50 mg, 75 mg hard capsules 
encorafenib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Braftovi is and what it is used for 
2. What you need to know before you take Braftovi  
3. How to take Braftovi 
4. Possible side effects 
5. How to store Braftovi 
6. Contents of the packaging and other information 

1. What Braftovi is and what it is used for

Braftovi is a cancer medicine that contains the active substance encorafenib. Changes ( mutations ) in the BRAF gene can give rise to proteins that cause the cancer to grow. Braftovi focuses on the proteins produced by this altered BRAF gene.

It is used in combination with another medicine that contains binimetinib to treat adult patients with a type of skin cancer called melanoma when it has

  • a specific change ( mutation ) in a gene responsible for producing a protein called BRAF, and
  • spread to other parts of the body, or can not be removed by surgery.

When Braftovi is used in combination with binimetinib, which targets another proteinthat stimulates the growth of cancer cells, the combination slows down the growth of the cancer or stops it completely.

Braftovi is also used in combination with another medicine containing cetuximab for the treatment of adult patients with a type of colon cancer when it has

  • a specific change ( mutation ) in a gene responsible for producing a protein called BRAF, and
  • spread to other parts of the body in patients who have previously been treated with other anticancer medicines.

When Braftovi is used in combination with cetuximab (which binds to the epidermalgrowth factor receptor (EGFR), a protein on the surface of certain cancer cells), the combination slows down or stops the growth of the cancer completely.

2. What you need to know before taking Braftovi 

Before starting treatment, your doctor will check if you have a mutation in the BRAF gene.

Because Braftovi is to be used in combination with binimetinib to treat melanoma , you should read both the binimetinib leaflet and this leaflet carefully.

Because Braftovi is to be used in combination with cetuximab to treat colon cancer, you should read both the cetuximab package leaflet and this leaflet carefully.

Do not take Braftovi

  • if you are allergic to encorafenib or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist or nurse before taking Braftovi and tell us about all your medical problems, especially if you have any of the following:

  • heart problems, e.g. change in the electrical activity of the heart (prolongation of QT interval )
  • bleeding problems or if you are taking any medicine that may cause bleeding
  • eye problems
  • liver or kidney problems.

Tell your doctor if you have had any type of cancer other than melanoma or colon cancer, as Braftovi may make certain types of cancer worse.

Tell your doctor, pharmacist or nurse immediately if you receive any of the following while taking this medicine:

  • Heart problems: Braftovi taken with binimetinib may make your heart work worse, alter the heart’s electrical activity in a way called “ QT prolongation” or aggravate pre-existing heart problems. Your doctor will check that your heart is functioning properly before and during treatment with these medicines. Talk to your doctor immediately if you experience any symptoms of heart problems such as feeling dizzy, tired or fainting, if you are short of breath, if you feel your heart pounding, rushing or beating irregularly, or if your legs are swollen.
  • Bleeding problems: Braftovi can cause serious bleeding problems. Tell your doctor immediately if you experience any symptoms of bleeding problems such as coughing up blood, having blood clots, vomiting blood or something resembling coffee grounds, red or black stools that look like tar, blood in the urine, abdominal pain or unusual vaginal bleeding. Also tell your doctor if you have a headache, feel dizzy or feel weak.
  • Eye problems: Braftovi can cause serious eye problems when taken with binimetinib. Talk to your doctor immediately if you get blurred vision, vision loss or other vision changes (eg colored dots in the field of vision ) or halo (blurred contour around objects). Your doctor will examine your eyes for any vision problems when you take Braftovi.
  • Skin changes: Braftovi can cause other types of skin cancer such as squamous cell carcinoma of the skin. New melanoma can also occur when taking Braftovi. Your doctor will check your skin for new skin cancer before treatment, every two months during treatment and for up to 6 months after you stop taking Braftovi. Tell your doctor immediately if you notice any skin changes during or after treatment such as: a new wart , a wound or a reddish lump that is bleeding or does not want to heal or if you have a birthmark that grows or changes color. Your doctor will also need to examine you for squamous cell carcinoma of your head, neck, mouth and lymph nodes , and you will be examined by computed tomography.periodically. This is a precaution in the event that squamous cell carcinoma develops inside your body. Examination of the genitals (for women) and the anal area is also recommended before treatment and when it ends.
  • Liver problems: Braftovi can cause abnormal blood tests related to how your liver works (increased levels of liver enzymes). Your doctor will take blood samples to check your liver before and during treatment.
  • Kidney problems: Braftovi may alter renal function (usually abnormal blood tests, more rare dehydration and vomiting). Your doctor will take blood samples to check your kidneys before and during treatment. Drink plenty of fluids during treatment. Tell your doctor immediately if you vomit and become dehydrated.

