Dabrafenib (Tafinlar)
Dabrafenib is used either alone or in combination with trametinib to treat certain types of cancer of the skin, lung, or thyroid.
Dabrafenib is used in adults and children at least 1 years old to treat solid tumors or to treat a type of brain tumor called low grade glioma.
Dabrafenib is also used when the cancer has worsened, has spread to other parts of the body (metastatic), when surgery is not an option, or to keep the cancer from coming back after surgery.
Your doctor will make sure you have the correct tumor type to be treated with dabrafenib.
Dabrafenib may also be used for purposes not listed in this medication guide.
uses
What is Dabrafenib (Tafinlar) used for?
- Non-Small Cell Lung Cancer
- Solid Tumors
- Melanoma -- Metastatic
- Thyroid Cancer
- Malignant Glioma
warnings
What is the most important information I should know about Dabrafenib (Tafinlar)?
You should not use dabrafenib if you are allergic to it.
Tell your doctor if you have or have ever had:
- heart disease;
- bleeding problems;
- diabetes;
- planned surgery, dental, or medical procedure;
- eye problems (especially a problem with your retina or uveitis);
- a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency; or
- liver or kidney disease.
Using dabrafenib alone or together with trametinib may increase your risk of developing other types of cancer. Ask your doctor about this risk.
Dabrafenib can harm an unborn baby if the mother or the father is using this medicine.
- If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 2 weeks after your last dose.
- If you are a man, use condoms if your sex partner is able to get pregnant. Keep using birth control, even if you had a vasectomy for at least 2 weeks after your last dose.
- Tell your doctor right away if a pregnancy occurs.
Dabrafenib can make hormonal birth control less effective, such as birth control pills, injections, implants, skin patches, and vaginal rings. Ask your doctor about other barrier birth control options such as condom, diaphragm, cervical cap, or contraceptive sponge.
Dabrafenib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.
Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.
Side Effects
What are the side effects of Dabrafenib (Tafinlar)?
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Using dabrafenib together with trametinib may make some side effects more likely including other serious skin reactions. Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Call your doctor at once if you have:
- unusual bruising or bleeding, new signs of infection (fever, weakness, cough, diarrhea, problems urinating);
- worsening acne or skin rash, flu-like symptoms, mouth sores;
- high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
- hemolytic anemia--pale or yellowed skin, dark colored urine, fever, confusion or weakness;
- signs of eye problems--eye pain or swelling, severe eye redness, small white or yellow patches on the surface of your eye, vision changes, seeing halos around lights, seeing color "dots" in your vision;
- signs of bleeding inside the body--weakness, dizziness, headache, red or pink urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
- signs of a heart problem-- feeling light-headed, shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.
Your cancer treatments may be changed, delayed, or permanently discontinued if you have certain side effects.
Common side effects may include:
- muscle, bone, or joint pain;
- stomach pain;
- headache, fever, chills, tiredness;
- bleeding;
- acne, skin infection around nails, dry skin, thickened skin, warts, rash;
- swelling in the legs, arms, and face;
- redness, swelling, peeling, or tenderness of hands or feet;
- nausea, vomiting, diarrhea, constipation, loss of appetite;
- cough, shortness of breath; or
- hair loss.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Dabrafenib (Tafinlar) if I’m pregnant or breastfeeding?
Dabrafenib can make hormonal birth control less effective, such as birth control pills, injections, implants, skin patches, and vaginal rings. Ask your doctor about other barrier birth control options such as condom, diaphragm, cervical cap, or contraceptive sponge.
Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.
Interactions
What drugs and food should I avoid while taking Dabrafenib (Tafinlar)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Dabrafenib (Tafinlar)?
Use Dabrafenib (Tafinlar) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.
Take dabrafenib on an empty stomach, at least 1 hour before or 2 hours after a meal.
Dabrafenib should be taken at evenly spaced intervals, about every 12 hours.
Swallow the capsule whole and do not crush, chew, break, or open it.
If you vomit shortly after taking dabrafenib, do not take another dose. Take your next dose as scheduled.
Read and carefully follow any Instructions for Use provided to you on how to prepare a mixture using dabrafenib tablets for oral suspension.
Do not swallow, crush, or chew a tablet for oral suspension.
The mixture prepared from the tablets for oral suspension can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.
Tell your doctor if you have a planned surgery, dental, or medical procedure.
You will need frequent medical tests while using dabrafenib. Your dose or medication schedule may be changed based on the results. Keep all follow-up visits with your healthcare provider.
Your doctor should check your skin before starting, during treatment, and up to 6 months after treatment with dabrafenib. You should also check your skin regularly. Tell your doctor if you notice any new skin changes such as redness, sores that will not heal, a new wart or mole that has changed in size or color.
Do not change your dose or dosing schedule without your doctor's advice.
Keep the medicine in the original container, along with the canister of moisture-absorbing preservative. Keep at room temperature away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Dabrafenib (Tafinlar)?
Images
GS LHF, 75 mg
Color: pink
Shape: capsule
Imprint: GS LHF, 75 mg
GS TEW, 50mg
Color: red
Shape: capsule
Imprint: GS TEW, 50mg
GS TEW, 50 mg
Color: red
Shape: capsule
Imprint: GS TEW, 50 mg