Bone and connective tissue cancer:

Indications for TURALIO:

Treatment of adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

Adult:

Swallow whole. Take on an empty stomach (at least 1hr before or 2hrs after a meal/snack). 400mg twice daily until disease progression or unacceptable toxicity. Mild to severe renal impairment (CrCl 15–89mL/min): 200mg in the AM and 400mg in the PM. Dose modifications for adverse reactions, concomitant strong CYP3A or UGT inhibitors, acid-reducing agents: see full labeling.

Children:

Not established.

Boxed Warning:

Hepatotoxicity.

Warnings/Precautions:

Risk of liver injury (may be fatal). Avoid in patients with pre-existing increased serum transaminases, total/direct bilirubin >ULN, or active liver or biliary tract disease, including increased ALP. Monitor LFTs prior to initiation, weekly for the first 8 weeks, every 2 weeks for the next month, and then every 3 months thereafter. Withhold and reduce dose or permanently discontinue based on severity of hepatotoxicity. Moderate to severe hepatic impairment. Embryo-fetal toxicity. Advise use of effective contraception during and for 1 month (females) or for 1 week (males w. female partners) after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after last dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Avoid concomitant other products known to cause hepatotoxicity. Potentiated by strong CYP3A (including grapefruit or grapefruit juice) or UGT inhibitors; avoid; if unavoidable, reduce Turalio dose. Antagonized by strong CYP3A inducers (including St. John's wort) or proton pump inhibitors (alternatively, can use antacids or H2-blockers); avoid.

Adverse Reactions:

Increased lactate dehydrogenase, hair color changes, fatigue, increased AST, decreased neutrophils, increased cholesterol, decreased lymphocytes, eye edema, increased ALP, increased ALT, decreased hemoglobin, rash, dysgeusia, decreased phosphate.

REMS:

YES

Generic Availability:

NO

How Supplied:

Caps—28, 120

Pricing for TURALIO

200mg capsule (Qty: 30)
Appx. price $4906
GoodRx