BRAFTOVI 50 mg Hard Capsules

Зміст інструкції

1. Braftovi 50 mg hard capsules, 75 mg hard capsules
   1. What is Braftovi 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. Package contents and other information

Braftovi 50 mg hard capsules, 75 mg hard capsules

encorafenib

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet
• 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 pack and other information

1. What is Braftovi and what it is used for

Braftovi is an anti-cancer medicine that contains the active substance encorafenib. Changes
(mutations) in the BRAF gene can produce proteins that cause tumors to grow. Braftovi targets
the proteins produced by this mutated BRAF gene.
It is used in association with another medicine containing binimetinib for the treatment of adult
patients with a type of skin cancer called melanoma or with a type of lung cancer
called non-small cell lung cancer (NSCLC), when the tumor:
has a specific variation (mutation) in a gene responsible for the production of a
protein called BRAF, and
has spread to other parts of the body or cannot be removed surgically.
When Braftovi is used in association with binimetinib, which targets another protein that
stimulates the growth of tumor cells, the combination slows down or blocks tumor development.
Braftovi is also used in association with another drug, cetuximab, for the treatment of adult
patients with a type of colorectal carcinoma that:
has a specific variation (mutation) in a gene responsible for the production of a
protein called BRAF, and
has spread to other parts of the body in patients previously treated with other anti-cancer drugs.
When Braftovi is used in association with cetuximab (which binds to the epidermal growth factor
receptor (EGFR), which is a protein present on the surface of some tumor cells),
the combination slows down or blocks tumor development.

2. What you need to know before you take Braftovi

Before starting treatment, your doctor will check for the presence of the BRAF mutation.
Because Braftovi must be used in combination with binimetinib for the treatment of melanoma and the
Because Braftovi must be used in combination with cetuximab for the treatment of carcinoma
illustrative.

Do not take Braftovi

• if you are allergic to encorafenib or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsBefore taking Braftovi, talk to your doctor, pharmacist or nurse about your medical conditions, especially if any of the following conditions apply to you:
• heart problems including changes in the electrical activity of the heart (prolonged QT interval)
• bleeding problems or if you are taking medicines that can cause bleeding
• eye problems
• liver or kidney problems Tell your doctor if you have had another type of cancer other than melanoma or colorectal cancer or non-small cell lung cancer, as Braftovi may worsen some other types of cancer. Immediately tell your doctor, pharmacist or nurse if you experience any of the following conditions while taking this medicine:
• Heart problems: Braftovi, when taken with binimetinib, can make the heart work less well, alter the electrical activity of the heart called “prolonged QT interval” or worsen existing heart problems. The doctor will check that the heart is functioning properly before and during treatment with these medicines. Talk to your doctor immediately if you have any symptoms of heart problems such as dizziness, fatigue, lightheadedness, shortness of breath, if you feel that your heart is beating strongly, quickly, irregularly or if you have swelling in your legs.
• Bleeding problems: Braftovi can cause serious bleeding problems. Talk to your doctor immediately if you have any symptoms of bleeding problems such as coughing up blood, blood clots, vomiting blood or that looks like “coffee grounds”, red or black stools that look like tar, blood in your urine, stomach (abdominal) pain, unusual vaginal bleeding. Also tell your doctor if you have a headache, dizziness or weakness.
• Eye problems: Braftovi, when taken in combination with binimetinib, can cause serious eye problems. Talk to your doctor immediately if you experience blurred vision, loss of vision or other visual disturbances (e.g. colored spots in vision), halos (blurred vision of the outline of objects). The doctor will check your eyes to check for any vision problems while taking Braftovi.
• Skin changes: Braftovi can cause other types of skin cancer such as squamous cell carcinoma. New melanomas may also occur while taking Braftovi. The doctor will check your skin to identify any new skin cancers

before treatment, every two months during treatment and up to 6 months after you have
stopped taking Braftovi. Immediately tell your doctor if you notice changes in your
skin during and after treatment, including: new wart, sore or reddish swelling
that bleeds or does not heal or changes in the size or color of a mole. The doctor,
will also check your head, neck, mouth and lymph nodes to identify squamous cell carcinoma and you will be regularly subjected to a CT scan. This is a precaution in
case a squamous cell carcinoma develops inside your body. A pelvic (for women) and anal exam is also
recommended before and at the end of
treatment.

