{"id":22554,"date":"2022-07-01T11:45:31","date_gmt":"2022-07-01T11:45:31","guid":{"rendered":"https:\/\/zeepedia.com\/?p=22554"},"modified":"2022-07-02T12:32:53","modified_gmt":"2022-07-02T12:32:53","slug":"rydapt","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/rydapt\/","title":{"rendered":"Rydapt &#8211; Midostaurin uses, dose and side effects"},"content":{"rendered":"\n<p>25 mg&nbsp;soft capsules<br>midostaurin<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Rydapt is and what it is used for<\/h2>\n\n\n\n<p><strong>What&nbsp;<\/strong>&nbsp;<strong>Rydapt is<\/strong><\/p>\n\n\n\n<p>Rydapt contains the active substance midostaurin.&nbsp;It belongs to a class of drugs called protein kinase inhibitors.<\/p>\n\n\n\n<p><strong>What Rydapt is used for<\/strong><\/p>\n\n\n\n<p>Rydapt is used to treat\u00a0acute myeloid leukemia\u00a0in adults who have a\u00a0defect\u00a0in the FLT3 gene.\u00a0Acute myeloid leukemia\u00a0(AML) is a form of cancer in some of the white\u00a0blood cells\u00a0(called myeloid\u00a0blood cells\u00a0), where the body overproduces an abnormal type of these\u00a0blood cells.<\/p>\n\n\n\n<p>Rydapt is also used to treat aggressive systemic\u00a0mastocytosis\u00a0(ASM), systemic\u00a0mastocytosis\u00a0with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) in adults.\u00a0In these diseases, too many mast cells are produced in the body, a type of\u00a0white blood cell.\u00a0Symptoms appear when too many\u00a0mast cells\u00a0enter organs such as the liver,\u00a0bone marrow,\u00a0or spleen, and release substances such as.\u00a0histamine\u00a0in the blood.<\/p>\n\n\n\n<p><strong>How Rydapt works<\/strong><\/p>\n\n\n\n<p>Midostaurin blocks the action of certain\u00a0enzymes\u00a0(\u00a0kinases\u00a0) in the abnormal cells and stops the division and growth of the cells.<\/p>\n\n\n\n<p>At the beginning of the treatment of AML, Rydapt is always used in combination with&nbsp;chemotherapy&nbsp;(medicines used to treat cancer).<\/p>\n\n\n\n<p>Ask your doctor, pharmacist, or nurse if you are wondering how Rydapt works or why it has been prescribed for you.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before taking Rydapt<\/h2>\n\n\n\n<p>Follow your doctor&#8217;s instructions carefully.&nbsp;They may differ from the general information in this leaflet.<\/p>\n\n\n\n<p><strong>Do not take Rydapt<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to midostaurin or any of the other ingredients of this medicine (listed in section 6).\u00a0Ask your doctor if you think you may be allergic.<\/li><li>if you are already taking any of the following medicines:<ul><li>drugs used to treat\u00a0tuberculosis, such as rifampicin;<\/li><li>drugs used to treat\u00a0epilepsy, such as carbamazepine or phenytoin;<\/li><li>enzalutamide, a drug used to treat prostate cancer;<\/li><li>St. John&#8217;s wort\u00a0(also called\u00a0Hypericum perforatum\u00a0), is a herbal remedy used to treat depression.<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>These medicines must be avoided during treatment with Rydapt.&nbsp;Talk to your doctor if you find out that you need to start taking one of them during treatment with Rydapt.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before taking Rydapt:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have an\u00a0infection.<\/li><li>if you have heart disease.<\/li><li>if you have lung problems or have difficulty breathing.<\/li><li>if you have kidney problems.<\/li><\/ul>\n\n\n\n<p>If you get any of the following symptoms while you are being treated with Rydapt, tell your doctor, pharmacist, or nurse immediately:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have a fever, sore throat, or cold sore.