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About DABRAFENIB

DABRAFENIB 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.

DABRAFENIB 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.

DABRAFENIB 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. DABRAFENIB should be taken as prescribed by your doctor. Do not take more than the recommended dose of medicine.

If you are allergic to DABRAFENIB or its components, inform your doctor. Before taking DABRAFENIB, 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 DABRAFENIB

Metastatic melanoma, Anaplastic thyroid cancer, Non-small cell lung cancer, Metastatic solid tumors.

Medicinal Benefits

DABRAFENIB 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, DABRAFENIB stops the body's production, spread and growth of cancerous cells.

Directions for Use

Take DABRAFENIB 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 DABRAFENIB 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

Side Effects of DABRAFENIB

  • 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

In-Depth Precautions and Warning

Drug Warnings

To treat your condition effectually, continue taking DABRAFENIB for the period that your doctor has prescribed. Avoid taking DABRAFENIB 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. DABRAFENIB 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 DABRAFENIB.

Drug Interactions

Drug-Drug Interactions: DABRAFENIB 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
  • Safety Advice

    • Safety Warning

      Alcohol

      consult your doctor

      It is unknown whether DABRAFENIB interacts with alcohol. Consult your doctor.

    • Safety Warning

      Pregnancy

      unsafe

      DABRAFENIB 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 DABRAFENIB. You should not become pregnant while you are taking DABRAFENIB for at least two weeks from the last dose of DABRAFENIB. Using effective birth control methods while on treatment with DABRAFENIB is suggested.

    • Safety Warning

      Breast Feeding

      unsafe

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

    • Safety Warning

      Driving

      unsafe

      DABRAFENIB 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.

    • Safety Warning

      Liver

      caution

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

    • Safety Warning

      Kidney

      caution

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

    • Safety Warning

      Children

      caution

      DABRAFENIB 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.

    Habit Forming

    No

    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.

    Special Advise

    • Using contraceptive pills while using DABRAFENIB 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.

    Patients Concern

    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. DABRAFENIB 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.

    FAQs

    How does DABRAFENIB work?

    DABRAFENIB contains Dabrafenib, which works by inhibiting the action of a tyrosine kinase enzyme that causes the multiplication of cancerous cells.

    What should I do if I miss a dose of DABRAFENIB?

    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.

    Available Medicines for

    DABRAFENIB