Instructions for Sonidegib

1. Common name: Solideji

Product name: Odomzo

All names: Sonidegib, Sonidegib, Sonidegib, Sonidegib, Oxidol

2. Indications:

Sonidegib is indicated for adult patients with locally advanced basal cell carcinoma (BCC) who have recurred after surgery or radiotherapy, or who are not suitable for surgery or radiotherapy.

3. Usage and dosage:

1. Before use: Before patients start treatment with solidegib, the pregnancy status of women of reproductive potential should be verified, and all patients should obtain serum creatine kinase (CK) levels and renal function tests.

2. Recommended dose: The recommended dose of solidegib is 200 mg, taken orally once a day on an empty stomach, at least 1 hour before or 2 hours after meals, until the disease worsens or unacceptable toxicity occurs. If a dose is missed, continue with the next scheduled dose.

3. Dosage adjustment:

(1) Interruption: For patients who experience severe or intolerable musculoskeletal adverse reactions, whose first serum CK increase is between 2.5 and 10 times the upper limit of normal (ULN), and whose recurrent serum CK increase is between 2.5 and 5 times ULN, the dose of solidagib should be interrupted. After the clinical signs and symptoms disappear, solidagib should be resumed at 200 mg per day.

(2) Permanent discontinuation: Solidegib should be permanently discontinued in patients with serum CK elevation greater than 2.5 times the ULN and worsening renal function, serum CK elevation greater than 10 times the ULN, recurrent serum CK elevation greater than 5 times the ULN, or recurrent severe or intolerable musculoskeletal adverse reactions.

4. Adverse reactions:

The safety of Solidegib was evaluated in BOLT compared with 200mg Common adverse reactions occurred more frequently in patients treated with solidegib 800 mg, including muscle cramps, alopecia, dysgeusia, fatigue, nausea, weight loss, decreased appetite, myalgia, pain, and vomiting. The most common adverse reactions, occurring in ≥10% of patients treated with Solidegib 200 mg, included muscle cramps, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, weight loss, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus. Two of 14 premenopausal women taking solidegib 200 mg or 800 mg once daily developed amenorrhea lasting at least 18 months.

5. Storage:

Solidegib is normally stored at 25°C (77°F); tolerance is 15°C to 30°C (59°F to 86°F).

6. Special groups:

1. Women: According to the mechanism of action of Solidegib and data from animal reproduction studies, taking Solidegib by pregnant women will cause harm to the fetus. Daily oral administration of Solidegib to pregnant rabbits can lead to miscarriage, complete fetal resorption or severe malformation. Therefore, it is recommended that women should not breastfeed during treatment with Solidegib and for 20 months after the last dose; women of reproductive potential should use effective contraception during treatment with Solidegib and for at least 20 months after the last dose.

2. Males: It is not clear whether solidegib is present in semen. Advise male patients to use condoms, even after vasectomy, to avoid potential drug exposure to pregnant partners and female partners of reproductive potential during treatment with solidegib and for at least 8 months after the last dose. Men should not donate semen during treatment with solidegib and for at least 8 months after the last dose.

7. Mechanism of action:

Solidagibis an inhibitor of the Hh pathway, and the hedgehog pathway is involved in many human cancers. Solidegibeffectively inhibits a regulatory factor calledsmoothened (Smo), preventing the function of the hedgehog pathway. As a result, tumors that rely on the hedgehog pathway cannot grow. Solidegib binds and inhibitsSmoothened, a transmembrane protein involved in Hh signal transduction.

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.