What are the precautions for Sonidegib?

During treatment with Sonidegib, patients should pay attention to the occurrence of embryo-fetal toxicity, musculoskeletal adverse reactions, premature epiphyseal fusion and other events. Patients are advised not to donate blood or blood products while taking Solidegib and for at least 20 months after the last dose of Solidegib because their blood or blood products may be transfused to a woman of reproductive potential.

1. Embryo-Fetotoxicity:

Solidegib can result in embryonic-fetal death or severe birth defects when taken by pregnant women. In animal reproduction studies, solidegib was embryotoxic, fetotoxic, and teratogenic when maternal exposure was below the recommended human dose of 200 mg. Women are advised to use effective contraception during treatment with solidegib and for at least 20 months after the last dose. , male patients with a female partner should use condoms, even after vasectomy, during treatment with Solidegib and for at least 8 months after the last dose to avoid potential exposure of pregnant women or women of reproductive potential.

2. Musculoskeletal adverse reactions:

Solidegib and other drugs that inhibit the hedgehog (Hh) pathway are associated with musculoskeletal adverse reactions, which may be accompanied by an increase in serum creatine kinase (CK), of which 9% were reported as grade 3 or 4. The most common manifestations of musculoskeletal adverse reactions reported as adverse events were muscle cramps (54%), musculoskeletal pain (32%), and myalgia (19%). Sixty-one percent of patients had elevated serum CK laboratory values, and 8% had grade 3 or 4 serum CK elevations. Musculoskeletal pain and myalgia usually precede an increase in serum CK.

. Depending on the severity of symptoms, musculoskeletal adverse reactions or serum CK elevation may require temporary dose interruption or discontinuation. Inform patients initiating treatment with solidegib of the risk of muscle-related adverse reactions. Advise patients to promptly report any new unexplained muscle pain, tenderness, or weakness that occurs during treatment or that persists after discontinuation of Solidegib.

3. Premature fusion of epiphyses:

Premature epiphyseal fusion has been reported in pediatric patients exposed to solidegib and other Hh pathway inhibitors. Case reports of epiphyseal fusion progression despite discontinuation have been reported in pediatric patients receiving other Hh pathway inhibitors. Solidegib is not suitable for use in pediatric patients.

Solidagen is a new type of drug for treating diseases. Although the original drug Solidagen has been marketed in China, it has not yet entered the scope of medical insurance, and its price has not yet been determined. The Original drug Solidaget listed overseas, European version specificationsThe price per box of 200mg*30 tablets is around RMB 46,000 (the price may fluctuate due to the exchange rate), which is relatively expensive. The ingredients of the two drugs are basically the same. There is currently no generic version of Solidaget produced and marketed. For specific prices and drug information, please consult Yaodei Medical Consultants.