For:
Advanced Systemic Mastocytosis*
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 for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

Access

Patient Support

RYDAPT NOW—BROUGHT TO YOU BY PATIENT ASSISTANCE NOW ONCOLOGY


During advanced SM* treatment with RYDAPT, Care Coordinators are there to support your patients:

  • Assisting your patients with access to RYDAPT® (midostaurin) capsules 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
     

*Aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) are collectively referred to as advanced systemic mastocytosis (SM).


RYDAPT NOW Access Program

If you prescribe RYDAPT for aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL), your patients may be eligible to receive a free 28-day supply of RYDAPT shipped directly to their home or another convenient location.

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 and Patient Assistance Now Oncology

PANO Service Request Form

Novartis Oncology is committed to simplifying access to patient support. That’s why you can now generate a streamlined Service Request Form (SRF) customized to your patient’s medication.

The PANO SRF is a single form with 2 parts:

  • The patient
  • The health care professional (HCP)

Both parts must be fully completed and submitted to open a case. No follow-up is necessary. PANO will:

  • Match the 2 parts
  • Contact the HCP once both parts are received or if the information submitted is incomplete

To access the HCP SRF, visit HCP.Novartis.com/Access.

 

Universal Co-Pay Program

Universal Co-pay Card

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, per product

Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who 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 Novartis Oncology Universal Co-pay Program by visiting Copay.NovartisOncology.com or calling 1-877-577-7756.

INDICATION for RYDAPT® (midostaurin) capsules.

Systemic Mastocytosis
RYDAPT is indicated for the treatment of adult patients with aggressive systemic  mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

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
Aggressive Systemic Mastocytosis (SM), SM With Associated Hematological Neoplasm, Mast Cell Leukemia
  • Most common adverse reactions (≥20%) excluding lab terms were nausea (82%), vomiting (68%), diarrhea (54%), edema (40%), musculoskeletal pain (35%), abdominal pain (34%), fatigue (34%), upper respiratory tract infection (30%), constipation (29%), pyrexia (27%), headache (26%), and dyspnea (23%)
  • Grade ≥3 adverse reactions (≥5%) excluding lab terms were fatigue (9%), sepsis (9%), gastrointestinal hemorrhage (9%), pneumonia (8%), diarrhea (8%), febrile neutropenia (7%), edema (7%), dyspnea (7%), nausea (6%), vomiting (6%), abdominal pain (6%), and renal insufficiency (5%)
  • Most common (≥10%) nonhematologic grade ≥3 lab abnormalities were hyperglycemia (nonfasting) (18%), lipase increase (18%), and hyperuricemia (11%)
  • Most common (≥20%) hematologic grade ≥3 lab abnormalities were thrombocytopenia (27%), neutropenia (22%), anemia (38%) and lymphopenia (27%)

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

*Aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) are collectively referred to as advanced systemic mastocytosis (SM).