MEKTOVI 15 mg Film-Coated Tablets

Зміст інструкції

1. Mektovi 15 mg film-coated tablets, 45 mg film-coated tablets
   1. What is Mektovi and what is it used for
   2. What you need to know before you take Mektovi
   3. How to take Mektovi
   4. Possible side effects
   5. How to store Mektovi
   6. Package Contents and Other Information

Mektovi 15 mg film-coated tablets, 45 mg film-coated tablets

binimetinib

Read this leaflet carefully before taking this medicine because 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 Mektovi is and what it is used for
• 2. What you need to know before you take Mektovi
• 3. How to take Mektovi
• 4. Possible side effects
• 5. How to store Mektovi
• 6. Contents of the pack and other information

1. What is Mektovi and what is it used for

Mektovi is an anti-cancer medicine that contains the active substance binimetinib. It is used in adults
in association with another medicine containing encorafenib for the treatment of a type of skin
cancer called melanoma or a type of lung tumor called non-small cell lung cancer (NSCLC), when the tumor:
has a particular variation (mutation) in a gene called BRAF, and
has spread to other parts of the body or cannot be removed surgically.
Mutations in the BRAF gene can produce proteins that cause tumor growth. Mektovi
acts on another protein called “MEK” which stimulates the growth of tumor
cells. When Mektovi is used in association with encorafenib, which targets the protein
produced by the modified “BRAF” gene, the combination slows down or blocks tumor development.

2. What you need to know before you take Mektovi

Before starting treatment, your doctor will check for the presence of the BRAF mutation.
Since Mektovi must be used in combination with encorafenib, carefully read both the leaflet

Do not take Mektovi
if you are allergic to binimetinib or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Before taking Mektovi, talk to your doctor, pharmacist or nurse about your medical conditions,
especially if any of the following apply to you:
heart problems
bleeding problems or if you are taking medicines that can cause
bleeding
eye problems including glaucoma or high eye pressure
muscle problems
high blood pressure
blood clots
lung problems or breathing problems
liver problems
Tell your doctor if you have ever had a blockage of the vein that drains blood away from the eye
(retinal vein occlusion) as Mektovi is not recommended in this case.
Tell your doctor if you have had a cancer of a type other than melanoma or non-small cell lung
cancer, as binimetinib, when taken with encorafenib, may worsen some other types of
cancers.
See your doctor, pharmacist or nurse immediately if you experience any of the following
conditions while taking this medicine:
Heart problems: Mektovi may make your heart work less well or worsen existing heart
problems. Your doctor will check that your heart is working properly before and during
treatment with this medicine. Talk to your doctor immediately if you have any symptoms
of heart problems such as dizziness, fatigue, lightheadedness, shortness of breath, if you feel
your heart beating strongly, quickly, irregularly, or if your legs are swollen.
Bleeding problems: Mektovi can cause serious bleeding problems. Tell your doctor
immediately if you experience 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 headache, dizziness or weakness.
Eye problems: Mektovi can cause serious eye problems. Talk to your doctor immediately if you
experience blurred vision, loss of vision or other visual disturbances (for example, colored spots
in your vision), halos (blurred vision of the outline of objects). Your doctor will check your eyes
to check for any vision problems during your Mektovi treatment.
Muscle problems: Mektovi can cause muscle breakdown (rhabdomyolysis). Your doctor will
perform blood tests to check for muscle problems before and during treatment. As a precaution,
drink plenty of fluids during treatment. Talk to your doctor immediately if you experience
muscle pain, cramps, stiffness, spasms, dark urine.
High blood pressure: Mektovi can increase your blood pressure. Your doctor or
nurse will check your blood pressure before and during treatment with Mektovi.
Tell your doctor immediately if you experience severe headache, dizziness, lightheadedness or if
your blood pressure measured with a blood pressure device you have at home is much higher than
normal.
Blood clots: Mektovi can cause blood clots in the arms or legs and if a
clot reaches the lungs it can lead to death. Tell your doctor immediately if you
experience chest pain, sudden shortness of breath, difficulty breathing, leg pain
with or without swelling, swelling in the legs and arms, or pale arm or leg.
If necessary, your doctor may temporarily interrupt or permanently discontinue treatment.
Lung or breathing problems: this medicine can cause lung or
breathing problems, including inflammation of the lungs (pneumonitis or interstitial lung
disease); signs and symptoms may include: cough, shortness of breath or fatigue. If
necessary, your doctor may temporarily interrupt or permanently discontinue treatment.
Skin changes: Mektovi, when taken with encorafenib, can cause other types of
skin cancer such as squamous cell carcinoma. Your doctor will check your
skin before starting treatment, every two months during treatment and up to 6 months
after you have stopped taking the medicine, to look for any new skin cancers. Tell your
doctor immediately if you notice any skin changes during and after treatment, including:
new wart, sore skin, or reddish bump that bleeds or does not heal or a change in the size or
color of a mole.
Your doctor also needs to check for squamous cell carcinoma on the head, neck, mouth and
lymph nodes 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: Mektovi can cause changes in your blood test results for the
liver (increased levels of liver enzymes). Your doctor will perform blood tests to
check your liver before and during treatment.
Contact your doctor immediately if you experience the following symptoms, as it 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 can be caused by the breakdown products of dying tumor cells
(Tumor Lysis Syndrome (TLS) and which can lead to impaired kidney function (see also section 4.
Possible side effects).

