Coding & Reimbursement

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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.

For US Healthcare Professionals For Patients

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Product description and NDC

The following information, including NDC, may be important when writing a prescription for and/or completing a prior authorization for TURALIO.

Tablet Strength	Tablet Description	Packing Configuration	NDC
125 mg	White opaque body and powder blue opaque cap with black print “DSC521”	28 count bottle	65597-407-28
125 mg		120 count bottle	65597-407-20

Tablet Strength	125 mg
Tablet Description	White opaque body and powder blue opaque cap with black print “DSC521”
Packing Configuration	28 count bottle
Packing Configuration	120 count bottle
NDC	65597-407-28
NDC	65597-407-28

Diagnosis codes

TURALIO prescriptions require an appropriate ICD-10-CM code. The table displays possible ICD-10-CM codes for patients prescribed TURALIO. The completion and submission of coverage-related documentation are the responsibility of the patient and healthcare provider.

ICD-10-CM*^†

Code	Description
M12.2^‡	Villonodular synovitis (pigmented)
M12.20	Villonodular synovitis (pigmented), unspecified site
M12.28	Villonodular synovitis (pigmented), other specified site
M12.29	Villonodular synovitis (pigmented), multiple sites
M12.21^‡	Villonodular synovitis (pigmented), shoulder
M12.211	Villonodular synovitis (pigmented), right shoulder
M12.212	Villonodular synovitis (pigmented), left shoulder
M12.219	Villonodular synovitis (pigmented), unspecified shoulder
M12.22^‡	Villonodular synovitis (pigmented), elbow
M12.221	Villonodular synovitis (pigmented), right elbow
M12.222	Villonodular synovitis (pigmented), left elbow
M12.229	Villonodular synovitis (pigmented), unspecified elbow
M12.23^‡	Villonodular synovitis (pigmented), wrist
M12.231	Villonodular synovitis (pigmented), right wrist
M12.232	Villonodular synovitis (pigmented), left wrist
M12.239	Villonodular synovitis (pigmented), unspecified wrist
M12.24^‡	Villonodular synovitis (pigmented), wrist
M12.241	Villonodular synovitis (pigmented), right hand
M12.242	Villonodular synovitis (pigmented), left hand
M12.249	Villonodular synovitis (pigmented), unspecified hand
M12.25^‡	Villonodular synovitis (pigmented), hip
M12.251	Villonodular synovitis (pigmented), right hip
M12.252	Villonodular synovitis (pigmented), left hip
M12.259	Villonodular synovitis (pigmented), unspecified hip
M12.26^‡	Villonodular synovitis (pigmented), knee
M12.261	Villonodular synovitis (pigmented), right knee
M12.262	Villonodular synovitis (pigmented), left knee
M12.269	Villonodular synovitis (pigmented), unspecified knee
M12.27^‡	Villonodular synovitis (pigmented), ankle and foot
M12.271	Villonodular synovitis (pigmented), right ankle and foot
M12.272	Villonodular synovitis (pigmented), left ankle and foot
M12.279	Villonodular synovitis (pigmented), unspecified ankle and foot
M65.8^‡	Other synovitis and tynosynovitis
M65.80	Other synovitis and tynosynovitis, unspecified site
M65.81^‡	Other synovitis and tynosynovitis, shoulder
M65.811	Other synovitis and tynosynovitis, right shoulder
M65.812	Other synovitis and tynosynovitis, left shoulder
M65.819	Other synovitis and tynosynovitis, unspecified shoulder
M65.82^‡	Other synovitis and tynosynovitis, upper arm
M65.821	Other synovitis and tynosynovitis, right upper arm
M65.822	Other synovitis and tynosynovitis, left upper arm
M65.829	Other synovitis and tynosynovitis, unspecified upper arm
M65.83^‡	Other synovitis and tynosynovitis, forearm
M65.831	Other synovitis and tynosynovitis, right forearm
M65.832	Other synovitis and tynosynovitis, left forearm
M65.839	Other synovitis and tynosynovitis, unspecified forearm
M65.84^‡	Other synovitis and tynosynovitis, hand
M65.841	Other synovitis and tynosynovitis, right hand
M65.842	Other synovitis and tynosynovitis, left hand
M65.849	Other synovitis and tynosynovitis, unspecified hand
M65.85^‡	Other synovitis and tynosynovitis, thigh
M65.851	Other synovitis and tynosynovitis, right thigh
M65.852	Other synovitis and tynosynovitis, left thigh
M65.859	Other synovitis and tynosynovitis, unspecified thigh
M65.86^‡	Other synovitis and tynosynovitis, lower leg
M65.861	Other synovitis and tynosynovitis, right lower leg
M65.862	Other synovitis and tynosynovitis, left lower leg
M65.869	Other synovitis and tynosynovitis, unspecified lower leg
M65.87^‡	Other synovitis and tynosynovitis, lower leg
M65.871	Other synovitis and tynosynovitis, right ankle and foot
M65.872	Other synovitis and tynosynovitis, left ankle and foot
M65.879	Other synovitis and tynosynovitis, unspecified ankle and foot
M65.88	Other synovitis and tynosynovitis, other site
M65.89	Other synovitis and tynosynovitis, multiple sites
M65.9	Synovitis and tynosynovitis, unspecified
M67.9^‡	Unspecified disorder of synovium and tendon
