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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD.
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The product code(s) for this leaflet is: PLGB 00603/0244.
Mektovi 15 mg film-coated tablets
Mektovi 15 mg film-coated tablets
binimetinib
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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
Mektovi is an anti-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
Mutations in the BRAF gene can produce proteins that cause the melanoma to grow. Mektovi targets another protein called “MEK” that stimulates cancer cell growth. When Mektovi is used in combination with encorafenib (which targets the changed “BRAF” protein), the combination slows down or stops the growth of your cancer.
Before starting treatment your doctor will check for BRAF mutation.
As Mektovi is to be used in combination with encorafenib, read the encorafenib leaflet carefully as well as this leaflet.
Talk to your doctor, pharmacist or nurse before taking Mektovi about all of your medical conditions, particularly if you have any of the following:
Tell your doctor if you have ever had blockage in the vein carrying blood away from the eye (retinal vein occlusion), as Mektovi is not recommended in such cases.
Tell your doctor if you have had a different type of cancer than melanoma, as binimetinib when taken with encorafenib may worsen certain other types of cancers.
Tell your doctor, pharmacist or nurse immediately if you get the following while you are taking this medicine:
Mektovi is not recommended for children and adolescents under 18 years of age. This medicine has not been studied in this age group.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Some medicines may affect how Mektovi works, or make it more likely that you will have side effects. In particular, tell your doctor if you are taking anything in this list or any other medicines:
Pregnancy
Mektovi is not recommended during pregnancy. It may cause permanent harm or birth defects to an unborn baby.
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 who could become pregnant, you must use reliable contraception while you are taking Mektovi, and you must continue to use reliable contraception at least 1 month after taking your last dose. Contact your doctor straightaway if you become pregnant while taking Mektovi.
Breast-feeding
Mektovi is not recommended while breast-feeding. It is not known if Mektovi passes into breast milk. If you are breast-feeding, or planning to breast-feed, ask your doctor for advice before taking this medicine.
Mektovi can affect your ability to drive or use machines. Avoid driving or using machines if you have any problems with your vision or have any other side effects that can affect your ability to drive or use machines (see section 4), while taking Mektovi. Talk to your doctor if you are not sure you can drive.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Mektovi is 45 mg (3 tablets of 15 mg) twice daily, taken about 12 hours apart (corresponding to a daily dose of 90 mg). You will also receive treatment with another medicine, encorafenib.
If you get serious side effects (such as heart, eye or skin problems) your doctor may lower the dose or stop treatment temporarily or permanently.
Swallow the tablets whole with water. Mektovi can be taken with food or between meals.
If you vomit at any time after taking Mektovi, do not take an additional dose. Take the next dose as scheduled.
If you take more tablets than you should, contact your doctor, pharmacist or nurse straightaway. If possible, show them this leaflet and the medicine package.
If you miss a dose of Mektovi, take it as soon as you remember. However, if the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time. Then continue taking your tablets at regular times as usual.
Do not take a double dose to make up for a forgotten dose.
It is important to 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 medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Mektovi may cause serious side effects. Tell your doctor immediately if you have 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 works (left ventricular ejection fraction decrease); signs and symptoms can include:
High blood pressure: Mektovi can increase blood pressure. Tell your doctor immediately if you get severe headache, feel dizzy or lightheaded or if your blood pressure measured on a home blood pressure device is much higher than usual.
Blood clots: Mektovi may cause blood clots (venous thromboembolism including pulmonary embolism); signs and symptoms can include:
Eye problems: Mektovi can cause fluid to leak under the retina in the eye, leading to detachment of different layers in the eye (retinal pigment epithelial detachment) which could lead to:
Muscle problems: Mektovi can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include:
Bleeding problems: Mektovi can cause serious bleeding problems. Tell your doctor right away if you have any unusual bleeding or signs of bleeding, including:
Other skin cancers: When Mektovi is taken with encorafenib, the patient may develop different types of skin cancer such as cutaneous squamous cell carcinoma. Usually, these skin cancers (see also section 2) are confined to a small area and can be removed with surgery and treatment with Mektovi (and encorafenib) can continue without interruption.
Besides the serious side effects mentioned above, people taking Mektovi and encorafenib together may also get the following side effects.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
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 via United Kingdom: Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine.
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 carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Mektovi film-coated tablets are yellow/dark yellow, unscored biconvex, oval film-coated tablets debossed with “A” on one side and “15” on the other side.
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.
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This leaflet was last revised in August 2019.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.