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

• Some medicines can affect how Mektovi works or make it more likely that you will experience side effects. In particular, tell your doctor if you are taking any of the medicines listed in this list or any other medicine:
• some medicines for the treatment of bacterial infections, such as rifampicin, ciprofloxacin
• medicines usually used to treat epilepsy such as phenytoin, phenobarbital, carbamazepine
• some medicines for the treatment of HIV such as indinavir, atazanavir
• a medicine used to treat cancer called sorafenib
• a herbal treatment for depression: St John's wort
• a medicine used to treat depression, such as duloxetine
• medicines usually used to treat high cholesterol, such as pravastatin
• a medicine used to treat breathing problems, theophylline PregnancyMektovi is not recommended during pregnancy. It can cause permanent damage or birth defects to the fetus.

If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor
for advice before taking this medicine.
If you are a woman of childbearing potential, you must use an effective method of contraception while
taking Mektovi and must continue to use a method of contraception for at least 1
month after taking the last dose. Contact your doctor immediately if you become pregnant
while taking Mektovi.

Breast-feeding
Mektovi is not recommended during breast-feeding. It is not known whether Mektovi passes into
breast milk. If you are breast-feeding or planning to breast-feed, ask your doctor for advice before
taking this medicine.

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

Mektovi contains lactose
If you have been diagnosed with intolerance to certain sugars, talk to your doctor before
taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
‘sodium-free’.

3. How to take Mektovi

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.
The recommended dose of Mektovi is 45 mg (3 tablets of 15 mg or one 45 mg tablet) twice a day, taken
approximately 12 hours apart, corresponding to a daily dose of 90 mg. You will also be given another
medicine, encorafenib.
If you experience serious side effects (such as problems with your heart, eyes or skin), your doctor may
decide to reduce the dose or stop treatment temporarily or permanently.

How to take Mektovi
Swallow the tablets whole with water. Mektovi can be taken with food or between meals.

In case of vomiting
If you vomit at any time after taking Mektovi, do not take another dose of the medicine. Take the next
dose as scheduled.

If you take more Mektovi than you should
If you take more tablets than you should, contact your doctor, pharmacist immediately.

