{"id":19490,"date":"2022-03-11T13:07:23","date_gmt":"2022-03-11T13:07:23","guid":{"rendered":"https:\/\/zeepedia.com\/?p=19490"},"modified":"2022-03-12T13:18:09","modified_gmt":"2022-03-12T13:18:09","slug":"odomzo","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/odomzo\/","title":{"rendered":"Odomzo &#8211; Sonidegib uses, dose and side effects"},"content":{"rendered":"\n<p>200 mg&nbsp;Hard capsules<br>sonidegib<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Odomzo is and what it is used for<\/h2>\n\n\n\n<p><strong>What Odomzo is<\/strong><\/p>\n\n\n\n<p>Odomzo contains the active substance sonidegib.\u00a0It is a cancer medicine.<\/p>\n\n\n\n<p><strong>What Odomzo is used for<\/strong><\/p>\n\n\n\n<p>Odomzo is used to treat adults with a type of skin cancer called basal cell carcinoma.&nbsp;It is used when the cancer has spread locally and cannot be treated by surgery or radiation.<\/p>\n\n\n\n<p><strong>How Odomzo works<\/strong><\/p>\n\n\n\n<p>The normal growth of cells is controlled by various chemical signals.&nbsp;In patients with basal cell carcinoma, changes occur in the genes that control part of this process known as the &#8220;hedgehog signaling pathway&#8221;.&nbsp;This connects to signals that cause the cancer cells to grow out of control. Odomzo works by blocking this process and preventing the cancer cells from growing and multiplying.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before taking Odomzo<\/h2>\n\n\n\n<p>Read the specific instructions given to you by your doctor, especially about the effect of Odomzo on the fetus.<\/p>\n\n\n\n<p>Read carefully and follow the instructions in the patient brochure and reminder card for patients that you received from your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Odomzo<\/h2>\n\n\n\n<p><strong>Do not take Odomzo<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to sonidegib or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you are pregnant, or think you may be pregnant.&nbsp;This is because Odomzo can harm or kill your unborn baby (see section &#8220;Pregnancy&#8221;).<\/li><li>if you are breast-feeding.&nbsp;It is not known whether Odomzo can pass into breast milk and harm the baby (see section \u201cBreastfeeding\u201d).<\/li><li>if you may be pregnant but are unable or unwilling to take the necessary pregnancy prevention measures listed in the Odomzo Pregnancy Prevention Program.<\/li><\/ul>\n\n\n\n<p>Do not take Odomzo if any of the above apply to you.&nbsp;If you are not sure, talk to your doctor or pharmacist before taking Odomzo.<\/p>\n\n\n\n<p>Further information on the above points can be found in the sections &#8220;Pregnancy, breast-feeding and fertility&#8221; and &#8220;Contraceptive methods for women and men&#8221;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Odomzo can cause muscle problems.&nbsp;Tell your doctor before taking Odomzo if you have previously had muscle cramps or muscle weakness, or if you are taking any other medicines.&nbsp;Some medicines (eg medicines for high cholesterol) may increase the risk of muscle problems.&nbsp;Talk to your doctor or pharmacist immediately if you experience muscle pain or if you experience unexplained muscle cramps or muscle weakness during treatment with Odomzo.&nbsp;Your doctor may need to change your&nbsp;dose&nbsp;or stop treatment temporarily or permanently.<\/li><li>You should not donate blood during treatment with Odomzo and for 20 months after the end of treatment.<\/li><li>If you are a man, do not donate semen at any time during treatment or for 6 months after the last&nbsp;dose&nbsp;.<\/li><li>Your doctor will examine your skin regularly for another type of cancer called&nbsp;cutaneous&nbsp;squamous&nbsp;cell carcinoma .&nbsp;It is unknown whether&nbsp;cutaneous&nbsp;squamous&nbsp;cell carcinoma may be associated with Odomzo treatment.&nbsp;This type of cancer is most commonly found on sun-damaged skin.&nbsp;It does not spread and can be cured.&nbsp;Tell your doctor if you notice any skin changes.<\/li><li>Never give this medicine to anyone else.&nbsp;You must return unused capsules after the treatment has ended.&nbsp;Talk to your doctor or pharmacist where the capsules are to be returned.<\/li><\/ul>\n\n\n\n<p><strong>Blood tests during treatment with Odomzo<\/strong><\/p>\n\n\n\n<p>The doctor takes blood samples before starting treatment and possibly also during the treatment period.&nbsp;These tests are done to check your muscles by measuring the amount of&nbsp;enzyme&nbsp;and creatine phosphokinase in your blood.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and adolescents (under 18 years)<\/h2>\n\n\n\n<p>Odomzo should not be given to children and adolescents under 18 years of age.