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Composition

DABRAFENIB-50MG

Manufacturer/Marketer

Novartis India Ltd

Consume Type

ORAL

Return Policy

Not Returnable

Expires on or after

Jan-25

for this medicine

About Rafinlar 50 mg Capsule

Rafinlar 50 mg Capsule is an anti-cancer medicine used in the treatment of various types of cancers. Cancer is a disease caused by the abnormal growth of cells that divide uncontrollably. This medicine is used as a single agent in treating patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation. It is also used along with trametinib in treating anaplastic thyroid cancer, non-small cell lung cancer with BRAF V600E mutation, and unresectable or metastatic solid tumours with BRAF V600E mutation.

Rafinlar 50 mg Capsule contains Dabrafenib, which belongs to the class of medicines known as kinase inhibitors. It works by inhibiting the action of an enzyme (tyrosine kinase) and thus stops the abnormal growth of cancer cells.

Rafinlar 50 mg Capsule may cause certain side effects such as diarrhoea, decreased appetite, nausea, vomiting, tiredness, itching, rash, headache, fever, acne, increased blood pressure, cough, and abdominal pain. Inform your doctor if any of these side effects bother you. Rafinlar 50 mg Capsule should be taken as prescribed by your doctor. Do not take more than the recommended dose of medicine.

If you are allergic to Rafinlar 50 mg Capsule or its components, inform your doctor. Before taking Rafinlar 50 mg Capsule , inform your doctor if you have/had liver or kidney disease, calcium deficiency, heart problems, increased blood pressure, seizures, bleeding disorders, vision problems, and a history of blood clots. This medicine is known to cause embryo-fetal toxicity. It is not recommended for use in pregnancy and breastfeeding.

Uses of Rafinlar 50 mg Capsule

Treatment of Metastatic melanoma, Anaplastic thyroid cancer, Non-small cell lung cancer and Metastatic solid tumors

Medicinal Benefits

Rafinlar 50 mg Capsule contains Dabrafenib, which is used in treating different types of cancer. It works by stopping the action of a tyrosine kinase enzyme that causes the multiplication of cancerous cells. This helps stop the abnormal growth of cancer cells and thus reduce the further spread to other parts of the body. It also decreases the blood supply to cancer tumors to slow down the growth of the tumor.  In this way, Rafinlar 50 mg Capsule stops the body's production, spread and growth of cancerous cells.

Side Effects of Rafinlar 50 mg Capsule

  • Nausea
  • Vomiting
  • Diarrhoea
  • Loss of appetite
  • Tiredness
  • Muscle/joint pain
  • Dizziness
  • Weakness
  • Warts
  • Cough
  • Headache
  • Itching
  • Rash
  • Abdominal pain
  • Vision problem
  • Increased blood pressure
  • Acne
  • Infection around finger and toenails

Directions for Use

Take Rafinlar 50 mg Capsule as prescribed by the doctor. It should be taken at least one hour before or 2 hours after meals. Swallow it as a whole with a glass of water. Do not crush, break, or chew it. Your doctor may suggest you take Rafinlar 50 mg Capsule twice daily in a 12-hour interval. It is advised not to take more than the recommended dose of medicine.

Storage

Store in a cool and dry place away from sunlight

Drug Warnings

To treat your condition effectually, continue taking Rafinlar 50 mg Capsule for the period that your doctor has prescribed. Avoid taking Rafinlar 50 mg Capsule if you are allergic to it or any other components present in it. Caution should be exercised if you have/had liver or kidney disease, heart disease, blood or bleeding disorders, diabetes, eye problems, or gastrointestinal disorders. Inform your doctor if you are pregnant or are planning to become pregnant before starting the treatment, as this medicine is known to cause embryo-fetal toxicity. Breastfeeding should be discontinued in nursing mothers during the treatment as it passes into breast milk and may cause a possible risk to the infant. Avoid driving and operating machines, as this medicine may cause visual disturbances. This medicine is not recommended for use in children below six years of age as the safety and efficacy are not established. Rafinlar 50 mg Capsule may cause hypertension, thrombotic events, hemorrhagic events, cardiomyopathy, severe skin reactions, Glucose-6-phosphate Dehydrogenase Deficiency (G6PD), uveitis, tumor promotion in BRAF wild-type tumors, the occurrence of new malignancies, and hyperglycemia in some patients. Hence, inform your doctor about your complete medication and medical history before taking Rafinlar 50 mg Capsule .

Therapeutic Class

ANTINEOPLASTIC

Drug Interactions

Drug-Drug Interactions: Rafinlar 50 mg Capsule may have interaction with CYP3A inhibitors (itraconazole, clarithromycin, fluconazole, erythromycin, diltiazem), CYP2C8 inhibitors (clopidogrel, warfarin, verapamil, ritonavir), etc.

Drug-Food Interactions: Avoid alcohol consumption and smoking.

Dug-Disease Interactions: Tell your doctor if you have liver or kidney disease, heart problems, GI disorders, and eye problems before starting the treatment.

