For:
Newly Diagnosed FLT3+ Acute Myeloid Leukemia (AML)
Important Safety Information:

CONTRAINDICATIONS
Do not use in patients with hypersensitivity to midostaurin or its excipients. Hypersensitivity reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and angioed…

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Indication: 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 an FDA-approved test.

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

Access

Patient Support

RYDAPT NOW—BROUGHT TO YOU BY PATIENT ASSISTANCE NOW ONCOLOGY

 

During FLT3+ AML treatment with RYDAPT® (midostaurin) capsules, Care Coordinators are there to support your patients:
  • Assisting your patients with access to RYDAPT as they transition between inpatient and outpatient settings
  • Offering support with insurance verification to help your patients understand how to get their medicine and what their financial responsibilities are
    • Providing information about prior authorization requirements
    • Initiating a benefits investigation in the inpatient setting in preparation for transitioning to the outpatient setting
  • Helping your patients find a pharmacy based on their insurance plan and get their medicine according to their plan’s guidelines
  • Providing information about financial assistance that may be available

RYDAPT NOW Access Program

If you prescribe RYDAPT for newly diagnosed FLT3+ AML based on the approved label, and there is a delay in your patients’ insurance coverage as they transition out of the hospital, they may be eligible to receive a free 14-day supply of RYDAPT shipped directly to their home to avoid disruption in their treatment.

No purchase of RYDAPT is required. Novartis cannot guarantee that every patient who enrolls in RYDAPT NOW will be successful in obtaining insurance coverage for treatment or will receive financial assistance.

To learn more about this support program and patient eligibility, or to enroll your patient, please call 1-800-282-7630.


RYDAPT NOW - Patient Assistance Now Oncology
How to enroll in RYDAPT NOW
 
OR
 
  • Call 1-800-282-7630 from 9 AM to 8 PM ET, Monday through Friday, to begin the enrollment process

Novartis Oncology Universal Co-Pay Program

Patients may be eligible for immediate co-pay savings on their next prescription of RYDAPT

 

  • Eligible patients with private insurance may pay $10 per month
  • Novartis will pay the remaining co-pay, up to $15,000 per calendar year*

*Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients that are enrolled in Medicare, Medicaid, or any other federal or state health care program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, visit CoPay.NovartisOncology.com or call 1-877-577-7756.

Encourage your patients to find out if they are eligible to enroll in the Universal Co-pay Program by visiting CoPay.NovartisOncology.com or calling 1-877-577-7756.

INDICATION for RYDAPT® (midostaurin) capsules

Acute Myeloid Leukemia
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 an FDA-approved test.

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

IMPORTANT SAFETY INFORMATION for RYDAPT® (midostaurin) capsules

CONTRAINDICATIONS
  • Do not use in patients with hypersensitivity to midostaurin or its excipients. Hypersensitivity reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and angioedema
WARNINGS AND PRECAUTIONS
Embryofetal Toxicity
  • Do not use during pregnancy. Midostaurin caused severe embryofetal abnormalities and death in animal studies
  • Verify pregnancy status of females of reproductive potential within 7 days prior to initiating RYDAPT
  • Advise females of reproductive potential to use effective contraception during treatment and for at least 4 months after the last dose
  • Males taking RYDAPT should use effective contraception with females of reproductive potential and pregnant women and for at least 4 months after the last dose
  • Pregnancy exposure registry to monitor pregnancy outcomes: Females who may have been exposed to RYDAPT during pregnancy, directly or through a male partner receiving RYDAPT, should contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 and/or at https://psi.novartis.com
Pulmonary Toxicity
  • Cases of interstitial lung disease and pneumonitis, some fatal, have occurred in patients treated with RYDAPT as monotherapy or with chemotherapy
  • Monitor patients for pulmonary symptoms. Discontinue RYDAPT in patients who experience signs or symptoms of interstitial lung disease or pneumonitis without an infectious etiology
ADDITIONAL CONSIDERATIONS
Lactation
  • Because of the potential for serious adverse reactions in breastfed infants from RYDAPT, advise women not to breastfeed during treatment with RYDAPT and for at least 4 months after the last dose
Infertility
  • Based on findings in animals, RYDAPT may impair fertility in females and males of reproductive potential. It is unknown whether these effects on fertility are reversible
Drug Interactions
  • Strong CYP3A4 Inducers: Avoid concomitant use as strong CYP3A4 inducers decrease exposure to midostaurin and may reduce efficacy
  • Strong CYP3A4 Inhibitors: Coadministration with strong CYP3A4 inhibitors may increase midostaurin concentrations and may increase the risk of toxicity. Monitor patients for increased risk of adverse reactions, especially during the first week of RYDAPT use in each chemotherapy cycle and the first week of consecutive RYDAPT administration. Consider alternative therapies that do not strongly inhibit CYP3A4 activity
ADVERSE REACTIONS
Acute Myeloid Leukemia
  • Most common adverse reactions (≥20%) were febrile neutropenia (83%), nausea (83%), mucositis (66%), vomiting (61%), headache (46%), petechiae (36%), musculoskeletal pain (33%), epistaxis (28%), device-related infection (24%), hyperglycemia (20%), and upper respiratory tract infection (20%)
  • Most frequent grade 3/4 adverse reactions (≥10%) were febrile neutropenia (84%), device-related infection (16%), and mucositis (11%)
  • Most common (≥10%) lab abnormalities were alanine aminotransferase increase (71%), hypernatremia (21%), and hypocalcemia (74%)

Please see full Prescribing Information for RYDAPT® (midostaurin) capsules.