&nbsp;Problems with growing teeth and bones have been noted for this medication.&nbsp;Odomzo can make bones stop growing in children and adolescents.&nbsp;This can also occur even at the end of treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other drugs and Odomzo<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.\u00a0This also applies to over-the-counter medicines and herbal medicines.\u00a0Odomzo may affect the way other medicines work.\u00a0Some medicines can in turn affect the way Odomzo works, or increase the likelihood of you getting\u00a0side effects.<\/p>\n\n\n\n<p>You must tell your doctor or pharmacist if you are taking any of the following medicines:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>drugs such as statins and fibric acid derivatives used to treat high&nbsp;cholesterol&nbsp;and fats<\/li><li>Vitamin&nbsp;B3, also called&nbsp;niacin<\/li><li>drugs such as methotrexate, mitoxantrone, irinotecan or <a href=\"https:\/\/zeepedia.com\/medical\/medicines\/topotecan-ebewe\/\">topotecan<\/a> used to treat certain types of cancer or other diseases such as severe joint problems (&nbsp;rheumatoid arthritis&nbsp;) and&nbsp;psoriasis<\/li><li>drugs such as telithromycin, rifampicin or rifabutin used to treat bacterial infections<\/li><li>medicines such as&nbsp;ketoconazole&nbsp;(excluding&nbsp;shampoos&nbsp;and&nbsp;creams&nbsp;), itraconazole, posaconazole and voriconazole used to treat fungal infections 32<\/li><li>drugs such as chloroquine and hydroxychloroquine used to treat parasitic infections as well as other diseases such as rheumatoid arthritis or lupus erythematosus<\/li><li>drugs such as ritonavir, saquvinavir and zidovudine used to treat&nbsp;AIDS&nbsp;or&nbsp;HIV<\/li><li>drugs such as carbamazepine,&nbsp;phenytoin&nbsp;and phenobarbital used to treat acute seizures<\/li><li>the drug nefazodone, which is used to treat depression<\/li><li>the drug penicillamine, which is used to treat&nbsp;rheumatoid arthritis<\/li><li>an herbal remedy called&nbsp;St. John&nbsp;&#8216;s wort (Hypericum perforatum) which is used to treat mild depression and mild anxiety<\/li><\/ul>\n\n\n\n<p>If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking Odomzo.<\/p>\n\n\n\n<p>These medicines should be used with caution or may need to be avoided altogether during treatment with Odomzo.&nbsp;If you are taking any of these, your doctor may need to prescribe you another alternative medicine.<\/p>\n\n\n\n<p>During treatment with Odomzo, you should also tell your doctor or pharmacist if you have been prescribed any other medicines that you have not taken before.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n<p><strong>Pregnancy<\/strong><\/p>\n\n\n\n<p>Do not take Odomzo if you are pregnant, think you may be pregnant or are planning to have a baby during treatment or within 20 months of stopping treatment.&nbsp;You must stop taking Odomzo and talk to your doctor immediately if you become pregnant or suspect you may be pregnant.&nbsp;Odomzo can cause severe birth defects and can even lead to fetal death.&nbsp;Special instructions (Odomzo Pregnancy Prevention Program) will be given to you by your doctor with information specifically regarding the effect of Odomzo on the fetus<\/p>\n\n\n\n<p><strong>Breast-feeding<\/strong>&nbsp;You should not breast-feed during treatment or within 20 months after the end of treatment.&nbsp;It is unknown if Odomzo can pass into breast milk and harm the baby.<\/p>\n\n\n\n<p><strong>Fertility<\/strong><\/p>\n\n\n\n<p>Odomzo can affect the&nbsp;fertility&nbsp;of men and women.&nbsp;Talk to your doctor if you plan to have children in the future.<\/p>\n\n\n\n<p><strong>Contraceptive methods for women and men<\/strong><\/p>\n\n\n\n<p><em>Women<\/em><\/p>\n\n\n\n<p>Before starting treatment with Odomzo, ask your doctor if you may become pregnant even though you are no longer menstruating (menopause).\u00a0You must check with your doctor if there is a risk that you may become pregnant.<\/p>\n\n\n\n<p>If you can get pregnant:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you need to take precautions so that you do not get pregnant while taking Odomzo,<\/li><li>you must use two methods of contraception: a very effective method and a&nbsp;barrier&nbsp;method (see example below) while taking Odomzo,<\/li><li>You must continue to use these contraceptives for 20 months after stopping Odomzo because traces of the medicine remain in the body for a long time.<\/li><\/ul>\n\n\n\n<p>You and your doctor will discuss which method of contraception is best for you.<\/p>\n\n\n\n<p>You need to use a very effective method such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>IUD&nbsp;or intrauterine (uterine) insert<\/li><li>sterilization by surgery.