TURALIO Access Central is now TURALIO4U. Our commitment to helping patients receive their prescribed TURALIO treatment remains the same. Learn More.

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Please see full Prescribing Information, Including Boxed Warning and Medication Guide

This information is intended for US healthcare professionals and/or healthcare professionals involved in healthcare reimbursement only.

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TURALIO Access Central is becoming
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During this time, you may see both program names in use.

Daiichi Sankyo remains dedicated to helping patients find financial assistance and resources to receive their medications with confidence. AccessCentral4U is here to provide support and information to help.

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TURALIO® (pexidartinib) Copay Program

The TURALIO Copay Program can help your patient with their out-of-pocket costs if they have commercial or private insurance.

Eligible patients may pay as little as $0 per prescription.

Qualifying patients may pay as little as $0 per prescription of TURALIO.

The patient must have commercial insurance coverage.

There are no income requirements for eligibility.

See below for full patient eligibility, Restrictions apply.
Copay Program

Easy enrollment

2 simple ways to enroll
If the patient is eligible, Biologics will enroll the patient and call your practice, so that you can inform the patient of their enrollment.  TURALIO4U may call your practice to address any issues with the copay assistance enrollment process.

OR

TURALIO Savings Program Terms and Conditions.
This program is available to eligible patients with commercial insurance. Patients participating in government healthcare insurance programs are not eligible, including patients participating in Medicare, Medicaid, Medigap, TRICARE, Veterans Affairs (VA), Department of Defense (DoD), or any state-funded programs. Eligible patients will be automatically reenrolled in the program on an annual basis contingent upon the patients ability to meet requirements set forth by the program. Amount paid under the program are not eligible for reimbursement by any third party. Patients may be required to notify their insurance company of any benefits received under the program The program is not insurance. Patients can enroll up to 30 days after the first TURALIO treatment and utilize a retroactive enrollment period for assistance on dates of service that took place prior to enrollment. The practice or patient must call TURALIO4U for assistance on retroactive enrollment. Daiichi Sankyo, Inc, reserves the right to rescind, revoke, or amend the program at any time, without notice.
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The completion and submission of coverage-related documentation are the responsibility of the patient and healthcare provider. Daiichi Sankyo, Inc. makes no representation or guarantee concerning coverage or reimbursement for any service or item. A completed form includes signatures from both the physician and the patient. Before submitting, please ensure all required information is provided.

Uninsured, underinsured, or Medicare enrollees who are unable to meet their out-of-pocket costs may be eligible for the TURALIO® (pexidartinib) Patient Assistance Program (PAP).

The TURALIO Patient Assistance Program may provide TURALIO at no cost for financially eligible patients who are uninsured or underinsured.

Do you have an uninsured or underinsured patient who needs financial assistance with their TURALIO treatment?

If you feel your patient may be eligible for PAP, complete the form and fax to 1-833-471-9988. This form does not need to be sent to Biologics for patients eligible for PAP.

Basic Eligibility Requirements

Patient has been denied coverage, is uninsured, or is functionally uninsured (denied prior authorization, formulary exclusion).

Additional terms and conditions apply.
Medicare enrollees may be eligible for the TURALIO Patient Assistance Program if they are unable to meet their 
out-of-pocket costs for TURALIO and meet the required income criteria.
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The completion and submission of coverage-related documentation are the responsibility of the patient and healthcare provider. Daiichi Sankyo, Inc. makes no representation or guarantee concerning coverage or reimbursement for any service or item. A completed form includes signatures from both the physician and the patient. Before submitting, please ensure all required information is provided.

Patients with government insurance

If your patient has government insurance (such as Medicare or Medicaid); there are outside, or third-party organizations, that may provide help with the cost of their medication. See Additional Support for a list of some of these organizations.

TURALIO® (pexidartinib) QuickStart Program

Patients experiencing a coverage delay greater than 5 business days may be eligible for the TURALIO QuickStart Program.

Getting started

When filling out the Patient Enrollment Form, completing the optional QuickStart prescription section will help expedite this process.
Eligible patients can receive a 14-day prescription at no cost.

Basic Eligibility Requirements

To be eligible, patients must:

Be new to TURALIO

Have commercial or government insurance

Be experiencing a coverage delay of 5 or more business days after submission of a completed prior authorization

Additional terms and conditions apply.
Please note that QuickStart prescriptions cannot be shipped until both the physician and patient have completed the REMS requirements, including signing the REMS Patient Enrollment Form.
Callout Image
The completion and submission of coverage-related documentation are the responsibility of the patient and healthcare provider. Daiichi Sankyo, Inc. makes no representation or guarantee concerning coverage or reimbursement for any service or item. A completed form includes signatures from both the physician and the patient. Before submitting, please ensure all required information is provided.

TURALIO® (pexidartinib) is available through Biologics.

Please submit prescriptions directly to Biologics via your preferred prescribing method (e-prescrlblng, fax, etc).
Biologics by McKesson
Phone: 1-800-850-4306
Fax: 1-800-823-4506

Need support?

Call Daiichi Sankyo AccessCentral4U today.

1-866-4-DSI-NOW (1-866-437-4669)
Mon – Fri, 8:00AM – 6:00PM ET, excluding holidays

Call Biologics (specialty pharmacy) with questions about TURALIO prescriptions and patient support

1-800-850-4306
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Important Safety Information SEE MORE

INDICATION

TURALIO® (pexidartinib) is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

WARNING: HEPATOTOXICITY

  • TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome.
  • Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity. Monitoring and prompt cessation of TURALIO may not eliminate the risk of serious and potentially fatal liver injury.
  • TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program.

