Cipla Lenvatol 4mg Lenvatol 4

Product Name: Lenvatinib 4mg

Specification: 10 tablets/box

Manufacturer: Cipla Ltd. (India)

[Product Overview]

Lenvatinib is a receptor kinase inhibitor. It is a multi-targeted therapeutic agent acting on several targets: VEGFR-1, VEGFR-2, VEGFR-3, FGFR1, PDGFR, cKit, and Ret. As a multi-targeted therapy, Lenvatinib combats cancer cell activity through two primary mechanisms: 1. Inhibiting tumor proliferation; and 2. Inhibiting angiogenesis and excessive growth signaling pathways, thereby achieving tumor regression. Currently, it is utilized in the treatment of various cancer types, including thyroid cancer, renal cancer, and liver cancer.

[Product Highlights]

Lenvatinib is an oral multi-targeted inhibitor of vascular endothelial growth factor receptors 1–3 (VEGFR 1-3), fibroblast growth factor receptors 1–4 (FGFR 1-4), platelet-derived growth factor receptor alpha (PDGFRα), RET, and KIT. It has received FDA approval for the treatment of differentiated thyroid cancer and advanced renal cell carcinoma. Recent data indicate that, as a first-line treatment for unresectable hepatocellular carcinoma (uHCC), Lenvatinib is non-inferior to Sorafenib in terms of Overall Survival (OS). Furthermore, within the Asia-Pacific population, first-line Lenvatinib treatment for liver cancer demonstrated superior OS benefits compared to Sorafenib. As a first-line therapeutic regimen for uHCC, Lenvatinib demonstrated significantly superior outcomes compared to Sorafenib regarding Progression-Free Survival (PFS), Time to Progression (TTP), and Objective Response Rate (ORR).

[Usage and Dosage]

Recommended Dosage:

1) For patients with thyroid cancer: 24 mg orally, once daily.

2) For patients with renal cell carcinoma: 18 mg Lenvatinib + 5 mg Everolimus orally, once daily.

3) For patients with severe renal or hepatic impairment: For thyroid cancer patients—14 mg orally, once daily; for renal cell carcinoma patients—10 mg orally, once daily.4) Dosage for Hepatocellular Carcinoma: For patients weighing less than 60 kg, the dosage is 8 mg once daily; for patients weighing 60 kg or more, the dosage is 12 mg once daily.

【Precautions】

1) Take the medication at the same time each day.

2) If a dose is missed, take the missed dose immediately, provided that more than 12 hours remain before the next scheduled dose.

3) If less than 12 hours remain before the next scheduled dose, do not take the missed dose; simply resume the medication at the usual time and dosage.

4) Continue treatment until disease progression occurs or until intolerable toxic side effects develop.

【Indications】

1) Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer.

2) Lenvatinib, in combination with everolimus, is indicated for the treatment of advanced renal cell carcinoma following prior anti-angiogenic therapy.

【Adverse Reactions】

The most common side effects of Lenvatinib include hypertension, fatigue, diarrhea, joint and muscle pain (arthralgia/myalgia), decreased appetite, vomiting, excessive protein in the urine (proteinuria), swelling and pain in the palms and/or soles of the feet (hand-foot syndrome), abdominal pain, and changes in voice (dysphonia).

Lenvatinib can cause serious side effects, including heart failure, blood clots (arterial thromboembolic events), liver damage (hepatotoxicity), kidney damage (renal failure and impairment), gastrointestinal perforation or abnormal connections between the stomach or intestines (fistula formation), changes in electrical activity of the heart (QT interval prolongation), hypocalcemia, headaches accompanied by seizures and visual changes (reversible posterior leukoencephalopathy syndrome), severe bleeding (hemorrhage), potential risk to the unborn child if taken during pregnancy, and suppressive effects on thyroid-stimulating hormone production.

【Precautions】

1) Hypertension: Control blood pressure prior to initiating treatment. Withhold Lenvatinib for Grade 3 hypertension that persists despite optimal antihypertensive therapy; discontinue the drug for life-threatening hypertension.

2) Heart Failure: Monitor for clinical signs and symptoms of cardiac decompensation. Withhold Lenvatinib for Grade 3 cardiac dysfunction; discontinue the drug for Grade 4 cardiac dysfunction.

3) Discontinue the drug following a single arterial thromboembolic event.

4) Hepatotoxicity: Monitor liver function tests periodically during treatment. Withhold Lenvatinib for Grade 3 or greater hepatic impairment; discontinue the drug for hepatic failure.

5) Proteinuria: Monitor for proteinuria periodically during treatment. Withhold Lenvatinib for 24-hour urine protein levels ≥ 2 g; discontinue the drug for nephrotic syndrome.

6) Renal Failure and Impairment: Withhold Lenvatinib for Grade 3 or 4 renal failure or impairment.

7) Discontinue the drug in patients who develop gastrointestinal perforation or a life-threatening fistula.

8) Withhold Lenvatinib for Grade 3 or greater QT interval prolongation.

9) Hypocalcemia: Monitor blood calcium levels and administer calcium supplementation as needed.

10) Withhold Lenvatinib in patients with Reversible Posterior Leukoencephalopathy Syndrome (RPLS) until complete resolution.

11) Hemorrhagic Events: Withhold Lenvatinib for Grade 3 hemorrhage or significant blood loss requiring transfusion; discontinue the drug for Grade 4 hemorrhage, or for blood loss resulting in debilitation, retinal or cerebral ischemia, or severe shock.

12) Impairment of Thyroid-Stimulating Hormone (TSH) Suppression: Monitor TSH levels monthly in patients with differentiated thyroid carcinoma (DTC) and adjust thyroid replacement therapy as necessary. 13) Embryo-Fetal Toxicity: May cause fetal harm.

[Use in Specific Populations]

Lactation: Discontinue breastfeeding.

Product Specifications

Product Name: Cipla Lenvatinib 4mg (Cipla Lenvatol 4mg) [This product is available for shipment from India only]

Common Name: Lenvatinib

Composition: Lenvatinib

Dosage Form: Tablets

Specification: 10 tablets/box

Manufacturer: Cipla Ltd. (India)

Indications: Lenvatinib is a receptor kinase inhibitor. It is a multi-targeted therapy acting on several targets: VEGFR-1, VEGFR-2, VEGFR-3, FGFR1, PDGFR, cKit, and Ret. As a multi-targeted agent, Lenvatinib inhibits cancer cell activity through two mechanisms: 1. Inhibiting tumor proliferation; 2. Inhibiting angiogenesis and excessive growth signaling, thereby achieving tumor regression. Currently, it is used in the treatment of various cancer types, including thyroid cancer, renal cell carcinoma, and hepatocellular carcinoma.

Dosage and Administration: Recommended Dosage:

1) For patients with thyroid cancer: 24 mg orally, once daily.

2) For patients with renal cell carcinoma: 18 mg Lenvatinib + 5 mg Everolimus orally, once daily.

3) For patients with severe renal or hepatic impairment: For thyroid cancer patients—14 mg orally, once daily; for renal cell carcinoma patients—10 mg orally, once daily.

4) Dosage for Hepatocellular Carcinoma: For patients weighing less than 60 kg, the dosage is 8 mg once daily; for patients weighing 60 kg or more, the dosage is 12 mg once daily.