25 mg soft capsules
midostaurin
What Rydapt is and what it is used for
What Rydapt is
Rydapt contains the active substance midostaurin. It belongs to a class of drugs called protein kinase inhibitors.
What Rydapt is used for
Rydapt is used to treat acute myeloid leukemia in adults who have a defect in the FLT3 gene. Acute myeloid leukemia (AML) is a form of cancer in some of the white blood cells (called myeloid blood cells ), where the body overproduces an abnormal type of these blood cells.
Rydapt is also used to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) in adults. In these diseases, too many mast cells are produced in the body, a type of white blood cell. Symptoms appear when too many mast cells enter organs such as the liver, bone marrow, or spleen, and release substances such as. histamine in the blood.
How Rydapt works
Midostaurin blocks the action of certain enzymes ( kinases ) in the abnormal cells and stops the division and growth of the cells.
At the beginning of the treatment of AML, Rydapt is always used in combination with chemotherapy (medicines used to treat cancer).
Ask your doctor, pharmacist, or nurse if you are wondering how Rydapt works or why it has been prescribed for you.
What you need to know before taking Rydapt
Follow your doctor’s instructions carefully. They may differ from the general information in this leaflet.
Do not take Rydapt
- if you are allergic to midostaurin or any of the other ingredients of this medicine (listed in section 6). Ask your doctor if you think you may be allergic.
- if you are already taking any of the following medicines:
- drugs used to treat tuberculosis, such as rifampicin;
- drugs used to treat epilepsy, such as carbamazepine or phenytoin;
- enzalutamide, a drug used to treat prostate cancer;
- St. John’s wort (also called Hypericum perforatum ), is a herbal remedy used to treat depression.
These medicines must be avoided during treatment with Rydapt. Talk to your doctor if you find out that you need to start taking one of them during treatment with Rydapt.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Rydapt:
- if you have an infection.
- if you have heart disease.
- if you have lung problems or have difficulty breathing.
- if you have kidney problems.
If you get any of the following symptoms while you are being treated with Rydapt, tell your doctor, pharmacist, or nurse immediately:
- if you have a fever, sore throat, or cold sore. This may mean that you have too few white blood cells.
- if you have new or worsening symptoms such as fever, cough with or without mucus formation, chest pain, difficulty breathing, or shortness of breath. This may be a sign of lung problems.
- if you have or experience pain or discomfort from the chest, fainting, fainting, dizziness, bluish lips, hands or feet, shortness of breath, swollen legs ( edema ), or swollen skin. This may be a sign of heart problems.
Your doctor may need to change your dose, take a break or stop treatment with Rydapt completely.
Check during treatment with Rydapt
Your doctor will take blood samples at regular intervals during treatment with Rydapt to check the number of blood cells ( white blood cells, red blood cells, and platelets ) and electrolytes (eg calcium, potassium, and magnesium ). You also check your heart and lung function.
Children and young people
Rydapt should not be used in children and adolescents under 18 years of age who are also receiving other chemotherapy, as it may cause a severe reduction in certain types of blood cells.
Other medicines and Rydapt
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines. Rydapt can affect the way some medicines work. Some other medicines may also affect the way Rydapt works.
The following medicines must be avoided during treatment with Rydapt:
- drugs against tuberculosis, e.g. rifampicin;
- antiepileptic drugs , e.g. carbamazepine or phenytoin;
- enzalutamide, a drug used to treat prostate cancer;
- St. John’s wort ( Hypericum perforatum ), is a herbal remedy used to treat depression.
Tell your doctor or pharmacist if you are taking any of the following medicines:
- certain medicines for infection, e.g. ketoconazole or clarithromycin;
- certain anti- HIV drugs , e.g. ritonavir or efavirenz;
- certain drugs used to treat depression, e.g. nefazodone or bupropion;
- certain drugs used to control blood cholesterol levels, e.g. atorvastatin or rosuvastatin;
- tizanidine, a drug used to relax muscles;
- chlorzoxazone, a drug used to treat muscle spasms.
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.
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.
Ask your doctor or pharmacist if you are not sure if any of your medicines are included in the above groups.
Pregnancy and breastfeeding
Rydapt can harm your unborn baby and is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Rydapt can harm your baby. You should not breastfeed during treatment with Rydapt and for at least 4 months after the end of treatment.
Contraceptives for women
If you become pregnant while taking Rydapt, it may harm your unborn baby. Your doctor will ask you for a pregnancy test before starting treatment with Rydapt to make sure you are not pregnant. You must use an effective method of contraception while taking Rydapt and for at least 4 months after stopping the medicine. You and your doctor will discuss which method of contraception is most suitable for you.
Tell your doctor immediately if you become pregnant or think you may be pregnant.
Fertility
Rydapt can reduce fertility in men and women. Discuss this with your doctor before starting treatment.
Driving and using machines
Take special care when driving and using machines as you may experience dizziness and dizziness while taking Rydapt.