<\/li><\/ul>\n\n\n\n<p>You must also use a&nbsp;barrier method&nbsp;such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>condom (if possible with spermicide)<\/li><li>pessaries&nbsp;(if possible with spermicides).<\/li><\/ul>\n\n\n\n<p>The doctor will perform pregnancy tests:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>at least 7 days before starting treatment to see that you are not already pregnant<\/li><li>every month during treatment.<\/li><\/ul>\n\n\n\n<p>During treatment and within 20 months after the end of treatment, tell your doctor immediately about:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you think your contraceptives have not worked for some reason<\/li><li>your periods stop<\/li><li>you stop using contraception<\/li><li>you need to change contraceptives.<\/li><\/ul>\n\n\n\n<p><em>Men<\/em><\/p>\n\n\n\n<p>While taking Odomzo, always use a condom (with a spermicide, if available) during sexual intercourse with a female partner, even if you have undergone vasectomy.&nbsp;You must continue to do this for 6 months after the end of treatment.<\/p>\n\n\n\n<p>Tell your doctor immediately if your partner becomes pregnant while you are taking Odomzo and for 6 months after your treatment has ended.<\/p>\n\n\n\n<p>You should not donate semen during treatment or within 6 months after the end of treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Odomzo is unlikely to affect your ability to drive or use tools or machines.&nbsp;Talk to your doctor if you are unsure.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Odomzo contains lactose<\/h2>\n\n\n\n<p>Odomzo contains&nbsp;lactose&nbsp;(milk sugar).&nbsp;If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take Odomzo<\/h2>\n\n\n\n<p>Always take this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p><strong>How to take this medicine<\/strong><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is 200 mg (1 capsule) per day.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Do not eat for 2 hours before taking Odomzo and 1 hour afterwards.<\/li><li>Take your capsule at about the same time each day.&nbsp;This will make it easier to remember when to take your medicine.<\/li><li>The capsule should be swallowed whole.&nbsp;It must not be opened, chewed or crushed.&nbsp;All contact with the contents of the capsules should be avoided, as it can have harmful effects.<\/li><\/ul>\n\n\n\n<p>Do not change the\u00a0dose\u00a0without talking to your doctor.\u00a0Do not take more medicines than your doctor prescribed.\u00a0If you vomit after swallowing the capsule, do not take any more capsules until the next scheduled\u00a0dose.<\/p>\n\n\n\n<p><strong>How long should you take Odomzo?<\/strong><\/p>\n\n\n\n<p>Continue to take Odomzo for as long as your doctor prescribes it.&nbsp;Talk to your doctor or pharmacist if you are wondering how long to take Odomzo.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Odomzo than you should<\/h2>\n\n\n\n<p>If you have taken too much Odomzo, or if someone else has accidentally taken your medicine, contact a doctor or go to the hospital immediately.&nbsp;Bring the medicine with the package and package leaflet.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Odomzo<\/h2>\n\n\n\n<p>If you forget to take a\u00a0dose\u00a0of Odomzo, take it as soon as you realize it.\u00a0If more than six hours have passed since 34\u00a0dose\u00a0one should have been taken, skip the missed\u00a0dose\u00a0one and then take the next\u00a0dose\u00a0at the appointed time.\u00a0Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop taking Odomzo<\/h2>\n\n\n\n<p>Do not stop taking Odomzo without talking to your doctor first.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p>Odomzo can cause severe birth defects.&nbsp;You must not become pregnant while taking this medicine (see &#8220;Pregnancy, breast-feeding and fertility&#8221; and &#8220;Contraceptive measures for women and men&#8221; in section 2 for further information).<\/p>\n\n\n\n<p>Stop taking Odomzo and tell your doctor immediately if you notice any of the following, as it may be a sign of an allergic reaction:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>difficulty breathing or swallowing<\/li><li>swelling of the face, lips, tongue or throat<\/li><li>severely itchy skin with red rashes or lumps.<\/li><\/ul>\n\n\n\n<p><strong>Some&nbsp;side effects&nbsp;can be serious<\/strong><\/p>\n\n\n\n<p>If you notice any of the following, tell your doctor or pharmacist immediately:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Severe muscle cramps, muscle pain or muscle weakness.&nbsp;This can be a sign of a complication called&nbsp;rhabdomyolysis&nbsp;, which involves breaking down muscle tissue.<\/li><li>Dark-colored urine, small amounts of urine or no urine at all.