\u00a0This may mean that you have too few\u00a0white blood cells.<\/li><li>if you have new or worsening symptoms such as fever, cough with or without mucus formation, chest pain, difficulty breathing, or shortness of breath.\u00a0This may be a sign of lung problems.<\/li><li>if you have or experience pain or discomfort from the chest, fainting, fainting, dizziness, bluish lips, hands or feet, shortness of breath, swollen legs (\u00a0edema\u00a0), or swollen skin.\u00a0This may be a sign of heart problems.<\/li><\/ul>\n\n\n\n<p>Your doctor may need to change your\u00a0dose, take a break or stop treatment with Rydapt completely.<\/p>\n\n\n\n<p>Check during treatment with Rydapt<\/p>\n\n\n\n<p>Your doctor will take blood samples at regular intervals during treatment with Rydapt to check the number of\u00a0blood cells\u00a0(\u00a0white blood cells,\u00a0red blood cells,\u00a0and\u00a0platelets\u00a0) and\u00a0electrolytes\u00a0(eg\u00a0calcium,\u00a0potassium,\u00a0and\u00a0magnesium\u00a0).\u00a0You also check your heart and lung function.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Rydapt should not be used in children and adolescents under 18 years of age who are also receiving other\u00a0chemotherapy, as it may cause a severe reduction in certain types of\u00a0blood cells.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Rydapt<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.\u00a0Rydapt can affect the way some medicines work.\u00a0Some other medicines may also affect the way Rydapt works.<\/p>\n\n\n\n<p>The following medicines must be avoided during treatment with Rydapt:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>drugs against\u00a0tuberculosis, e.g.\u00a0rifampicin;<\/li><li>antiepileptic\u00a0drugs\u00a0, e.g.\u00a0carbamazepine or phenytoin;<\/li><li>enzalutamide, a drug used to treat prostate cancer;<\/li><li>St. John&#8217;s wort\u00a0(\u00a0Hypericum perforatum\u00a0), is a herbal remedy used to treat depression.<\/li><\/ul>\n\n\n\n<p>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>certain medicines for\u00a0infection, e.g.\u00a0ketoconazole\u00a0or clarithromycin;<\/li><li>certain anti- HIV\u00a0drugs\u00a0, e.g.\u00a0ritonavir or efavirenz;<\/li><li>certain drugs used to treat depression, e.g.\u00a0nefazodone or bupropion;<\/li><li>certain drugs used to control blood cholesterol levels, e.g.\u00a0atorvastatin or rosuvastatin;<\/li><li>tizanidine, a drug used to relax muscles;<\/li><li>chlorzoxazone, a drug used to treat muscle spasms.<\/li><\/ul>\n\n\n\n<p>If you are taking any of these medicines, your doctor may prescribe another medicine for you to take while you are being treated with Rydapt.<\/p>\n\n\n\n<p>You should also tell your doctor if you are already taking Rydapt and you are being prescribed a new medicine that you have not taken at the same time as Rydapt before.<\/p>\n\n\n\n<p>Ask your doctor or pharmacist if you are not sure if any of your medicines are included in the above groups.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Rydapt can harm your unborn baby and is not recommended during pregnancy.\u00a0If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.<\/p>\n\n\n\n<p>Rydapt can harm your baby.\u00a0You should not breastfeed during treatment with Rydapt and for at least 4 months after the end of treatment.<\/p>\n\n\n\n<p><strong>Contraceptives for women<\/strong><\/p>\n\n\n\n<p>If you become pregnant while taking Rydapt, it may harm your unborn baby.&nbsp;Your doctor will ask you for a pregnancy test before starting treatment with Rydapt to make sure you are not pregnant.&nbsp;You must use an effective method of contraception while taking Rydapt and for at least 4 months after stopping the medicine.