Prospect: information for the patient

Koselugo 10 mg hard capsules

Koselugo 25 mg hard capsules

selumetinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects that do not appear in this prospect. See section 4.

What is Koselugo and how it works

Koselugo contains the active ingredient selumetinib.

Selumetinib is a type of medication called a MEK inhibitor. It acts by blocking certain proteins that are involved in the growth of cancer cells.

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

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

What is Koselugo used for

Koselugo is used to treat children aged 3 years and older 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 medication, consult your doctor.

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 a severe liver disease

If you are unsure, consult your doctor, pharmacist or nurse before starting to take Koselugo.

Warnings and precautions

Consult 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 entire capsule

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

Eye problems

Koselugo may cause eye problems (see section 4 “Possible side effects”). Inform your doctor immediately if you experience blurred vision or any other change in 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 functioning 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 take blood tests before and during treatment to check how your liver is functioning.

Vitamin E supplements

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

• aspirin for pain and inflammation
• anticoagulant medicines like warfarin or other medicines used to prevent blood clotting
• supplements that may increase the risk of bleeding, such as vitamin E

Difficulty swallowing capsules

Speak with your doctor if you think you may have difficulty swallowing the entire capsule (see section 3 “How to take Koselugo”).

Skin, nail and hair problems

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

Children under 3 years

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

Other medicines and Koselugo

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes medicines based on plants, supplements and medicines obtained without a prescription.

Koselugo may affect the mechanism of action of other medicines. There are also some medicines that may affect the mechanism of action of Koselugo. Inform your doctor if you are taking any of these 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 other bacterial infections)
• St. John's Wort (Hypericum perforatum), a plant-based medicine (used to treat mild depression and other conditions)
• ticlopidine (used to prevent blood clotting)

Inform your doctor or pharmacist if you are taking or have taken recently any of the above medicines or any other medicine, 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

Do not use Koselugo during pregnancy. It may cause harm to the fetus.

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

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

Breastfeeding

Do not breastfeed 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).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Amount 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 you should take.

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

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

How to Take It

• Take Koselugo twice a day with a 12-hour interval, with or without food.
• Swallow the capsules whole with water.
• Do not chew, dissolve, or open the capsules.
• If you have or think you may have difficulty swallowing the capsules whole, talk to your doctor before starting treatment.

If You Have Vomiting

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 to do if you forget to take a dose of Koselugo depends on the time until the next dose.

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

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

If You Interrupt Treatment with Koselugo

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

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Eye problems (vision)

Koselugo can cause eye problems. Inform your doctor immediately if you experience blurry vision (a very common side effect that can affect more than 1 in 10 people) or any other change in 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:

• Blurry 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 severe side effects mentioned above.

Other side effects

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

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

• Vomiting, nausea
• Diarrhea
• Swollen mouth (stomatitis)
• Skin and nail problems; signs may include dry skin, skin rash, and redness around the nails
• Hair loss (alopecia), change in hair color
• 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 (decreased ejection fraction); signs may include difficulty breathing or swelling in the legs, ankles, or feet
• High blood pressure (hypertension)
• Decreased albumin levels, an essential protein in the blood (detected in blood tests)
• Decreased hemoglobin levels, the protein that carries oxygen in red blood cells (detected in blood tests)
• Increased enzymes that suggest liver stress, kidney damage, or muscle degradation (detected in blood tests)

Common (can affect up to 1 in 10 people)

• Dry mouth
• Swelling of the face (facial edema)
• Difficulty breathing (dyspnea)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the bottle and the box, after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

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

Keep the bottle perfectly closed.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Koselugo

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 components of Koselugo 10 mg hard capsules are:

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

The other components of Koselugo 25 mg hard capsules are:

• filling of the capsule: vitamin E polyethylene glycol succinate (D-α-tocopheryl polyethylene glycol succinate).
• coating of the capsule: hydroxypropylmethylcellulose (E464), carrageenan (E407), potassium chloride (E508), diiron trioxide (E171), aluminium lake of indigotin (E132), iron oxide yellow (E172), carnauba wax (E903), maize starch.
• printing ink: iron oxide red (E172), iron oxide yellow (E172), aluminium lake of indigotin (E132), carnauba wax (E903), standard shellac (E904), mono- and diglycerides of fatty acids.

Appearance of the product and contents of the pack

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

The hard capsule of Koselugo 25 mg 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 white cap (10 mg) or blue cap (25 mg), containing 60 hard capsules and a silica gel desiccant. Do not remove the desiccant from the bottle and do not swallow it.

Marketing authorisation holder

AstraZeneca AB

SE-15185 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Karlebyhusentrén Astraallén

SE-15257 Södertälje

Sweden

For further information about this medicinal product, please contact the representative of the marketing authorisation holder in your country:

Last update of this leaflet:10/2023

This medicinal product has been approved under a conditional approval. This type of approval means that more information is expected to be obtained about this medicinal product.

The European Medicines Agency will review the new information about this medicinal product at least once a year and this leaflet will be updated as necessary.

Other sources of information

Further information about this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu