Dabrafenib

Unless your doctor tells you otherwise, continue your normal diet.

Dabrafenib is part of the drug class:

• Protein kinase inhibitors

Your doctor will perform blood tests to make sure you have the correct tumor type to be treated with dabrafenib.

Dabrafenib is usually taken twice daily. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take dabrafenib on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not crush, chew, break, or open a dabrafenib capsule. Swallow it whole.

If you need surgery, dental work, or a medical procedure, tell the doctor ahead of time that you are using dabrafenib.

Your doctor will need to check your skin every 2 months while you are using dabrafenib, and for up to 6 months after your treatment ends.

Store at room temperature away from moisture and heat.

Dabrafenib is used alone or in combination with trametinib to treat melanoma (skin cancer) that has spread or that cannot be removed by surgery. It is only used if the melanoma cells have the BRAF V600E or V600K mutations. It also treats non-small cell lung cancer (NSCLC) that has spread if the NSCLC cells have the BRAF V600E mutation in combination with trametinib. Your doctor will use a special test to look for these mutations. Dabrafenib belongs to the group of medicines, called antineoplastics (cancer medicines).

dabrafenib is available only with your doctor's prescription.

Medicines used to treat cancer are very strong and can have many side effects. Before using dabrafenib, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take dabrafenib exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

dabrafenib usually comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take dabrafenib at least 1 hour before or 2 hours after a meal.

Swallow the capsule whole. Do not open, crush, or break it.

Dosing

The dose of dabrafenib will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of dabrafenib. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For melanoma (skin cancer) and non-small cell lung cancer:
    • Adults—150 milligrams (mg) two times a day, taken 12 hours apart.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of dabrafenib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 6 hours until your next regular dose, skip the missed dose and go back to your regular dosing schedule. If you miss a dose and it is more than 6 hours until your next dose, take it as soon as possible and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bleeding gums
• bloody or cloudy urine
• blurred vision
• coughing up blood
• difficulty in breathing or swallowing
• dizziness
• dry mouth
• fever
• flushed, dry skin
• fruit-like breath odor
• greatly decreased frequency of urination or amount of urine
• headache
• increased hunger
• increased thirst
• increased urination
• lump or growth on the skin
• nausea
• nosebleed
• prolonged bleeding from cuts
• red or dark brown urine
• red or black, tarry stools
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• skin blisters
• skin rash
• stomach pain
• sweating
• swelling of the feet or lower legs
• tingling of the hands and feet
• ulceration of the skin
• unable to move
• unexplained weight loss
• unusual tiredness or weakness
• vomiting

• Blurred vision or other change in vision
• change in color vision
• difficulty seeing at night
• eye pain
• increased sensitivity of the eyes to sunlight
• redness of the eye
• tearing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• constipation
• cough
• difficulty having a bowel movement
• difficulty with moving
• fast heartbeat
• hair loss or thinning of the hair
• headache
• indigestion
• loss of appetite
• muscle aches
• muscle pain or stiffness
• pain in the joints
• pains in the stomach, side, or abdomen, possibly radiating to the back
• sore throat
• stuffy or runny nose
• yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat a type of skin cancer (melanoma).

(da BRAF e nib)

• GSK2118436

Mild impairment: No dosage adjustment necessary.

Moderate to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, metabolism is primarily hepatic and exposure may be increased in patients with moderate to severe impairment.

Administer orally at least 1 hour before or 2 hours after a meal; doses should be ~12 hours apart. Do not open, crush, or break capsules. A missed dose may be administered up to 6 hours prior to the next dose. When administered in combination with trametinib, take the once-daily dose of trametinib at the same time each day with either the morning or evening dose of dabrafenib.

Adverse effects were observed in animal reproduction studies. Based on its mechanism of action, dabrafenib would be expected to cause fetal harm if administered to a pregnant woman. Females of reproductive potential should use a highly effective nonhormonal contraceptive during therapy and for at least 2 weeks for single-agent therapy or 4 months for combination therapy with trametinib after treatment is complete; hormonal contraceptives may not be effective. Spermatogenesis may be impaired in males (observed in animal studies); family planning and fertility counseling should be considered prior to therapy.

-Mild to Moderate Renal Impairment: No adjustment recommended.
-Severe Renal Impairment: Dose adjustment(s) may be required; however, an appropriate dose has not been established. Caution is recommended.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.