• Liver problems: Braftovi can cause changes in blood tests relating to the function of your liver (increased levels of liver enzymes). The doctor will perform blood tests to check your liver before and during treatment.
• Kidney problems: Braftovi can alter the activity of your kidneys (frequent changes in blood tests, more rarely dehydration and vomiting). The doctor will perform blood tests to check your kidneys before and during treatment. Drink plenty of fluids during treatment. Immediately tell your doctor if you vomit and become dehydrated.

Contact your doctor immediately if you experience the following symptoms, as this may be a life-threatening condition:
nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, decreased urine production and fatigue.
These symptoms may be caused by a group of metabolic complications that can occur
during cancer treatment, which may be caused by the breakdown products of dying tumor cells (Tumor Lysis Syndrome (TLS) and which can lead to changes in
renal function (see also section 4. Possible side effects).

Children and adolescents
Braftovi is not recommended in children and adolescents under 18 years of age. This medicine
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 may
take any other medicine.
Some medicines can affect how Braftovi works or make it more likely that you
experience side effects. In particular, tell your doctor if you are taking any
medicine listed in this list or any other medicine:

• some medicines for the treatment of fungal infections (such as itraconazole, posaconazole, fluconazole)
• some medicines for the treatment of bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin, penicillin)
• medicines usually used to treat epilepsy (convulsions) (such as phenytoin, carbamazepine)
• medicines usually used to treat tumors (such as methotrexate, imatinib)
• medicines usually used to lower cholesterol (such as rosuvastatin, atorvastatin)
• a herbal treatment for depression: St John's wort
• some medicines for the treatment of HIV such as ritonavir, amprenavir, raltegravir, dolutegravir
• contraceptive medicines containing hormones
• medicines usually used to treat high blood pressure (such as diltiazem, bosentan, furosemide)
• a medicine used to treat irregular heartbeat: amiodarone. Braftovi with food and drink

Do not drink grapefruit juice during treatment with Braftovi, as this may increase
the side effects of Braftovi.

Pregnancy
Braftovi is not recommended during pregnancy. It can cause harm or birth defects to the fetus.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine.
If you are a woman of childbearing potential, you should use an effective contraceptive method while
taking Braftovi and should continue to use a contraceptive method for at least 1
month after taking the last dose. Contraceptive medicines containing hormones [e.g.
pills, injections, patches, implants and some intrauterine devices (IUDs) that release hormones]
may not work as expected while you are taking Braftovi. You should use another
effective method of contraception, such as a barrier method (e.g. condom) so as not to
become pregnant while taking this medicine. Ask your doctor or
pharmacist.
Contact your doctor immediately if you become pregnant while taking Braftovi.

Breastfeeding
Braftovi is not recommended during breastfeeding. It is not known whether Braftovi passes into breast milk. If
you are breastfeeding or planning to breastfeed, ask your doctor for advice before taking
this medicine.

Fertility
Braftovi may reduce the number of sperm in men. This may affect your ability to have
a child. Talk to your doctor if this concerns you.

Driving and using machines
Braftovi can affect your ability to drive or use machines. Avoid driving vehicles or using
machinery if you have any vision problems or other side effects that may affect your
ability to drive or use machinery (see section 4) while taking Braftovi. Talk
to your doctor if you are not sure you can drive.

