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INTRODUCTION
CABOTIB 40 TABLET contains Cabozantinib which belongs to the group of medicines called Anticancer drugs. It is used in adults to treat advanced kidney cancer. It can also be used in the treatment of liver cancer and advanced thyroid cancer when treatment with other conventional cancer medicines (such as sorafenib) and radiotherapy is not responding appropriately.
Take CABOTIB 40 TABLET on an empty stomach. You should not eat anything for at least 2 hours before and for 1 hour after taking the medicine. Before taking CABOTIB 40 TABLET inform your doctor if you have any liver, kidney or heart problems.
You must also inform your doctor if you have high blood pressure, thyroid problems, inflammatory bowel diseases, abnormal bulging or tear in blood vessels or a recent history of blood clot formation, stroke or heart attack as a precaution.
During treatment with CABOTIB 40 TABLET, it is important for you to practise a good oral hygiene. You must also inform your dentist about this medicine if you have a need to visit dentist regularly.
Avoid eating grapefruit or drinking grapefruit juice while taking CABOTIB 40 TABLET as it may increase the risk of side effects. CABOTIB 40 TABLET is not recommended for use in pregnant or breastfeeding women.
Men and women taking CABOTIB 40 TABLET must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with CABOTIB 40 TABLET. Men may also seek advice on sperm preservation, if necessary, prior to the therapy with this medicine.
The most common side effects of taking CABOTIB 40 TABLET are nausea, vomiting, stomach upset, skin rashes, blisters and pain in the hands or soles of the feet, weight loss, altered taste sensation, tiredness, weakness, sore mouth, throat and tongue, fistula and piles. Contact your doctor if any of these side effect worsens.
USES OF CABOTIB 40 TABLET
It is used in adults to treat:
- advanced kidney cancer
- liver cancer
- advanced thyroid cancer
HOW CABOTIB 40 TABLET WORKS
CABOTIB 40 TABLET is an anti-cancer medicine. It works by blocking the actions of certain proteins (such as receptor tyrosine kinases) in the body that triggers cancer formation. As a result, it prevents abnormal cell division within the body and slows down the growth of cancer cells in the body.
DIRECTIONS FOR USE
Take CABOTIB 40 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. CABOTIB 40 TABLET should not be taken with food. You should not eat anything for at least 2 hours before and for 1 hour after taking the medicine.
Try to take CABOTIB 40 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 CABOTIB 40 TABLET unless advised by your doctor.
SIDE EFFECTS OF CABOTIB 40 TABLET
COMMON
- nausea, vomiting
- stomach upset, diarrhoea, constipation, indigestion and stomach pain
- skin rashes, abscess with pus, blisters and pain in the hands or soles of the feet
- loss of appetite, weight loss, altered taste sensation, acid reflux
- tiredness, weakness, headache, dizziness
- high blood pressure
- anaemia due to low levels of red blood cells
- low blood platelet and white blood cell counts
- pain, redness and swelling in the mouth or throat, difficulty in speaking, hoarse voice, cough, difficulty in swallowing, sore tongue
- shortness of breath
- low thyroid functions causing weight gain, tiredness, constipation, cold and dry skin
- painful or swollen arms and legs
- dehydration
- ringing in ears (tinnitus)
- blood clot formation
- increased or decreased blood sugar levels
- low calcium, sodium and phosphate in the blood, high blood potassium levels
- high bilirubin levels in the blood
- high blood cholesterol and triglyceride levels
- numbness, tingling, burning sensation or pain in the limbs
- fistula (a painful tear or abnormal connection of the tissues in your body), piles
- dry mouth and pain in the mouth
- dry skin and severe itching of skin, acne
- hair loss and thinning, hair colour change
- joint pain, muscle spasms
- protein in urine
- respiratory tract infections, increased thyroid activity, lung infections when used in combination with nivolumab
UNCOMMON
- stroke, fits
- problems in bile flow
Stop taking CABOTIB 40 TABLET and contact your doctor immediately if you experience any of the following side effects such as:
- excessive tiredness, chills, deep voice
- signs of GI bleeding (such as stomach pain, nausea, vomiting, constipation, fever, blood vomits, black stools, bloody urine, headache, coughing up blood)
- shortness of breath and swollen hands and feet
- a wound that does not heal
- posterior reversible encephalopathy syndrome (signs includes fits, headaches, confusion or finding it difficult to concentrate)
- drowsiness, confusion and loss of consciousness due to liver problems
- signs of jawbone damage (such as pain in the mouth, teeth or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth)
HOW TO MANAGE SIDE EFFECTS
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.
Diarrhea
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.
Dizziness Or Drowsiness
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.
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.
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.
Nausea And Vomiting
Stick to simple meals. Avoid eating oil rich or spicy foods. If your nausea worsens, consult your doctor for advice.
Skin Rash Or Itching
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.