Rydapt contains anhydrous ethanol (alcohol) and macrogol glycerol hydroxy stearate (castor oil)
Rydapt contains anhydrous ethanol (alcohol)
This medicine contains 666 mg of alcohol ( ethanol ) per 200 mg dose (maximum daily dose ), equivalent to 14% by volume of anhydrous ethanol. The amount in a dose of 200 mg of this medicine corresponds to 17 ml of beer or 7 ml of wine. The low amount of alcohol in this medicine does not produce any noticeable effects. Alcohol can be harmful if you have alcohol problems, epilepsy, or liver problems or if you are pregnant or breastfeeding.
Rydapt contains macrogol glycerol hydroxy stearate (castor oil)
This medicine contains macrogol glycerol hydroxy stearate, which may cause stomach upset and diarrhea.
How to take Rydapt
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Do not exceed the dose prescribed by your doctor.
How much Rydapt should you take?
Your doctor will tell you exactly how many capsules to take.
- Patients with AMLThe usual daily dose is 50 mg (2 capsules) twice daily.
- Patients with ASM, SM – AHN, or MCLThe usual daily dose is 100 mg (4 capsules) twice daily.
Depending on how you react to Rydapt, your doctor may reduce your dose or stop treatment temporarily.
How to take this medicine
- Take Rydapt at the same time each day to make it easier to remember.
- Take Rydapt twice a day at approximately 12-hour intervals (eg with breakfast and supper).
- Take Rydapt with food.
- Swallow the capsules whole with a glass of water. Do not open, crush or chew the capsules to ensure proper dosing and to avoid the unpleasant taste of the capsule contents.
- Patients with AML take Rydapt together with chemotherapy drugs. You must follow your doctor’s recommendations.
- If you vomit after swallowing the capsules, do not take any more capsules until the next dose.
How long should you take Rydapt?
- Continue to take Rydapt for as long as your doctor tells you to. Your doctor will check your condition at regular intervals to see if the treatment has the desired effect.
- 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.
- If you are being treated for ASM, SM – AHN, or MCL, you will receive Rydapt as a long-term treatment, perhaps for months or years.
Talk to your doctor or pharmacist if you are wondering how long to take Rydapt.
If you take more Rydapt than you should
If you take more than one capsule or if someone else takes your medicine, contact a doctor or go to the hospital immediately. Bring the medicine pack as medical treatment may be needed.
If you forget to take Rydapt
If you forget to take Rydapt, do not take the missed dose. Only take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose. Instead, wait until it’s time for the next dose.
If you stop taking Rydapt
If you stop taking Rydapt, your disease may get worse. Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Rydapt and tell your doctor immediately if you notice any of the following as it may be a sign of an allergic reaction:
- difficulty breathing or swallowing
- dizziness
- swelling of the face, lips, tongue, or throat
- severely itchy skin with red rashes or lumps
Some side effects in patients with AML can be serious.
Tell your doctor, pharmacist, or nurse immediately if you get any of the following:
- weakness, bleeding or bruising without cause, frequent infection with fever, chills, sore throat, or cold sores (signs of low blood cell count )
- fever, cough with or without mucus, chest pain, difficulty breathing, or shortness of breath (signs of non-infectious interstitial lung disease or pneumonitis )
- severe shortness of breath, strained and usually rapid breathing, dizziness, fainting, confusion, and extreme tiredness (signs of acute respiratory distress syndrome)
- infection, fever, low blood pressure, decreased urine output, fast heart rate, rapid breathing (signs of sepsis or neutropenic sepsis)
Other possible side effects are in patients with AML
Other side effects that may occur are listed below. If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Most of the side effects are mild to moderate and generally disappear after a few weeks of treatment.