3. How to take Braftovi

How much to take
Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.
For the treatment of melanoma and non-small cell lung cancer
The recommended dose of Braftovi for the treatment of melanoma is 6 capsules of 75 mg once a
day (corresponding to a daily dose of 450 mg). You will also be given another
medicine, binimetinib.
For the treatment of colorectal carcinoma
The recommended dose of Braftovi for the treatment of colorectal carcinoma is 4 capsules
of 75 mg once a day (corresponding to a daily dose of 300 mg). You will also be
given another medicine, cetuximab.
If you have liver or kidney problems, your doctor may prescribe you a lower dose.
If severe side effects occur (such as heart, eye problems or bleeding) your
doctor may reduce the dose or temporarily or permanently stop treatment.

How to take Braftovi

Instructions for opening the blister:

• Do not push the capsule through the blister.
• Detach a blister cell by folding and gently tearing it along the perforations.
• Carefully peel off the blister foil starting from the corner with an arrow.
• Gently remove the capsule Swallow the capsules whole with water. Braftovi can be taken with food or between meals. In case of vomitingIf you vomit at any time after taking Braftovi, do not take another dose of the medicine. Take the next dose as scheduled. If you take more Braftovi than you shouldIf you take more capsules than you should, contact your doctor, pharmacist or nurse immediately. Undesirable effects of Braftovi such as nausea, vomiting, dehydration and blurred vision may occur or worsen. If possible, show your doctor, pharmacist or nurse this leaflet and the medicine packaging. If you forget to take BraftoviIf you forget to take a dose of Braftovi, take it as soon as you remember. However, if more than 12 hours have passed since the forgotten dose, skip that dose and take the next dose at the usual time. Then continue to take the capsules at regular intervals as usual. Do not take a double dose to make up for a missed dose. If you stop taking BraftoviIt is important that you continue to take Braftovi for the entire time your doctor has prescribed it. Do not stop it unless your doctor tells you to. If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
Braftovi can cause serious side effects. Tell your doctor immediatelyif you experience any of the following serious side effects for the first time, or if they worsen (see also section 2):
Heart problems: Braftovi, when taken with binimetinib, can affect how the heart works (decreased left ventricular ejection fraction); signs and symptoms may include:

• feeling dizzy, tired, or lightheaded
• shortness of breath
• feeling as if your heart is beating fast, racing, or irregularly
• swelling of the legs Eye problems: Braftovi, when taken with binimetinib, can cause serious eye problems such as fluid leaking from under the retina of the eye leading to detachment of different layers in the eye

(retinal pigment epithelium detachment). Contact your doctor immediately if you experience these symptoms of eye problems:

