10 mg and 20 mg hard capsules
selumetinib<\/p>\n\n\n\n
What Koselugo is and how it works<\/strong><\/p>\n\n\n\n Koselugo contains the active substance selumetinib.<\/p>\n\n\n\n Selumetinib is a type of medicine called MEK inhibitor. It works by blocking certain proteins that are involved in the growth of tumor cells.<\/p>\n\n\n\n Koselugo is expected to shrink tumors that grow along nerves and are called plexiform neurofibromas.<\/p>\n\n\n\n These tumors are caused by an inherited condition called neurofibromatosis type 1 (NF1).<\/p>\n\n\n\n What Koselugo is used for<\/strong><\/p>\n\n\n\n Koselugo is used to treat children aged 3 years and older who have plexiform neurofibromas that cannot be completely removed with\u00a0surgery.<\/p>\n\n\n\n Talk to your doctor if you have any questions about how Koselugo works or why you have been prescribed this medicine.<\/p>\n\n\n\n If you are not sure, talk to your doctor, pharmacist, or nurse before taking Koselugo.<\/p>\n\n\n\n Talk to your doctor, pharmacist, or nurse before and during your treatment with Koselugo:<\/p>\n\n\n\n If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking this medicine.<\/p>\n\n\n\n Eye problems<\/strong><\/p>\n\n\n\n Koselugo may cause eye problems (see section 4 \u201cPossible side effects\u201d). Contact a doctor immediately<\/strong> 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.<\/p>\n\n\n\n Heart problems<\/strong><\/p>\n\n\n\n Koselugo can reduce the amount of blood your heart can pump around (see section 4 \u201cPossible side effects\u201d). Your doctor will check how well your heart is working before and during treatment with Koselugo.<\/p>\n\n\n\n Liver problem<\/strong><\/p>\n\n\n\n Koselugo may increase the number of certain liver enzymes in your blood (see section 4 \u201cPossible side effects\u201d).\u00a0Your doctor will take blood samples before and during treatment with Koselugo to check how well your liver is working.<\/p>\n\n\n\n Vitamin E supplement<\/strong><\/p>\n\n\n\n Koselugo capsules contain\u00a0vitamin E, which may increase the risk of bleeding.\u00a0This means that you need to tell your doctor if you are taking other medicines that increase the risk of bleeding, such as:<\/p>\n\n\n\n Difficulty swallowing capsules<\/strong><\/p>\n\n\n\n Talk to your doctor if you think you may have difficulty swallowing the capsules whole (see section 3 \u201cHow to take Koselugo\u201d).<\/p>\n\n\n\n Problems with skin, nails, and hair<\/strong><\/p>\n\n\n\n Koselugo may cause skin rash, a nail infection or thinness of hair, or changes in hair color (see section 4 \u201cPossible side effects\u201d).\u00a0Talk to your doctor if you have any of these symptoms during treatment.<\/p>\n\n\n\n Do not give Koselugo to children under 3 years of age, as the drug has not been studied in this age group.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0This also includes (traditional) herbal and herbal medicines, dietary supplements, and over-the-counter medicines.<\/p>\n\n\n\n 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:<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Do not drink grapefruit juice when you are being treated with Koselugo, as this may affect the way the medicine works.<\/p>\n\n\n\n Pregnancy – information for women<\/strong><\/p>\n\n\n\n Koselugo is not recommended during pregnancy. It can harm an unborn baby.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Tell your doctor immediately if you become pregnant during treatment.<\/p>\n\n\n\n Pregnancy – information for men<\/strong><\/p>\n\n\n\n If your partner becomes pregnant while you are taking this medicine, talk to your doctor immediately.