LENTIB 4mg Capsule 10's

Introduction About LENTIB 4MG CAPSULE

LENTIB 4MG CAPSULE contains Lenvatinib which belongs to the group of medicines
called Antineoplastic agents. LENTIB 4MG 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.

LENTIB 4MG 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).

LENTIB 4MG CAPSULE is not recommended for use in patients allergic to
Lenvatinib. Before taking LENTIB 4MG 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).

LENTIB 4MG CAPSULE is generally not recommended for use during pregnancy unless
it is clearly necessary. It is also not recommended for use in breastfeeding
women.

LENTIB 4MG 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 LENTIB 4MG 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 LENTIB 4MG 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 LENTIB 4MG CAPSULE Works

LENTIB 4MG 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 LENTIB 4MG CAPSULE

Take LENTIB 4MG 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 LENTIB 4MG 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 LENTIB 4MG 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 LENTIB 4MG 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

LENTIB 4MG CAPSULE is generally not recommended for use during pregnancy unless
it is clearly necessary. If you become pregnant while taking LENTIB 4MG CAPSULE,
consult your doctor immediately who may advise you to use a barrier method of
contrace
month after stopping the management with LENTIB 4MG CAPSULE.

!### Breastfeeding

LENTIB 4MG 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
LENTIB 4MG CAPSULE.

!### Kidney

LENTIB 4MG 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

LENTIB 4MG 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 LENTIB 4MG CAPSULE if you are allergic to Lenvatinib, and/or any
other ingredients in the medicine.

!### Heart Disease

LENTIB 4MG 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 LENTIB 4MG 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:

LENTIB 4MG CAPSULE is not recommended for use in children and adolescents (below
18 years). Consult your doctor before taking the medicine.

Use in Geriatrics:

LENTIB 4MG CAPSULE should be used with caution in elderly patients (aged above
75 years). Consult your doctor before taking LENTIB 4MG CAPSULE

Interactions

A. Drug - Drug interactions:

Before taking LENTIB 4MG 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 contrace
• antiresor
• angiogenesis inhibitors (used to block growth of blood vessels) Ex. axitinib, bevacizumab

Overdosage:

If you or anyone else accidentally took more of LENTIB 4MG 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 LENTIB 4MG CAPSULE out of reach of children
• Do not store LENTIB 4MG CAPSULE above 25°C

FAQs About LENTIB 4MG CAPSULE

Is LENTIB 4MG CAPSULE a chemotherapy drug?

No, LENTIB 4MG 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 LENTIB 4MG CAPSULE go away?

Your doctor will explain the common, uncommon and rare side effects associated
with the use of LENTIB 4MG 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 LENTIB 4MG CAPSULE taken?

Take LENTIB 4MG 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 LENTIB 4MG CAPSULE make you tired?

Yes, LENTIB 4MG 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 consum
and try to take LENTIB 4MG 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 LENTIB 4MG CAPSULE?

The most common side effects of taking LENTIB 4MG 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.

Useful Diagnostic Tests

• Liver Function Test
• Kidney Function Test
• Dental Check-up