Giaccone, Michael B. Atkins, and Edward A. Sausville. Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. New York McGraw Hill Medical 2018 Page – 1203-1236.
2. Nida Iqbal and Naveed Iqbal. Imatinib: A Breakthrough of Targeted Therapy in Cancer. Journal of chemotherapy research and practice. May 2014. [Accessed on 19th November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4055302/
3. Andreas Hochhaus, Richard A. Larson, François Guilhot, Jerald P. Radich, Susan Branford, Timothy P. Hughes, Michele Baccarani, Michael W. Deininger, Francisco Cervantes, Satoko Fujihara, Christine-Elke Ortmann, Hans D. Menssen, et al. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. The New England of Medicine. March 2017. [Accessed on 19th November 2022] https://www.nejm.org/doi/full/10.1056/nejmoa1609324
4. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in August 2022] [Accessed on 19th November 2022] https://www.medicines.org.uk/emc/files/pil.2289.pdf
USEFUL DIAGNOSTIC TESTS
- Bcr-Abl Gene Translocation
- Bcr-Abl Gene Translocation
- Complete Blood Count
- Peripheral Smear Examination
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