• blurred vision, loss of vision, or other visual changes (such as colored spots in your vision)
• halo vision (blurred edges of objects)
• eye pain, swelling, or redness Bleeding problems: Braftovi can cause serious bleeding problems. Tell your doctor immediately if you have signs of unusual bleeding, including:
• headache, dizziness, or weakness
• coughing up blood or blood clots
• vomiting blood or that looks like “coffee grounds”
• red or black stools that look like tar
• blood in your urine
• stomach (abdominal) pain
• unusual vaginal bleeding Muscle problems: Braftovi, when taken with binimetinib, can cause muscle breakdown (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms may include:
• muscle pain, cramps, stiffness, or spasms
• dark urine Other skin cancers: treatment with Braftovi can cause a type of skin cancer such as squamous cell carcinoma. Usually, these skin changes (see also section
• 2) are confined to a small area and can be removed with surgery and treatment with Braftovi can continue without interruption. Some people taking Braftovi may also notice new melanomas. These melanomas are usually removed surgically and treatment with Braftovi can continue without interruption. Tumor lysis syndrome: treatment with Braftovi can cause a rapid breakdown of cancer cells which in some people can be fatal. Symptoms may include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, decreased urine production, and fatigue. Other side effectsIn addition to the serious side effects mentioned above, people taking Braftovi may also experience other side effects. Side effects when Braftovi and binimetinib are taken together for the treatment ofmelanoma or non-small cell lung cancer Verycommon(may affect more than 1 in 10 people)
• low levels of red blood cells (anemia)
• nerve problems resulting in pain, loss of sensation, or tingling in the hands and feet
• headache
• dizziness
• bleeding in various parts of the body
• high blood pressure
• vision disturbances (impaired vision)
• stomach pain
• diarrhea
• vomiting
• nausea
• constipation
• itching
• dry skin
• hair loss or thinning (alopecia)
• rash of various types
• thickening of the outer layers of the skin
• joint pain (arthralgia)
• muscle disorders
• back pain
• pain in the limbs
• fever
• swelling of the hands or feet (peripheral edema), localized swelling
• fatigue
• altered laboratory test results for liver function
• altered laboratory test results for creatine kinase (an enzyme found in the blood that can indicate muscle inflammation or damage) Common(may affect up to 1 in 10 people)
• certain types of skin cancer such as cutaneous papilloma
• allergic reaction that may include swelling of the face and difficulty breathing
• changes in the perception of the taste of things
• inflammation of the eye (uveitis)
• blood clots
• inflammation of the colon (colitis)
• redness, cracking, or scaling of the skin
• inflammation of the fat layer under the skin, symptoms include soft skin nodules
• rash with a flat discolored area or raised pimple-like bumps (acneiform dermatitis)
• redness, peeling, or blistering of the skin on the hands and feet (palmo-plantar erythrodysesthesia or hand-foot syndrome)
• kidney problems (decreased kidney function)
• altered laboratory test results related to the kidneys (increased creatinine)
• altered laboratory test results for liver function (alkaline phosphatase)
• altered laboratory test results for pancreatic function (amylase, lipase)
• increased sensitivity of the skin to sunlight Uncommon(may affect up to 1 in 100 people)
• certain types of skin cancer such as basal cell carcinoma
• weakness and paralysis of the facial muscles
• inflammation of the pancreas (pancreatitis) causing severe abdominal pain Side effects when Braftovi was used alone in clinical trials conducted in patientswith melanomaIf you continue to take Braftovi alone while the other medicine (binimetinib) has been temporarily stopped based on your doctor’s decision, you may experience some of the side effects reported above, although the frequency may change (increase or decrease). Very common(may affect more than 1 in 10 people)
• fatigue
• nausea
• vomiting
• constipation
• rash of various types
• redness, peeling, or blistering of the skin on the hands and feet (palmo-plantar erythrodysesthesia or hand-foot syndrome)
• thickening of the outer layer of the skin (hyperkeratosis)
• dry skin
• itching
• abnormal hair loss or thinning (alopecia)
• redness, cracking, or scaling of the skin
• skin darkening
• loss of appetite
• difficulty sleeping (insomnia)
• headache
• nerve problem that can produce pain, loss of sensation, or tingling in the hands and feet
• changes in the perception of taste
• joint pain (arthralgia)
• muscle pain, spasm, or weakness
• pain in the limbs
• back pain
• fever
• certain types of benign skin tumors such as melanocytic nevus and cutaneous papilloma
• altered blood test results related to the liver Common(may affect up to 1 in 10 people)
• allergic reaction that may include swelling of the face and difficulty breathing
• weakness and paralysis of the facial muscles
• paralysis or alterations in facial movements
• fast heartbeat
• rash with a flat discolored area or raised pimple-like bumps (acneiform dermatitis)
• skin exfoliation or scaling
• inflammation of the joints (arthritis)
• kidney problems (decreased kidney function)
• altered blood test results related to the kidneys (increased creatinine)
• increased sensitivity of the skin to sunlight
• altered laboratory test results for pancreatic function (lipase) Uncommon(may affect up to 1 in 100 people)
• type of skin cancer such as basal cell carcinoma
• inflammation of the eye (uveitis)
• inflammation of the pancreas (pancreatitis) causing severe abdominal pain
• altered laboratory test results for pancreatic function (amylase) Side effects when Braftovi and cetuximab are taken together for the treatment ofcolorectal cancerIn addition to the adverse events described above, the following side effects may occur in patients taking Braftovi together with cetuximab. Very common(may affect more than 1 in 10 people)
• new moles called “melanocytic nevi”
• loss of appetite
• difficulty sleeping (insomnia)
• nerve problem that can produce pain, loss of sensation, or tingling in the hands and feet
• headache
• bleeding in various parts of the body
• diarrhea
• stomach pain
• nausea
• vomiting
• constipation
• rash with a flat discolored area or raised pimple-like bumps (acneiform dermatitis)
• rash of various types
• dry skin
• itching
• joint pain (arthralgia) and muscle and/or bone pain (musculoskeletal pain)
• muscle pain, spasm, or weakness
• pain in the limbs
• back pain
• fatigue
• fever Common(may affect up to 1 in 10 people)
• certain types of skin cancer such as cutaneous papilloma
• allergic reaction that may include swelling of the face and difficulty breathing
• dizziness
• change in the taste of food
• fast heartbeat
• skin darkening
• redness, peeling, or blistering of the skin on the hands and feet (palmo-plantar erythrodysesthesia or hand-foot syndrome)
• thickening of the outer layer of the skin (hyperkeratosis)
• redness, cracking, or scaling of the skin
• hair loss or thinning (alopecia)
• kidney problems
• altered blood test results related to the kidneys (increased creatinine)
• altered blood test results for liver function Uncommon(may affect up to 1 in 100 people)
• certain types of skin cancer such as basal cell carcinoma
• inflammation of the pancreas (pancreatitis) causing severe abdominal pain
• skin exfoliation
• altered laboratory test results for pancreatic function (amylase, lipase) Reporting of side effectsIf you get any side effects, even if not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