&nbsp;This can be a sign that the muscle fibers are being broken down, which is damaging the kidneys.<\/li><\/ul>\n\n\n\n<p><strong>Other possible&nbsp;side&nbsp;effects<\/strong><\/p>\n\n\n\n<p>If any of these&nbsp;side effects&nbsp;gets worse, talk to your doctor or pharmacist.<\/p>\n\n\n\n<p><strong>Very common:<\/strong>&nbsp;may affect more than 1 in 10 people<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>muscle cramps, muscle aches, pain in the skeleton, ligaments and tendons<\/li><li>no menstruation<\/li><li>diarrhea or heartburn<\/li><li>reduced appetite<\/li><li>headache<\/li><li>altered taste experience or strange taste in the mouth<\/li><li>abdominal pain<\/li><li>feeling sick<\/li><li>vomiting<\/li><li>itching<\/li><li>hair loss<\/li><li>fatigue<\/li><li>pains<\/li><li>weight loss.<\/li><\/ul>\n\n\n\n<p><strong>Common<\/strong>&nbsp;can occur in up to 1 in 10 people<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>upset stomach or indigestion<\/li><li>constipation<\/li><li>rash<\/li><li>abnormal hair growth<\/li><li>thirst, small amounts of urine, weight loss, dry and&nbsp;reddened&nbsp;skin, irritability (possible symptoms of low fluid levels in the body, ie dehydration, also called&nbsp;dehydration&nbsp;).<\/li><\/ul>\n\n\n\n<p><strong>During treatment with Odomzo you may also get some<\/strong>\u00a0abnormal blood counts<strong>.\u00a0These can alert your doctor about possible changes in the function of various parts of your body, for example:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>high levels of the following enzymes: creatine phosphokinase (muscle function),&nbsp;lipase&nbsp;and \/ or amylase (pancreatic function),&nbsp;alanine aminotransferase&nbsp;(&nbsp;ALT&nbsp;) and \/ or&nbsp;aspartate aminotransferase&nbsp;(&nbsp;ASAT&nbsp;) (liver function)<\/li><li>high creatinine value (renal function)<\/li><li>high blood sugar (&nbsp;hyperglycaemia&nbsp;)<\/li><li>low hemoglobin value (&nbsp;hemoglobin&nbsp;is needed to transport oxygen in the blood)<\/li><li>low&nbsp;white blood cell count&nbsp;.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Odomzo<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Keep this medicine out of the sight and reach of children.<\/li><li>Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.&nbsp;The expiration date is the last day of the specified month.<\/li><li>Do not store above 30 \u00b0 C.<\/li><li>Store in the original package.&nbsp;Moisture sensitive.<\/li><li>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the pack and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is sonidegib (as&nbsp;phosphate&nbsp;).&nbsp;Each capsule contains 200 mg of sonidegib.<\/li><li>Other ingredients are:<\/li><li>Capsule contents: crospovidone type A,&nbsp;lactose monohydrate&nbsp;(see section 2, &#8216;Odomzo contains lactose&#8217;), magnesium stearate, poloxamer (188),&nbsp;colloidal&nbsp;anhydrous silica, sodium lauryl sulphate.<ul><li>Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171).<\/li><li>Ink: black iron oxide (E172), propylene glycol (E1520), shellac.<\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Odomzo 200 mg capsules are pink and opaque, imprinted with \u201cSONIDEGIB 200MG\u201d and \u201cNVR\u201d.<\/p>\n\n\n\n<p>Odomzo is packaged in perforated unit dose blisters containing 10 x 1 capsules.&nbsp;It is available in packs of 10 or 30 capsules.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Sun Pharmaceutical Industries Europe BV<\/p>\n\n\n\n<p>Polarisavenue 87<\/p>\n\n\n\n<p>2132JH Hoofddorp<\/p>\n\n\n\n<p>Netherlands<\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n<p>Sun Pharmaceutical Industries Europe BV<\/p>\n\n\n\n<p>Tel: +31 23 568 55 0<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Odomzo contains the active substance sonidegib. It is a medicine for cancer.<\/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":[2200,18526],"tags":[19596,19591,19592,19595,19587,19590,19593,19588,19594,19589],"class_list":["post-19490","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-odomzo","tag-benefits-of-sonidegib","tag-odomzo","tag-odomzo-side-effects","tag-sonidegib","tag-sonidegib-side-effects","tag-what-is-odomzo","tag-what-is-sonidegib","tag-what-odomzo-is-used-for","tag-what-sonidegib-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19490","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=19490"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19490\/revisions"}],"predecessor-version":[{"id":19521,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19490\/revisions\/19521"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19490"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19490"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}