Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Ezmekly contains the active substance mirdametinib, and is a mitogen‑activated protein kinase (MEK) inhibitor. Ezmekly is used to treat plexiform neurofibromas in adults, adolescents, and children 2 years of age and older with a genetic condition called neurofibromatosis type 1 (NF1). People with NF1 have a mutation (change) in the gene that encodes for the protein neurofibromin. This leads to a loss of this protein, which allows tumours to grow on the nerves in the body. Ezmekly works by blocking certain proteins involved in the growth of these tumour cells, which is expected to shrink them. If you have any questions about how Ezmekly works or why this medicine has been prescribed for you, ask your doctor. 2. What you (or your child) need to know before you take Ezmekly Do not take Ezmekly • If you (or your child) are allergic to mirdametinib or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Ezmekly, or if the following happen to you (or your child) while taking Ezmekly. Your doctor may decide to lower your dose, stop treatment temporarily or permanently: • Eye problems Ezmekly can cause eye problems that can lead to blindness (see section 4 'Possible side effects'). A doctor (eye specialist) will have to check your vision (the vision of your child) before and regularly during treatment. Tell your doctor straight away if you get blurred vision, or any other changes to your vision during treatment. • Heart problems Ezmekly can lower the amount of blood pumped by your heart (see section 4 'Possible side‑effects'). In clinical studies of Ezmekly at the recommended dose, this did not cause any symptoms, however it can make you feel tired. Tell your doctor if you feel tired. Your doctor will check how well your heart works before and during your treatment with Ezmekly. • Skin rash Skin rashes are very common with Ezmekly and can also become severe. Tell your doctor if you get a skin rash which may be bumpy or acne‑like (see section 4 'Possible side effects'). Your doctor may provide guidance for managing your skin rash, including treatment (e.g., cream). • Pregnancy Ezmekly is not recommended during pregnancy. Tell your doctor straight away if you or your partner becomes pregnant while taking this medicine. See 'Pregnancy, breast‑feeding and fertility' section below. Children younger than 2 years of age Do not give Ezmekly to children younger than 2 years old. It has not been studied in this age group. Other medicines and Ezmekly Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines while receiving Ezmekly. Pregnancy, breast‑feeding and fertility Ezmekly is not recommended during pregnancy. It may cause harm to your 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. Your doctor may ask you to take a pregnancy test before starting treatment. You or your partner should not become pregnant while taking this medicine. If you are able to become pregnant, you must use effective contraception (birth control). See 'Contraception ‑ information for women and men' below. If you or your partner become pregnant during treatment, tell your doctor straight away. Contraception – information for women and men If you are a woman who could become pregnant, you should use effective contraception while you are taking this medicine and for 6 months after the last dose. If you are a man whose partner could become pregnant, you should use effective contraception while you are taking this medicine and for 3 months after the last dose. It is not known if Ezmekly reduces how well hormonal contraceptives work. Please tell your doctor if you or your partner are taking a hormonal contraceptive, as your doctor may recommend using a second form of birth control (e.g. condoms).
Breast‑feeding It is not known if Ezmekly passes into breast milk. A risk to the breast‑fed child cannot be excluded. Do not breast‑feed if you are taking Ezmekly and for one week after the last dose of Ezmekly. Fertility (ability to have children) Ezmekly may reduce fertility in men and women. You should discuss this with your doctor before starting treatment. Driving and using machines Ezmekly can cause side effects, including fatigue (feeling tired or weak) and blurred vision (see section 4 'Possible side‑effects'), that may affect your ability to drive or use machines. Do not drive or use machines if you feel tired or if you have problems with your vision (such as blurred vision). Ezmekly contains sodium Each capsule contains less than 23 mg sodium (main component of cooking/table salt), that is to say it is essentially 'sodium‑free'.
• Take Ezmekly by mouth twice a day, about 12 hours apart. You should take this medicine every day for 21 days, and then stop taking it for 7 days. Each 28‑day period is called a treatment cycle. • Take Ezmekly with or without food. • Swallow the capsules whole with water. • Do not chew, break or open the capsules • You can continue taking this medicine in treatment cycles until your disease gets worse or side effects become unacceptable. If you get side effects, your doctor may decide to lower your dose, stop treatment temporarily or permanently (see section 2 'Warnings and precautions'). • Ezmekly is also available as a dispersible tablet. Your doctor will determine the correct formulation for you. If you (or your child) are sick after taking Ezmekly If you are sick (vomit) at any time after taking Ezmekly, do not take an extra dose. Take the next dose at the normal time. If you (or your child) take more Ezmekly than you should If you have taken more Ezmekly than you should, contact your doctor or pharmacist immediately. If you (or your child) forget to take Ezmekly If you forget to take a dose of Ezmekly, skip the missed dose and then take the next dose at the normal time. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you (or your child) stop taking Ezmekly Do not stop taking Ezmekly unless your doctor tells you as it may worsen your condition.
