Lenome 5mg Capsule 10'S

Introduction About LENOME 5MG CAPSULE

LENOME 5MG CAPSULE contains Lenalidomide, which belongs to the group of
medicines called Immunomodulatory agents. It is used in the management of
multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular
lymphoma. Cancer is a disease in which abnormal cells divide uncontrollably in
the body and destroy body tissue.

Multiple myeloma is a type of cancer that affects a type of white blood cell
(plasma cell) that collects in the bone marrow and divides uncontrollably,
leading to kidney and bone damage. Myelodysplastic syndromes are a group of
disorders that occur due to the abnormal functioning of blood cells.

Mantle cell lymphoma is a cancer of the lymph tissue where the B-cells or B
lymphocytes (white blood cells) grow in an uncontrolled manner and build up in
the lymph tissue, blood or bone marrow. Follicular lymphoma is slow-growing
cancer that affects B lymphocytes that help fight infection.

Before taking LENOME 5MG CAPSULE, inform your doctor if you have ever had blood
clots, hepatitis B infection, varicella-zoster, HIV, kidney problems or a heart
attack. LENOME 5MG CAPSULE is not recommended for use among pregnant or
breastfeeding women. Consult your doctor before taking it.

The most common side effects of taking LENOME 5MG CAPSULE are rashes, itching,
muscle cramps, muscle weakness, muscle pain, muscle aches, bone pain, joint
pain, back pain, pain in the extremities, weakness, tiredness, constipation,
diarrhoea, nausea, vomiting, stomach pain and heartburn. Consult your doctor if
any of the symptoms worsen.

Uses Of LENOME 5MG CAPSULE

It is used to manage:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma

How LENOME 5MG CAPSULE Works

LENOME 5MG CAPSULE works by enhancing the immune system that indirectly attacks
the cancer cells. It stops the growth of new blood vessels within the tumour. It
also limits the production of chemical messengers (cytokine and growth factor)
which are responsible for the growth of cancer cells.

How to use LENOME 5MG CAPSULE

Take LENOME 5MG 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 on your age, body weight and disease
condition.

Side Effects Of LENOME 5MG CAPSULE

Common

• anemia (symptoms include tiredness and weakness), hemolytic anemia (destruction of red blood cells)
• rashes, itching
• muscle cramps, muscle pain, muscle aches, muscle weakness, bone pain, joint pain, back pain, pain in the extremities
• generalized swelling (swelling of arms and legs)
• weakness, tiredness
• fever and flu-like symptoms (fever, muscle ache, headache, earache, cough and chills)
• numbness, pains in hands or feet, tremors, tingling or burning sensation to the skin, dizziness
• decreased appetite, change in the way things taste
• increase in pain, tumor size or redness around the tumor
• weight loss
• constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• low levels of potassium or calcium and/or sodium in the blood
• less thyroid functioning
• thrombosis and pulmonary embolism (symptoms include leg pain, chest pain, shortness of breath and blood clots in the lungs)
• infections of all types (including infections of the sinuses that surround the nose, infections of the lung and the upper respiratory tract)
• shortness of breath
• blurred vision
• clouding of your eye (cataract)
• kidney problems
• abnormal liver test results
• vasculitis (changes to a protein in the blood that can cause swelling of the arteries)
• diabetes
• headache
• nosebleed
• dry skin
• depression, mood change, difficulty sleeping
• cough
• decreased blood pressure
• a vague feeling of bodily discomfort, feeling bad
• sore inflamed mouth, dry mouth
• dehydration
• certain types of skin tumors
• bleeding of the bowel, stomach or gums
• increased blood pressure, fast, slow or irregular heartbeat
• normal and abnormal breakdown of red blood cells
• increase in a type of protein that indicates inflammation in the body
• darkening of the skin, discoloration of the skin resulting from bleeding underneath, typically caused by bruising, swelling of skin filled with blood, bruise
• increased blood uric acid
• skin eru
• increased sweating, night sweats
• difficulty swallowing, sore throat, difficulty with voice quality or voice changes
• runny nose
• less urine than usual or the inability to control when to urinate
• blood in the urine
• shortness of breath particularly when lying down (which may be a symptom of heart failure)
• difficulty getting an erection
• stroke, vertigo, fainting, temporary loss of consciousness
• chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling sick or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• muscle weakness, lack of energy
• neck pain
• joint swelling
• bile flow from the liver slowed or blocked
• low levels of magnesium or phosphate in the blood
• difficulty speaking
• liver injury
• impaired balance, difficulty moving
• deafness, ringing in the ears (tinnitus)
• nerve pain, unpleasant abnormal sensation, especially to touch
• excess of iron in the body
• thirst
• confusion
• toothache
• fall which may result in injury

Uncommon

• bleeding within the skull
• circulatory problems
• loss of vision
• loss of sex drive (libido)
• kidney disorder (Fanconi syndrome) (symptoms include passing large amounts of urine with bone pain and weakness)
• jaundice (yellow pigmentation to the skin, mucus membrane or eyes), pale-colored stools, dark-colored urine, skin itch, rash, pain or swelling of the stomach (symptoms of injury to the liver) (hepatic failure)
• colitis or caecitis (symptom includes stomach pain, bloating or diarrhea)
• renal tubular necrosis (damage to the cells of the kidney)
• changes to the color of skin, sensitivity to sunlight
• tumor lysis syndrome (symptoms include changes to blood chemistry, high potassium, phosphorus, uric acid and low calcium consequently leading to changes in kidney function, heartbeat, seizures and sometimes death)
• pulmonary hypertension (increase in blood pressure within blood vessels that supply the lungs)

Rare

Stop taking LENOME 5MG CAPSULE and contact your doctor immediately if you
experience any of the following side effects;

• angioedema and anaphylactic reaction (symptoms include hives, rashes, swelling of eyes, mouth or face, difficulty breathing or itching)
• Stevens-Johnson syndrome and/or toxic epidermal necrolysis (a serious allergic reaction that may begin as a rash in one area but spread with extensive loss of skin over the whole body)
• drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome (symptom includes widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement)

How To Manage Side Effects

Nausea or vomiting:

Take this medicine with meals or just after meals. Stick to simple meals. Avoid
eating oil-rich or spicy foods. Consult your doctor if your symptom gets worse
or persist.