&nbsp;You and your doctor will discuss which method of contraception is most suitable for you.<\/p>\n\n\n\n<p>Tell your doctor immediately if you become pregnant or think you may be pregnant.<\/p>\n\n\n\n<p><strong>Fertility<\/strong><\/p>\n\n\n\n<p>Rydapt can reduce fertility in men and women.&nbsp;Discuss this with your doctor before starting treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Take special care when driving and using machines as you may experience dizziness and dizziness while taking Rydapt.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Rydapt contains anhydrous ethanol (alcohol) and macrogol glycerol hydroxy stearate (castor oil)<\/h2>\n\n\n\n<p><strong>Rydapt contains anhydrous&nbsp;ethanol&nbsp;(alcohol)<\/strong><\/p>\n\n\n\n<p>This medicine contains 666 mg of alcohol (\u00a0ethanol\u00a0) per 200 mg\u00a0dose\u00a0(maximum daily\u00a0dose\u00a0), equivalent to 14% by volume of anhydrous\u00a0ethanol.\u00a0The amount in a\u00a0dose\u00a0of 200 mg of this medicine corresponds to 17 ml of beer or 7 ml of wine.\u00a0The low amount of alcohol in this medicine does not produce any noticeable effects.\u00a0Alcohol can be harmful if you have alcohol problems,\u00a0epilepsy,\u00a0or liver problems or if you are pregnant or breastfeeding.<\/p>\n\n\n\n<p><strong>Rydapt contains macrogol glycerol<\/strong> hydroxy stearate<strong> (castor oil)<\/strong><\/p>\n\n\n\n<p>This medicine contains macrogol glycerol hydroxy stearate, which may cause stomach upset and diarrhea.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take Rydapt<\/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>Do not exceed the&nbsp;dose&nbsp;prescribed by your doctor.<\/p>\n\n\n\n<p><strong>How much Rydapt should you take?<\/strong><\/p>\n\n\n\n<p>Your doctor will tell you exactly how many capsules to take.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><em>Patients with AML<\/em>The usual daily\u00a0dose\u00a0is 50 mg (2 capsules) twice daily.<\/li><li><em>Patients with ASM, SM\u00a0<\/em><strong>&#8211;\u00a0<\/strong><em>AHN, or MCL<\/em>The usual daily\u00a0dose\u00a0is 100 mg (4 capsules) twice daily.<\/li><\/ul>\n\n\n\n<p>Depending on how you react to Rydapt, your doctor may reduce your&nbsp;dose&nbsp;or stop treatment temporarily.<\/p>\n\n\n\n<p><strong>How to take this medicine<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Take Rydapt at the same time each day to make it easier to remember.<\/li><li>Take Rydapt twice a day at approximately 12-hour intervals (eg with breakfast and supper).<\/li><li>Take Rydapt with food.<\/li><li>Swallow the capsules whole with a glass of water.\u00a0Do not open, crush or chew the capsules to ensure proper\u00a0dosing\u00a0and to avoid the unpleasant taste of the capsule contents.<\/li><li>Patients with AML take Rydapt together with chemotherapy drugs.\u00a0You must follow your doctor&#8217;s recommendations.<\/li><li>If you vomit after swallowing the capsules, do not take any more capsules until the next dose.<\/li><\/ul>\n\n\n\n<p><strong>How long should you take Rydapt?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Continue to take Rydapt for as long as your doctor tells you to.\u00a0Your doctor will check your condition at regular intervals to see if the treatment has the desired effect.<\/li><li>If you are being treated for AML, after you stop taking Rydapt together with chemotherapy drugs, you will continue to receive Rydapt alone for a maximum of 12 months.<\/li><li>If you are being treated for ASM, SM\u00a0<strong>&#8211;<\/strong>\u00a0AHN, or MCL, you will receive Rydapt as a long-term treatment, perhaps for months or years.<\/li><\/ul>\n\n\n\n<p>Talk to your doctor or pharmacist if you are wondering how long to take Rydapt.