Very common (may affect more than 1 in 10 people)
- infection at the site of the catheter
- red or purple, flat pin-sized dots on the skin ( petechiae )
- difficulty falling asleep (insomnia)
- headache
- shortness of breath, labored breathing ( dyspnoea )
- abnormal ECG results ( electrocardiogram ) that may indicate to your doctor that you have an abnormality in your heart’s electrical activity called QT prolongation
- dizziness, fainting (low blood pressure )
- nosebleeds
- sore throat
- cold sores ( stomatitis )
- nausea, vomiting
- upper abdominal pain
- hemorrhoids
- abnormally heavy sweating
- skin rash with flaky or scaly skin (exfoliative dermatitis )
- back pain
- joint pain ( arthralgia )
- fever
- thirst, high urine output, dark urine, dry red-flaming skin (signs of high blood sugar, so-called hyperglycemia )
- muscle weakness, drowsiness, confusion, seizures, decreased level of consciousness (signs of high sodium in the blood, so-called hypernatremia )
- muscle weakness, muscle cramps, abnormal heart rhythm (signs of low potassium in the blood, so-called hypokalaemia )
- bruising and bleeding (abnormal blood clotting)
- abnormal blood test results that may indicate to your doctor how well certain parts of the body are functioning: high ALT and/or AST values ( alanine aminotransferase and aspartate aminotransferase, respectively ) (showing liver function)
Common (may affect up to 1 in 10 people)
- upper respiratory tract infection
- nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness, and twitching (signs of high calcium in the blood, so-called hypercalcemia)
- fainting
- uncontrolled tremors in the body
- headache, dizziness (high blood pressure )
- fast heartbeat (sinus tachycardia)
- fluid accumulation around the heart, which in severe cases can impair the heart’s ability to pump blood (fluid outflow into the pericardium)
- accumulation of fluid in the lungs/chest cavity, as if severe, may make you short of breath (pleural effusion)
- sore throat and runny nose (runny nose)
- swollen eyelids
- discomfort in the anus and rectum
- abdominal pain, nausea, vomiting, constipation (abdominal discomfort)
- dry skin
- eye pain, blurred vision, photosensitivity ( keratitis )
- neck pain
- skeletal pain
- pain in legs and arms
- weight gain
- blood clot in the catheter
- abnormal blood test results that may indicate to your doctor how well certain parts of the body are functioning: high uric acid content
Some side effects in patients with ASM, SM ‑AHN, and MCL can be serious.
Tell your doctor, pharmacist, or nurse immediately if you get any of the following:
- weakness, bleeding or bruising without cause, frequent infection with fever, chills, sore throat, or cold sores (signs of low blood cell count )
- fever, cough, difficulty breathing or pain when breathing, wheezing / breathing, chest pain when breathing (signs of pneumonia )
- fever, cough with or without mucus, chest pain, difficulty breathing, or shortness of breath (signs of non-infectious interstitial lung disease or pneumonitis )
- infection, fever, dizziness, fainting, decreased urine output, rapid pulse, rapid breathing (signs of sepsis or neutropenic sepsis)
- vomiting, black or blood-mixed stools (signs of bleeding in the gastrointestinal tract)
Other possible side effects are in patients with ASM, SM ‑AHN, and MCL
Other side effects that may occur are listed below. If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Most of the side effects are mild to moderate and generally disappear after a few weeks of treatment.
Very common (may affect more than 1 in 10 people)
- urinary tract infection
- upper respiratory tract infection
- headache
- dizziness
- shortness of breath, labored breathing ( dyspnoea )
- cough
- fluid accumulation in the lungs/chest cavity, which if severe, can make you short of breath (pleural effusion)
- abnormal ECG results ( electrocardiogram ) that may indicate to your doctor that you have an abnormality in your heart’s electrical activity called QT prolongation
- nosebleeds
- nausea, vomiting
- diarrhea
- constipation
- swollen legs (calves, ankles)
- severe fatigue
- fever
- thirst, high urine output, dark urine, dry red-flaming skin (signs of high blood sugar, so-called hyperglycemia )
- yellow skin and eyes (signs of high bilirubin in the blood)
- abnormal blood test results indicating possible problems with the pancreas (high lipase or amylase values) and the liver (high levels of alanine aminotransferase ( ALT ) or aspartate aminotransferase ( AST ))
Common (may affect up to 1 in 10 people)
- uncontrolled tremors in the body
- mucus cough, chest pain, fever ( bronchitis )
- cold sores due to viral infection ( oral herpes )
- painful and frequent urination ( cystitis )
- the feeling of pressure or pain in cheeks and forehead (sinusitis)
- red, raised, painful rash somewhere on the skin (rose fever)
- shingles ( herpes zoster)
- attention deficit disorder
- dizziness with a tingling sensation ( vertigo )
- bruising (hematoma)
- upset stomach, indigestion
- the feeling of weakness ( asthenia )
- overindulge
- general swelling ( edema )
- weight gain
- contusions (bruises)
- fall accidents
- dizziness, fainting (low blood pressure )
- sore throat
- rapid weight gain
How to store Rydapt
- 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 carton and blister after EXP. The expiration date is the last day of the specified month.
- No special temperature instructions. Store in the original package. Moisture sensitive.
- Do not use this medicine if you notice that the packaging is damaged or appears to have been tampered with in any way.
- 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 packaging and other information
Content declaration
- The active substance is midostaurin. Each soft capsule contains 25 mg of midostaurin.
- The other ingredients are macrogol glycerol hydroxy stearate (see “Rydapt contains macrogol glycerol hydroxy stearate (castor oil)” in section 2), gelatin, macrogol, glycerol, anhydrous ethanol (see “Rydapt contains anhydrous ethanol (alcohol)” in section 2), mono-di – triglyceride from 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.
What the medicine looks like and the contents of the pack
Rydapt 25 mg soft capsules (capsules) are bright orange, oblong capsules with “PKC NVR” in red.
The capsules are available in blister packs packed in packs of 56 capsules (2 packs of 28 capsules each) or 112
capsules (4 packs of 28 capsules each). Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 88 04 52 555 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370 |