What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Rydapt (Midostaurin)
Prescription Required
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Product Details
Description
Rydapt (midostaurin) is an oral medication prescribed with other treatments for adults with newly diagnosed acute myeloid leukemia (AML). It is also used to treat adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematologic neoplasm (SM-AHN), or mast cell leukemia (MCL).
Rydapt is available in 25 mg capsules.
Fact Table
Formula
C35H30N4O4
License
US FDA, EMA
Bioavailability
57%
Legal status
Prescription only
Chemical Name
Midostaurin
Elimination half-life
20-40 hours
Dosage (Strength)
25 mg capsules
Pregnancy
Consult a doctor
Brands
Rydapt
Protein binding
98%
PubChem CID
9576885
MedlinePlus
a617037
ChEBI
63630
ATC code
L01XE39
DrugBank
DB09073
KEGG
D10561
Routes of administration
Oral
Directions
Take Rydapt exactly as prescribed by your doctor. Carefully read the medication guide that comes with your prescription.
Recommended dosing for AML: 50 mg by mouth two times a day with food.
Recommended dosing for ASM, SM-AHN, and MCL: 100 mg by mouth two times a day with food.
Rydapt storage: Keep Rydapt capsules in their original container at room temperature between 68°F and 77°F (20°C and 25°C). Keep the medication out of reach of children.
If you have any questions or concerns about Rydapt, talk to your doctor or pharmacist.
Ingredients
The active ingredient in Rydapt is midostaurin.
Inactive ingredients include carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E.
Contraindications
Patients who are allergic to Rydapt or to any of its ingredients should not take it.
Cautions
- Before you start taking Rydapt, tell your doctor about:
- All the prescription and over-the-counter medications you take
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Rydapt may cause harm to an unborn baby. Effective contraception is recommended for females of childbearing age and males with female partners who are of childbearing age during treatment with Rydapt and for 4 months after taking the final dose.
- Rydapt may cause pulmonary toxicity that can be fatal.
- Breastfeeding is not recommended.
Side Effects
Low white blood cell counts, nausea, sore or inflamed mouth or gut, vomiting, headache, bleeding spots under the skin, musculoskeletal pain, nose bleeds, device-related infection, high blood glucose, abnormal heart rhythms, upper respiratory tract infections, swelling, fatigue, constipation, shortness of breath, and fever are some common side effects associated with Rydapt. However, other side effects may also occur. Immediately inform your doctor of any side effects that bother you or won’t go away.
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Reference:
Rydapt. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14552
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