10 mg and 20 mg hard capsules
selumetinib

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 MEK inhibitor. It works by blocking certain proteins that are involved in the growth of tumor cells.

Koselugo is expected to shrink tumors that grow along nerves and are called plexiform neurofibromas.

These tumors are caused by an inherited 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 with surgery.

Talk to your doctor if you have any questions about how Koselugo works or why you have been prescribed this medicine.

What you need to know before using 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 not sure, talk to your doctor, pharmacist, or nurse before taking Koselugo.

Warnings and cautions

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

  • if you have eye problems
  • if you have heart problems
  • if you have liver problems
  • if you are taking supplements that contain vitamin E.
  • if you can not swallow the capsule whole

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking this medicine.

Eye problems

Koselugo may cause eye problems (see section 4 “Possible side effects”). Contact a doctor immediately if you get blurred vision (blurred vision) or any other vision change during treatment. Your doctor should examine your eyes to see if you have any new or worsening vision problems while taking this medicine.

Heart problems

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

Liver problem

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

Vitamin E supplement

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

  • acetylsalicylic acid (for pain and inflammation )
  • anticoagulants (blood thinners) such as warfarin and other medicines used to prevent blood clots
  • supplements that can increase your 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”).

Problems with skin, nails, and hair

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

Children under 3 years

Do not give Koselugo to children under 3 years of age, as the drug 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. This also includes (traditional) herbal and herbal medicines, dietary supplements, and over-the-counter medicines.

Koselugo may affect the way some medicines work. Some other medicines may also affect the way 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 allergic symptoms)
  • fluconazole or itraconazole (used to treat fungal infections)
  • ketoconazole (used to treat Cushing’s syndrome)
  • furosemide (used to treat fluid retention in the body by increasing the amount of urine excreted)
  • methotrexate (used to treat certain types of cancerpsoriasis or rheumatoid arthritis )
  • omeprazole (used to treat acid reflux or stomach ulcers )
  • rifampicin (used to treat tuberculosis (TB) and certain other bacterial infections)
  • St. John’s wort ( Hypericum perforatum ), a (traditional) 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 or any other medicines, including medicines obtained without a prescription.

Koselugo with food and drink

Do not drink grapefruit juice when you are being treated with Koselugo, as this may affect the way the medicine works.

Pregnancy, breastfeeding and fertility

Pregnancy – information for women

Koselugo is not recommended during pregnancy. It can harm an unborn baby.

If you 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 should not get pregnant while taking this medicine. If you can get pregnant, you must use safe contraception. See “Contraceptives – information for women and men” below.

Tell your doctor immediately if you become pregnant during treatment.

Pregnancy – information for men

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

Contraceptives – information for women and men

If you are sexually active, use safe contraception while taking this medicine and for at least 1 week after taking the last dose. It is not known if Koselugo can affect how well hormonal contraceptives work. Tell your doctor if you are taking a hormonal contraceptive; Your doctor may recommend the addition of a non-hormonal method of contraception.

Breast-feeding

Do not breastfeed if you are taking Koselugo. It is not known if Koselugo passes into breast milk.

Driving and using machines

Koselugo can 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).

How to take Koselugo

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much to take

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

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

Your doctor may lower your dose, interrupt treatment, or stop it altogether if you get some side effect is while taking Koselugo (see section 4 “Possible Side Effects”).

How to take

  • Take Koselugo twice daily at approximately 12 hour intervals.
  • Take the capsules on an empty stomach. This means that:
    • you must wait at least 2 hours before taking Koselugo after eating and
    • after taking Koselugo, you must wait at least 1 hour before eating.
  • Swallow the capsules whole with water.
  • You must 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 vomit

If you vomit after taking Koselugo, no matter when, do not take any extra dose. Take the next dose at the usual time.

If you take more Koselugo than you should

If you take more Koselugo then you should Contact a doctor or pharmacist immediately.

If you forget to take Koselugo

What to do if you forget to take a dose of Koselugo depends on how much time is left until the next dose.

  • If there is more, there are 6 hours left until the next dose: take the missed dose one. Then take the next dose at the usual time.
  • If it is less, there are 6 hours left until the next dose: skip the missed dose . Then take the next dose at the usual time.

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

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 product, ask your doctor, pharmacist, or nurse.