<\/p>\n\n\n\n Contraceptives – information for women and men<\/strong><\/p>\n\n\n\n If you are sexually active, use safe contraception while taking this medicine and for at least 1 week after taking the last\u00a0dose.\u00a0It is not known if Koselugo can affect how well hormonal contraceptives work.\u00a0Tell your doctor if you are taking a hormonal contraceptive;\u00a0Your doctor may recommend the addition of a non-hormonal method of contraception.<\/p>\n\n\n\n Breast-feeding<\/strong><\/p>\n\n\n\n Do not breastfeed if you are taking Koselugo.\u00a0It is not known if Koselugo passes into breast milk.<\/p>\n\n\n\n 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).<\/p>\n\n\n\n Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n How much to take<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Your doctor may prescribe a lower dose if you have liver problems (hepatic impairment).<\/p>\n\n\n\n Your doctor may lower your\u00a0dose, interrupt treatment, or stop it altogether if you get some\u00a0side effect\u00a0is while taking Koselugo (see section 4 “Possible Side Effects”).<\/p>\n\n\n\n How to take<\/strong><\/p>\n\n\n\n If you vomit<\/strong><\/p>\n\n\n\n If you vomit after taking Koselugo, no matter when, do not take any extra\u00a0dose.\u00a0Take the next\u00a0dose\u00a0at the usual time.<\/p>\n\n\n\n If you take more Koselugo then you should Contact a doctor or pharmacist immediately.<\/p>\n\n\n\n What to do if you forget to take a\u00a0dose of\u00a0Koselugo depends on how much time is left until the next\u00a0dose.<\/p>\n\n\n\n Do not take a double\u00a0dose\u00a0(two\u00a0doses\u00a0at the same time) to compensate for a missed\u00a0dose.<\/p>\n\n\n\n Do not stop taking Koselugo unless your doctor tells you to.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Any serious side effects ar<\/strong><\/p>\n\n\n\n Eye problems (vision problems)<\/p>\n\n\n\n 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:<\/p>\n\n\n\n Contact a doctor immediately if you experience any of the serious side effects above.<\/p>\n\n\n\n Other side effects are<\/strong><\/p>\n\n\n\n Tell your doctor or pharmacist if you experience any of the following side effects:<\/p>\n\n\n\n Very common (may affect more than 1 user in 10)<\/strong><\/p>\n\n\n\n Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Do not store above 30 \u00b0 C.<\/p>\n\n\n\n Store in the original jar. Moisture sensitive. Sensitive to light.<\/p>\n\n\n\n Close the jar tightly.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n The active substance is selumetinib.\u00a0Each Koselugo 10 mg hard capsule contains 10 mg selumetinib (as hydrogen sulfate).\u00a0Each Koselugo 25 mg hard capsule contains 25 mg selumetinib (as hydrogen sulfate).<\/p>\n\n\n\n The other ingredients of Koselugo 10 mg hard capsules are:<\/p>\n\n\n\n The other ingredients of Koselugo 25 mg hard capsules are:<\/p>\n\n\n\n Koselugo 10 mg hard capsules are white to off-white, opaque, hard capsules that have a band in the middle and are marked with \u201cSEL 10\u201d in black ink.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n AstraZeneca AB<\/p>\n\n\n\n SE \u2011 151 85 S\u00f6dert\u00e4lje<\/p>\n\n\n\n Sweden<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n AstraZeneca AB<\/p>\n\n\n\n Global External Sourcing (GES)<\/p>\n\n\n\n Astraall\u00e9n<\/p>\n\n\n\n G\u00e4rtunaporten<\/p>\n\n\n\n SE \u2011 151 85 S\u00f6dert\u00e4lje<\/p>\n\n\n\n Sweden<\/p>\n\n\n\n Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n 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 <\/p>\n","protected":false},"excerpt":{"rendered":" Koselugo contains the active substance selumetinib.