WARNING & PRECAUTIONS
PREGNANCY
Monitoring requiredCABOTIB 40 TABLET is not recommended for use in pregnant women unless considered necessary by the physician. Therefore, inform your doctor before taking CABOTIB 40 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 CABOTIB 40 TABLET and until 4 months after the last dose.
BREASTFEEDING
ContraindicatedCABOTIB 40 TABLET may pass through the breast milk. Therefore, it is not recommended for use in breastfeeding women during the therapy and until 4 months after the last dose. Consult your doctor for advice before taking it.
DRIVING AND USING MACHINES
Use with CautionCABOTIB 40 TABLET may cause tiredness and weakness. Therefore, do not drive or operate any heavy tools or machines if your ability is affected by this medicine.
ALCOHOL
ContraindicatedAvoid consumption of alcohol while taking CABOTIB 40 TABLET as it could make you feel dizzier.
KIDNEY
Use with CautionCABOTIB 40 TABLET should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.
LIVER
Use with CautionCABOTIB 40 TABLET should be used with caution in patients with liver problems. Therefore, consult your doctor before taking it.
ALLERGY
ContraindicatedDo not take CABOTIB 40 TABLET if you are allergic to Cabozantinib.
HEART DISEASE
Use with CautionCABOTIB 40 TABLET should be used with caution in patients with hypertension. Therefore, consult your doctor before taking it.
USE IN PEDIATRICS
ContraindicatedCABOTIB 40 TABLET is not recommended for use in children and adolescents (aged below 18 years). Therefore, consult your doctor before taking it.
USE IN GERIATRICS
Use with CautionCABOTIB 40 TABLET should be used with caution in elderly patients (aged 65 years or above). Therefore, consult your doctor before taking it.
OTHERS
Before taking CABOTIB 40 TABLET inform your doctor if you:
- have or ever had an aneurysm (abnormal bulging of arteries)
- have a tear in the walls of blood vessels
- have diarrhoea
- recently suffered significant bleeding
- have recently undergone or planning for any surgery in the upcoming days (including minor dental surgeries)
- have inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis, diverticulitis, or appendicitis)
- have a previous history of blood clot formation in the legs
- suffered a stroke or heart attack due to blood clots
- have thyroid problems
INTERACTIONS
A. Drug-Drug Interactions:
Before taking CABOTIB 40 TABLET, inform your doctor, if you are taking any of the following medicines such as:
- medicines used to treat fungal infections (such as itraconazole, ketoconazole and posaconazole)
- medicines used to treat bacterial infections (such as erythromycin, clarithromycin and rifampicin)
- medicines used to treat allergic conditions (such as fexofenadine)
- medicines used to treat chest pain (Ex. ranolazine)
- medicines used to treat epilepsy (such as phenytoin, carbamazepine, and phenobarbital)
- St. John’s Wort (a herbal preparations used to treat depression)
- medicines used for blood thinning (such as warfarin and dabigatran etexilate)
- medicines used to treat high blood pressure or other heart conditions (such as aliskiren, ambrisentan, digoxin, talinolol and tolvaptan)
- medicines used to treat diabetes (Ex. saxagliptin and sitagliptin)
- medicines used to treat gout (Ex. colchicine)
- medicines used to treat HIV infection (such as efavirenz, ritonavir, maraviroc and emtricitabine)
- immunosuppressants (used to manage auto-immune conditions and to prevent graft rejection) such as ciclosporin
B. Drug-Food Interactions:
Avoid eating grapefruit or drinking grapefruit juice while taking CABOTIB 40 TABLET as it may increase the risk of side effects.
Overdosage:
If you or anyone else accidentally took more CABOTIB 40 TABLET, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Cabozantinib |
| Pharmacological Category | : | Tyrosine Kinase Inhibitor |
| Therapeutic Indication | : | Kidney cancer, Liver cancer, Thyroid cancer |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep CABOTIB 40 TABLET out of reach of children
- Store CABOTIB 40 TABLET at room temperature
FAQs ABOUT CABOTIB 40 TABLET
Q: What is the use of CABOTIB 40 TABLET?
A: CABOTIB 40 TABLET is used in adults to treat advanced kidney cancer. It can also be used in the treatment of liver cancer and advanced thyroid cancer when treatment with other conventional cancer medicines (such as sorafenib) and radiotherapy is not responding appropriately.
Q: How CABOTIB 40 TABLET works on my body?
A: CABOTIB 40 TABLET is an anti-cancer medicine. It works by blocking the actions of certain proteins (such as receptor tyrosine kinases) in the body that triggers cancer formation. As a result, it prevents abnormal cell division within the body and slows down the growth of cancer cells in the body.
Q: Can CABOTIB 40 TABLET cure cancer?
A: The cure rate of cancer depends upon the severity of the disease. However, CABOTIB 40 TABLET acts by preventing the abnormal growth and multiplication of cancer cells in the body, which may help in curing cancer completely.
