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Introduction About LENVATOL 10 CAPSULE
LENVATOL 10 CAPSULE contains Lenvatinib which belongs to the group of medicines called Antineoplastic agents. LENVATOL 10 CAPSULE is used on its own to manage locally recurrent/metastatic thyroid cancer in adults when radioactive iodine management becomes insufficient to stop the disease.
LENVATOL 10 CAPSULE is also used on its own to manage liver cancer (hepatocellular carcinoma) when it becomes unresectable in adult patients. It is also used together with pembrolizumab (anticancer medicine) to manage endometrial carcinoma when cancer has spread and cannot be managed by surgery/radiation management. The medicine is also indicated for use in combination with everolimus (anticancer medicine) to manage advanced renal cell carcinoma (kidney cancer) in adults prior to anti-angiogenic therapy (cancer therapy).
LENVATOL 10 CAPSULE is not recommended for use in patients allergic to Lenvatinib. Before taking LENVATOL 10 CAPSULE, inform your doctor if you have high blood pressure, aneurysm (enlargement and weakening of blood vessel wall), history of blood clots in your arteries, heart diseases (such as congestive heart failure, heart attack), kidney diseases (such as mild/moderate/severe renal impairment), and/or liver diseases (such as mild/moderate/severe hepatic impairment).
LENVATOL 10 CAPSULE is generally not recommended for use during pregnancy unless it is clearly necessary. It is also not recommended for use in breastfeeding women.
LENVATOL 10 CAPSULE is not recommended for use in children and adolescents (aged below 18 years) and is advised to be used with caution in elderly patients (aged 75 years/above) after consulting the doctor.
The most common side effects of taking LENVATOL 10 CAPSULE are nausea, redness, rashes, peeling of skin, weight loss, vomiting, and/or hoarseness of voice. Consult your doctor if any of these symptoms worsen.
Uses Of LENVATOL 10 CAPSULE
- Manage locally recurrent/metastatic thyroid cancer in adult patients.
- Manage unresectable liver cancer (hepatocellular carcinoma)
- Manage advanced endometrial carcinoma when used with pembrolizumab (anticancer medicine) in adults in whom the cancer has spread and cannot be removed by surgery/radiation management.
- Manage advanced renal cell carcinoma (kidney cancer) when used in combination with everolimus (anticancer medicine) following prior anti-angiogenic therapy in affected individuals
How LENVATOL 10 CAPSULE Works
LENVATOL 10 CAPSULE works by inhibiting the action of receptor tyrosine kinases (proteins responsible for development of new blood vessels) which leads to poor oxygen and nutrient supply to the cancer cell resulting in its destruction thus managing cancer in affected individuals.
How to use LENVATOL 10 CAPSULE
Take LENVATOL 10 CAPSULE as advised by your physician. Swallow the medicine 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 LENVATOL 10 CAPSULE
Common
- high/low blood pressure
- muscle pain, feeling unwell with body pain
- dizziness, tiredness, weakness
- bleeding (most commonly nose bleeds)
- signs of blood clots in the lungs such as difficulty breathing, chest pain
- signs of decreased red blood cells such as weakness, dizziness, chest pain
- pounding/racing heartbeat
- reduced appetite/weight loss
- nausea, vomiting, constipation, stomach pain, diarrhoea, indigestion
- hoarse voice
- swelling of the legs
- rash
- dry/sore/inflamed mouth
- loss of proper taste sensation
- joint pain, back pain
- headache, hair loss
- difficulty in sleeping
- signs of palmar-plantar erythrodysesthesia (hand-foot syndrome) such as swelling, redness and soreness of skin on hands and feet
- signs of underactive thyroid such as weight gain, tiredness, constipation, dry skin, feeling cold
- signs of decreased count of white blood cells such as body aches, chills, fever and headaches.
