Koselugo 25 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Koselugo 10 mg hard capsules

Koselugo 25 mg hard capsules

selumetinib

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Koselugo is and what it is used for
2. What you need to know before taking Koselugo
3. How to take Koselugo
4. Possible side effects
5. How to store Koselugo
6. Contents of the pack and other information

1. What Koselugo is and what it is used for

What Koselugo is and how it works

Koselugo contains the active substance selumetinib.

Selumetinib is a type of medicine called a MEK inhibitor. It works by blocking certain proteins involved in the growth of tumour cells.

Koselugo is expected to reduce the size of tumours that grow along the nerves, known as plexiform neurofibromas.

These tumours are caused by a genetic condition called neurofibromatosis type 1 (NF1).

What Koselugo is used for

Koselugo is used to treat children aged 3 years and older who have plexiform neurofibromas that cannot be completely removed by surgery.

If you have any questions about how Koselugo works or why it has been prescribed for you, please consult your doctor.

2. What you need to know before starting to take Koselugo

Do not take Koselugo:

• if you are allergic to selumetinib or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver disease

If you have any doubts, consult your doctor, pharmacist, or nurse before starting to take Koselugo.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before and during treatment with Koselugo:

• if you have eye problems
• if you have heart problems
• if you have liver problems
• if you are taking supplements containing vitamin E
• if you cannot swallow the capsule whole

If any of the situations above apply to you (or if you have any doubts), speak with your doctor, pharmacist, or nurse before taking this medicine.

Eye problems

Koselugo may cause eye problems (see section 4 “Possible side effects”). Tell your doctor immediately if you experience blurred vision or any other changes in vision during treatment. Your doctor should examine your eyes if you develop new or worsening vision problems while taking this medicine.

Heart problems

Koselugo may reduce the amount of blood pumped by the heart (see section 4 “Possible side effects”). Your doctor will check how well your heart is working before and during treatment with Koselugo.

Liver problems

Koselugo may increase the levels of certain liver enzymes in the blood (see section 4 “Possible side effects”). Your doctor will perform blood tests before and during treatment to monitor how well your liver is functioning.

Vitamin E supplements

Koselugo capsules contain vitamin E, which may increase the risk of bleeding. This means you must inform your doctor if you are taking other medicines that increase the risk of bleeding, such as:

• acetylsalicylic acid (also known as aspirin) for pain and inflammation
• anticoagulant medicines like warfarin or other medicines used to prevent blood clots
• supplements that may increase the risk of bleeding, such as vitamin E

Difficulty swallowing capsules

Talk to your doctor if you think you may have difficulty swallowing the capsules whole (see section 3 “How to take Koselugo”).

Skin, nail, and hair problems

Koselugo may cause skin rash, nail infection, hair thinning, or changes in hair color (see section 4 “Possible side effects”). Inform your doctor if any of these symptoms become problematic during treatment.

Children under 3 years of age

Do not give Koselugo to children under 3 years of age. This is because it has not been studied in this age group.

Other medicines and Koselugo

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal medicines, supplements, and over-the-counter medicines.

Koselugo may affect how other medicines work. Likewise, some medicines may affect how Koselugo works. Inform your doctor if you are taking any of the following medicines:

• clarithromycin or erythromycin (used to treat bacterial infections)
• carbamazepine or phenytoin (used to treat seizures and epilepsy)
• digoxin (used to treat heart failure)
• fexofenadine (used to treat allergy symptoms)
• fluconazole or itraconazole (used to treat fungal infections)
• ketoconazole (used to treat Cushing's syndrome)
• furosemide (used to treat fluid retention by increasing urine production)
• methotrexate (used to treat certain types of cancer, psoriasis, or rheumatoid arthritis)
• omeprazole (used to treat acid reflux or stomach ulcers)
• rifampicin (used to treat tuberculosis and certain other bacterial infections)
• St John's wort (Hypericum perforatum), a herbal medicine (used to treat mild depression and other conditions)
• ticlopidine (used to prevent blood clots)

Inform your doctor or pharmacist if you are taking or have recently taken any of the medicines listed above or any other medicines, including those obtained without a prescription.

Taking Koselugo with food and drinks

Do not drink grapefruit juice while taking Koselugo, as it may affect how the medicine works.

Pregnancy – information for women

The use of Koselugo during pregnancy is not recommended. It may harm the unborn baby.

If you are pregnant or planning to become pregnant, consult your doctor before using this medicine. Your doctor may ask you to take a pregnancy test before starting treatment.

You must not become pregnant while taking this medicine. If you can become pregnant, you should use an effective method of contraception. See below “Information on contraception for women and men.”

If you become pregnant during treatment, inform your doctor immediately.

Pregnancy – information for men

If your partner becomes pregnant while you are taking this medicine, inform your doctor immediately.

Information on contraception for women and men

If you are sexually active, you should use an effective method of contraception while taking this medicine and for at least 1 week after the last dose. It is not known whether Koselugo may interfere with the effectiveness of hormonal contraceptives. Inform your doctor if you are using a hormonal contraceptive, as your doctor may recommend adding a non-hormonal contraceptive method.