If you forget to take Mektovi
If you forget to take a dose of Mektovi, take it as soon as you remember. However, if more than 6 hours
have passed, skip that dose and take the next dose at the usual time. Then continue to take the tablets at
regular intervals as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Mektovi
It is important that you continue to take Mektovi for as long as your doctor has prescribed it. Do not stop
taking it unless your doctor tells you to.
If you have any questions about using 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
Mektovi 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: Mektovi 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 like your heart is beating fast, racing or irregularly
• swelling in the legs High blood pressure: Mektovi can increase blood pressure. Tell your doctor immediately if you experience severe headaches, feel dizzy or lightheaded, or if your blood pressure measured with a blood pressure monitor at home is much higher than normal. Blood clots: Mektovi can cause blood clots (venous thromboembolism including pulmonary embolism); signs and symptoms may include:
• chest pain
• sudden shortness of breath or difficulty breathing
• pain in the leg with or without swelling
• swelling in the arms and legs
• if an arm or leg is cold, pale Eye problems: Mektovi can cause fluid to build up under the retina of the eye, leading to detachment of different layers in the eye (retinal pigment epithelium detachment) which may lead to the following symptoms:
• blurred vision, vision loss or other visual changes (such as colored spots in vision)
• vision with a halo (blurred edges of objects)
• pain, swelling or redness of the eyes, Muscle problems :Mektovi 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 Bleeding problems: Mektovi can cause serious bleeding problems. Tell your doctor immediately if you have unusual bleeding or signs of 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 Other skin cancers: when Mektovi is taken with encorafenib, you may develop different types of skin cancer such as squamous cell skin carcinoma. Usually, these skin tumors (see also section 2) are confined to a small area and can be removed with surgery and treatment with Mektovi (and encorafenib) can be continued without interruption. Tumor lysis syndrome: treatment with Mektovi can cause a rapid breakdown of cancer cells which can be fatal in some people. Symptoms may include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, decreased urine production, and fatigue.

Other side effects when Mektovi and encorafenib are taken together
In addition to the serious side effects mentioned above, people taking Mektovi and encorafenib
together may also experience the following side effects.

Verycommon(may affect more than 1 in 10 people)

• decreased red blood cell count (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
• vision problems (impaired vision)
• stomach pain
• diarrhea
• feeling unwell (vomiting)
• feeling sick (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
• abnormal liver function test results
• abnormal creatine kinase test results, indicating damage to the heart and muscle Common(may affect up to 1 in 10 people)
• some types of skin cancer such as skin papilloma
• allergic reaction that may include swelling of the face and difficulty breathing
• changes in taste perception
• inflammation of the eye (uveitis)
• inflammation of the colon (colitis)
• redness, cracking or scaling of the skin
• inflammation of the fat layer under the skin, symptoms include soft lumps on the skin
• rash with a flat discolored area or raised acne-like bumps (acneiform dermatitis)
• redness, peeling of the skin or blisters on the hands and feet (palmo-plantar erythrodysesthesia or hand-foot syndrome)
• kidney problems
• abnormal kidney test results (increased creatinine)
• abnormal liver function test results (alkaline phosphatase)
• abnormal pancreatic function test results (amylase, lipase)
• increased sensitivity of the skin to sunlight Uncommon(may affect up to 1 in 100 people)
• some 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 Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. 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 Mektovi

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 blister and the packaging after
Expiry date/EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water 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 Mektovi contains

• The active ingredient is binimetinib. Mektovi 15 mg film-coated tablets: each film-coated tablet contains 15 mg of binimetinib. Mektovi 45 mg film-coated tablets: each film-coated tablet contains 45 mg of binimetinib.
• The other ingredients are:
• Tablet core: lactose monohydrate, microcrystalline cellulose (E460i), anhydrous colloidal silica (E551), sodium croscarmellose (E468) and magnesium stearate (E470b). See section 2 “Mektovi contains lactose”.
• Tablet film: Mektovi 15 mg film-coated tablets: polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E533b), yellow iron oxide (E172) and black iron oxide (E172). Mektovi 45 mg film-coated tablets: polyvinyl alcohol (E1203), macrogol 4000 (E1521), calcium carbonate (E170), talc (E533b). Description of the appearance of Mektovi and package contentsMektovi 15 mg film-coated tablets The film-coated tablets are film-coated, biconvex, smooth, ovoid tablets, coloured yellow/dark yellow, with “A” imprinted on one side and “15” on the other side.

Mektovi 15 mg film-coated tablets is available in packs of 84 tablets (7 blisters of
12 tablets each) or 168 tablets (14 blisters of 12 tablets each).
Mektovi 45 mg film-coated tablets
The film-coated tablets are film-coated, biconvex, smooth, ovoid tablets, coloured from white to off-white,
with “45” imprinted on one side.
Mektovi 45 mg film-coated tablets is available in packs of 28 tablets (2 blisters of
14 tablets each) or 56 tablets (4 blisters of 14 tablets each).
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 detailed information on this medicine is available on the website of the European
Medicines Agency, https://www.ema.europa.eu.