Tafinlar (Dabrafenib) capsules 75 mg No. 120 - Instructions

Tafinlar (Dabrafenib) is a new generation antitumor drug developed in the UK and already approved in many countries. It is intended to fight metastatic melanoma when surgery is not possible.

The action of the drug is aimed at tumor cells originating from pigment tissue. It works in the case of a mutation in the BRAF gene, when uncontrolled division of cancer cells occurs.

The drug is used separately from chemotherapy and radiation therapy, but can be used in combination with the antitumor drug Mekinist.

pharmachologic effect

Tafinlar is a kinase inhibitor designed to block the BRAF gene in pathogenic cells. This gene is involved in the process of cell division. When it is in a pathological state, tumor cells begin to divide uncontrollably, promoting the growth of melanoma in a short time.

Dabrafenib blocks the BRAF gene, which does not function properly in cell division, thereby stopping tumor development. The effect of the drug lasts 2.5 months longer than chemotherapy, and there are fewer side effects.

Clinical trials have confirmed the effectiveness of treatment with Tafinlar. They involved 152 patients with an average age of 53 years. All had a diagnosis of inoperable melanoma with a disruption of the BRAF gene. Participants received dabrafenib twice daily. Observation was carried out for 14 months. During this time, most patients managed to achieve a positive result in the form of stopping the growth of melanoma and reducing its size.

The effectiveness of the drug has been shown to increase when used together with trametinib.

Indications for use

Tafinlar is prescribed to patients with unresectable metastatic melanoma with a mutation in the BRAF gene, identified using a special test. This pathology occurs in 50% of melanoma patients, so the medicine can help a large number of patients without the use of chemotherapy and high doses of radiation.

The drug is prescribed by the attending physician after testing for the presence of a BRAF gene mutation. It is often used in combination with the drug Mekinist (Trametinib).

Contraindications

Dabrafenib has a number of contraindications that must be taken into account before prescribing therapy. The drug is not used to treat children under 18 years of age, since its effect on the children's body has not been studied.

Before taking the medicine, the patient should inform the doctor about possible pregnancy. Then it is better to refuse Tafinlar therapy due to its toxic effect on the fetus. To prevent pregnancy during treatment, contraception should be used. It is also necessary to avoid conception for 4 months after completion of the course.

The drug is not prescribed during breastfeeding - severe adverse reactions for the child's body are possible. Medicinal substances are secreted into mother's milk.

People with kidney and liver failure can use Tafinlar, but should be careful. The same rule applies if you are diagnosed with diabetes.

The drug is not prescribed together with other strong inhibitors - nefazodone, clarithromycin, ketoconazole, gemfibrozil. Contraindications apply to strong inducers - phenytoin, rifampicin, phenobarbital, carbamazepine. Taking these drugs together will decrease the effectiveness of dabrafenib.

Side effects

Tafinlar is taken as prescribed by a doctor. You need to carefully monitor your well-being after taking the prescribed dose, as adverse reactions of varying severity are possible. Sometimes the patient experiences a severe allergic reaction. In such cases, the drug is immediately stopped and is not used again.

In most cases, side effects are not severe and do not cause major problems for patients. If you feel very bad after taking the medicine, you can reduce the daily dose until the body’s condition returns to normal.

The following side effects are currently known when undergoing treatment with Tafinlar:

  • Dizziness, headaches, general weakness.
  • Vomiting and coughing up blood.
  • Black stool with blood.
  • Pain in the arms and legs, swelling of the extremities.
  • Chest pain, difficulty breathing, shortness of breath.
  • Blood clots in the arms or legs.
  • Redness of the eyes, blurred vision.
  • The appearance of fever, increased blood pressure, chills.
  • Severe skin rash that does not go away for a long time.
  • Anemia, increased blood sugar.
  • Hair loss.
  • The appearance of new cancerous tumors on the skin.

In addition, it can affect reproductive function in men and women and cause problems with conception in the future. The drug should be used if the positive effect of therapy outweighs the possible risk.

Tafinlar Dabrafenib 50 mg / 75 mg

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Directions for use and dosage

Tafinlar is taken orally as prescribed by a doctor in the prescribed dose. Capsules are swallowed whole, washed down with a small amount of water. The drug is used twice a day - morning and evening, 150 mg. It is recommended to take the medication at the same time, one hour before meals or two hours after meals.

If you miss a dose, you can take the medicine no later than six hours before your next dose, or you can skip the dose and take it at your usual time. It is recommended to maintain a twelve-hour interval between daily doses of the drug.

If Trametinib is used in parallel, it is taken once a day with a morning or evening dose of Tafinlar.

The duration of the course of treatment is determined by the doctor. Typically, therapy lasts until positive results appear in the form of stopping the growth of melanoma, achieving stable remission of the disease, or severe side effects.

Undesirable reactions of the body are not a reason to stop treatment if they are not dangerous to the patient’s life. It is possible to reduce the dose to 50-100 mg twice a day and carefully monitor the condition of a patient diagnosed with melanoma with a BRAF gene mutation.

No dose adjustment is required for people with mild renal or hepatic impairment. For older people over 65 years of age, a generally prescribed dose is prescribed. The drug is not used for the treatment of children and pregnant women due to a lack of information about the effect of its substances on the children's body. The effect of an overdose on the body has not been studied. In this case, you need to urgently contact your doctor and undergo an examination.

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