What are the precautions for Vismodegib?

In clinical studies of Vismodegib (Vismodegib) , warnings and precautions such as embryo-fetotoxicity, serious skin adverse reactions, musculoskeletal adverse reactions, and premature epiphyseal fusion have emerged.

1. Embryonic-Fetal Toxicity: Based on its mechanism of action, Vimodegib can cause embryonic-fetal death or severe birth defects when administered to pregnant women. In animal reproduction studies, vismodegib was embryotoxic, fetotoxic, and teratogenic at maternal exposures below human exposures (recommended dose is 150 mg once daily).

(1) Females: Verify the pregnancy status of females of reproductive potential within 7 days before starting Vimodegib. Advise females of reproductive potential to use effective contraception during treatment with vismodegib and for 24 months after the last dose.

(2) Males: Vimodeji is present in semen. Advise male patients to use condoms, even after vasectomy, to avoid drug exposure to pregnant partners and female partners of reproductive potential during treatment and for 3 months after the last dose of vismodegib; advise men not to donate semen during treatment with vismodegib and for 3 months after the last dose.

(3) Blood donation: Patients are advised not to donate blood or blood products during treatment with vismodegib and within 24 months after the last dose of drug treatment.

2. Serious skin adverse reactions: During treatment with Vimodegib, serious skin adverse reactions (scars) have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions may be life-threatening or cause death. Patients who experience these reactions should permanently discontinue vismodegib.

3. Musculoskeletal adverse reactions:Musculoskeletal adverse reactions have been reported with ERIVEDGE and other drugs that inhibit the hedgehog (Hh) pathway, possibly accompanied by increases in serum creatine phosphokinase (CPK), with the most common manifestations being muscle cramps and arthralgia. Baseline CPK and creatinine levels and clinical indications (e.g., if muscle symptoms are reported) will be obtained from patients prior to treatment. Depending on the severity of symptoms, musculoskeletal adverse reactions or serum CPK elevations may require temporary dose interruption or discontinuation.

4. Premature epiphyseal fusion: Premature epiphyseal fusion has been reported in pediatric patients exposed to vismodegib. In some cases, fusion progressed after discontinuation of the drug.

The original drug of Vimodegib is not currently on the market in the country, so it cannot be included in medical insurance. Overseas, Vimodegiboriginal drug has Turkish version and European version, specificationsThe price of 150mg*28 capsules per box may be around RMB 10,000-30,000 (the price may fluctuate due to the exchange rate). The price is very expensive, and there are currently no generic versions of Vimodegib. For more drug information and specific prices, please consult Yaodei Medical Consultants.