Fruquin 5 mg (Fruquintinib 5 mg) Tablets

Introduction

Fruquin 5 mg (Fruquintinib) is a highly potent, oral, next-generation targeted oncology medication classified as a selective small-molecule inhibitor of Vascular Endothelial Growth Factor Receptors (VEGFR). Manufactured by Everest Pharmaceuticals Ltd. and supplied globally by Onco Solution, Fruquin represents a major therapeutic advancement for patients fighting advanced colorectal malignancies. By specifically targeting structural drivers of tumor blood vessel formation, Fruquin effectively starves cancer cells of oxygen and essential nutrients, offering a vital line of defense for patients who have progressed on standard therapies.

Indications

Fruquin 5 mg (Fruquintinib) is indicated for:

• Metastatic Colorectal Cancer (mCRC): Treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
• Refractory Disease: For patients whose disease has progressed following standard chemotherapy, targeted biological therapies, or trifluridine-tipiracil/regorafenib.

Pharmacology

Fruquintinib, the active ingredient in Fruquin, is a highly selective inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3 tyrosine kinases.

• Mechanism: It blocks the binding of VEGF ligands to their cell surface receptors, which shuts down the intracellular signaling cascades responsible for endothelial cell proliferation, migration, and lumen formation.
• Tumor Suppression: This targeted anti-angiogenic action directly inhibits tumor neo-vascularization (the formation of new blood vessels), restricting tumor volume expansion and suppressing metastatic dissemination. Its high selectivity for VEGFR kinases minimizes the off-target toxicities commonly associated with earlier multi-kinase inhibitors.

Dosage & Administration

Oral Administration for Adults:

• Standard Recommended Dose: 5 mg taken orally once daily.
• Treatment Cycle: Taken for 3 consecutive weeks followed by 1 week off (a 28-day complete cycle: 21 days on, 7 days off).
• Administration: Can be taken with or without food, preferably at the same time each day.
• Method: Swallow the 5 mg tablet whole with a full glass of water. Do not crush, split, dissolve, or chew the tablet.
• Missed Dose: If a dose is missed by less than 12 hours, the patient should take it immediately. If more than 12 hours have passed, skip the missed dose and resume the normal schedule the following day.

Drug Interactions

• Strong CYP3A Inducers: Avoid co-administration (e.g., Rifampin, Phenytoin, Carbamazepine) as they can significantly decrease fruquintinib plasma levels, drastically reducing its therapeutic efficacy.
• Moderate CYP3A Inducers: Co-administration may lower Fruquin concentrations; use with caution and monitor clinical response closely.
• Strong CYP3A Inhibitors: While fruquintinib is metabolized by multiple pathways, use caution when administered with strong inhibitors (e.g., Ketoconazole, Clarithromycin) due to a potential increase in systemic drug exposure.

Contraindications

• Hypersensitivity: Known severe hypersensitivity or allergic reaction to Fruquintinib or any of the structural components inside the tablet.
• Severe Active Bleeding: Contraindicated in patients experiencing severe gastrointestinal hemorrhage or other major active bleeding episodes.

Side Effects

Patients receiving Fruquin 5 mg may experience:

• Vascular: Hypertension (high blood pressure, which is common with anti-VEGF therapies).
• Dermatological: Hand-foot skin reaction (palmar-plantar erythrodysesthesia), dry skin, and hair thinning.
• Gastrointestinal: Diarrhea, nausea, stomatitis (mouth sores), decreased appetite, and abdominal pain.
• Systemic: Fatigue, asthenia (weakness), and dysphonia (voice changes/hoarseness).
• Laboratory Alterations: Proteinuria (protein in the urine) and elevated liver enzymes (ALT/AST).

Pregnancy & Lactation

• Pregnancy: Can cause severe fetal harm or embryo-fetal death. Females of reproductive potential must verify a negative pregnancy status prior to starting treatment and use highly effective contraception during therapy and for at least 2 weeks after the last dose.
• Lactation: Due to potential risks of serious adverse reactions in nursing infants, lactating women should not breastfeed during treatment and for at least 2 weeks after the final dose.

Precautions & Warnings

• Hypertension Management: Blood pressure should be well-controlled before starting Fruquin. Monitor blood pressure weekly during the first cycle and periodically thereafter.
• Hemorrhage Risks: Anti-angiogenic agents increase the risk of bleeding. Discontinue Fruquin permanently if severe or life-threatening hemorrhage occurs.
• Hand-Foot Skin Reaction (HFSR): Mild topical emollient creams or structural dose modifications may be required if severe palmar-plantar redness, peeling, or pain develops.
• Proteinuria Monitoring: Perform regular urinalysis before and during treatment. Temporarily suspend therapy if significant proteinuria (greater than or equal to 2 grams per 24 hours) is detected.
• Wound Healing Complications: Impaired wound healing can occur. Temporarily discontinue Fruquin at least 2 weeks prior to elective major surgery and do not resume for at least 2 weeks post-surgery until adequate healing is achieved.

Use in Special Populations

• Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment. It has not been sufficiently studied in patients with moderate to severe liver disease.
• Pediatric Use: Safety and effectiveness in children and adolescents under 18 years of age have not been established.

Overdose Effects

Symptoms of overdose may manifest as exaggerated adverse effects, including severe hypertension, severe hand-foot skin reactions, or advanced gastrointestinal distress. Treatment consists of immediate medical evaluation, drug discontinuation, and supportive symptomatic measures.

Storage

• Condition: Store at controlled room temperature (15°C to 30°C).
• Protection: Store in the original blister packaging or container to shield the tablets from moisture and direct heat. Keep securely out of reach of children.

Supplier Information

Onco Solution is a premier global oncology medicine supplier dedicated to bridging the gap in advanced cancer care. We ensure secure, reliable, and authentic global distribution of breakthrough therapies like Fruquin 5 mg. For clinical quotes or wholesale export inquiries, visit www.oncosolution.com.

Manufacturer Information

Fruquin 5 mg is manufactured by Everest Pharmaceuticals Ltd., a leading high-tech pharmaceutical company based in Bangladesh, globally recognized for its strict adherence to international standards in the production of specialized generic oncology medications.