COMBINIB 250mg Tablet 30’s

INTRODUCTION OF COMBINIB 250MG

COMBINIB 250MG contains Lapatinib which belongs to the group of medicines called antineoplastic agent. It is used to treat HER2-positive breast cancer which have spread beyond the original tumor or to other organs (advanced or metastatic breast cancer). HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which is capable of promoting the growth of cancer cells. Lapatinib is generally prescribed with other anti-cancer medicine like capecitabine, trastuzumab (for patients with hormone receptor-negative metastatic breast cancer) or aromatase inhibitor (for patients with hormone sensitive metastatic breast cancer). It slows or stops cancer cells from growing or may kill them.

Always take this medicine as directed by your physician. Take this medicine, either at least 1 hour before or 1 hour after food. Prior to the treatment, your doctor will check whether your heart and lungs are working properly or not. Avoid consumption of alcohol while taking this medicine. Do not drive or operate any machines if your ability is affected by this medicine. Talk to your doctor immediately at the first sign of diarrhea, because it is important that this is treated right away. Do not take this medicine, if you have diarrhea, liver, kidney or lung problems or are pregnant. The most common side effect of taking this medicine is diarrhea, rash, dry skin, itching, loss of appetite, stomach pain, indigestion, constipation, nausea or vomiting, tiredness, mouth ulcers, trouble in sleeping, pain in hands and feet.

USES OF COMBINIB 250MG:

HER2-positive metastatic breast cancer

HOW COMBINIB 250MG WORKS:

COMBINIB 250MG is an inhibitor of intracellular tyrosine kinase domains of both HER2 and epidermal growth factor receptor (EGFR). It passes through the cell membrane and binds to HER2 and EGFR, found inside the cell. Inhibition of HER2 and EGFR receptors by lapatinib, inhibits the HER2-derived tumor cell growth and division, which in turn reduces tumor cell proliferation.

DIRECTIONS FOR USE:

Always take this medicine as directed by your physician. Take this medicine, either at least 1 hour before or 1 hour after food. Your doctor will decide the correct dose for you depending upon your condition. Swallow the medicine as a whole with a glass of water. Do not crush or chew the medicine. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results. Do not drink grapefruit juice while you are taking COMBINIB 250MG.

SIDE EFFECTS OF COMBINIB 250MG:

SERIOUS

• Diarrhea

COMMON

• Rash, dry skin, itching
• Loss of appetite, stomach pain, indigestion, constipation
• Nausea or vomiting
• Tiredness
• Mouth ulcers
• Trouble in sleeping
• Pain in hands and feet
• Joint or back pain
• Skin reaction on palms of hands or soles of feet (including tingling, numbness, pain, swelling or reddening)
• Cough, shortness of breath
• Headache
• Nose-bleed
• Hot flush
• Unusual hair loss or thinning
• Jaundice (yellow eyes or skin)
• Dark urine
• Nail infection

HOW TO MANAGE SIDE EFFECTS:

Nausea or vomiting:

Try taking this medicine with, or just after a meal or a snack. Stick to simple meals. Do not eat rich or spicy food.

Constipation:

Eat fibre rich foods like fresh fruit, vegetables and cereals. Drink plenty of water. Exercise more regularly.

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

Stomach pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

WARNING AND PRECAUTIONS:

PREGNANCY

COMBINIB 250MG should be used with caution in pregnant women. Consult your doctor before taking this medicine.

BREASTFEEDING

COMBINIB 250MG should be used with caution in breastfeeding women. Consult your doctor before taking this medicine.

DRIVING AND USING MACHINES

Do not drive or operate any machines if your ability is affected by this medicine.

ALCOHOL

Avoid consumption of alcohol while taking this medicine.

KIDNEY

COMBINIB 250MG should be taken with caution in patients with severe kidney disease. Consult your doctor for advice.

LIVER

COMBINIB 250MG should be taken with caution in patients with severe liver disease. Consult your doctor for advice.

ALLERGY

Do not take this medicine if you are allergic (hypersensitive) to lapatinib.

LUNGS

COMBINIB 250MG should be taken with caution in patients with severe lung disease. Consult your doctor for advice.

INTERACTIONS:

Talk to your doctor, if you are taking,

Medicine used to treat depression (nefazodone, St John?s Wort)
Medicines used to treat infections (e.g. erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin, telithromycin)
Medicines used to treat HIV (e.g. ritonavir, saquinavir)
Medicines used to treat seizures (e.g. phenytoin, carbamazepine)
Medicines used to treat heart problems (e.g. quinidine, digoxin)
Medicines used to treat certain types of cancer (e.g. topotecan, paclitaxel, irinotecan, docetaxel)
Medicines that decrease stomach acidity (e.g. aluminium hydroxide)
Cyclosporine (used to suppress the immune system)
Cisapride (used to treat digestive system problems)
Pimozide (used to treat mental health problems)
Repaglinide (used to treat diabetes)
Verapamil (used to treat high blood pressure or angina)
Rosuvastatin (used to treat high cholesterol levels)

SYNOPSIS:

Drug : Lapatinib
Pharmacological Category : Antineoplastic Agent, HER2-inhibitor, EGFR inhibitor, Tyrosine Kinase Inhibitor
Therapeutic Indication :
HER2-positive metastatic breast cancer

Dosage Forms : Tablet

MORE INFORMATION:

Store below 20-25°C and keep out of reach of children.

FAQ’s ABOUT COMBINIB 250MG:

Q: What is the most common side effect of COMBINIB 250MG?
A: The most common side effect of this medicine is diarrhoea. Drink lots of fluids, such as water or juice, to avoid dehydration. Consult your doctor immediately if it is severe.

Q: Will COMBINIB 250MG cause hair loss?
A: Yes. This medicine may cause unusual hair thinning or loss. Consult your doctor for advice.

Q: Can we take COMBINIB 250MG with juice?
A: No. Take this tablet only with water. Avoid drinking juices while taking this medicine, especially grapefruit juice, as it may lead to serious interactions.