Dabrafenib

Say 'da-BRAF-e-nib'

Key points about dabrafenib

  • Dabrafenib is used to treat some types of cancer.
  • It belongs to a group of medicines called targeted therapies.
  • It works by blocking specific changes in cancer cells that help them grow.
  • It can used used on its own, or with other medicines.
  • Dabrafenib is known by the brand name Tafinlar®.
2 people sit on a log at Christchurch NZ beach

Dabrafenib belongs to a group of medicines called targeted therapies. When treating melanoma, it's used together with trametinib (Mekinist®). It may sometimes be used to treat other cancers and it can be used on it's own. 

Dabrafenib and trametinib are used to treat stage 3 melanoma that was completely removed with surgery. They reduce the risk of the cancer coming back (called adjuvant treatment). They're also used to treat melanoma that cannot be removed with surgery or has spread to other organs of the body. These medicines are used if cancer cells have a mutation (change) in a gene called BRAF. The BRAF gene causes cells to produce a protein that encourages cancer to grow. Dabrafenib and trametinib block this protein. Read more about trametinib.

When melanoma or certain other types of cancer are diagnosed, BRAF testing is done to check if the tumour has the BRAF V600 mutation. If the mutation is found, your healthcare team may recommend targeted therapies such as dabrafenib, with or without trametinib, which specifically target the mutated BRAF protein to slow cancer growth.

In Aotearoa New Zealand dabrafenib is funded for certain cancers under a Special Authority, for people who meet certain criteria. A special authority means your specialist will need to make an application to Pharmac (the government medicine funding agency) for approval before the medicine can be funded for you.

Dabrafenib comes as capsules (50 mg and 75 mg).

  • Dose: The usual dose is 150 mg two times a day either as two 75 mg capsules OR three 50 mg capsules. 
    Your dose may be changed depending on any side effects you may have. It's important to make sure you're taking the correct dose every time. Before every dose, check that what you're taking matches what you've been prescribed.
  • Timing of your dose: Take dabrafenib two times a day, in the morning and evening, about 12 hours apart.
  • Food: Take dabrafenib capsules on an empty stomach. Don't eat for 2 hours before you take them. After taking them, don't eat for 1 hour.
  • Swallow the capsules whole with a glass of water: Don't open, crush, break or chew them.
  • Missed dose: If you forget your dose, take it as soon as you remember that day unless it's 6 hours or less until your next dose is due. If that's the case, skip the forgotten dose and take your next dose at the usual time. Don't take 2 doses at once to make up for a missed dose.

Here are some things to know when you're taking dabrafenib. Other things may be important as well, so ask your healthcare provider what you should know about.

  • Tests and monitoring: While you're taking dabrafenib, you'll need regular blood tests to monitor for side effects and to check whether the treatment is working. Blood tests are very important during the first few months of treatment. Over time, these tests are needed less often.
  • Pregnancy: Dabrafenib can harm an unborn baby. You should not become pregnant while you're taking dabrafenib and for 14 days after stopping treatment, or 16 weeks if taken with trametinib. Discuss with your healthcare provider which types of contraception are suitable for you and your partner. If you and your partner are planning a pregnancy, talk to your healthcare provider.
  • Increased risk of infections:  Dabrafenib, when given with chemotherapy medicines, weakens your body’s immune (defence) system, so you're more likely to pick up infections. It's important to avoid anyone who has chickenpox or shingles.
  • Vaccines: Some vaccines shouldn't be taken if yo're on dabrafenib. Always check with your healthcare provider or pharmacist first. The annual flu vaccine is safe.
  • Taking other medicines: Dabrafenib interacts with some medicines and herbal supplements, so check with your healthcare provider or pharmacist before starting dabrafenib or any new medicines. This includes those you may buy over the counter.
  • Protect yourself from sunlight: Dabrafenib can make your skin more sensitive to sunburn and rash if you're exposed to the sun. When you're outside, protect your skin with sunblock and cover up with long sleeves and a hat while taking dabrafenib.
  • Storing your capsules: Keep dabrafenib capsules in the bottle until it's time to take them. Light, heat, and dampness will affect the medicine, so don't store the bottle in the bathroom, near a sink, on a windowsill or in the car. There is a desiccant (moisture absorber) in the bottle to protect the capsules from moisture. Keep the desiccant in the bottle during use and keep the capsules in their original container.

Like all medicines, dabrafenib can cause side effects, although not everyone gets them. Side effects can occur at any time during your treatment. Most side effects are likely to improve after you stop having treatment, but some may last longer.

To monitor side effects, your healthcare team will carry out regular blood tests and other tests to check your heart, liver, kidneys and blood before and during your treatment.

Note: This isn't a full list of side effects, and they can vary between people. If you're unsure whether your symptoms are side effects of the medicine, contact your healthcare team straight away.


Common side effects

Tell your healthcare provider if they're not getting better or are getting worse.

  • Feeling very tired and weak (fatigue).
  • Diarrhoea (runny poo) or nausea (feeling sick).
  • Headache.
  • Cough, chills, fever, flu-like symptoms.
  • Constipation.
  • Skin rash, itching, dryness.
  • Muscle and joint pain.
  • Loss of appetite.


Tell your healthcare provider immediately or phone Healthline free on 0800 611 116 if these occur

  • Signs of a fever or temperature such as chills, sweats, shivers or shakes. If your temperature is 38C or higher stop taking dabrafenib (and trametinib) and contact your healthcare provider.
  • Problems with your eyes such as blurring or loss of vision, eye pain or redness or sensitivity to light.
  • Signs of heart problems such as shortness of breath, dizziness, changes to your heartbeat (palpitations) or swollen feet and ankles.
  • Signs of blood clots in your legs, arms or lungs such as swelling, redness, or pain in a leg or arm, chest pain or pressure, or shortness of breath.
  • Signs of bleeding such as coughing up blood or vomiting blood or there is blood in your urine (wee) or bowel motion (poo).


Phone 111 for an ambulance or go to your nearest accident and emergency (A&E) clinic if these occur

  • Signs of an allergic reaction such as itchy skin, and rash, swollen lips or tongue, problems breathing, like a tight chest or shortness of breath.
  • Signs of heart problems such as chest pain, pressure, heaviness, tightness or squeezing across the chest difficulty breathing.
  • Temperature of 38C or higher if not getting better, despite stopping the dabrafenib (and trametinib).

The following links provide more information on dabrafenib:

Tafinlar(external link) Medsafe consumer medicine information, NZ

Brochures

Chemotherapy, Immunotherapy and Targeted Treatment(external link) Cancer Society, NZ, 2019
5 questions to ask about your medications (external link)Health Quality and Safety Commission, NZ, 2019 English(external link), te reo Māori(external link)


References

  1. Dabrafenib(external link) NZ Formulary, NZ
  2. Tafinlar(external link) Medsafe datasheet, NZ

Brochures

5 questions to ask about your medications
5 questions to ask about your medications

Health Quality and Safety Commission, NZ, 2019 English, te reo Māori

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Credits: Sandra Ponen, Pharmacist, Healthify He Puna Waiora. Healthify is brought to you by Health Navigator Charitable Trust.

Reviewed by: Joanna Buchanan, Oncology Pharmacist, Auckland; Angela Lambie, Pharmacist, Auckland

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