15 mg film-coated tablets
binimetinib

What Mektovi is and what it is used for

Mektovi is a cancer medicine that contains the active substance binimetinib. It is used in adults in combination with another medicine containing encorafenib to treat 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.

Mutations in the BRAF gene can give rise to proteins that cause melanoma to grow. Mektovi targets another protein, “MEK”, which stimulates the growth of cancer cells. When Mektovi is used in combination with encorafenib (which targets the altered “BRAF” protein ), the combination slows the growth of cancer or stops it completely.

What you need to know before taking Mektovi

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

Because Mektovi is to be used in combination with encorafenib, you should read both the encorafenib package leaflet and this leaflet carefully.

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 cautions

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

  • heart problems
  • bleeding problems or if you are taking any medicine that may cause bleeding
  • eye problems, such as glaucoma ( glaucoma ) or increased pressure in the eye
  • muscle problem
  • high blood pressure
  • blood clots
  • problems with the lungs or breathing
  • liver problem.

Tell your doctor if you have ever had a blood clot in the vein that carries blood away from the eye (retinal vein occlusion), as Mektovi is not recommended in such cases.

Tell your doctor if you have had any other type of cancer other than melanoma, as binimethinib taken with encorafenib 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: Mektovi can make your heart work worse or aggravate pre-existing heart problems. Your doctor will check that your heart is functioning properly before and during treatment with this medicine. 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: Mectovia 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: Mektovi can cause serious eye problems. 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 while you are taking Mektovi.
  • Muscle problems: Mectovia can cause muscle breakdown ( rhabdomyolysis ). Your doctor will take blood samples to check for any muscle problems before and during treatment. As a precaution, you should drink plenty of fluids during treatment. Tell your doctor immediately if you experience muscle pain, cramps, stiffness, seizures or dark urine.
  • High blood pressure: Mektovi may increase blood pressure . Your doctor or nurse will check your blood pressure before and during treatment with Mektovi. Tell your doctor immediately if you have a severe headache, feel dizzy or dizzy or if your blood pressure is much higher than usual when measured with a blood pressure monitor at home.
  • Blood clots: Mektovi can cause blood clots in the arms or legs and if a clot passes to the lungs, it can be life-threatening. Tell your doctor immediately if you experience chest pain, sudden shortness of breath, difficulty breathing, pain in your legs with or without swelling, swollen arms and legs or if an arm or leg becomes cold and pale. If necessary, your doctor may interrupt your treatment or discontinue it altogether.
  • Lung or breathing problems: This medicine may cause lung or breathing problems such as inflammation of the lungs ( pneumonia or interstitial lung disease). Signs and symptoms of this can be: cough, shortness of breath or fatigue. If necessary, your doctor may interrupt your treatment or discontinue it altogether.
  • Skin changes: Mektovi, when taken with encorafenib, can cause other types of skin cancer such as squamous cell carcinoma of the skin. Your doctor will examine your skin before starting treatment, every two months during treatment and for up to 6 months after you stop taking these medicines, to make sure you have not developed any new skin cancer. 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 not healing 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 with computed tomography at regular intervals. 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 starting treatment and when it ends.
  • Liver problems: Mektovi 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.

Children and young people

Mektovi 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 Mektovi

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 Mektovi works or increase the likelihood of side effects. You must tell your doctor if you are taking any medicine on this list or any other medicine:

  • Some medicines used to treat bacterial infections e.g. rifampicin, ciprofloxacin
  • Some drugs that are normally used to treat epilepsy e.g. phenobarbital, phenytoin , carbamazepine
  • Some drugs used to treat HIV e.g. indinavir, atazanavir
  • A drug used to treat cancer, sorafenib
  • (Traditional) herbal medicines for depression: St. John’s wort
  • Drugs used to treat depression e.g. duloxetine
  • Drugs commonly used to treat high cholesterol (eg pravastatin)
  • A drug used to treat respiratory problems, theophylline.