Children and young people

Braftovi is not recommended for children and adolescents under 18 years of age. This drug has not been studied in this age group.

Other medicines and Braftovi

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Some medicines may affect the way Braftovi works or increase the likelihood of side effects .

It is especially important that you tell your doctor if you are taking any medicine on this list or any other medicine:

  • Some medicines used to treat fungal infections (eg itraconazole, posaconazole, fluconazole )
  • Some medicines used to treat bacterial infections (eg rifampicin, clarithromycin, telithromycin, erythromycin, penicillin )
  • Drugs commonly used to treat epilepsy (seizures) (eg phenytoin , carbamazepine)
  • Drugs commonly used to treat cancer (eg methotrexate, imatinib)
  • Drugs commonly used to treat high cholesterol (eg rosuvastatin, atorvastatin)
  • (Traditional) herbal medicines for depression: St. John’s wort
  • Some medicines used to treat HIV (eg ritonavir, amprenavir, raltegravir, dolutegravir)
  • Contraceptives containing the hormone s
  • Medicines commonly used to treat high blood pressure (eg diltiazem , bosentan , furosemide )
  • One drug to treat irregular heartbeats: amiodarone

Braftovi with food and drink

During your treatment with Braftovi, do not drink grapefruit juice, as Braftovi’s side effects may increase.

Pregnancy, breastfeeding and fertility

Pregnancy

Braftovi is not recommended during pregnancy. It can cause damage or malformations in the fetus.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are a woman and could become pregnant, you must use a reliable contraceptive while taking Braftovi, and you must continue to use a reliable contraceptive for at least one month after the last dose . Contraceptives that contain hormones (eg on pills , on syringes, on patches , implants and some IUDs that release hormones ) may not work as well as expected while you are taking Braftovi. You should therefore use another reliable contraceptive method, e.g. a barrier method(such as a condom) so that you do not get pregnant while taking this medicine. Consult your doctor, pharmacist or nurse.

Contact your doctor immediately if you become pregnant while taking Braftovi.

Breast-feeding

Braftovi is not recommended during breast-feeding. It is unknown whether Braftovi is excreted in human milk. If you are breast-feeding or planning to breast-feed, ask your doctor for advice before taking this medicine.

Fertility

Braftovi can reduce the number of sperm in men. It can affect the ability to get a woman pregnant. Talk to your doctor if you are worried about this.

Driving and using machines

Braftovi may affect your ability to drive or use machines. Avoid driving or using machines if you experience vision problems, or have any other side effects that may affect your ability to drive or use machines (see section 4) while taking Braftovi.

Consult your doctor if you are unsure of your ability to drive.

3. How to take Braftovi

How much to take

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

For the treatment of melanoma

The recommended dose of Braftovi for the treatment of melanoma is 6 capsules with 75 mg once daily (equivalent to a daily dose of 450 mg). You will also be treated with another medicine, binimetinib.

For the treatment of colon cancer

The recommended dose of Braftovi for the treatment of colon cancer is 4 capsules with 75 mg once daily (equivalent to a daily dose of 300 mg). You will also be treated with another medicine, cetuximab.

If you have liver or kidney problems, your doctor may prescribe a lower dose .

If you experience serious side effects (eg problems with your heart, eyes or bleeding), your doctor may reduce your dose , stop treatment or stop it altogether.

How to take Braftovi

Swallow the capsules whole with water.

Braftovi can be taken with food or between meals.

If you vomit

If you vomit after taking Braftovi, do not take any extra dose . Take the next dose at the usual time.

If you take more Braftovi than you should

If you take more than one capsule, contact your doctor, pharmacist or nurse immediately. Side effects of Braftovi such as nausea, vomiting, dehydration and blurred vision may occur or worsen. If possible, show this leaflet and the package leaflet.

If you forget to take Braftovi

If you forget a dose of Braftovi, take it as soon as you remember. However, if the missed dose one should have been taken more than 12 hours ago, skip the one doseand take the next dose at the usual time. Then continue taking your capsules as usual.

Do not take a double dose to make up for a forgotten dose .

If you stop taking Braftovi

It is important that you take Braftovi for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Serious side effects are

Braftovi can cause serious side effects . Tell your doctor immediately if you get any of the following serious side effects , either for the first time or if they get worse (see also section 2):

Heart problems: Braftovi may affect how well your heart is functioning (reducing the ejection fraction of the left ventricle ) when taken with binimetinib. Signs and symptoms of this can be:

  • dizziness, tiredness or feeling unsteady
  • shortness of breath
  • hard, fast or irregular heartbeat
  • swollen legs.

