regomaks regorafenib tablets 40mg

[Drug Name] Regorafenib Tablets

[English Name] Regorafenib Tablets

[Specification] 40 mg × 28 tablets/box

[Manufacturer] State-owned Pharmaceutical Factory No. 2, Lao People's Democratic Republic

[Indications]

Regorafenib tablets are a kinase inhibitor indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy, and—in cases of KRAS wild-type status—anti-EGFR therapy.

[Dosage and Administration]

Recommended dosage: 160 mg orally once daily for the first 21 days of each 28-day cycle.

Take Regorafenib tablets with food (a low-fat breakfast).

[Specification] 40 mg/tablet, 28 tablets/box.

[Warnings and Precautions]

Hemorrhage: Permanently discontinue Regorafenib tablets in cases of severe or life-threatening hemorrhage.

Dermatologic toxicity: Interrupt, reduce the dose, or discontinue Regorafenib tablets based on the severity and duration of dermatologic toxicity.

Hypertension: Temporarily or permanently discontinue Regorafenib tablets for severe or uncontrolled hypertension.

Cardiac ischemia and infarction: Withhold Regorafenib tablets for new or acute cardiac ischemia/infarction; resume only after the acute ischemic event has resolved.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue Regorafenib tablets.

Gastrointestinal perforation or fistula: Discontinue Regorafenib tablets.

Wound healing complications: Stop using Regorafenib tablets prior to surgery. Discontinue use in patients with wound dehiscence.

Embryo-fetal toxicity: May cause fetal harm. Advise females of the potential risk to the fetus.

[Adverse Reactions]

The most common adverse reactions (≥30%) are asthenia/fatigue, decreased appetite and food intake, hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)], diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia. [Drug Interactions]

Potent CYP3A4 inducers: Avoid the use of potent CYP3A4 inducers.

[Use in Specific Populations]

Lactation: Weigh the benefits of the drug to the mother and the benefits of breastfeeding to the infant to decide whether to discontinue the drug or discontinue breastfeeding.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); brief excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.

[Manufacturer Profile]

Pharmaceutical Factory No. 2 (Pharma 2 Vientiane) of the Lao People's Democratic Republic (hereinafter referred to as "Lao Pharmaceutical Factory No. 2") is a state-owned pharmaceutical enterprise operating directly under the Lao Ministry of Health. Established in the 1970s, the factory boasts a history spanning over 40 years. It is the largest and oldest pharmaceutical manufacturer in Laos, offering the most comprehensive range of pharmaceutical products.

Lao Pharmaceutical Factory No. 2 supplies over 160 types of medicines annually to patients, including infusions, injections, oral tablets, oral capsules, oral syrups, and ointments. Keeping pace with the times, the factory actively explores new avenues and continuously introduces advanced international technologies. It seeks breakthroughs in production processes and drug research and development to ensure its capabilities align with international standards. Currently, the factory holds ISO 9001:2008 certification for its production processes. Its mission is to provide high-quality, internationally-standardized pharmaceutical products and services to an ever-growing number of customers and patients through continuous progress and active innovation. Specifications

Product Name: Regorafenib Tablets (40mg x 28 tablets/box)

Common Name: Regorafenib Tablets

Active Ingredient: Regorafenib

Dosage Form: Tablets

Specification: 40mg x 28 tablets/box

Manufacturer: State Pharmaceutical Factory No. 2, Lao PDR

Indications: Regorafenib is a kinase inhibitor indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy, and—in cases of KRAS wild-type status—anti-EGFR therapy.

Dosage and Administration: Recommended dose: 160 mg taken orally once daily for the first 21 days of each 28-day cycle.

Take Regorafenib tablets with food (a low-fat breakfast).