Consumer medicine information

1. Why am I taking BRAFTOVI?

BRAFTOVI contains the active ingredient encorafenib. BRAFTOVI can be used:

• in combination with a medicine called binimetinib (MEKTOVI^®) to treat adult patients with a type of skin cancer called melanoma, which has spread to other parts of the body, or cannot be removed by surgery; or

• in combination with a medicine called cetuximab to treat adults with cancer of the large intestine (colorectal cancer) that has been previously treated with other anticancer medicines.

2. What should I know before I take BRAFTOVI?

Do not use if you have ever had an allergic reaction to Braftovi or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take BRAFTOVI? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BRAFTOVI and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take BRAFTOVI?

• Melanoma - The recommended dose of BRAFTOVI, when taken in combination with MEKTOVI, is six 75 mg capsules once daily (corresponding to a daily dose of 450 mg).

• Colorectal cancer - The recommended dose of BRAFTOVI, when taken in combination with cetuximab is four 75 mg capsules once daily (corresponding to a daily dose of 300 mg).

• Swallow the capsules whole with a full glass of water. BRAFTOVI can be taken with or without food. Avoid grapefruit juice.

5. What should I know while taking BRAFTOVI?

6. Are there any side effects?

When BRAFTOVI was taken with binimetinib, very common side effects included fatigue, nausea, diarrhoea, vomiting, problems with vision, stomach pain, joint pain, abnormal blood test results and muscle pain. When BRAFTOVI was taken with cetuximab, very common side effects included fatigue, nausea, diarrhoea, acne type rash, rash, stomach pain, decreased appetite and muscle pain. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Encorafenib.

2 Qualitative and Quantitative Composition

Each Braftovi 50 mg hard capsule contains encorafenib 50 mg.
Each Braftovi 75 mg hard capsule contains encorafenib 75 mg.
For the list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Braftovi 50 mg hard capsules. Swedish orange opaque cap and flesh-coloured opaque body, printed with a stylised "A" on the cap and "LGX 50 mg" on the body. The length of the capsule is approximately 22 mm.
Braftovi 75 mg hard capsules. Flesh-coloured opaque cap and white opaque body, printed with a stylised "A" on the cap and "LGX 75 mg" on the body. The length of the capsule is approximately 23 mm.

4 Clinical Particulars

4.9 Overdose

At doses of encorafenib between 600 to 800 mg once daily, renal dysfunction (grade 3 hypercreatinemia) was observed in 3 out of 14 patients. The highest administered dose occurred as a dosing error in one patient who took encorafenib at a dose of 600 mg twice daily for 1 day (total dose 1200 mg). AEs reported by this patient were Grade 1 events of nausea, vomiting and blurred vision; all were subsequently resolved.
Management of overdose. There is no specific treatment for overdose with encorafenib. If overdose occurs, encorafenib treatment should be interrupted and renal function must be monitored as well as adverse reactions. Symptomatic treatment and supportive care should be provided as needed. Since encorafenib is moderately bound to plasma proteins, haemodialysis is likely to be ineffective in the treatment of overdose with encorafenib.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Based on the results of in vitro bacterial reverse mutation assays, an in vitro human peripheral blood lymphocyte chromosomal aberration assay and an in vivo rat bone marrow micronucleus test, encorafenib is not genotoxic.
Carcinogenicity. The carcinogenic potential of encorafenib was not evaluated.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSENCORA.gif CAS number. Chemical Abstracts Service (CAS) registry number: 1269440-17-6.
Chemical name: Methyl N-[(1S)-2-[[4-[3-[5-chloro-2-fluoro-3-[(methylsulfonyl)amino]phenyl]-1-(1- methylethyl)-1H-pyrazol-4-yl]-2-pyrimidinyl]amino]-1-methylethyl]carbamate.
Encorafenib is a white to almost white powder with the molecular formula C₂₂H₂₇ClFN₇O₄S and a molecular weight of 540.0. It is slightly soluble in aqueous media at pH 1, very slightly soluble at pH 2 (0.01 to 0.1%), and insoluble at pH 3 and above. Its dissociation constants (pKa) are 4.49 and 7.21. Encorafenib is not hygroscopic.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BRAFTOST.gif