Eye problems: Braftovi can cause serious eye problems when taken with binimetinib, such as fluid leakage under the retina that causes different layers of the retina to become detached in the eye (retinal detachment). Contact your doctor immediately if you experience the following symptoms of eye problems:

  • blurred vision, vision loss, or other vision changes (eg colored dots in the field of view )
  • halo (blurred contour around objects)
  • eye pain. swelling or redness

Bleeding problems: Braftovi can cause serious bleeding problems. Tell your doctor immediately if you get any unusual signs of bleeding, for example:

  • headache, dizziness or weakness
  • you cough up blood or coagulated blood
  • you vomit blood or something resembling coffee grounds
  • red or black stools that look like tar
  • blood in the urine
  • abdominal pain
  • unusual bleeding from the vagina .

Muscle problems: Braftovi may cause muscle breakdown ( rhabdomyolysis ) when taken with binimethinib. This can lead to kidney failure and can be life threatening. Signs and symptoms can be:

  • muscle pain, cramps, stiffness or spasm s
  • dark-colored urine.

Other skin cancer: Treatment with Braftovi can result in a type of skin cancer, such as squamous cell carcinoma of the skin. These types of skin changes (see also section 2) are usually limited to a small area and can be removed by surgery. Braftovi treatment can be continued without interruption. Some people taking Braftovi may discover new melanoma . These melanomas are usually removed surgically and treatment with Braftovi can be continued without interruption.

Other side effects are

In addition to the serious side effects mentioned above, people taking Braftovi may also experience other side effects .

Side effects are when Braftovi and binimetinib are taken together to treat melanoma

Very common (may affect more than 1 in 10 people):

  • decreased number of red blood cells ( anemia )
  • problems with the nerves that can lead to pain, decreased sensation or tingling in the hands and feet
  • headache
  • dizziness
  • bleeding in various places in the body
  • high blood pressure
  • problems with your vision (visual impairment)
  • abdominal pain
  • diarrhea
  • vomiting
  • nausea
  • constipation
  • itching
  • dry skin
  • hair loss or thinning hair ( alopecia )
  • different types of skin rashes
  • thickening of the outer layer of the skin
  • joint pain ( arthralgia )
  • muscle pain, weakness or spasm s
  • back pain
  • pain in arms and legs
  • fever
  • swollen hands or feet (peripheral edema ), local swelling
  • fatigue
  • abnormal results on blood tests for liver function
  • abnormal results on samples that measure creatine kinase in the blood (an enzyme present in the blood that may indicate muscle inflammation or muscle damage)

Common (may affect up to 1 in 10 people)

  • certain types of skin tumors such as skin papilloma and basal cell carcinoma
  • allergic reaction which may include swelling of the face and difficulty breathing
  • altered sense of taste
  • inflammation of the eye ( uveitis )
  • blood clots
  • inflammation of the colon ( colitis )
  • redness or cracked skin
  • inflammation of the fat layer under the skin, symptoms can be sore lumps in the skin
  • skin rash with flat discolored areas or raised lumps reminiscent of acne(acneiform dermatitis )
  • redness , flaky skin or blisters on hands and feet ( palmar-plantar erythrodysesthesia or hand-foot syndrome)
  • kidney failure
  • abnormal results on kidney tests (increased creatinine )
  • abnormal results on blood tests for liver function (alkaline phosphatase in the blood)
  • abnormal results on blood tests for pancreatic function (amylase, lipase )
  • increased skin sensitivity to sunlight

Uncommon (may affect up to 1 in 100 people)

  • weakness and paralysis of facial muscles
  • inflammation of the pancreas ( pancreatitis ) with severe abdominal pain.

Side effects are when only Braftovi is used in clinical trials in patients with melanoma

If you continue to take Braftovi alone when you are temporarily taking the other medicine (binimetinib) as decided by your doctor, you may experience some of the side effects listed above, but the frequency may change ( side effect may be more common or more unusual).

Very common (may affect more than 1 in 10 people)

  • fatigue
  • nausea
  • vomiting
  • constipation
  • different types of skin rashes
  • redness , flaky skin or blisters on hands and feet ( palmar-plantar erythrodysesthesia or hand-foot syndrome)
  • thickening of the outer layer of the skin ( hyperkeratosis )
  • dry skin
  • itching
  • abnormal hair loss or thinning hair ( alopecia )
  • redness or cracked skin
  • darker skin
  • reduced appetite
  • sleep disorders ( insomnia )
  • headache
  • problems with the nerves that can lead to pain, decreased sensation or tingling in the hands and feet
  • altered sense of taste
  • joint pain ( arthralgia )
  • muscle aches, muscle spasms or muscle weakness
  • pain in the extremity er
  • back pain
  • fever
  • certain types of benign skin tumors such as pigment nevus (liver spots) and skin papillomas
  • abnormal results on blood tests showing liver function.