Breastfeeding

Do not breastfeed while taking Koselugo. It is unknown whether Koselugo passes into breast milk.

Driving and using machines

Koselugo may cause side effects that may affect your ability to drive or operate machinery. Do not drive or operate machinery if you feel tired or if you have vision problems (such as blurred vision).

3. How to take Koselugo

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

Your doctor will calculate the correct dose for you based on your height and weight. Your doctor will tell you how many Koselugo capsules you should take.

Your doctor may prescribe a lower dose if you have liver problems (hepatic impairment).

Your doctor may reduce your dose if you experience certain adverse effects while taking Koselugo (see section 4 “Possible side effects”), or may interrupt or permanently discontinue treatment.

How to take it

• Take Koselugo twice daily approximately 12 hours apart, with or without food.
• Swallow the capsules whole with water.
• Do not chew, crush, or open the capsules.
• If you have or think you may have difficulty swallowing the capsules whole, speak with your doctor before starting treatment.

If you vomit

If you vomit at any time after taking Koselugo, do not take an additional dose. Take the next dose at the usual time.

If you take more Koselugo than you should

If you take more Koselugo than you should, consult your doctor or pharmacist immediately.

If you forget to take Koselugo

What you should do if you miss a dose of Koselugo depends on how long it is until your next scheduled dose.

• If more than 6 hours remain before your next dose, take the missed dose. Then take the next dose at the usual time.
• If less than 6 hours remain before your next dose, skip the missed dose. Take the next dose at the usual time.

Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Koselugo

Do not stop taking Koselugo unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Serious possible adverse effects

Eye problems (vision-related)

Koselugo may cause eye problems. Inform your doctor immediately if you experience blurred vision (a very common adverse effect that may affect more than 1 in 10 people) or any other changes in vision during treatment. Your doctor may ask you to stop taking this medicine or refer you to a specialist if you develop symptoms such as:

• blurred vision
• loss of vision
• dark spots in your vision (floaters)
• other changes in vision (such as reduced vision)

Inform your doctor immediately if you notice any of the serious adverse effects listed above.

Other adverse effects

Inform your doctor or pharmacist if you notice any of the following adverse effects:

Very common (may affect more than 1 in 10 people)

• vomiting, nausea
• diarrhea
• mouth inflammation (stomatitis)
• skin and nail problems; signs may include dry skin, skin rash, and redness around the nails
• hair weakening (alopecia), change in hair color
• feeling tired, weak, or lacking energy
• fever (pyrexia)
• swelling of the hands or feet (peripheral edema)
• slight decrease in the amount of blood pumped by the heart (reduced ejection fraction); signs may include difficulty breathing or swelling in the legs, ankles, or feet
• high blood pressure (hypertension)
• decreased level of albumin, an essential protein in the blood (detected in blood tests)
• decreased hemoglobin, the oxygen-carrying protein in red blood cells (detected in blood tests)
• increased liver enzymes suggesting liver stress, kidney damage, or muscle breakdown (detected in blood tests)

Common (may affect up to 1 in 10 people)

• dry mouth
• facial swelling (facial edema)
• difficulty breathing (dyspnea)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Koselugo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and carton, after "EXP". The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Store in the original bottle to protect from moisture and light.

Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Koselugo

The active substance is selumetinib. Each Koselugo 10 mg hard capsule contains 10 mg of selumetinib (as hydrogen sulfate). Each Koselugo 25 mg hard capsule contains 25 mg of selumetinib (as hydrogen sulfate).

The other components of Koselugo 10 mg hard capsules are:

• capsule fill: vitamin E polyethylene glycol succinate (D‑α‑tocopheryl polyethylene glycol succinate).
• capsule shell: hypromellose (E464), carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), carnauba wax (E903).
• printing ink: shellac glaze (E904), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527).

The other components of Koselugo 25 mg hard capsules are:

• capsule fill: vitamin E polyethylene glycol succinate (D‑α‑tocopheryl polyethylene glycol succinate).
• capsule shell: hypromellose (E464), carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), indigo carmine aluminium lake (E132), yellow iron oxide (E172), carnauba wax (E903), corn starch.
• printing ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax (E903), shellac glaze (E904), glycerol monoleate.

Appearance of the product and contents of the container

The Koselugo 10 mg hard capsule is an opaque, white or off-white hard capsule with a central band, printed with “SEL 10” in black ink.

The Koselugo 25 mg hard capsule is an opaque, blue hard capsule with a central band, printed with “SEL 25” in black ink.

Koselugo is supplied in white plastic bottles closed with a white (10 mg) or blue (25 mg) child-resistant cap, containing 60 hard capsules and a silica gel desiccant. Do not remove the desiccant from the bottle and do not swallow it.

Marketing Authorization Holder

AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer

AstraZeneca AB
Karlebyhusentrén Astraallén
SE-152 57 Södertälje
Sweden

More information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary: 10/2023

This medicinal product has been authorized under a "conditional approval". This type of approval means that further information on this medicinal product is expected.

The European Medicines Agency will review new information on this medicinal product at least once a year, and this summary will be updated as necessary.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu