The Food and Drug Administration approved Turalio (pexidartinib) capsules for the treatment of adult sufferers with symptomatic tenosynovial giant cell tumor (TGCT) related to severe morbidity or useful limitations and not responsive to improvement with surgery.
TGCT is a sporadic tumor that affects the synovium – a thin layer of tissue that covers the surface of the joint spaces and tendon sheaths. The tumor is unusually malignant but causes the synovium and tendon sheaths to thicken and overgrow, causing damage to surrounding tissue.
The prescribing knowledge for Turalio includes a Boxed Warning to inform health care professionals and sufferers concerning the risk of severe and probably deadly liver injury. Health care professionals ought to monitor liver checks previous to starting treatment and at specified intervals during treatment. If liver exams become abnormal, Turalio could have to be withheld, the dose reduced, or permanently suspended, depending on the severity of the liver injury. Turalio is offered solely through the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program.
Common side effects for patients taking Turalio had been elevated lactate, increased aspartate aminotransferase, loss of hair color, elevated alanine aminotransferase, and high cholesterol. Additional side effects included neutropenia, elevated alkaline phosphatase, decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and reduced phosphate.
The FDA advises health care professionals to advise females of reproductive age and males with a female partner of reproductive health to use effective contraception throughout remedy with Turalio. Women who’re pregnant or breastfeeding mustn’t take Turalio as a result of it could cause hurt to a developing fetus or newborn baby. Turalio must be distributed with a patient Medicine Guide that describes vital details about the drug’s uses and risks.
The FDA granted this application Breakthrough Therapy designation and Priority Review designation. Turalio additionally received Orphan Drug designation, which offers incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Turalio to Daiichi Sankyo.