Common (may affect up to 1 in 10 people)

  • allergic reaction which may include swelling of the face and difficulty breathing
  • weakness and paralysis of facial muscles
  • fast heartbeat
  • skin rash with flat discolored areas or raised lumps reminiscent of acne(acneiform dermatitis )
  • flaky or scaly skin
  • inflammation of the joints ( arthritis )
  • kidney failure
  • abnormal results on kidney tests (increased creatinine )
  • increased skin sensitivity to sunlight
  • abnormal results on blood tests for pancreatic function ( lipase ) 

Uncommon (may affect up to 1 in 100 people)

  • a type of skin cancer called basal cell carcinoma
  • inflammation of the eye ( uveitis )
  • inflammation of the pancreas ( pancreatitis ) with severe abdominal pain.
  • abnormal results on blood tests for pancreatic function (amylase)

Side effects are when Braftovi and cetuximab are taken together to treat colon cancer

In addition to the serious side effects mentioned above, people taking Braftovi with cetuximab may also experience the following side effects .

Very common (may affect more than 1 in 10 people)

  • new liver spots, so-called “pigment nevus”
  • reduced appetite
  • sleep disorders ( insomnia )
  • problems with the nerves that can lead to pain, decreased sensation or tingling in the hands and feet
  • headache
  • bleeding in various places in the body
  • diarrhea
  • abdominal pain
  • nausea
  • vomiting
  • constipation
  • skin rash with flat discolored areas or raised lumps reminiscent of acne(acneiform dermatitis )
  • different types of skin rashes
  • dry skin
  • itching
  • joint pain ( arthralgia ) and musculoskeletal pain (musculoskeletal pain)
  • muscle aches, muscle weakness or muscle spasms
  • pain in the extremity er
  • back pain
  • fatigue
  • fever

Common (may affect up to 1 in 10 people)

  • certain types of skin tumors such as skin papillomas
  • allergic reaction which may include swelling of the face and difficulty breathing
  • dizziness
  • altered sense of taste
  • fast heartbeat
  • darker skin
  • redness , flaky skin or blisters on hands and feet ( palmar-plantar erythrodysesthesia or hand-foot syndrome)
  • thickening of the outer layer of the skin ( hyperkeratosis )
  • redness or cracked skin
  • hair loss or thinning hair ( alopecia )
  • kidney failure
  • abnormal results on kidney tests (increased creatinine )
  • abnormal results on blood tests for liver function

Uncommon (may affect up to 1 in 100 people)

  • a type of skin cancer called basal cell carcinoma
  • inflammation of the pancreas ( pancreatitis ) which causes severe abdominal pain
  • flaky skin
  • abnormal results on blood tests for pancreatic function (amylase, lipase )

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Braftovi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Content declaration

  • The active substance is encorafenib.Braftovi 50 mg: One hard capsule contains 50 mg of encorafenib.Braftovi 75 mg: One hard capsule contains 75 mg of encorafenib.
  • Other ingredients are:
    • Capsule contents – copovidone (E1208), poloxamer 188, microcrystalline cellulose (E460i), succinic acid (E363), crospovidone (E1202), colloidalanhydrous silica (E551), magnesium stearate (E470b)
    • Capsule shell – gelatin (E441), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
    • Ink: shellac (E904), black iron oxide (E172), propylene glycol (E1520).

What the medicine looks like and contents of the pack

Braftovi 50 mg hard capsules

The hard capsule (capsule) has an orange opaque top and skin-colored opaque bottom, marked with a stylized “A” on the top and “LGX 50mg” on the bottom.

Braftovi 50 mg is available in packs of 28 capsules (7 blisters with 4 capsules in each) or 112 capsules (28 blisters with 4 capsules in each). Not all pack sizes may be marketed.

Braftovi 75 mg hard capsules

The hard capsule (capsule) has a skin-colored opaque upper part and a white opaque lower part, marked with a stylized “A” on the upper part and “LGX 75mg” on the lower part.

Braftovi 75 mg is available in packs of 42 capsules (7 blisters with 6 capsules each) or 168 capsules (28 blisters with 6 capsules each). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Pierre Fabre Medicine

45, place Abel Gance

92100 Boulogne-Billancourt

France

Manufacturer

Pierre Fabre Medicine Production

Aquitaine Pharm International 1

Avenue du Béarn

64320 Idron

France

or

PIERRE FABRE MEDICAMENT PRODUCTION

Progipharm site, rue du Lycée

45500 GIEN

Muhammad Nadeem

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