• blurred vision • other changes to your vision (such as reduced vision, coloured dots in your vision) Tell your doctor straight away if you notice any of the serious side effects above. Other side effects Talk to your doctor if you get any of the following side effects. Adults Very common (may affect more than 1 in 10 people):
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor if you experience any side effects. Your doctor may pause treatment with Ezmekly until your symptoms improve and/or they may reduce the dose you receive (see Section 3 "How to take"). Serious side effects Eye problems (common: may affect up to 1 in 10 people) Ezmekly can cause eye problems in adults and children. Some of these eye problems may lead to a blockage of the vein draining to the eye (retinal vein occlusion or detachment of different layers of the eye (retinal pigment epithelial detachment)). Tell your doctor straight away if you get blurred vision or any other changes to your sight during treatment. Your doctor may ask you to stop taking this medicine or send you to a specialist, if you develop symptoms that include:
• skin rash with a flat discoloured area or raised acne‑like bumps (dermatitis acneiform) • diarrhoea • increased blood levels of creatine phosphokinase, an enzyme found mainly in heart, brain and skeletal muscle • feeling sick (nausea) • being sick (vomiting) • pain in muscles or bone • feeling tired, weak or lacking energy (fatigue) • stomach (abdominal) pain • constipation • rash • headache • increased levels of liver enzymes, as shown in blood tests • swelling of the hands or feet (oedema peripheral) • a decrease in the amount of blood that the heart is pumping (decreased left ventricular ejection fraction) • dry skin • itching • hair loss or thinning (alopecia) Common (may affect up to 1 in 10 people):
• decreased blood levels of neutrophils and leukocytes (types of white blood cells that help fight infections) • mouth sores (stomatitis) • dry mouth • infection around the nails (paronychia) • dry or itchy skin rash (eczema) • changes in hair color
• changes in hair texture Paediatrics Very common (may affect more than 1 in 10 people):
• changes in hair texture • swelling of the hands or feet (oedema peripheral) 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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App Store.
• increased blood levels of creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle • diarrhoea • skin rash with a flat discoloured area or raised acne‑like bumps (dermatitis acneiform) • pain in muscles or bone • stomach (abdominal) pain • feeling sick (nausea) • being sick (vomiting) • a decrease in the amount of blood that the heart is pumping (decreased ejection fraction) • headache • rash • infection around the nails (paronychia) • decreased blood levels of neutrophils and leukocytes (types of white blood cells that help fight infections) • mouth sores (stomatitis) • increased levels of liver enzymes as shown in blood tests • dry skin • hair loss or thinning (alopecia) • dry or itchy skin rash (eczema) • itching • changes in hair color • feeling tired, weak or lacking energy (fatigue) • constipation Common (may affect up to 1 in 10 people):
Marketing Authorisation Holder Merck Serono Ltd 5 New Square Bedfont Lakes Business Park Feltham Middlesex TW14 8HA UK an affiliate of Merck KGaA, Darmstadt, Germany. Manufacturer Mias Pharma Limited Suite 1 First Floor, Stafford House Strand Road, Portmarnock, D13 WC83 Ireland Patheon France 40 Boulevard De Champaret 38300 Bourgoin Jallieu France This leaftlet was last revised in 08/2026 This medicine has been given 'conditional approval'. This means that there is more evidence to come about this medicine. The Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Ezmekly 2 mg hard capsules comes as capsule containing 2 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Ezmekly 2 mg hard capsules is mirdametinib.
This leaflet reproduces the patient information leaflet approved for Ezmekly 2 mg hard capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.
Treatment with Ezmekly should be initiated by a physician experienced in the diagnosis and the treatment of patients with NF1 related tumours.
Posology
The recommended dose of Ezmekly is 2 mg/m2 of body surface area (BSA), twice daily (approximately every 12 hours) for the first 21 days of each 28‑day cycle. The maximum dose is 4 mg twice daily (see Table 1).