- signs of reduced platelets count such as bruising and delayed wound healing
- signs of increased amylase and lipase levels in blood such as ulcer, pancreatitis (inflammation of pancreas)
- dehydration
- dry skin, itching and thickening of the skin
- feeling bloated or having excess wind
- signs of liver failure such as dizziness, loss of sleep, confusion, decreased concentration, loss of consciousness
- inflammation of the gallbladder
- signs of stroke such as feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy
- anal fistula (a small channel between the anus and surrounding skin)
- signs of urinary infections such as increased frequency in urination and pain in passing urine
Uncommon
- painful infection and irritation near the anus
- signs of heart problems such as chest pain/pressure, pain in arms, back, neck/ jaw, shortness of breath, rapid/ irregular heart rate, coughing, bluish color of lips/fingers, and feeling very tired
- mini stroke
- damage to the liver
- signs of splenic infarction (condition marked by poor blood supply to spleen) such as chills, fever, nausea and pain in the upper left part of the abdomen
- signs of inflammation of the pancreas such as upper abdominal pain, fever, fast pulse
- problems in wound healing
- osteonecrosis (damage to the bones in jaw)
Rare
Stop taking LENVATOL 10 CAPSULE and contact your doctor if you experience any of the following side effects:
- signs of stroke such as feeling weak or numb on one side of the body, severe headache, seizure, confusion, visual disturbances, dizziness, severe increase in blood pressure,
- signs of heart problems such as chest pain/pressure, pain in arms/back/ neck/jaw, shortness of breath, rapid/irregular heartbeat, coughing, bluish lips or fingers, tiredness
- signs of lung problems such as blood clot in lungs, inability of the lungs to inflate due to leak of air from lungs into chest
- signs of fistula in gut such as severe pain in the belly
- signs of bleeding such as coughing up blood, black, tarry or bloody stools, severe and persistent nose bleeds, blood in urine, vomiting blood, heavy/new onset vaginal bleeding
- signs of liver problems (grade 3 liver impairment) such as yellow skin or yellowing of the whites of the eyes, drowsiness, confusion, poor concentration
- signs of dehydration leading to kidney failure such as serious diarrhoea, nausea, and vomiting
- signs of osteonecrosis (death of bone tissue due to lack of blood supply) such as pain in the mouth, teeth or jaw, swelling/sores inside the mouth, numbness or feeling of heaviness in the jaw, loosening teeth
- life threatening consequences such as malignant hypertension (high blood pressure)
- asthenia (weakness)
- signs of nephrotic syndrome (kidney disorder marked by high protein in urine) such as edema, weakness, loss of appetite
- signs of arterial thromboembolism (serious disorder marked by blood clot in artery) such as cold arm, pain in affected area, weakness of arm or leg
- sign of reversible posterior leukoencephalopathy syndrome (rare condition marked by swelling of brain) such as severe headache, weakness, fits, confusion, visual problems
- heart failure, heart attack
- signs of kidney failure and impairment such as decreased urine output, shortness of breath, weakness
How To Manage Side Effects
Nausea/vomiting:
Try to take LENVATOL 10 CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if symptom gets worse.
Constipation:
Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly.
Diarrhoea:
Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor.
Stomach pain:
Try to rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.
Warning & Precautions
Pregnancy
LENVATOL 10 CAPSULE is generally not recommended for use during pregnancy unless it is clearly necessary. If you become pregnant while taking LENVATOL 10 CAPSULE, consult your doctor immediately who may advise you to use a barrier method of contraception to manage pregnancy which may be advised to be continued next one month after stopping the management with LENVATOL 10 CAPSULE.
Breastfeeding
LENVATOL 10 CAPSULE is generally not recommended for use in breastfeeding women as it may pass through the breast milk and may seriously harm the breastfed baby. Consult your doctor before taking [GBNKEWORD].
Driving and Using Machines
Do not drive or operate any machines if you feel dizzy or tired after taking LENVATOL 10 CAPSULE.
Kidney
LENVATOL 10 CAPSULE should be used with caution in patients with kidney disease such as mild, moderate/severe renal impairment. Consult your doctor before taking the medicine.
Liver
LENVATOL 10 CAPSULE should be used with caution in patients with liver problems such as mild, moderate/severe hepatic impairment. Consult your doctor before taking the medicine.
Allergy
Do not take LENVATOL 10 CAPSULE if you are allergic to Lenvatinib, and/or any other ingredients in the medicine.
Heart Disease
LENVATOL 10 CAPSULE should be used with caution in patients with heart disease such as congenital long QT syndrome, congestive heart failure, heart attack, stroke, bradyarrhythmia. Consult your doctor before taking the medicine.
Others
Before taking LENVATOL 10 CAPSULE, inform your doctor if you:
- have or had an aneurysm (enlargement and weakening of blood vessel wall) or a tear in a blood vessel wall.
- have high blood pressure
- have history of blood clots in your arteries
- have a history of a tear (perforation) in your stomach or intestine
- have recently undergone radiotherapy/surgery
- are scheduled for a major surgery or dental management
- weigh less than 60kg
- had a history of fistula (abnormal connection between organs)
- have or had pain in the mouth, teeth and/or jaw, swelling/sores inside the mouth, numbness/ feeling of heaviness in the jaw, and/or loosening of a tooth.
