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Tafinlar (dabrafenib) - patient safety update

Tafinlar, for Melanoma and Lung cancer (Non-Small Cell) from Novartis

Novartis the manufacturers of cancer treatment dabrafenib, brand name Tafinlar, have updated the side effect information to report cases of:
  • severe cutaneous (skin) adverse reactions (SCARs), including
    - Stevens‑Johnson syndrome, and
    - drug reaction with eosinophilia and systemic symptoms (DRESS) 
which can be life-threatening or fatal with dabrafenib/trametinib combination therapy. Trametinib is used with dabrafenib in treating melanoma and non-small cell lung cancer. It's brand name is Mekinist.

The advice is that before starting treatment, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If you are starting dabrafenib treatment please ask your doctor to describe the symptoms to look out for.

If signs and symptoms suggestive of SCARs appear, dabrafenib and trametinib should be withdrawn.

Stevens-Johnson syndrome (source NHS)
Stevens-Johnson syndrome is a rare but serious disorder that affects the skin, mucous membrane, genitals and eyes.

The mucous membrane is the soft layer of tissue that lines the digestive system from the mouth to the anus, as well as the genital tract (reproductive organs) and eyeballs.

Stevens-Johnson syndrome is usually caused by an unpredictable adverse reaction to certain medications. It can also sometimes be caused by an infection.

The syndrome often begins with flu-like symptoms, followed by a red or purple rash that spreads and forms blisters. The affected skin eventually dies and peels off.

Stevens-Johnson syndrome is a medical emergency that requires treatment in hospital, often in intensive care or a burns unit.

Treatment aims to identify the underlying cause, control the symptoms and prevent complications.

Erythema multiforme is a similar, but less severe, skin reaction that's usually caused by infection, particularly herpes viral infections, and chest infections.

Symptoms of Stevens-Johnson syndrome
Skin pain is the most common symptom of Stevens-Johnson syndrome.

Flu-like symptoms are also usually present during the initial stages, and may include:
  • feeling generally unwell
  • a high temperature (fever) of 38C (100.4F) or above
  • a headache
  • joint pain
  • a cough
After a few days a rash appears, which consists of individual blemishes that may look like a target – darker in the middle and lighter around the outside.

The rash isn't usually itchy, and spreads over a number of hours or days.

Large blisters then develop on the skin, which leave painful sores after bursting.

Drug reaction with eosinophilia and systemic symptoms (DRESS)
DRESS syndrome is a complex syndrome with a broad spectrum of clinical features.

The clinical manifestations are not immediate and usually appear 2 to 8 weeks after introduction of the triggering drug.

Common features consist of:
  • fever
  • rash
  • swollen lymph nodes - lymphadenopathy
  • haematological findings (eosinophilia, leukocytosis, etc.)
  • abnormal liver function tests, which can mimic viral hepatitis.
Patients taking dabrafenib who experience any unusual symptoms should consult their doctor immediately.

You can follow developments on Tafinlar by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

About Tafinlar (source EMA)
Tafinlar is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) called ‘BRAF V600’. It is used for the treatment of:
  • melanoma (a skin cancer) that has spread or cannot be removed surgically. Tafinlar is used on its own or in combination with another cancer medicine, trametinib;
  • advanced (stage III) melanoma after surgery for it. Tafinlar is used in combination with trametinib;
  • advanced non-small cell lung cancer. It is used in combination with trametinib.
Tafinlar contains the active substance dabrafenib.

How Tafinlar works
The active substance in Tafinlar, dabrafenib, works by blocking BRAF, a protein involved in stimulating cell division. In melanoma and non-small cell lung cancer with the BRAF V600 mutation, the abnormal form of BRAF plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells. By blocking the action of the abnormal BRAF, Tafinlar helps to slow down the growth and spread of the cancer.

Why Tafinlar was approved
The European Medicines Agency decided that Tafinlar’s benefits in cancers that carry the BRAF V600 mutation are greater than its risks and it can be authorised for use in the EU. The Agency considered that Tafinlar when used alone or in combination with trametinib had shown clinically relevant benefit in patients with advanced non-small cell lung cancer or with melanoma that had spread or could not be removed surgically. The Agency also found it to be of benefit in patients with advanced melanoma that had been removed surgically. Tafinlar’s side effects were considered acceptable and manageable with appropriate measures.

EMA information on Tafinlar

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

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