Pregnancy and breastfeeding

Pregnancy

Mektovi is not recommended during pregnancy. It can cause permanent damage or malformations to 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 Mektovi, and you must continue to use a reliable contraceptive for at least one month after the last dose. Contact your doctor immediately if you become pregnant while taking Mektovi.

Breast-feeding

Mektovi is not recommended during breastfeeding. It is unknown whether Mektovi is excreted in human milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice before taking this medicine.

Driving and using machines

Mektovi may affect your ability to drive or use machines. Avoid driving or using machines if you experience vision problems or any other side effects that may affect your ability to drive or use machines while taking Mektovi. Talk to your doctor if you are unsure if you can drive.

Mektovi contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Mektovi

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.

The recommended dose of Mektovi is 45 mg (3 tablets of 15 mg) taken twice daily at approximately 12-hour intervals (equivalent to a daily dose of 90 mg). You will also be treated with another medicine, encorafenib.

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

How to take Mektovi

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

If you vomit

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

If you take more Mektovi than you should

If you have taken too many tablets, contact your doctor, pharmacist, or nurse immediately. If possible, show them this leaflet and the tablet pack.

If you forget to take Mektovi

If you forget to take a dose of Mektovi, take it as soon as you remember. However, if the missed dose one should have been taken more than 6 hours ago, skip the one dose and take the next dose at the usual time. Then continue to take your tablets as usual.

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

If you stop taking Mektovi

You must take Mektovi 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.

Possible side effects

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

Serious side effects are

Mektovi 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: Mektovi can affect how well your heart is functioning (reducing the ejection fraction of the left ventricle ). Signs and symptoms of this can be:

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

High blood pressure: Mektovi may increase blood pressure. Tell your doctor immediately if you have a severe headache, feel dizzy or dizzy, or if your blood pressure is much higher than usual when measured with a blood pressure monitor at home.

Blood clots: Mectovia can cause blood clots (venous thromboembolism and pulmonary embolism ). Signs and symptoms can be:

  • chest pain
  • sudden shortness of breath or difficulty breathing
  • pain in the legs with or without swelling
  • swollen arms and legs
  • an arm or leg becomes cold and pale.

Eye problems: Mectovia can cause fluid leakage under the retina of the eye leading to detachment of various layers of the eye (retinal detachment), which can lead to:

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

Muscle problems: Mectovia can cause muscle breakdown ( rhabdomyolysis ), which can lead to kidney failure and can be life-threatening. Signs and symptoms can be:

  • muscle aches, cramps , stiffness or spasms
  • dark-colored urine.

Bleeding problems: Mectovia can cause serious bleeding problems. Tell your doctor immediately if you experience any unusual bleeding or 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

Other types of skin cancer: When Mektovi is taken with encorafenib, the patient may develop different types of skin cancer, such as squamous cell carcinoma of the skin. These types of skin cancer (see also section 2) are usually limited to a small area and can be removed by surgery. Treatment with Mektovi (and encorafenib) can be continued without interruption.

Other side effects are 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.

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
  • 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
  • back pain
  • pain in the extremity er
  • 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, which indicate damage to the heart and muscles.

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 )
  • 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 test result on kidney tests (elevated creatinine )
  • abnormal test results on blood tests for liver function (alkaline phosphatase)
  • 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 ) that causes severe abdominal pain.

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 carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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.

Contents of the pack and other information

Content declaration

  • The active substance is binimethinib. One film-coated tablet contains 15 mg binimetinib.
  • Other ingredients are:
    • Tablet core: lactose monohydrate , microcrystalline cellulose (E460i), colloidal anhydrous silica (E551), croscarmellose sodium (E468) and magnesium stearate (E470b). See section 2 “Mektovi contains lactose”.
    • Film coating: polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E533b), yellow iron oxide (E172) and black iron oxide (E172).

What the medicine looks like and contents of the pack

Mektovi film-coated tablets are yellow to dark yellow, biconvex, oval, and film-coated tablets without a notch, with “A” imprinted on one side and “15” on the other.

Mektovi is available in packs of 84 tablets (7 blisters of 12 tablets each) or 168 tablets (14 blisters of 12 tablets 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

Muhammad Nadeem

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