CONTRAINDICATIONS:

None

WARNINGS AND PRECAUTIONS

Hepatotoxicity

  • Hepatotoxicity, including liver failure and life-threatening vanishing bile duct syndrome (VBDS), ductopenia, and symptomatic cholestasis (including severe pruritus) can occur in patients treated with TURALIO and can occur despite monitoring and prompt drug cessation.
  • The mechanism of cholestatic hepatotoxicity is unknown and its occurrence cannot be predicted. It is unknown whether liver injury can also occur in the absence of increased transaminases.
  • Of the first 609 patients who received TURALIO under the REMS program, 32 (5.3%) developed a liver injury event of concern, defined as any serious liver-related outcome or any liver abnormality that triggers drug discontinuation per the US Prescribing Information. These 32 patients developed liver toxicity within 71 days of the first dose of TURALIO; ten required hospitalization and two developed VBDS. Sixteen of the 32 patients had not fully recovered at the time of the analysis, including 6 patients followed for at least 6 months after discontinuation.
  • Among 768 patients who received TURALIO in clinical trials, there were two irreversible cases of cholestatic liver injury. One patient with advanced cancer and ongoing liver toxicity died and one patient with a confirmed case of VBDS required a liver transplant.
  • In ENLIVEN, 3 of 61 (5%) patients who received TURALIO developed signs of serious liver injury, defined as alanine aminotransferase (ALT) or alanine aminotransferase (AST) ≥3 × upper limit of normal (ULN) with total bilirubin ≥2 × ULN. In these patients, peak ALT ranged from 6 to 9 × ULN, peak total bilirubin ranged from 2.5 to 15 × ULN, and alkaline phosphatase (ALP) was ≥2 × ULN. ALT, AST, and total bilirubin improved to <2 Å~ ULN in these three patients 1 to 7 months after discontinuing TURALIO.
  • Avoid TURALIO in patients with preexisting increased serum transaminases, total bilirubin, or direct bilirubin (>ULN); or active liver or biliary tract disease, including increased ALP.
  • Monitor liver tests, including AST, ALT, total bilirubin, direct bilirubin, ALP, and gamma-glutamyl transferase (GGT), prior to initiation of TURALIO, weekly for the first 8 weeks, every 2 weeks for the next month and every 3 months thereafter.
  • Withhold and dose reduce, or permanently discontinue TURALIO based on the severity of the hepatotoxicity. Refer patients to a hepatologist if liver tests do not return to normal. Rechallenge with a reduced dose of TURALIO may result in a recurrence of increased serum transaminases, bilirubin, ALP or other signs of liver injury. Monitor liver tests weekly for the first month after rechallenge

TURALIO REMS

  • Requirements include: 1) prescribers must be certified by enrolling and completing training, 2) patients must complete and sign an enrollment form for inclusion in a patient registry, and 3) pharmacies must be certified and must dispense only to patients who are authorized (enrolled in the REMS patient registry).
  • Further information is available at www.TURALIOREMS.com or 1-833-887-2546.

Embryo-Fetal Toxicity

  • TURALIO may cause fetal harm when administered to a pregnant woman. Advise patients of reproductive potential of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to the initiation of TURALIO.
  • Advise females of reproductive potential to use an effective nonhormonal method of contraception. TURALIO can render hormonal contraceptives ineffective during treatment with TURALIO and for 1 month after the final dose.
  • Advise males with female partners of reproductive potential to use effective contraception during treatment with TURALIO and for 1 week after the final dose.

Potential Risks Associated with a High-Fat Meal

  • Taking TURALIO with a high-fat meal increases pexidartinib concentrations, which may increase the incidence and severity of adverse reactions, including hepatotoxicity.
  • Instruct patients to take TURALIO with a low-fat meal (approximately 11 to 14 grams of total fat) and to avoid taking TURALIO with a high-fat meal (approximately 55 to 65 grams of total fat).

ADVERSE REACTIONS

  • The most common adverse reactions (>20%) were increased lactate dehydrogenase (92%), increased AST (88%), hair color changes (67%), fatigue (64%), increased ALT (64%), decreased neutrophils (44%), increased cholesterol (44%), increased ALP (39%), decreased lymphocytes (38%), eye edema (30%), decreased hemoglobin (30%), rash (28%), dysgeusia (26%), and decreased phosphate (25%).

DRUG INTERACTIONS

  • Hepatotoxic products: Avoid coadministration in patients with increased serum transaminases, total bilirubin, or direct bilirubin (>ULN) or active liver or biliary tract disease.
  • Moderate or strong CYP3A inhibitors and UGT inhibitors: Concomitant use may increase pexidartinib concentrations. Reduce TURALIO dosage if concomitant use cannot be avoided.
  • Strong CYP3A inducers: Avoid concomitant use due to decreased pexidartinib concentrations.
  • Acid-reducing agents: Avoid concomitant use of proton pump inhibitors due to decreased pexidartinib concentrations. Use histamine-2 receptor antagonists or antacids if needed.
  • CYP3A substrates: Avoid concomitant use where minimal concentration changes may lead to serious therapeutic failure (e.g., hormonal contraceptives) due to decreased concentrations of CYP3A substrates.

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise not to breastfeed and for at least 1 week after the final dose.
  • Renal impairment: Reduce the dosage for patients with mild to severe renal impairment.
  • Hepatic impairment: Reduce the dosage for patients with moderate hepatic impairment. TURALIO has not been studied in patients with severe hepatic impairment.
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc, at 1-877-437-7763 or the FDA at 1-800-FDA-1088 or fda.gov/medwatch.
Please see accompanying Full Prescribing Information, including Boxed WARNING, and Medication Guide.