Treating Patients With TURALIO

There are important steps to take to get TURALIO to your appropriate adult patients. Take a look at the step-by-step process below.

TURALIO REMS Program1

Because of the risk of hepatotoxicity, TURALIO is available only through a Risk Evaluation and Mitigation Strategy (REMS) Program. Under TURALIO REMS, only certified healthcare providers and pharmacies may prescribe and dispense TURALIO. In addition, a registry is used to collect information about the effects of taking TURALIO over time. Patients must complete and sign an enrollment form for the TURALIO REMS Program and the registry.


Further information is available at turalioREMS.com or by telephone at 1-833-887-2546.


  • Review the TURALIO full Prescribing Information.
  • Review the Program
    Overview and the
    Prescriber Training.
  • Complete and submit the Prescriber Knowledge Assessment and the Prescriber Enrollment Form.
  • Assess the patients
    by obtaining liver
    tests (should precede
    initial patient visit).
    Test
    Please include all tests included on the REMS Patient Enrollment Form. To be compliant with the REMS, the following must be included: AST or SGOT, ALT or SGPT, GGT, TBIL, DBIL, and ALP.
    ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; DBIL, direct bilirubin; GGT, gamma-glutamyltransferase; SGOT, serum glutamic-oxaloacetic transaminase; SGPT, serum glutamic-pyruvic transaminase; TBIL, total bilirubin.
  • Counsel patients on the TURALIO REMS Patient Guide and TURALIO Medication Guide.
  • Note: Enroll and Prescribe steps may be completed concurrently.

    Enroll
    To have patients included in the patient registry, complete the TURALIO REMS Patient Enrollment Form, and then have them review and sign it.

    Prescribe
    Submit prescriptions to Biologics,
    via the Access Central Patient
    Enrollment form.

    Complete and submit online at
    turalioREMS.com.
    Or download forms and send
    completed forms by:
    Email
    Enroll@turalioREMS.com
    Fax
    1-833-TRL-REMS
    (1-833-875-7367)

    Enroll
    To have patients included in the patient registry, complete the TURALIO REMS Patient Enrollment Form, and then have them review and sign it.

    Complete and submit online at
    turalioREMS.com.
    Or download forms and send
    completed forms by:
    Email
    Enroll@turalioREMS.com
    Fax
    1-833-TRL-REMS
    (1-833-875-7367)

    Prescribe
    Submit prescriptions to Biologics,
    via the Access Central Patient
    Enrollment form.

  • Biologics will process the prescriptions, and the prescribers will be notified on resolution.
  • Patients receive TURALIO.

Monitor the patients’ liver tests and complete and submit the Patient Status Forms to the REMS Program according to the following schedule:

Liver function tests1

Patient Status Forms

Month 1 Weekly Once
Month 2 Weekly Once
Month 3 Every 2 weeks Once
Month 4 - -
Month 5 - -
Month 6 Once Once
Month 7 - -
Month 8 - -
Month 9 Once Once
Month 10 - -
Month 11 - -
Month 12 Once Once
After 1 year Every 3 months Every 6 months

Visit turalioREMS.com to complete Patient Status Forms and Liver Adverse Event Reporting Forms.

For more information, visit turalioREMS.com or call 1-833-887-2546.

TURALIO offers straightforward, twice-daily oral dosing for TGCT1

The recommended dose of TURALIO is 400 mg taken twice daily for a total of 800 mg per day. TURALIO should be taken on an empty stomach: no food or snack at least 2 hours before taking it and at least 1 hour after taking it.

Have patients follow these instructions when taking TURALIO:
  • It’s important to swallow capsules whole and not open, break, or chew them
  • If patients vomit or miss a dose of TURALIO, they should take the next dose at its scheduled time
Recommended starting dose 800 mg
total daily dose
400 mg twice daily
First dose reduction 600 mg
total daily dose
200 mg in the morning and
400 mg in the evening
Second dose reduction 400 mg
total daily dose
200 mg twice daily
Permanently discontinue TURALIO in patients who are unable to tolerate 200 mg orally twice daily.
  • The recommended dosage modifications for TURALIO for adverse reactions are summarized in Table 2 of the TURALIO full Prescribing Information
  • Avoid concomitant use of TURALIO with moderate or strong CYP3A inhibitors or UGT inhibitors during treatment with TURALIO. If concomitant use with a moderate or strong CYP3A inhibitor or UGT inhibitor cannot be avoided, reduce the TURALIO dose according to the recommendation in Table 3 of the TURALIO full Prescribing Information. If concomitant use of a moderate or strong CYP3A inhibitor or UGT inhibitor is discontinued, increase the TURALIO dose (after 3 plasma half-lives of the moderate or strong CYP3A inhibitor or UGT inhibitor) to the dose that was used before starting the inhibitor
  • The recommended dosage of TURALIO for patients with mild to severe renal impairment (creatinine clearance [CLcr] 15 to 89 mL/min estimated by Cockcroft-Gault using actual body weight) is 200 mg in the morning and 400 mg in the evening

Refer to TURALIO full Prescribing Information for additional dosing guidelines.

CYP3A, cytochrome P450, family 3, subfamily A; UGT, uridine diphosphate glucuronosyltransferase.

TURALIO prescribing at a glance

Download this helpful guide for you and your office staff.

Interested in TURALIO?

Request to speak with a Daiichi Sankyo representative to get more information and resources about TURALIO.