For paediatric patients 2 to <6 years of age and for patients who are unable to swallow capsules whole, Ezmekly is also available as a 1 mg dispersible tablet formulation that can be dispersed in water. The recommended dose for patients with a BSA less than 0.40 m2 has not been established.
Table 1: Recommended dose based on body surface area
| Body surface area (BSA) | Recommended dose |
| 0.40 to 0.69 m2 | 1 mg twice daily |
| 0.70 to 1.04 m2 | 2 mg twice daily |
| 1.05 to 1.49 m2 | 3 mg twice daily |
| ≥ 1.50 m2 | 4 mg twice daily |
Duration of treatment
Treatment with Ezmekly should continue until PN progression or the development of unacceptable toxicity.
Missed dose
If a dose of Ezmekly is missed, an additional dose is not to be taken. The patient should continue with the next scheduled dose.
Vomiting
If vomiting occurs after Ezmekly is administered, an additional dose is not to be taken. The patient should continue with the next scheduled dose. Manage events of vomiting as clinically indicated, including use of anti‑emetics.
Dose adjustments
Interruption and/or dose reduction or permanent discontinuation of Ezmekly may be required based on individual safety and tolerability (see Sections 4.4 and 4.8). Recommended dose reductions are given in Table 2. Permanently discontinue treatment in patients unable to tolerate Ezmekly after one dose reduction.
Table 2: Recommended dose reductions
| Body surface area (BSA) | Reduced dose | |
| Morning | Evening | |
| 0.40 to 0.69 m2 | 1 mg once daily | |
| 0.70 to 1.04 m2 | 2 mg | 1 mg |
| 1.05 to 1.49 m2 | 2 mg | 2 mg |
| ≥ 1.50 m2 | 3 mg | 3 mg |
Management of patients according to the adverse reactions associated with this medicinal product are presented in Table 3.
Table 3: Recommended dose modifications for adverse reactions
| Severity of adverse reactiona | Recommended dose modification for Ezmekly |
| Ocular toxicity (see Sections 4.4 and 4.8) | |
| Grade ≤ 2 | Continue treatment. Consider ophthalmologic examinations every 2 to 4 weeks until improvement. |
| Grade ≥ 3 | Interrupt treatment until improvement. If recovery occurs ≤14 days, resume at reduced dose (see Table 2). If recovery occurs in >14 days, consider discontinuation. |
| Asymptomatic retinal pigment epithelium detachment (RPED) | Continue treatment. Ophthalmic assessment should be conducted every 3 weeks until resolution. |
| Symptomatic RPED | Interrupt treatment until resolution. Resume at reduced dose (see Table 2). |
| Retinal vein occlusion (RVO) | Discontinue treatment permanently. |
| Decreased left ventricular ejection fraction (LVEF) (see Sections 4.4 and 4.8) | |
| Asymptomatic, absolute decrease in LVEF less than 20% from baseline and is greater than the lower limit of normal | Continue treatment. |
| Asymptomatic, absolute decrease in LVEF of 10 % or greater from baseline and is less than the lower limit of normal. | Interrupt treatment until improvement. Resume at reduced dose (see Table 2). |
| For any absolute decrease in LVEF 20 % or greater from baseline. | Discontinue treatment permanently. |
| Skin toxicity (see Section 4.4 and 4.7) | |
| Grade 1 or 2 dermatitis acneiform or non‑acneiform rash | Continue treatment. |
| Intolerable Grade 2 or Grade 3 dermatitis acneiform or non‑acneiform rash | Interrupt treatment until improvement. Resume at reduced dose (see Table 2). |
| Grade 3 or Grade 4 dermatitis acneiform or non‑acneiform rash | Interrupt treatment until improvement. Resume at reduced dose (see Table 2). |
| Other adverse reactions (see Section 4.8) | |
| Intolerable Grade 2 or Grade 3 | Interrupt treatment until improvement. Resume at reduced dose (see Table 2). |
| Grade 4 | Interrupt treatment until improvement. Resume at reduced dose (see Table 2). Consider discontinuation. |
a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Special populations
Elderly
No dose adjustment is recommended for patients who are aged 65 or over. Clinical data in patients aged 65 or over is limited (see Section 5.1).
Renal impairment
No dose adjustment is recommended in patients with mild or moderate renal impairment based on a population pharmacokinetic analysis. Ezmekly has not been studied in patients with severe renal impairment (CrCL ≥ 15 to < 30 mL/min) or patients with end stage renal disease (ESRD), and therefore, no dose recommendations can be made (see Section 5.2).
Hepatic impairment
No dose adjustment is recommended in patients with mild hepatic impairment (total bilirubin > ULN to 1.5 x ULN or total bilirubin ≤ ULN and AST > ULN), based on a population pharmacokinetic analysis. Ezmekly has not been studied in patients with moderate or severe hepatic impairment, and therefore, no dose recommendation can be made (see Section 5.2).
Paediatric population
The safety and efficacy of Ezmekly in children below 2 years of age have not been established.
No data are available.
Method of administration
Ezmekly is for oral use.
The capsules can be taken with or without food (see Section 5.2).
Ezmekly capsules should be swallowed whole with drinking water. The capsules should not be chewed, broken or opened to ensure the full dose is administered.
For paediatric patients 2 to <6 years of age and for patients who are unable to swallow whole capsules, Ezmekly is also available as a 1 mg dispersible tablet formulation that can be dispersed in water. Refer to the SmPC for Ezmekly dispersible tablets for method of administration.
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
No clinical interaction studies have been performed (see Section 5.2).
Effects of other medicinal products on mirdametinib pharmacokinetics
In vitro studies showed that mirdametinib is metabolised by multiple uridine diphosphate glucuronosyltransferase (UGT) and carboxyl esterase (CES) enzymes. No clinical studies assessing the effect of a strong inducer and inhibitor of these enzymes have been performed. Therefore, caution should be made when mirdametinib is concomitantly used with medicinal products known to either induce or inhibit these enzymes: probenecid, diclofenac (UGTs inhibitors), rifampicin (UGT inducer) (see Section 5.2).
Effects of mirdametinib on the pharmacokinetics of other medicinal products
Hormonal contraceptives
The effect of mirdametinib on the exposure of systemically acting hormonal contraceptives has not been evaluated. Therefore, use of an additional barrier method should be recommended to women using systemically acting hormonal contraceptives (see Section 4.6).
Effects of gastric acid reducing agents on mirdametinib
The combination of mirdametinib with proton‑pump inhibitors, antacids, or H2‑receptor antagonists is not expected to be clinically meaningful as mirdametinib does not exhibit pH dependent dissolution. Ezmekly can be used concomitantly with gastric pH modifying agents (i.e., H2‑receptor antagonists and proton pump inhibitors) without restrictions.
Women of childbearing potential/Contraception in females and males
Women of childbearing potential should be advised that Ezmekly may cause foetal harm and to avoid becoming pregnant while receiving Ezmekly. It is recommended that a pregnancy test should be performed on women of childbearing potential prior to initiating treatment. Both female and male patients (of reproductive potential) should be advised to use effective contraception during treatment and for 6 months and 3 months, respectively, after the last dose. The effect of mirdametinib on the exposure of systemically acting hormonal contraceptives has not been evaluated, therefore women using systemically acting hormonal contraceptives should be recommended to add a barrier method.
Pregnancy
There are limited data on the use of mirdametinib in pregnant women. Studies in animals have shown reproductive toxicity (see Section 5.3). Ezmekly should not be used during pregnancy and in women of childbearing potential not using contraception. If a female patient or a female partner of a male patient receiving Ezmekly becomes pregnant, she should be apprised of the potential risk to the foetus.
Breast‑feeding
It is not known whether mirdametinib or its metabolites are excreted in human milk. A risk to the breast‑fed child cannot be excluded, therefore breast‑feeding should be discontinued during treatment with Ezmekly and should not be resumed for 1 week after the last dose.
Fertility
Based on findings in animals, Ezmekly may impair fertility in males and females of reproductive potential. The reversibility of the effects on male and female reproductive organs in animals is unknown (see Section 5.3). There are no data on the effect of mirdametinib on human fertility. The potential risk for humans is unknown.
Ezmekly may have a moderate influence on the ability to drive and use machines. Fatigue and blurred vision have been reported during treatment with mirdametinib (see Section 4.8). Patients who experience these symptoms should observe caution when driving or using machines.
There is no specific treatment for overdose. If overdose occurs, patients should be closely monitored for signs and symptoms of adverse reactions and treated supportively with appropriate monitoring as necessary. Dialysis is ineffective in the treatment of overdose.
Ask anything about Ezmekly 2 mg hard capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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