KOSELUGO 25 mg HARD CAPSULES

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 for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet contains information on how to report side effects.

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Koselugo and what is it used for

What is Koselugo and how does it work

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 tumor cells.

Koselugo is expected to reduce the size of tumors that grow along the nerves, called plexiform neurofibromas.

These tumors are caused by a genetic disorder called neurofibromatosis type 1 (NF1).

What is Koselugo used for

Koselugo is used to treat children from 3 years of age with plexiform neurofibromas that cannot be completely removed by surgery.

If you have any questions about how Koselugo works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Koselugo

Do not take Koselugo:

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

If you are unsure, consult your doctor, pharmacist, or nurse before taking 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 take supplements containing vitamin E
• if you have difficulty swallowing the capsule whole

If any of the above applies to you (or if you are unsure), talk to 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 immediatelyif you experience blurred vision or any other changes in your vision during treatment. Your doctor should examine your eyes if you have 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 your heart is working before and during treatment with Koselugo.

Liver problems

Koselugo may increase the level of certain liver enzymes in the blood (see section 4 “Possible side effects”). Your doctor will do blood tests before and during treatment to check how your liver is working.

Vitamin E supplements

Koselugo capsules contain vitamin E, which may increase the risk of bleeding. This means you should tell your doctor if you take other medicines that increase the risk of bleeding, such as:

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

Difficulty swallowing the 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 loss, or changes in hair color (see section 4 “Possible side effects”). Tell your doctor if you experience any of these symptoms during treatment.

Children under 3 years

Do not give Koselugo to children under 3 years. 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 take any other medicines, including those obtained without a prescription. This includes herbal medicines, supplements, and medicines bought without a prescription.

Koselugo may affect how other medicines work. Also, some medicines may affect how Koselugo works. Tell 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 some 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)

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

Taking Koselugo with food and drink

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

Pregnancy – information for women

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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor may ask you to have a pregnancy test before starting treatment.

Do not become pregnant while taking this medicine. If you can become pregnant, you must use effective contraception. See below “Contraception information for women and men”.

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

Pregnancy – information for men

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

Contraception information for women and men

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

Breast-feeding

Do not breast-feed while taking Koselugo. It is not known if Koselugo passes into breast milk.

Driving and using machines

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

3. How to take Koselugo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, check with your doctor or pharmacist.

How much to take

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

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

Your doctor may reduce your dose if you have certain side effects while taking Koselugo (see section 4 “Possible side effects”) or the doctor may stop treatment or discontinue it permanently.

How to take it

• Take Koselugo twice a day, 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 difficulty swallowing the capsules whole, talk to 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, talk to your doctor or pharmacist immediately.

If you forget to take Koselugo

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

• If it is more than 6 hours until your next dose, take the missed dose. Then, take the next dose at the usual time.
• If it is less than 6 hours until 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 missed doses.

If you stop taking Koselugo

Do not stop taking Koselugo unless your doctor tells you to.

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

4. Possible side effects

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

Serious side effects

Eye problems (vision problems)

Koselugo may cause eye problems. Tell your doctor immediatelyif you experience blurred vision or any other changes in your vision during treatment. Your doctor may ask you to stop taking this medicine or refer you to a specialist if you experience symptoms such as:

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

Tell your doctor immediately if you notice any of the above serious side effects.

Other side effects

Tell your doctor or pharmacist if you notice any of the following side 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 loss (alopecia), hair color changes
• feeling tired, weak, or lacking energy
• fever (pyrexia)
• swelling of the hands or feet (peripheral edema)
• mild 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)
• decrease in the level of albumin, an essential protein in the blood (detected in blood tests)
• decrease in hemoglobin, the oxygen-carrying protein in red blood cells (detected in blood tests)
• increase in enzymes that suggest 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side 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 which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package 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 medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Koselugo composition

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

The other ingredients of Koselugo 10 mg hard capsules are:

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

The other ingredients of Koselugo 25 mg hard capsules are:

• capsule filling: vitamin E polyethylene glycol succinate (D-α-tocopherol polyethylene glycol succinate).
• capsule shell: hydroxypropylmethylcellulose (E464), carrageenan (E407), potassium chloride (E508), titanium dioxide (E171), aluminum lake of indigo carmine (E132), yellow iron oxide (E172), carnauba wax (E903), corn starch.
• printing ink: red iron oxide (E172), yellow iron oxide (E172), aluminum lake of indigo carmine (E132), carnauba wax (E903), standard shellac (E904), glycerol monooleate.

Product appearance and container contents

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

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

Koselugo is supplied in white plastic bottles, closed with a child-resistant closure of white (10 mg) or blue (25 mg) color, 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:10/2023

This medicinal product has been authorized with a “conditional approval”. This type of approval means that more information is expected to be obtained for this medicinal product.

The European Medicines Agency will review the new information for this medicinal product at least once a year and this leaflet 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