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Rydapt than you should<\/h2>\n\n\n\n<p>If you take more than one capsule or if someone else takes your medicine, contact a doctor or go to the hospital immediately.&nbsp;Bring the medicine pack as medical treatment may be needed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Rydapt<\/h2>\n\n\n\n<p>If you forget to take Rydapt, do not take the\u00a0missed\u00a0dose.\u00a0Only take the next\u00a0dose\u00a0at the scheduled time.\u00a0Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.\u00a0Instead, wait until it&#8217;s time for the next\u00a0dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop taking Rydapt<\/h2>\n\n\n\n<p>If you stop taking Rydapt, your disease may get worse.&nbsp;Do not stop taking this medicine unless your doctor tells you to.<\/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><strong>Stop taking Rydapt and tell your doctor immediately if you notice any of the following<\/strong>&nbsp;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>dizziness<\/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;in patients with AML can be serious.<\/strong><\/p>\n\n\n\n<p>Tell your doctor, pharmacist, or nurse immediately if you get any of the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>weakness, bleeding or bruising without cause, frequent\u00a0infection\u00a0with fever, chills, sore throat, or cold sores (signs of low\u00a0blood cell count\u00a0)<\/li><li>fever, cough with or without mucus, chest pain, difficulty breathing, or shortness of breath (signs of non-infectious\u00a0interstitial lung disease or\u00a0pneumonitis\u00a0)<\/li><li>severe shortness of breath, strained and usually rapid breathing, dizziness, fainting, confusion, and extreme tiredness (signs of\u00a0acute\u00a0respiratory distress syndrome)<\/li><li>infection, fever, low\u00a0blood pressure, decreased urine output, fast\u00a0heart rate, rapid breathing (signs of sepsis or\u00a0neutropenic\u00a0sepsis)<\/li><\/ul>\n\n\n\n<p><strong>Other possible&nbsp;side effects&nbsp;are in patients with AML<\/strong><\/p>\n\n\n\n<p>Other&nbsp;side effects&nbsp;that may occur are listed below.&nbsp;If any of these&nbsp;side effects&nbsp;gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.<\/p>\n\n\n\n<p>Most of the&nbsp;side effects&nbsp;are mild to moderate and generally disappear after a few weeks of treatment.<\/p>\n\n\n\n<p><strong>Very common (may affect more than 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>infection\u00a0at the site of the catheter<\/li><li>red or purple, flat pin-sized dots on the skin (\u00a0petechiae\u00a0)<\/li><li>difficulty falling asleep (insomnia)<\/li><li>headache<\/li><li>shortness of breath, labored breathing (\u00a0dyspnoea\u00a0)<\/li><li>abnormal\u00a0ECG\u00a0results (\u00a0electrocardiogram\u00a0) that may indicate to your doctor that you have an abnormality in your heart&#8217;s electrical activity called\u00a0QT\u00a0prolongation<\/li><li>dizziness, fainting (low\u00a0blood pressure\u00a0)<\/li><li>nosebleeds<\/li><li>sore throat<\/li><li>cold sores (\u00a0stomatitis\u00a0)<\/li><li>nausea, vomiting<\/li><li>upper abdominal pain<\/li><li>hemorrhoids<\/li><li>abnormally heavy sweating<\/li><li>skin rash with flaky or scaly skin (exfoliative\u00a0dermatitis\u00a0)<\/li><li>back pain<\/li><li>joint pain (\u00a0arthralgia\u00a0)<\/li><li>fever<\/li><li>thirst, high urine output, dark urine, dry red-flaming skin (signs of high blood sugar, so-called\u00a0hyperglycemia\u00a0)<\/li><li>muscle weakness, drowsiness, confusion, seizures, decreased level of consciousness (signs of high sodium in the blood, so-called\u00a0hypernatremia\u00a0)<\/li><li>muscle