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RYDAPT

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Overview

What is RYDAPT?

RYDAPT (midostaurin) is a multikinase inhibitor for oral use. The molecular formula for midostaurin is CHNO. The molecular weight is 570.65 g/mole. The chemical name of midostaurin is N-[(2S,3R,4R,6R)-3-Methoxy-2-methyl-16-oxo-29-oxa-1,7,17-triazaoctacyclo[12.12.2.12,6.07,28.08,13.015,19.020,27.021,26]nonacosa-8,10,12,14,19,21,23,25,27-nonaen-4-yl]-N-methylbenzamide. The chemical structure of midostaurin is shown below:

RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains polyoxyl 40 hydrogenated castor oil, gelatin, polyethylene glycol 400, glycerin 85%, dehydrated alcohol, corn oil mono-di-triglycerides, titanium dioxide, vitamin E, ferric oxide yellow, ferric oxide red, carmine, hypromellose 2910, propylene glycol, and purified water.



What does RYDAPT look like?



What are the available doses of RYDAPT?

Capsules: 25 mg ()

What should I talk to my health care provider before I take RYDAPT?

Lactation: Advise females not to breastfeed ()

How should I use RYDAPT?

RYDAPT is indicated, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by a FDA approved test

Limitations of Use

RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.

Select patients for the treatment of AML with RYDAPT based on the presence of FLT3 mutation positivity Information on FDA-approved tests for the detection of FLT3 mutation in AML is available at: http://www.fda.gov/CompanionDiagnostics.


What interacts with RYDAPT?

Sorry No Records found


What are the warnings of RYDAPT?

Sorry No Records found


What are the precautions of RYDAPT?

Sorry No Records found


What are the side effects of RYDAPT?

Sorry No records found


What should I look out for while using RYDAPT?

RYDAPT is contraindicated in patients with hypersensitivity to midostaurin or to any of the excipients Hypersensitivity reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment)


What might happen if I take too much RYDAPT?

Sorry No Records found


How should I store and handle RYDAPT?

Store at 20° to 25°C (68° to 77° F). [See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.RYDAPT 25 mg capsulesPale orange oblong soft capsule with red ink imprint ‘PKC NVR’; available in:56 soft capsules………………………………………………………………………………………NDC 0078-0698-99 Contents: Each carton contains two inner packs, each with 28 capsules (7 blister cards with 4 capsules each) 112 soft capsules……………………………………………………………………………………..NDC 0078-0698-19Contents: Each carton contains four inner packs, each with 28 capsules (7 blister cards with 4 capsules each)Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Store in the original package to protect from moisture.RYDAPT 25 mg capsulesPale orange oblong soft capsule with red ink imprint ‘PKC NVR’; available in:56 soft capsules………………………………………………………………………………………NDC 0078-0698-99 Contents: Each carton contains two inner packs, each with 28 capsules (7 blister cards with 4 capsules each) 112 soft capsules……………………………………………………………………………………..NDC 0078-0698-19Contents: Each carton contains four inner packs, each with 28 capsules (7 blister cards with 4 capsules each)Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Store in the original package to protect from moisture.RYDAPT 25 mg capsulesPale orange oblong soft capsule with red ink imprint ‘PKC NVR’; available in:56 soft capsules………………………………………………………………………………………NDC 0078-0698-99 Contents: Each carton contains two inner packs, each with 28 capsules (7 blister cards with 4 capsules each) 112 soft capsules……………………………………………………………………………………..NDC 0078-0698-19Contents: Each carton contains four inner packs, each with 28 capsules (7 blister cards with 4 capsules each)Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Store in the original package to protect from moisture.RYDAPT 25 mg capsulesPale orange oblong soft capsule with red ink imprint ‘PKC NVR’; available in:56 soft capsules………………………………………………………………………………………NDC 0078-0698-99 Contents: Each carton contains two inner packs, each with 28 capsules (7 blister cards with 4 capsules each) 112 soft capsules……………………………………………………………………………………..NDC 0078-0698-19Contents: Each carton contains four inner packs, each with 28 capsules (7 blister cards with 4 capsules each)Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Store in the original package to protect from moisture.RYDAPT 25 mg capsulesPale orange oblong soft capsule with red ink imprint ‘PKC NVR’; available in:56 soft capsules………………………………………………………………………………………NDC 0078-0698-99 Contents: Each carton contains two inner packs, each with 28 capsules (7 blister cards with 4 capsules each) 112 soft capsules……………………………………………………………………………………..NDC 0078-0698-19Contents: Each carton contains four inner packs, each with 28 capsules (7 blister cards with 4 capsules each)Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Store in the original package to protect from moisture.RYDAPT 25 mg capsulesPale orange oblong soft capsule with red ink imprint ‘PKC NVR’; available in:56 soft capsules………………………………………………………………………………………NDC 0078-0698-99 Contents: Each carton contains two inner packs, each with 28 capsules (7 blister cards with 4 capsules each) 112 soft capsules……………………………………………………………………………………..NDC 0078-0698-19Contents: Each carton contains four inner packs, each with 28 capsules (7 blister cards with 4 capsules each)Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Store in the original package to protect from moisture.RYDAPT 25 mg capsulesPale orange oblong soft capsule with red ink imprint ‘PKC NVR’; available in:56 soft capsules………………………………………………………………………………………NDC 0078-0698-99 Contents: Each carton contains two inner packs, each with 28 capsules (7 blister cards with 4 capsules each) 112 soft capsules……………………………………………………………………………………..NDC 0078-0698-19Contents: Each carton contains four inner packs, each with 28 capsules (7 blister cards with 4 capsules each)Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Store in the original package to protect from moisture.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Midostaurin is a small molecule that inhibits multiple receptor tyrosine kinases. In vitro biochemical or cellular assays have shown that midostaurin or its major human active metabolites CGP62221 and CGP52421 inhibit the activity of wild type FLT3, FLT3 mutant kinases (ITD and TKD), KIT (wild type and D816V mutant), PDGFRα/β, VEGFR2, as well as members of the serine/threonine kinase PKC (protein kinase C) family.

Midostaurin demonstrated the ability to inhibit FLT3 receptor signaling and cell proliferation, and it induced apoptosis in leukemic cells expressing ITD and TKD mutant FLT3 receptors or overexpressing wild type FLT3 and PDGF receptors. Midostaurin also demonstrated the ability to inhibit KIT signaling, cell proliferation and histamine release and induce apoptosis in mast cells.

Non-Clinical Toxicology
RYDAPT is contraindicated in patients with hypersensitivity to midostaurin or to any of the excipients Hypersensitivity reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment)

See "" under .

Based on its mechanism of action and findings from animal reproduction studies, RYDAPT may cause fetal harm when administered to pregnant women. In animal studies, midostaurin caused embryo-fetal toxicities, including late embryo-fetal death and reduced fetal birth weight, with delays in fetal growth at doses lower than the recommended human dose. Advise pregnant women of the potential risk to the fetus. Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating RYDAPT therapy. Advise females of reproductive potential to use effective contraception during treatment with RYDAPT and for at least 4 months after the last dose. Advise males with female partners to use effective contraception during treatment with RYDAPT and for 4 months after the last dose

The following serious adverse reactions are described elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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