Regocent 40mg Tablet 1 Strip

✔️ Uses

• Colorectal Cancer (CRC): Regocent is prescribed for the treatment of metastatic colorectal cancer (CRC) in patients who have previously undergone chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan, along with anti-VEGF therapy. If the patient is RAS wild-type, an anti-EGFR therapy should have been tried.
• Gastrointestinal Stromal Tumors (GIST): Regocent is indicated for the management of locally advanced, unresectable, or metastatic GIST in patients who have previously been treated with Imatinib Mesylate and Sunitinib Malate.
• Hepatocellular Carcinoma (HCC): Regocent is recommended for patients suffering from hepatocellular carcinoma (HCC) who have already received treatment with Sorafenib.

✔️ Common side effects of Regocent include:

• Liver Toxicity: Can cause severe liver injury, sometimes fatal, especially in the first two months of treatment. Liver function tests should be regularly monitored.
• Infections: Increased risk of infections like urinary tract infections, pneumonia, and fungal infections, some of which can be fatal.
• Hemorrhage: Can increase the risk of bleeding, including life-threatening hemorrhages in vital organs.
• Gastrointestinal Issues: Perforations or fistulas in the gastrointestinal tract.
• Skin Reactions: Dermatological issues, including Hand-foot skin reaction (HFSR).
• Hypertension: Can cause a significant rise in blood pressure, especially during the first cycle of treatment.
• Cardiac Issues: Myocardial ischemia and infarction may occur in some patients.
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS): This syndrome, characterized by brain swelling, has been reported in a small number of patients.

✔️ Dosage and Administration:

The recommended dosage for Regocent is 160 mg, taken once daily (four 40 mg tablets) for the first 21 days of each 28-day treatment cycle. Treatment should continue until disease progression or if severe side effects occur. Regocent should be taken with a low-fat meal containing less than 600 calories and no more than 30% fat. The drug should be swallowed whole with water, and missing a dose should not be compensated by taking two doses on the same day.

✔️ Dose Modifications:

If dose adjustment is needed due to side effects, the dose should be reduced in increments of 40 mg, with the lowest recommended dose being 80 mg per day.

✔️ Pediatric Use:

Regocent is not approved for use in children under 18 years, as its safety and efficacy in this age group have not been established.

✔️ Drug Interactions:

• Strong CYP3A4 Inducers: Drugs like Rifampin, Phenytoin, and St. John’s Wort can lower the plasma concentration of Regocent, reducing its effectiveness. These combinations should be avoided.
• Strong CYP3A4 Inhibitors: Medications such as Clarithromycin, Grapefruit juice, and Ketoconazole can increase the plasma concentration of Regocent, leading to increased toxicity. These should also be avoided.
• BCRP Substrates: Regocent can raise the levels of BCRP substrates, such as Methotrexate and Fluvastatin. Patients should be closely monitored for toxicity.

✔️ Contraindications:

Regocent is contraindicated for individuals with a known hypersensitivity to Regorafenib or any of its components.

✔️ Pregnancy and Lactation:

• Pregnancy: Regocent should not be used during pregnancy due to potential fetal harm. Effective contraception is recommended for female patients during treatment and for two months after completion.
• Lactation: Regocent is not recommended during breastfeeding, as its effects on infants are unknown.

✔️ Overdose Effects:

In the event of an overdose, Regocent should be temporarily stopped, and supportive care should be provided. Common symptoms of overdose include dermatological issues, dysphonia, diarrhea, and fatigue. There is no known antidote for Regorafenib overdose.

✔️ Precautions and Warnings:

• Liver Function: Patients should be monitored for liver damage during the first two months of treatment.
• Infections and Hemorrhages: Close monitoring and withholding of the drug in case of severe infections or bleeding.
• Wound Healing: Regocent may impair wound healing; treatment should be discontinued two weeks before scheduled surgery.

✔️ Storage Conditions:

Store Regocent below 30°C in a cool, dry place, away from sunlight, and out of reach of children.