Flatulence:

Eat smaller and more frequent meals. Eat and drink slowly and exercise
regularly. If the symptom does not improve, contact your doctor.

Constipation:

Eat plenty of fiber-rich foods, such as fresh fruits, vegetables and cereals and
drink plenty of water. Exercise more regularly. Consult your doctor if your
symptom gets worse or persist.

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. Consult
your doctor if your symptom gets worse or persist.

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to have smaller and more
frequent meals. Keep a heating pad on your stomach. If the symptom does not
improve, contact your doctor.

Warning & Precautions

!### Pregnancy

LENOME 5MG CAPSULE is generally not recommended for use in pregnant women unless
considered necessary. Consult your doctor before taking it.

!### Breastfeeding

LENOME 5MG CAPSULE is generally not recommended for use in breastfeeding women
as it may pass through breast milk. Consult your doctor before taking it.

!### Driving and Using Machines

Do not drive or operate any machines if you feel dizzy, tired, sleepy or have
vertigo or blurred vision after taking LENOME 5MG CAPSULE.

!### Alcohol

Avoid consum

!### Kidney

LENOME 5MG CAPSULE should be used with caution in patients with kidney problems.
Consult your doctor before taking it.

!### Liver

LENOME 5MG CAPSULE should be used with caution in patients with liver problems.
Consult your doctor before taking it.

!### Allergy

Do not take LENOME 5MG CAPSULE if you are allergic to lenalidomide or any of the
other ingredients of the medicines.

!### Heart Disease

LENOME 5MG CAPSULE should be used with caution in patients with heart problems.
Consult your doctor before taking it.

Others

Before taking LENOME 5MG CAPSULE, inform your doctor if you:

• have had blood clots in the past
• have any signs of an infection (such as a cough or fever)
• have or have ever had a previous viral infection, particularly: hepatitis B infection, varicella-zoster, HIV
• have drug reaction with eosinophilia and systemic symptoms (DRESS) or drug hypersensitivity syndrome (symptoms include widespread rash, red skin, high body temperature, flu-like symptoms, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes)

Use in pediatrics:

LENOME 5MG CAPSULE is not recommended for use in children and adolescents (under
18 years of age). Consult your doctor before taking it.

Use in geriatrics:

LENOME 5MG CAPSULE should be used with caution in elderly patients (aged 75
years and above). Consult your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking LENOME 5MG CAPSULE, inform your doctor if you are taking any of
the following medicine:

• medicines used to manage heart problems (Ex. digoxin)
• medicines used to manage thin the blood (Ex. warfarin)
• oral contrace
• medicine used to manage multiple myeloma (Ex. thalidomide)

Overdosage:

If you or anyone else accidentally take too much of LENOME 5MG CAPSULE, consult
your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Lenalidomide
Pharmacological Category	:	Immunomodulatory agents
Therapeutic Indication	:	Multiple myeloma, Myelodysplastic syndromes, Mantle cell lymphoma and Follicular lymphoma
Dosage Forms	:	Capsule, Tablet

More Information

• Keep LENOME 5MG CAPSULE out of reach from children
• Store at room temperature

FAQs About LENOME 5MG CAPSULE

How does LENOME 5MG CAPSULE work?

LENOME 5MG CAPSULE works by enhancing the immune system, which indirectly
attacks cancer cells. It stops the growth of new blood vessels within the
tumour. It also limits the production of chemical messengers (cytokines and
growth factors), which are responsible for the growth of cancer cells.

Is it safe to use LENOME 5MG CAPSULE on the elderly?

In elderly patients (75 years and older), LENOME 5MG CAPSULE should be used with
caution. Consult your doctor before taking LENOME 5MG CAPSULE.

For what is LENOME 5MG CAPSULE used?

LENOME 5MG CAPSULE is an immunomodulatory agent used in the management of
multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular
lymphoma.

Are there any dietary restrictions when taking LENOME 5MG CAPSULE?

LENOME 5MG CAPSULE can be taken with or without food; there is no food
restriction as such. Consult your doctor before taking LENOME 5MG CAPSULE.

Is LENOME 5MG CAPSULE safe in patients with kidney problems?

LENOME 5MG CAPSULE should be used with caution in patients with kidney problems.
Consult your doctor before taking LENOME 5MG CAPSULE.

Can I stop taking LENOME 5MG CAPSULE on my own?

Do not stop taking LENOME 5MG CAPSULE on your own. You are advised to take
LENOME 5MG CAPSULE for as long as your doctor has prescribed it for you,
depending on your medical condition. Do not hesitate to talk to your doctor if
you experience any difficulty while taking LENOME 5MG CAPSULE.

How do I take LENOME 5MG CAPSULE?

Take LENOME 5MG CAPSULE as advised by your physician. Swallow the medicine with
a glass of water. Do not crush or chew the medicine. Your doctor will determine
the correct dose and duration for you depending on your age, body weight and
disease condition.