weakness, muscle cramps, abnormal heart rhythm (signs of low potassium in the blood, so-called\u00a0hypokalaemia\u00a0)<\/li><li>bruising and bleeding (abnormal blood clotting)<\/li><li>abnormal blood test results that may indicate to your doctor how well certain parts of the body are functioning: high\u00a0ALT\u00a0and\/or\u00a0AST\u00a0values \u200b\u200b(\u00a0alanine aminotransferase\u00a0and\u00a0aspartate\u00a0aminotransferase, respectively ) (showing liver function)<\/li><\/ul>\n\n\n\n<p><strong>Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>upper respiratory tract infection<\/li><li>nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness, and twitching (signs of high calcium in the blood, so-called\u00a0hypercalcemia)<\/li><li>fainting<\/li><li>uncontrolled tremors in the body<\/li><li>headache, dizziness (high\u00a0blood pressure\u00a0)<\/li><li>fast heartbeat (sinus tachycardia)<\/li><li>fluid accumulation around the heart, which in severe cases can impair the heart&#8217;s ability to pump blood (fluid outflow into the pericardium)<\/li><li>accumulation of fluid in the lungs\/chest cavity, as if severe, may make you short of breath (pleural effusion)<\/li><li>sore throat and runny nose (runny nose)<\/li><li>swollen eyelids<\/li><li>discomfort in the anus and rectum<\/li><li>abdominal pain, nausea, vomiting, constipation (abdominal discomfort)<\/li><li>dry skin<\/li><li>eye pain, blurred vision, photosensitivity (\u00a0keratitis\u00a0)<\/li><li>neck pain<\/li><li>skeletal pain<\/li><li>pain in legs and arms<\/li><li>weight gain<\/li><li>blood clot in the catheter<\/li><li>abnormal blood test results that may indicate to your doctor how well certain parts of the body are functioning: high\u00a0uric acid content<\/li><\/ul>\n\n\n\n<p><strong>Some\u00a0side effects\u00a0in patients with\u00a0ASM, SM\u00a0\u2011AHN, and MCL can be serious.<\/strong><\/p>\n\n\n\n<p>Tell your doctor, pharmacist, or nurse immediately if you get any of the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>weakness, bleeding or bruising without cause, frequent\u00a0infection\u00a0with fever, chills, sore throat, or cold sores (signs of low\u00a0blood cell count\u00a0)<\/li><li>fever, cough, difficulty breathing or pain when breathing, wheezing \/ breathing, chest pain when breathing (signs of\u00a0pneumonia\u00a0)<\/li><li>fever, cough with or without mucus, chest pain, difficulty breathing, or shortness of breath (signs of non-infectious\u00a0interstitial lung disease or\u00a0pneumonitis\u00a0)<\/li><li>infection, fever, dizziness, fainting, decreased urine output, rapid\u00a0pulse, rapid breathing (signs of sepsis or\u00a0neutropenic\u00a0sepsis)<\/li><li>vomiting, black or blood-mixed stools (signs of bleeding in the gastrointestinal tract)<\/li><\/ul>\n\n\n\n<p><strong>Other possible\u00a0side effects\u00a0are in patients with\u00a0ASM, SM\u00a0\u2011AHN, and MCL<\/strong><\/p>\n\n\n\n<p>Other&nbsp;side effects&nbsp;that may occur are listed below.&nbsp;If any of these&nbsp;side effects&nbsp;gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.<\/p>\n\n\n\n<p>Most of the&nbsp;side effects&nbsp;are mild to moderate and generally disappear after a few weeks of treatment.