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Dabrafenib oral

Updated 2 Feb 2023 | RAF Inhibitor


Oral formulations of dabrafenib.

Drugs List

  • dabrafenib 50mg capsules
  • dabrafenib 75mg capsules
  • TAFINLAR 50mg capsules
  • TAFINLAR 75mg capsules
  • Therapeutic Indications


    Advanced non-small cell lung cancer BRAFV600 mutation:Combination treatment
    Treatment of unresectable or metastatic melanoma with BRAF V600 mutation

    Monotherapy or in combination with trametinib in adults with unresectable or metastatic melanoma with a BRAF V600 mutation.

    Adjuvant treatment of melanoma
    In combination with trametinib in adults for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation, following complete resection.

    Non-small cell lung cancer
    In combination with trametinib in adults with advanced non-small cell lung cancer with a BRAF V600 mutation.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    The recommended dose of dabrafenib is 150mg twice daily.

    Treatment should continue until treatment no longer benefits patient or the development of unacceptable toxicity.

    Additional Dosage Information

    Missed Dose
    If a dose is missed, it should not be taken if it is less than 6 hours until the next dose.

    Dose modification
    When modifying the dose of dabrafenib, consider if a reduction in the dose of trametinib may also be necessary.

    Grade 1 or grade 2 (tolerable) adverse events
    Continue treatment and monitor as clinically indicated.
    Grade 2 (intolerable) or grade 3 adverse events
    Interrupt therapy until toxicity is grade 0 to 1 and reduce by one dose level when resuming therapy.
    Grade 4 adverse events
    Discontinue permanently, or interrupt therapy until grade 0 to 1 and reduce by one dose level when resuming therapy.

    Patients with uveitis that is controlled by local ocular therapies should remain on the normal dose regimen. If uveitis does not respond to local treatments suspend treatment until resolution and resume treatment at a dose reduced by one dose level.

    Interrupt treatment with dabrafenib if fever occurs. Dabrafenib can be restarted once the fever resolves with appropriate prophylaxis using NSAIDs or paracetamol. If fever is associated with other severe signs and symptoms, dabrafenib should be restarted at a reduced dose once fever resolves and as clinically appropriate.

    Dose modifications or interruptions are not recommended for adverse reactions of cutaneous squamous cell carcinoma or new primary melanoma.

    Dose level reductions
    Full dose: 150mg twice daily.
    First dose reduction: 100mg twice daily.
    Second reduction: 75mg twice daily.
    Third reduction: 50mg twice daily.
    Reductions below 50mg are not recommended.

    Once adverse reactions are under control, dose re-escalation following the same dosing levels as reduction may be considered.


    Children under 18 years

    Precautions and Warnings

    Moderate hepatic impairment
    RAS mutation associated cancer
    Severe renal impairment

    Advise ability to drive/operate machinery may be affected by side effects
    Confirm BRAF V600 mutation status of tumour prior to treatment
    Consider use of corticosteroids if adverse reactions occur
    CT scan recommended prior to and every 6 months during treatment
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Anal examination advised before, during and at end of treatment
    Examine head and neck prior to and every 3 months during treatment
    Pelvic examination advised before, during and at end of treatment
    Monitor for skin lesions prior to, during and for 6 months after treatment
    Monitor full blood count regularly
    Monitor patient constantly for signs of new infection
    Monitor serum creatinine
    Advise patient of thromboembolic symptoms and to report them if they occur
    Advise patient to report any blurred vision or any other eye symptoms
    Advise patients to report symptoms of acute pancreatitis immediately
    Consider pancreatitis in patients with unexplained abdominal pain
    Discontinue or suspend treatment if grade 4 toxicities occur
    Risk of pancreatitis
    When fever resolves, use NSAID or paracetamol prophylactically
    Discontinue if pulmonary embolism occurs
    Interrupt treatment if patients temperature is 38 degrees C or more
    Suspend treatment if grade 3 or intolerable grade 2 toxicities
    Advise patient not to take St John's wort concurrently
    Advise patient grapefruit products may increase plasma level
    May cause impaired fertility
    Female: Contraception required during and for 2 weeks after treatment
    Female: Effect of hormonal contraceptive may be reduced
    Advise patient to inform physician of any skin changes immediately

    An increased risk of non-cutaneous malignancies may be seen when dabrafenib is administered to patients with RAS mutations. Careful consideration of the benefits and risks must be carried out before administering dabrafenib to patients with prior or concurrent cancer associated with RAS mutations.

    New primary melanoma should be excised but do not require treatment modification.

    Monitoring for new or recurrent malignancies should continue for 6 months following discontinuation of treatment.

    Patients with unexplained abdominal pain should be investigated for pancreatitis, including measurements of serum amylase and lipase. Closely monitor patients when re-starting dabrafenib after an episode of pancreatitis.

    Pregnancy and Lactation


    Dabrafenib is contraindicated during pregnancy.

    The manufacturer recommends that dabrafenib is not used during pregnancy unless the potential benefit to the mother outweighs any potential risk to the foetus. Animal studies have shown reproductive toxicity and embryofoetal developmental toxicities, including teratogenic effects.


    Dabrafenib is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues dabrafenib or discontinues breastfeeding. It is not known whether dabrafenib is excreted in breast milk. LactMed suggests the amount of dabrafenib present in breast milk is likely to be low. The effect on a breastfed infant is unknown, but a risk cannot be excluded.

    Side Effects

    Abdominal pain
    Acneform changes
    Actinic keratosis
    Acute renal failure
    Alanine aminotransferase increased
    Aspartate aminotransferase increased
    Basal cell carcinoma
    Blurred vision
    Creatine phosphokinase increased
    Decreased appetite
    Decreased ejection fraction
    Dry mouth
    Dry skin
    Facial oedema
    Gamma glutamyl transferase (GGT) increased
    Gastro-intestinal perforation
    Hypersensitivity reactions
    Impaired vision
    Increase in alkaline phosphatase
    Influenza-like symptoms
    Mucosal inflammation
    Muscle spasm
    Night sweats
    Painful extremities
    Palmar-Plantar Erythrodysaesthesia syndrome
    Periorbital oedema
    Peripheral oedema
    Primary melanoma
    Pustular rash
    Reduced left ventricular output
    Renal failure
    Retinal detachment
    Skin fissures
    Skin lesions
    Skin papilloma
    Squamous cell carcinoma
    Urinary tract infections


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2019

    Reference Sources

    NICE Evidence Services Available at: Last accessed: 22 August 2019

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Dabrafenib Last revised: 03 December 2018
    Last accessed: 17 April 2019

    Summary of Product Characteristics: Tafinlar 50mg and 75mg hard capsules. Novartis Pharmaceuticals UK Ltd. Revised May 2019.

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