Instructions for Vismodegib

1. Common name: Vimodeji

Product name:Erivedge

All names: Vismodegib, Vismodegib, Vismodegib, Avide

2. Indications: Vismodegib (Vismodegib) is used to treat metastatic basal cell carcinoma or locally advanced basal cell carcinoma (BCC) that relapses after surgery or adult patients who are not suitable for surgery and radiotherapy.

3. Usage and dosage:

1. Before use: Patients should verify the pregnancy status of women with reproductive potential within 7 days before starting Vimodegib.

2. Recommended dose: The recommended dose of Vimodegib is 150 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

3. Dose adjustment: For intolerable adverse reactions, withhold for up to 8 weeks until symptoms improve or resolve.

Vimodageb should be permanently discontinued if a patient develops serious cutaneous adverse reactions (scarring), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS). Treatment should be interrupted for severe or intolerable musculoskeletal adverse reactions. For recurrent, severe, or intolerable musculoskeletal adverse reactions, vismodegib should be permanently discontinued.

4. Adverse reactions:

In clinical studies of vismodegib, the most common (≥10%) adverse reactions were muscle cramps, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgia, vomiting, and hypogeusia. Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia (4%), azotemia (2%), and hypokalemia (1%). After Vimodegib was put on the market, adverse events such as drug-induced liver injury, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reactions with eosinophilia and systemic symptoms (DRESS) have occurred.

5. Storage:

Vimodegib Usually At room temperatureStore at 20°C to 25°C (68°F to 77°F); tolerances are allowed between 15°C to 30°C (59°F to 86°F), bottles need to be kept tightly closed to prevent moisture.

6. Special groups:

1. Women: According to its mechanism of action and the results of animal reproduction studies, Vimodegib can cause harm to the fetus when used by pregnant women. Therefore, it is recommended that women of reproductive potential use effective contraception during treatment with vismodegib and for 24 months after the last dose; it is recommended that women not breastfeed during treatment with vismodegib and for 24 months after the last dose.

2、男性：维莫德吉存在于精液中。 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.

7. Mechanism of action:

Vimodegib is an inhibitor of theHedgehog pathway by binding to and inhibiting Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

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.