- have bleeding problems
- have fits, vision problems or headache
Use in Pediatrics:
LENVATOL 10 CAPSULE is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking the medicine.
Use in Geriatrics:
LENVATOL 10 CAPSULE should be used with caution in elderly patients (aged above 75 years). Consult your doctor before taking LENVATOL 10 CAPSULE
Interactions
A. Drug - Drug interactions:
Before taking LENVATOL 10 CAPSULE, inform your doctor if you are taking any of the following medicine:
- carboplatin, paclitaxel (used to manage ovarian cancer)
- midazolam (used to relieve anxiety before surgery or certain procedures)
- oral contraceptives (used to manage pregnancy) Ex. desogestrel and ethinyl estradiol
- antiresorptive medicines (used to manage osteoporosis) Ex. alendronate, risedronate
- angiogenesis inhibitors (used to block growth of blood vessels) Ex. axitinib, bevacizumab
Overdosage:
If you or anyone else accidentally took more of LENVATOL 10 CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are hypertension, nausea, diarrhoea, fatigue, stomatitis (inflammation and soreness of mouth), proteinuria (increased concentration of protein in urine), and/or headache.
Synopsis
| Drug | : | Lenvatinib |
| Pharmacological Category | : | Kinase inhibitor |
| Therapeutic Indication | : | Differentiated thyroid carcinoma, Endometrial carcinoma, Hepatocellular carcinoma, Advanced renal cell carcinoma |
| Dosage Forms | : | Capsule |
More Information
- Keep LENVATOL 10 CAPSULE out of reach of children
- Do not store LENVATOL 10 CAPSULE above 25°C
FAQs About LENVATOL 10 CAPSULE
Is LENVATOL 10 CAPSULE a chemotherapy drug?
No, LENVATOL 10 CAPSULE is a target therapy drug (cancer therapy which targets precisely cancer cells and destroys it) which is used to manage differentiated thyroid carcinoma & hepatocellular carcinoma when used alone, and endometrial carcinoma & advanced renal cell carcinoma when used with pembrolizumab and everolimus in affected individuals.
Do the side effects of LENVATOL 10 CAPSULE go away?
Your doctor will explain the common, uncommon and rare side effects associated with the use of LENVATOL 10 CAPSULE which generally goes away as the body adjusts to the medicine. Consult your doctor immediately if you experience any serious side effects and for managment of the adverse effects
How is LENVATOL 10 CAPSULE taken?
Take LENVATOL 10 CAPSULE as advised by your physician. Swallow the medicine 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.
Does LENVATOL 10 CAPSULE make you tired?
Yes, LENVATOL 10 CAPSULE might make you tired as it is a common side effect associated with the use of the medicine. If you experience such side effect, then take rest and drink plenty of fluids. Avoid or limit consumption of alcohol and try to take LENVATOL 10 CAPSULE at a time when you can sit down (or lie down). Avoid driving or using tools or machinery until you feel well.
What are the common side effects of LENVATOL 10 CAPSULE?
The most common side effects of taking LENVATOL 10 CAPSULE are nausea, redness, rashes, peeling of skin, weight loss, vomiting, and/or hoarseness of voice. Consult your doctor if any of these symptoms worsen.
References
1. Leonard Wartofsky, Leonidas H. Duntas, Markus Luster. Targeted Molecular Therapy. The Thyroid and Its Diseases. Seventh edition. 2019. Page – 651
2. Shunji Takahashi, Makoto Tahara, Koichi Ito, Masayuki Tori, Naomi Kiyota, Katsutoshi Yoshida, Yukinori Sakata, and Akira Yoshida. Safety and Effectiveness of Lenvatinib in 594 Patients with Unresectable Thyroid Cancer in an All-Case Post-Marketing Observational Study in Japan. NIH National Library of Medicine. National center for biotechnology information. PMC PubMed Central. July 2020. [Accessed on 16th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444395/
3. Eisai Manufacturing Limited. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed 16th August 2022] https://www.medicines.org.uk/emc/product/6840/pil
4. Eisai GmbH. European Medicines Agency (EMA). [Revised in May 2015] [Accessed 16th August 2022] https://www.ema.europa.eu/en/documents/product-information/lenvima-epar-product-information_en.pdf
5. Patheon Inc. U.S. Food & Drug Administration (USFDA). [Revised in February 2015] [Accessed 16th August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf
6. Ciplamed. Lenvatol Capsules. [Revised in August 2020] [Accessed on 16th August 2022] https://www.ciplamed.com/content/lenvatol-capsules
Useful Diagnostic Tests
- Liver Function Test
- Kidney Function Test
- Dental Check-up
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