Dabrafenib Oral Capsule (DABRAFENIB - ORAL)

For treating cancer.

Brand Name(s): Tafinlar

Generic Name: Dabrafenib

Instructions

Swallow the medicine without crushing or chewing it.

Take on empty stomach - 1 hour before or 2 hours after eating.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Keep the desiccant (drying) packet in the bottle and keep the bottle closed tightly.

If you vomit after taking a dose, do not take an extra dose. Take your next dose at the usual time.

If you forget to take a dose on time, take it as soon as you remember. If it is less than 6 hours to the next dose, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

This medicine may cause higher blood sugar levels or diabetes. Please follow your doctor's instructions and check your blood sugar level regularly while on this medicine.

This medicine may decrease the effectiveness of some birth controls which use hormones (such as birth control pills and patches). Use an extra form of birth control, such as condoms, while on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Avoid touching any powder from an open or broken capsule. If the powder touches the skin, nose, or eyes, rinse thoroughly with water.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

Do not use the medication any more than instructed.

Do not breastfeed while on this medicine. You may safely start breastfeeding 2 weeks after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women or men must use reliable forms of birth control while taking this medicine and for 2 weeks after stopping to prevent pregnancy.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • hair loss
  • headaches
  • pain in the joints

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • bleeding or bruising
  • confusion
  • coughing up blood or vomit that looks like coffee grounds
  • swelling of the legs, feet, and hands
  • eye pain, redness, or itching
  • fainting
  • fever or chills
  • swelling in the neck or throat
  • severe or persistent headache
  • fast or irregular heart beats
  • high blood sugar
  • sensitivity to light
  • red, burning, or itchy skin
  • seizures
  • shortness of breath
  • change in the size or color of a skin mole
  • sore throat
  • slurred speech
  • bloody or dark, tarry stools
  • unusual or unexplained tiredness or weakness
  • urinating less often
  • blood in urine
  • blurring or changes of vision
  • weakness on one side of the body
  • sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.