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,12118],"tags":[15110,15104,15105,15108,15109,15099,15102,15103,15106,15100,15107,15101],"class_list":["post-15908","post","type-post","status-publish","format-standard","hentry","category-medicines","category-k","tag-benefits-of-koselugo","tag-benefits-of-selumetinib","tag-koselugo","tag-koselugo-capsule","tag-koselugo-side-effects","tag-selumetinib","tag-selumetinib-capsule","tag-selumetinib-side-effects","tag-what-is-koselugo","tag-what-is-selumetinib","tag-what-koselugo-is-used-for","tag-what-selumetinib-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/15908","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=15908"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/15908\/revisions"}],"predecessor-version":[{"id":15951,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/15908\/revisions\/15951"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=15908"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=15908"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=15908"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before using Koselugo<\/h2>\n\n\n\n
Do not take Koselugo:<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Children under 3 years<\/h2>\n\n\n\n
Other medicines and Koselugo<\/h2>\n\n\n\n
Koselugo with food and drink<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
How to take Koselugo<\/h2>\n\n\n\n
If you take more Koselugo than you should<\/h2>\n\n\n\n
If you forget to take Koselugo<\/h2>\n\n\n\n
If you stop taking Koselugo<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Koselugo<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Belgium \/ Belgique \/ Belgien<\/strong>AstraZeneca SA \/ NVTel: +32 2 370 48 11<\/td> Lithuania<\/strong>UAB AstraZeneca LietuvaTel: +370 5 2660550<\/td><\/tr> Bulgaria<\/strong>Australia Bulgaria \u0415\u041e\u041e\u0414Tel: +359 24455000<\/td> Luxembourg \/ Luxemburg<\/strong>AstraZeneca SA \/ NVTel: +32 2 370 48 11<\/td><\/tr> Czech Republic<\/strong>AstraZeneca Czech Republic sroTel: +420 222 807 111<\/td> Hungary<\/strong>AstraZeneca Kft.Tel .: +36 1 883 6500<\/td><\/tr> Denmark<\/strong>AstraZeneca A \/ STel: +45 43 66 64 62<\/td> Malta<\/strong>Associated Drug Co. Ltd.Tel: +356 2277 8000<\/td><\/tr> Germany<\/strong>AstraZeneca GmbHTel: +49 41 03 7080<\/td> The Netherlands<\/strong>AstraZeneca BVTel: +31 79 363 2222<\/td><\/tr> Eesti<\/strong>AstraZenecaTel: +372 6549 600<\/td> Norway<\/strong>AstraZeneca ASTel: +47 21 00 64 00<\/td><\/tr> Greece<\/strong>AstraZeneca AE:\u0397\u03bb: +30 210 6871500<\/td> Austria<\/strong>AstraZeneca \u00d6sterreich GmbHTel: +43 1 711 31 0<\/td><\/tr> Spain<\/strong>AstraZeneca Pharmac\u00e9utica Spain, SATel: +34 91 301 91 00<\/td> Poland<\/strong>AstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00<\/td><\/tr> France<\/strong>AstraZenecaTel: +33 1 41 29 40 00<\/td> Portugal<\/strong>AstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00<\/td><\/tr> Croatia<\/strong>AstraZeneca dooTel: +385 1 4628 000<\/td> Romania<\/strong>AstraZeneca Pharma SRLTel: +40 21 317 60 41<\/td><\/tr> Ireland<\/strong>AstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100<\/td> Slovenia<\/strong>AstraZeneca UK LimitedTel: +386 1 51 35 600<\/td><\/tr> Iceland<\/strong>Vistor hf.Phone: +354 535 7000<\/td> Slovak Republic<\/strong>AstraZeneca AB, ozTel: +421 2 5737 7777<\/td><\/tr> Italy<\/strong>AstraZeneca SpATel: +39 02 9801 1<\/td> Finland \/ Finland<\/strong>AstraZeneca OyPuh \/ Tel: +358 10 23 010<\/td><\/tr> .\u03a0\u03c1\u03bf\u03c2<\/strong>Alexander the Great:\u0397\u03bb: +357 22490305<\/td> Sweden<\/strong>AstraZeneca ABTel: +46 8 553 26 000<\/td><\/tr> Latvia<\/strong>SIA AstraZeneca LatvijaTel: +371 67377100<\/td> United Kingdom (Northern Ireland)<\/strong>AstraZeneca UK LtdTel: +44 1582 836 836<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n