LENVENIB 10mg Capsule 10?s Allschoolabs -

Description

INTRODUCTION
LENVENIB 10MG CAPSULE contains Lenvatinib which belongs to the group of medicines called Antineoplastic agents. LENVENIB 10MG CAPSULE is used on its own to treat locally recurrent/metastatic thyroid cancer in adults when radioactive iodine treatment becomes insufficient to stop the disease.
LENVENIB 10MG CAPSULE is also used on its own to treat liver cancer (hepatocellular carcinoma) when it becomes unresectable in adult patients. It is also used together with pembrolizumab (anticancer medicine) to treat endometrial carcinoma when cancer has spread and cannot be treated by surgery/radiation treatment. The medicine is also indicated for use in combination with everolimus (anticancer medicine) to treat advanced renal cell carcinoma (kidney cancer) in adults prior to anti-angiogenic therapy (cancer therapy).
LENVENIB 10MG CAPSULE is not recommended for use in patients allergic to Lenvatinib. Before taking LENVENIB 10MG 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).
LENVENIB 10MG CAPSULE is generally not recommended for use during pregnancy unless it is clearly necessary. It is also not recommended for use in breastfeeding women.
LENVENIB 10MG 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 LENVENIB 10MG 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 LENVENIB 10MG CAPSULE

Treats locally recurrent/metastatic thyroid cancer in adult patients.

Treats unresectable liver cancer (hepatocellular carcinoma)

Treats advanced endometrial carcinoma when used with pembrolizumab (anticancer medicine) in adults in whom the cancer has spread and cannot be removed by surgery/radiation treatment.

Treats advanced renal cell carcinoma (kidney cancer) when used in combination with everolimus (anticancer medicine) following prior anti-angiogenic therapy in affected individuals

HOW LENVENIB 10MG CAPSULE WORKS
LENVENIB 10MG 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 treating cancer in affected individuals.
DIRECTIONS FOR USE
Take LENVENIB 10MG 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 LENVENIB 10MG 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 LENVENIB 10MG 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 LENVENIB 10MG 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
LENVENIB 10MG CAPSULE is generally not recommended for use during pregnancy unless it is clearly necessary. If you become pregnant while taking LENVENIB 10MG CAPSULE, consult your doctor immediately who may advise you to use a barrier method of contraception to prevent pregnancy which may be advised to be continued next one month after stopping the treatment with LENVENIB 10MG CAPSULE.
BREASTFEEDING
LENVENIB 10MG 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 LENVENIB 10MG CAPSULE.
KIDNEY
LENVENIB 10MG 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
LENVENIB 10MG 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 LENVENIB 10MG CAPSULE if you are allergic to Lenvatinib, and/or any other ingredients in the medicine.
HEART DISEASE
LENVENIB 10MG 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 LENVENIB 10MG 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 treatment

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:
LENVENIB 10MG CAPSULE is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking the medicine.
Use in Geriatrics:
LENVENIB 10MG CAPSULE should be used with caution in elderly patients (aged above 75 years). Consult your doctor before taking LENVENIB 10MG CAPSULE
INTERACTIONS
A. Drug ? Drug interactions:
Before taking LENVENIB 10MG CAPSULE, inform your doctor if you are taking any of the following medicine:
Carboplatin, paclitaxel (used to treat ovarian cancer)

Midazolam (used to relieve anxiety before surgery or certain procedures)

Oral contraceptives (used to prevent pregnancy) Ex. desogestrel and ethinyl estradiol

Antiresorptive medicines (used to treat 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 LENVENIB 10MG 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 LENVENIB 10MG CAPSULE out of reach of children

Do not store LENVENIB 10MG CAPSULE above 25?C

FAQs ABOUT LENVENIB 10MG CAPSULE
Is LENVENIB 10MG CAPSULE a chemotherapy drug?
No, LENVENIB 10MG CAPSULE is a target therapy drug (cancer therapy which targets precisely cancer cells and destroys it) which is used to treat 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 LENVENIB 10MG CAPSULE go away?
Your doctor will explain the common, uncommon and rare side effects associated with the use of LENVENIB 10MG 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 LENVENIB 10MG CAPSULE taken?
Take LENVENIB 10MG 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 LENVENIB 10MG CAPSULE make you tired?
Yes, LENVENIB 10MG 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 LENVENIB 10MG 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 LENVENIB 10MG CAPSULE?
The most common side effects of taking LENVENIB 10MG 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