Drug-Drug Interactions Checker List

  • ITRACONAZOLE
  • KETOCONAZOLE
  • FLUCONAZOLE
  • CLARITHROMYCIN
  • ERYTHROMYCIN
  • DILTIAZEM
  • WARFARIN
  • VERAPAMIL
  • RITONAVIR

Diet & Lifestyle Advise

  • Eat food rich in antioxidants such as berries, spinach, etc.
  • Foods containing fibre help in better digestion. These include beans, peas, lentils, whole grains, nuts, and seeds.
  • Physical activity helps strengthen muscles, reduces fatigue, helps in weight loss, and gives strength. Gentle activities like 20-30 minutes of walking or swimming would be helpful.
  • Maintain a healthy weight by performing regular low-strain exercises and eating healthy food.
  • Getting adequate sleep as resting helps improve your health and mental ability and improves attention.
  • Avoid smoking and alcohol consumption.
  • Maintain a healthy weight.

Habit Forming

No

What if I have taken an overdose of Rafinlar 50 mg Capsule

Do not take more than the prescribed dose. Using more medication will not improve your symptoms; instead, they may cause poisoning or serious side effects. If you suspect that you may have overdosed of Rafinlar 50 mg Capsule or observe any side effects, please go to the emergency department of the closest hospital or nursing home. No specific side effects have been reported under these circumstances.

Special Advise

  • Using contraceptive pills while using Rafinlar 50 mg Capsule to prevent pregnancy is advised.
  • Thyroid function and symptoms of anemia will be monitored during treatment to avoid any life-threatening side effects.
  • Seek medical attention immediately if you have swelling in your lower legs, fast heartbeats, or trouble breathing, as it may be a sign of a heart problem.
  • An ECG and ECHO will be performed frequently to check for left ventricular ejection fraction (LVEF) during the treatment course.

Disease/Condition Glossary

Metastatic Malignant Melanoma: Melanoma is a type of skin cancer in which the cancer cells grow in melanocytes. It is mainly caused by harmful UV radiation from the sun. Malignant melanoma is common in fair-skinned and freckled individuals. It results in mole formation, typically on the skin of the face.

Non-Small Cell Lung Cancer (NSCLC): It is the most common form of lung cancer, which occurs when cells that form the lining of the lung start growing uncontrollably. It is mostly seen in persons who smoke. Symptoms may include chest pain, weight loss, hoarseness, and difficulty breathing. Rafinlar 50 mg Capsule is used in combination with pemetrexed and platinum chemotherapy as first-line treatment or in combination with carboplatin and either paclitaxel or paclitaxel protein-bound as first-line treatment of patients with metastatic squamous NSCLC.

Anaplastic Thyroid cancer: This condition occurs when the cancer cells grow abnormally in the thyroid gland. The thyroid gland is a butterfly-shaped organ present under the neck. This gland is useful in producing hormones responsible for the functioning of the body. Anaplastic thyroid cancer, also known as undifferentiated, is a rare type of thyroid carcinoma with an aggressive malignant tumor.

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Alcohol

Consult your doctor

It is unknown whether Rafinlar 50 mg Capsule interacts with alcohol. Consult your doctor.

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Pregnancy

Unsafe

Rafinlar 50 mg Capsule is not recommended for use in pregnancy as it may cause embryo-fetal toxicity and harm your foetus. Hence, if you are pregnant or planning pregnancy, inform your doctor before taking Rafinlar 50 mg Capsule . You should not become pregnant while you are taking Rafinlar 50 mg Capsule for at least two weeks from the last dose of Rafinlar 50 mg Capsule . Using effective birth control methods while on treatment with Rafinlar 50 mg Capsule is suggested.

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Breast Feeding

Unsafe

Inform your doctor if you are intending to breastfeed. Breastfeeding should be avoided while getting Rafinlar 50 mg Capsule and for at least two weeks from the final dosage of administration.

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Driving

Unsafe

Rafinlar 50 mg Capsule may cause visual disturbances such as loss of vision or blurred vision in some patients. Hence, avoid driving and operating machines until you are completely alert.

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Liver

Caution

If you have a pre-existing or a history of liver problems, tell your doctor before taking this medicine.

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Kidney

Caution

If you have a pre-existing or a history of kidney problems, tell your doctor before taking this medicine.

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Children

Caution

Rafinlar 50 mg Capsule is not recommended for use in children below six years of age, as the safety and efficacy have not been established. In children above six years, it is used in the treatment of unresectable or metastatic solid tumours with BRAF V600E mutation when prescribed by your doctor.

Country of origin

INDIA

Manufacturer/Marketer address

Sandoz House, Shiv Sagar Estate, Worli Mumbai -400 018, India.
Other Info - RAF0040

FAQs

Rafinlar 50 mg Capsule is used to treat Metastatic melanoma, Anaplastic thyroid cancer, Non-small cell lung cancer and Metastatic solid tumors.
Rafinlar 50 mg Capsule contains Dabrafenib, which works by inhibiting the action of a tyrosine kinase enzyme that causes the multiplication of cancerous cells.
It is advised not to miss any dose of medicine. If you miss it, take the medicine as soon as you remember. However, if it is time for your next dose, avoid taking the missed dose and do not double the dose.

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