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Now approved in combination with azacitidine

For patients with newly diagnosed aml

TIBSOVO® is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

Prescribing Information Press Release more
Servier One

Patient support services

ServierONE Patient Support Services is a program that helps with access and financial assistance

ServierONE Patient Support Services for TIBSOVO® (ivosidenib tablets) includes:

  • Support with insurance coverage and reimbursement
  • Financial assistance to help patients pay for TIBSOVO
  • Prescription fulfillment through our network of specialty pharmacies and distributors

To enroll patients in ServierONE, visit ServierONE.com or call 1‑800‑813‑5905,
Monday through Friday, 8 AM to 6 PM ET.

Register online for the Commercial Co-Pay Program at ServierOne-copay.com.

Ordering and distribution network

National Drug Code (NDC)

NDCs Dosage strength Description
10-digit code: 72694-617-60
11-digit code: 72694-0617-60
250 mg/
tablet
250-mg tablet: Blue oval-shaped film-coated tablet debossed “IVO” on one side and “250” on the other side
The red zero converts the 10-digit NDC to the 11-digit NDC. Some payers may require each NDC to be listed on the claim. Payer requirements regarding the use of NDCs may vary. Electronic data exchange generally requires use of the 11-digit NDC.

Product information

How TIBSOVO supplied: 250-mg tablets, supplied in 60-count bottles (30-day supply) with a desiccant canister

Storage: Store at 20 to 25 ºC (68 to 77 ºF)

TIBSOVO® Bottle

Distribution network for TIBSOVO

TIBSOVO is only available through our specialty distributors and network specialty pharmacies.

Specialty distributors: TIBSOVO is available through specialty distributors for shipment directly to office- or hospital-based pharmacies.
Network specialty pharmacies: TIBSOVO ships directly from the specialty pharmacy to your patient’s home or preferred location.

TIBSOVO resources for you and your practice

TIBSOVO resources for your patients and their caregivers

These resources may be useful to patients and caregivers throughout treatment with TIBSOVO

 
 

INDICATIONS

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with:

Newly Diagnosed Acute Myeloid Leukemia (AML)

  • In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy
  • Adult patients with relapsed or refractory AML.
Indications & Important Safety Information

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.