<\/p>\n\n\n\n<p><strong>Very common (may affect more than 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>urinary tract infection<\/li><li>upper respiratory tract infection<\/li><li>headache<\/li><li>dizziness<\/li><li>shortness of breath, labored breathing (\u00a0dyspnoea\u00a0)<\/li><li>cough<\/li><li>fluid accumulation in the lungs\/chest cavity, which if severe, can make you short of breath (pleural effusion)<\/li><li>abnormal\u00a0ECG\u00a0results (\u00a0electrocardiogram\u00a0) that may indicate to your doctor that you have an abnormality in your heart&#8217;s electrical activity called\u00a0QT\u00a0prolongation<\/li><li>nosebleeds<\/li><li>nausea, vomiting<\/li><li>diarrhea<\/li><li>constipation<\/li><li>swollen legs (calves, ankles)<\/li><li>severe fatigue<\/li><li>fever<\/li><li>thirst, high urine output, dark urine, dry red-flaming skin (signs of high blood sugar, so-called\u00a0hyperglycemia\u00a0)<\/li><li>yellow skin and eyes (signs of high\u00a0bilirubin\u00a0in the blood)<\/li><li>abnormal blood test results indicating possible problems with the pancreas (high\u00a0lipase\u00a0or amylase values) and the liver (high levels of\u00a0alanine aminotransferase\u00a0(\u00a0ALT\u00a0) or\u00a0aspartate aminotransferase\u00a0(\u00a0AST\u00a0))<\/li><\/ul>\n\n\n\n<p><strong>Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>uncontrolled tremors in the body<\/li><li>mucus cough, chest pain, fever (\u00a0bronchitis\u00a0)<\/li><li>cold sores due to viral infection (\u00a0oral\u00a0herpes\u00a0)<\/li><li>painful and frequent urination (\u00a0cystitis\u00a0)<\/li><li>the feeling of pressure or pain in cheeks and forehead (sinusitis)<\/li><li>red, raised, painful rash somewhere on the skin (rose fever)<\/li><li>shingles\u00a0(\u00a0herpes\u00a0zoster)<\/li><li>attention deficit disorder<\/li><li>dizziness with a tingling sensation (\u00a0vertigo\u00a0)<\/li><li>bruising (hematoma)<\/li><li>upset stomach, indigestion<\/li><li>the feeling of weakness (\u00a0asthenia\u00a0)<\/li><li>overindulge<\/li><li>general swelling (\u00a0edema\u00a0)<\/li><li>weight gain<\/li><li>contusions (bruises)<\/li><li>fall accidents<\/li><li>dizziness, fainting (low\u00a0blood pressure\u00a0)<\/li><li>sore throat<\/li><li>rapid weight gain<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Rydapt<\/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>No special temperature instructions.&nbsp;Store in the original package.&nbsp;Moisture sensitive.<\/li><li>Do not use this medicine if you notice that the packaging is damaged or appears to have been tampered with in any way.<\/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 packaging 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 midostaurin.\u00a0Each soft capsule contains 25 mg of midostaurin.<\/li><li>The other ingredients are macrogol glycerol hydroxy stearate (see \u201cRydapt contains macrogol glycerol hydroxy stearate (castor oil)\u201d in section 2), gelatin, macrogol,\u00a0glycerol, anhydrous\u00a0ethanol\u00a0(see \u201cRydapt contains anhydrous\u00a0ethanol\u00a0(alcohol)\u201d in section 2), mono-di\u00a0&#8211;\u00a0triglyceride\u00a0from corn oil, titanium dioxide (E171), all-rac-alpha-tocopherol, yellow iron oxide (E172), red iron oxide (E172), carmine (E120), hypromellose, propylene glycol, and purified water.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Rydapt 25 mg soft capsules (capsules) are bright orange, oblong capsules with \u201cPKC NVR\u201d in red.<\/p>\n\n\n\n<p>The capsules are available in blister packs packed in packs of 56 capsules (2 packs of 28 capsules each) or 112 <\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>capsules (4 packs of 28 capsules each).