LuciVemu Vemurafenib 240mg 56 tablets exported to China 3% customs VAT

LuciVemu Tablets Instructions

Please use under the guidance of a physician

Product Name: LuciVemu

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Vemurafenib tablets

English name: Vemurafenib tablets

Drug approval number: 06 L 1107/24

【Indications】

LuciVemu is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma who have a BRAF V600E mutation as detected by a U.S. Food and Drug Administration-approved test.

LuciVemu is indicated for the treatment of patients with Erdheim-Chester disease who have a BRAF V600 mutation.

Limitation of Use: LuciVemu is not indicated for the treatment of patients with wild-type BRAF melanoma.

【Usage and Dosage】

Confirm the presence of the BRAF V600E mutation in tumor samples prior to initiating treatment with LuciVemu.

Recommended dose: Take orally twice daily, 960 mg each time, approximately 12 hours apart, on an empty stomach or with meals.

【Specification】

240mg/tablet, 56 tablets/box.

【Contraindications】

none

【Warnings and precautions】

1. New or primary skin malignancies: Perform a dermatological assessment before starting treatment, every 2 months during treatment, and up to 6 months after discontinuation of LuciVemu. Continue treatment after excision without dose adjustment.

2. New non-cutaneous squamous cell carcinoma: Evaluate for symptoms or clinical signs of new non-cutaneous squamous cell carcinoma before starting treatment and regularly during treatment.

3. Other malignancies: Closely monitor patients receiving LuciVemu for signs or symptoms of other malignancies.

4. Tumor promotion in BRAF wild-type melanoma: BRAF inhibitors can increase cell proliferation.

5. Severe hypersensitivity reactions, including anaphylaxis and drug reactions, accompanied by eosinophilia and systemic symptoms (DRESS syndrome): LuciVemu should be discontinued for severe hypersensitivity adverse reactions.

6. Severe dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis: Patients with severe dermatologic diseases should stop taking LuciVemu.

7. QT interval prolongation: Monitor ECG and electrolytes before and during treatment. When QTc reaches or exceeds 500 milliseconds, suspend LuciVemu. Correct electrolyte abnormalities and control cardiac risk factors for QT interval prolongation.

8. Hepatotoxicity: Test liver enzymes and bilirubin before starting LuciVemu treatment and monitor monthly during treatment.

9. Photosensitivity: Patients are advised to avoid sunlight.

10. Severe ophthalmic reactions: Monitor for signs and symptoms of uveitis.

11. Embryo-fetal toxicity: May cause harm to the fetus. Inform women of the potential risk to the fetus and use effective contraception.

12. Radiation sensitization and radiation recall: severe cases have been reported.

13. Renal Failure: Measure serum creatinine prior to starting LuciVemu and monitor regularly during treatment.

14. Dupuytren's Contracture and Plantar Fasciatic Fibromatosis: Events should be managed by dose reduction, treatment interruption, or discontinuation.

【Adverse Reactions】

Melanoma: The most common adverse reactions (≥30%) were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma.

Erdheim-Chester Disease: The most common adverse reactions (>50%) were arthralgia, rash, maculopapular rash, alopecia, fatigue, QT interval prolongation on the electrocardiogram, and cutaneous papilloma.

【Drug Interactions】

Avoid coadministration of LuciVemu with strong CYP3A4 inhibitors or inducers.

CYP1A2 Substrates: LuciVemu can increase concentrations of CYP1A2 substrates. Avoid coadministration of LuciVemu and CYP1A2 substrates within the short therapeutic window. If coadministration cannot be avoided, monitor closely for toxicity and consider reducing the dose of the CYP1A2 substrate.

【Use by specific groups】

Lactation: Do not breast-feed while taking LuciVemu.

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.