Possible side effects

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

Any serious side effects ar

Eye problems (vision problems)

Koselugo can cause eye problems. Contact a doctor immediately if you experience blurred vision (a common side effect that may affect up to 1 in 10 people) or any other vision changes during treatment. Your doctor may ask you to stop taking this medicine or send you to a specialist if you experience symptoms that include:

  • dimsyn
  • vision loss
  • dark dots in the field of view (floaters)
  • other vision changes (such as impaired vision)

Contact a doctor immediately if you experience any of the serious side effects above.

Other side effects are

Tell your doctor or pharmacist if you experience any of the following side effects:

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

  • vomiting, nausea
  • diarrhea
  • inflammation of the mouth ( stomatitis )
  • skin and nail problems – signs can be dry skin, rash, redness around the fingernails
  • hair thinning ( alopecia ), changes in hair color
  • fatigue, weakness or lack of energy
  • fever ( pyrexia )
  • swelling of hands or feet (peripheral edema )
  • a slight decrease in the volume of blood that the heart pumps around (decreased ejection fraction ) – signs may include shortness of breath, shortness of breath or swelling of the legs, ankles or feet
  • high blood pressure ( hypertension )
  • reduced levels of albumin, a vital protein in the liver (seen on blood tests)
  • decreased level of hemoglobin , the protein that carries oxygen in the red blood cells (seen during blood tests)
  • elevated enzymes (seen in blood tests) that indicate liver damage, kidney damage or muscle breakdown

Common (may affect up to 1 in 10 people)

  • dry mouth
  • swelling of the face (facial edema)
  • shortness of breath or shortness of breath ( dyspnoea )

How to store 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 can and carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store in the original jar. Moisture sensitive. Sensitive to light.

Close the jar tightly.

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 to protect the environment.

Contents of the pack and other information

Content declaration

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

The other ingredients of Koselugo 10 mg hard capsules are:

  • capsule content: tocopherol ( 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 inks: shellac (E904), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527).

The other ingredients of Koselugo 25 mg hard capsules are:

  • capsule content: tocopherol ( 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 aluminum lacquer (E132), yellow iron oxide (E172), carnauba wax (E903), corn starch.
  • printing inks: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminum lacquer (E132), carnauba wax (E903), shellac (E904), glyceryl monooleate.

What the medicine looks like and contents of the pack

Koselugo 10 mg hard capsules are white to off-white, opaque, hard capsules that have a band in the middle and are marked with “SEL 10” in black ink.

Koselugo 25 mg hard capsules are blue, opaque, hard capsules that have a band in the middle and are marked with “SEL 25” in black ink.

Koselugo is supplied in white plastic jars closed with white (10 mg) or blue (25 mg) child-resistant lids. The jar contains 60 hard capsules and a desiccant of silica gel. Do not remove the desiccant from the jar or swallow it.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

AstraZeneca AB

SE ‑ 151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Global External Sourcing (GES)

Astraallén

Gärtunaporten

SE ‑ 151 85 Södertälje

Sweden

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550
BulgariaAustralia Bulgaria ЕООДTel: +359 24455000 Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11
Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 HungaryAstraZeneca Kft.Tel .: +36 1 883 6500
DenmarkAstraZeneca A / STel: +45 43 66 64 62 MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000
GermanyAstraZeneca GmbHTel: +49 41 03 7080 The NetherlandsAstraZeneca BVTel: +31 79 363 2222
EestiAstraZenecaTel: +372 6549 600 NorwayAstraZeneca ASTel: +47 21 00 64 00
GreeceAstraZeneca AE:Ηλ: +30 210 6871500 AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0
SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00
FranceAstraZenecaTel: +33 1 41 29 40 00 PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00
CroatiaAstraZeneca dooTel: +385 1 4628 000 RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41
IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100 SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777
ItalyAstraZeneca SpATel: +39 02 9801 1 Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010
.ΠροςAlexander the Great:Ηλ: +357 22490305 SwedenAstraZeneca ABTel: +46 8 553 26 000
LatviaSIA AstraZeneca LatvijaTel: +371 67377100 United Kingdom (Northern Ireland)AstraZeneca UK LtdTel: +44 1582 836 836

This medicine has been authorized according to the rules of “conditional marketing authorization”. This means that more information about the drug is expected. The European Medicines Agency reviews new information on this medicine at least every year and updates

Muhammad Nadeem

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