M67.91^‡	Unspecified disorder of synovium and tendon, shoulder
M67.911	Unspecified disorder of synovium and tendon, right shoulder
M67.912	Unspecified disorder of synovium and tendon, left shoulder
M67.919	Unspecified disorder of synovium and tendon, unspecified shoulder
M67.92^‡	Unspecified disorder of synovium and tendon, upper arm
M67.921	Unspecified disorder of synovium and tendon, right upper arm
M67.922	Unspecified disorder of synovium and tendon, left upper arm
M67.929	Unspecified disorder of synovium and tendon, unspecified upper arm
M67.93^‡	Unspecified disorder of synovium and tendon, forearm
M67.931	Unspecified disorder of synovium and tendon, right forearm
M67.932	Unspecified disorder of synovium and tendon, left forearm
M67.939	Unspecified disorder of synovium and tendon, unspecified forearm
M67.94^‡	Unspecified disorder of synovium and tendon, hand
M67.941	Unspecified disorder of synovium and tendon, right hand
M67.942	Unspecified disorder of synovium and tendon, left hand
M67.949	Unspecified disorder of synovium and tendon, unspecified hand
M67.95^‡	Unspecified disorder of synovium and tendon, thigh
M67.951	Unspecified disorder of synovium and tendon, right thigh
M67.952	Unspecified disorder of synovium and tendon, left thigh
M67.959	Unspecified disorder of synovium and tendon, unspecified thigh
M67.96^‡	Unspecified disorder of synovium and tendon, lower leg
M67.961	Unspecified disorder of synovium and tendon, right lower leg
M67.962	Unspecified disorder of synovium and tendon, left lower leg
M67.969	Unspecified disorder of synovium and tendon, unspecified lower leg
M67.97^‡	Unspecified disorder of synovium and tendon, ankle and foot
M67.971	Unspecified disorder of synovium and tendon, right ankle and foot
M67.972	Unspecified disorder of synovium and tendon, left ankle and foot
M67.979	Unspecified disorder of synovium and tendon, unspecified ankle and foot
M67.98^‡	Unspecified disorder of synovium and tendon, other site
M67.99^‡	Unspecified disorder of synovium and tendon, multiple sites
D21.1^‡	Benign neoplasm of connective and other soft tissue of upper limb, including shoulder
D21.10	Benign neoplasm of connective and other soft tissue of unspecified upper limb, including shoulder
D21.11	Benign neoplasm of connective and other soft tissue of right upper limb, including shoulder
D21.12	Benign neoplasm of connective and other soft tissue of left upper limb, including shoulder
D21.2^‡	Benign neoplasm of connective and other soft tissue of lower limb, including hip
D21.20	Benign neoplasm of connective and other soft tissue of unspecified lower limb, including hip
D21.21	Benign neoplasm of connective and other soft tissue of right lower limb, including hip
D21.22	Benign neoplasm of connective and other soft tissue of left lower limb, including hip
D21.9	Benign neoplasm of connective and other soft tissue, unspecified
D36.0	Benign neoplasm of lymph nodes
D36.1^‡	Benign neoplasm of peripheral nerves and autonomic nervous system
D36.11	Benign neoplasm of peripheral nerves and autonomic nervous system of face, head and neck
D36.12	Benign neoplasm of peripheral nerves and autonomic nervous system, upper limb, including shoulder
D36.13	Benign neoplasm of peripheral nerves and autonomic nervous system of lower limb, including hip
D36.14	Benign neoplasm of peripheral nerves and autonomic nervous system of thorax
D36.15	Benign neoplasm of peripheral nerves and autonomic nervous system of abdomen
D36.16	Benign neoplasm of peripheral nerves and autonomic nervous system of pelvis
D36.17	Benign neoplasm of peripheral nerves and autonomic nervous system of trunk, unspecified
D36.7	Benign neoplasm of other specified sites
D36.9	Benign neoplasm, unspecified site
D48.1	Neoplasm of uncertain behavior of connective and other soft tissue

*International Classification of Diseases, Tenth Revision, Clinical Modification.

^†A joint effort between the healthcare provider and the coder is essential to achieve complete and accurate documentation, code assignment, and reporting of diagnoses and procedures. This guidance has been developed to assist both the healthcare provider and the coder in identifying those diagnoses that are to be reported. The importance of consistent, complete documentation in the medical record cannot be overemphasized. Without such documentation, accurate coding cannot be achieved. The entire record should be reviewed to determine the specific reason for the encounter and the conditions treated.

^‡This is a nonbillable diagnosis code that indicates a subcategory. For reporting purposes, only codes with the full number of required characters are permissible.

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.

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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.

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