  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 box and blister after
  Expiry Date/EXP. The expiry date refers to the last day of that month.
  Store at a temperature below 30 °C. Store in the original package to protect the
  medicine from moisture.
  Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
  dispose of medicines you no longer use. This will help protect the environment.

  6. Package contents and other information

  What Braftovi contains

  • The active ingredient is encorafenib. Braftovi 50 mg hard capsules: each hard capsule contains 50 mg of encorafenib. Braftovi 75 mg hard capsules: each hard capsule contains 75 mg of encorafenib.
  • The other ingredients are:
  • Capsule content: copovidone (E1208), poloxamer 188, microcrystalline cellulose (E460i), succinic acid (E363), crospovidone (E1202), anhydrous colloidal silica (E551), magnesium stearate (E470b)
  • Capsule shell: gelatin (E441), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)
  • Printing ink: shellac (E904), black iron oxide (E172), propylene glycol (E1520) Description of the appearance of Braftovi and package contentsBraftovi 50 mg hard capsules The hard capsule (capsule) has an opaque orange cap and an opaque flesh-colored body, with a stylized “A” imprinted on the cap and “LGX50mg” on the body. Braftovi 50 mg is available in packs of 28x1 capsules or 112x1 capsules in perforated unit-dose blisters. Not all pack sizes may be marketed.

  Braftovi 75 mg hard capsules
  The hard capsule (capsule) has an opaque flesh-colored cap and an opaque white body, with a stylized “A”
  imprinted on the cap and “LGX75mg” on the body.
  Braftovi 75 mg is available in packs of 42x1 capsules or 168x1 capsules in perforated
  unit-dose blisters.
  Not all pack sizes may be marketed.

  Marketing Authorisation Holder
  PIERRE FABRE MEDICAMENT
  Les Cauquillous
  81500 Lavaur
  France

  Manufacturer
  PIERRE FABRE MEDICAMENT PRODUCTION
  Site Progipharm, rue du Lycée
  45500 GIEN
  France
  Further details on this medicine are available on the website of the European
  Medicines Agency, https://www.ema.europa.eu .