\u00a0Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Novartis Europharm Limited<\/p>\n\n\n\n<p>Vista Building<\/p>\n\n\n\n<p>Elm Park, Merrion Road<\/p>\n\n\n\n<p>Dublin 4<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Novartis Pharma GmbH<\/p>\n\n\n\n<p>Roonstrasse 25<\/p>\n\n\n\n<p>90429 Nuremberg<\/p>\n\n\n\n<p>Germany<\/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<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Belgium \/ Belgique \/ Belgien<\/strong>Novartis Pharma NVTel: +32 2 246 16 11<\/td><td><strong>Lithuania<\/strong>SIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>Novartis Bulgaria EOODTel: +359 2 489 98 28<\/td><td><strong>Luxembourg \/ Luxemburg<\/strong>Novartis Pharma NVTel: +32 2 246 16 11<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>Novartis sroTel: +420 225 775 111<\/td><td><strong>Hungary<\/strong>Novartis Hungary Kft.Tel .: +36 1 457 65 00<\/td><\/tr><tr><td><strong>Denmark<\/strong>Novartis Healthcare A \/ STel: +45 39 16 84 00<\/td><td><strong>Malta<\/strong>Novartis Pharma Services Inc.Tel: +356 2122 2872<\/td><\/tr><tr><td><strong>Germany<\/strong>Novartis Pharma GmbHTel: +49 911 273 0<\/td><td><strong>The Netherlands<\/strong>Novartis Pharma BVTel: +31 88 04 52 555<\/td><\/tr><tr><td><strong>Eesti<\/strong>SIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810<\/td><td><strong>Norway<\/strong>Novartis Norge ASTel: +47 23 05 20 00<\/td><\/tr><tr><td><strong>Greece<\/strong>Novartis (Hellas) AEBE:\u0397\u03bb: +30 210 281 17 12<\/td><td><strong>Austria<\/strong>Novartis Pharma GmbHTel: +43 1 86 6570<\/td><\/tr><tr><td><strong>Spain<\/strong>Novartis Pharmac\u00e9utica, SATel: +34 93 306 42 00<\/td><td><strong>Poland<\/strong>Novartis Poland Sp.&nbsp;z ooTel .: +48 22 375 4888<\/td><\/tr><tr><td><strong>France<\/strong>Novartis Pharma SASTel: +33 1 55 47 66 00<\/td><td><strong>Portugal<\/strong>Novartis Farma &#8211; Pharmaceutical Products, SATel: +351 21 000 8600<\/td><\/tr><tr><td><strong>Croatia<\/strong>Novartis Hrvatska dooTel.&nbsp;+385 1 6274 220<\/td><td><strong>Romania<\/strong>Novartis Pharma Services Romania SRLTel: +40 21 31299 01<\/td><\/tr><tr><td><strong>Ireland<\/strong>Novartis Ireland LimitedTel: +353 1 260 12 55<\/td><td><strong>Slovenia<\/strong>Novartis Pharma Services Inc.Tel: +386 1 300 75 50<\/td><\/tr><tr><td><strong>Iceland<\/strong>Vistor hf.Phone: +354 535 7000<\/td><td><strong>Slovak Republic<\/strong>Novartis Slovakia sroTel: +421 2 5542 5439<\/td><\/tr><tr><td><strong>Italy<\/strong>Novartis Farma SpATel: +39 02 96 54 1<\/td><td><strong>Finland \/ Finland<\/strong>Novartis Finland OyPuh \/ Tel: +358 (0) 10 6133 200<\/td><\/tr><tr><td><strong>\u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>Novartis Pharma Services Inc.:\u0397\u03bb: +357 22 690 690<\/td><td><strong>Sweden<\/strong>Novartis Sverige ABTel: +46 8 732 32 00<\/td><\/tr><tr><td><strong>Latvia<\/strong>SIA Novartis BalticsTel: +371 67 887 070<\/td><td><strong>United Kingdom (Northern Ireland)<\/strong>Novartis Ireland LimitedTel: +44 1276 698370<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Rydapt contains the active substance midostaurin. It belongs to a class of drugs called protein kinase inhibitors.<\/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":[2200,18529],"tags":[23565,23570,23561,23564,23566,23569,23562,23567,23563,23568],"class_list":["post-22554","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-benefits-of-midostaurin","tag-benefits-of-rydapt","tag-midostaurin","tag-midostaurin-side-effects","tag-rydapt","tag-rydapt-side-effects","tag-what-is-midostaurin","tag-what-is-rydapt","tag-what-midostaurin-is-used-for","tag-what-rydapt-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22554","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=22554"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22554\/revisions"}],"predecessor-version":[{"id":22589,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22554\/revisions\/22589"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22554"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22554"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22554"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}