Q: Can the use of CABOTIB 40 TABLET cause hair loss?
A: Hair loss is one of the common side effects of taking CABOTIB 40 TABLET. This side effect is usually temporary and disappears once after therapy with this medicine stops completely. If it bothers you, consult your doctor for advice.
Q: Can the use of CABOTIB 40 TABLET cause mouth ulcers?
A: Mouth ulcers are one of the common side effects of taking CABOTIB 40 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 this side effect bothers you.
Q: Can CABOTIB 40 TABLET be used in children?
A: CABOTIB 40 TABLET is not recommended for use in children and adolescents (aged below 18 years). Therefore, consult your doctor before taking it.
Q: Is CABOTIB 40 TABLET a chemo drug?
A: Yes. CABOTIB 40 TABLET contains a medicine called Cabozantinib which is a chemotherapeutic agent. It stops abnormal growth and multiplication of cancer cells in the body.
Q: What happens if I forgot to take a dose of CABOTIB 40 TABLET?
A: If you forgot to take a dose of CABOTIB 40 TABLET, take it as soon as you remember. However, if it is time for the next dose of CABOTIB 40 TABLET, skip the missed dose and take the next one regularly. Do not take a double dose of CABOTIB 40 TABLET to compensate the missed ones.
Q: Will taking a higher dose of CABOTIB 40 TABLET be more effective?
A: No, taking a higher dose of CABOTIB 40 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
Q: What happens if I stop taking CABOTIB 40 TABLET?
A: No. Do not stop taking CABOTIB 40 TABLET without consulting your doctor as it may make your symptoms reappear. Therefore, take CABOTIB 40 TABLET as advised by your doctor for the stipulated duration.
Q: Can CABOTIB 40 TABLET be used during pregnancy?
A: CABOTIB 40 TABLET is not recommended for use in pregnant women unless considered necessary by the physician. Therefore, inform your doctor before taking CABOTIB 40 TABLET if you are pregnant or think you may be pregnant.
Q: Can the use of CABOTIB 40 TABLET make me feel tired?
A: Yes. CABOTIB 40 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 CABOTIB 40 TABLET. Tiredness can also occur if you have any pre-existing disease conditions such as liver or kidney impairment while taking this medicine.
Q: Can I drive a car after taking CABOTIB 40 TABLET?
A: CABOTIB 40 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 CABOTIB 40 TABLET.
Q: How to take CABOTIB 40 TABLET?
A: Take CABOTIB 40 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. CABOTIB 40 TABLET should not be taken with food. You should not eat anything for at least 2 hours before and for 1 hour after taking the medicine.
Q: How to control nausea caused due to CABOTIB 40 TABLET?
A: 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 CABOTIB 40 TABLET. If not, consult your doctor for a suitable anti-emetic medicine. Do not self-treat nausea.
Q: What are the side effects of taking CABOTIB 40 TABLET?
A: The most common side effects of taking CABOTIB 40 TABLET are nausea, vomiting, stomach upset, skin rashes, blisters and pain in the hands or soles of the feet, weight loss, altered taste sensation, tiredness, weakness, sore mouth, throat and tongue, fistula and piles. Contact your doctor if any of these side effect worsens.
Q: Who should avoid taking CABOTIB 40 TABLET?
A: CABOTIB 40 TABLET is not recommended for use if you are allergic to Cabozantinib. It is also not recommended for use in pregnant or breastfeeding women and in children (aged below 18 years).
Q: Is CABOTIB 40 TABLET safe to use in kidney disease?
A: CABOTIB 40 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.
Q: Can the use of CABOTIB 40 TABLET affect the liver?
A: Yes. CABOTIB 40 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. Yeong Hak Bang, Choong-kun Lee and Baek-Yeol Ryoo. Real-world efficacy and safety of cabozantinib in Korean patients with advanced hepatocellular carcinoma: a multicenter retrospective analysis. Therapeutic Advances in Medical Oncology. May 2022. [Accessed on 29th March 2023] https://journals.sagepub.com/doi/10.1177/17588359221097934?icid=int.sj-abstract.similar-articles.3
2. Patheon France. CABOMETYX 20 mg, 40 mg, 60 mg film-coated tablets. Cabozantinib. Electronic Medicines Compendium (EMC). [Revised in July 2022]. [Accessed on 29th March 2023]. https://www.medicines.org.uk/emc/files/pil.4331.pdf
3. Exelixis, Inc. CABOMETYX® (cabozantinib) tablets, for oral use. U.S. Food and Drug Administration. [Revised in January 2019]. [Accessed on 29th March 2023]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208692s003lbl.pdf
AUTHOR DETAILS
Written By Srilekha. R, B.Pharm
Last updated on 31 Mar 2023 | 10:43 AM(IST)
PRODUCT DETAILS
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