Lenvat 4mg 30s Capsules lenvatinib

Lenvatinib (Lenvima), developed by Eisai Co., targets receptors such as VEGFR-1, VEGFR-2, VEGFR-3, FGFR1, PDGFR, cKit, and Ret. Its currently approved indications include hepatocellular carcinoma (liver cancer), thyroid cancer, and renal cell carcinoma (kidney cancer). In China, it is approved for the treatment of patients with unresectable hepatocellular carcinoma who have not previously received systemic therapy.

[Specification] 4 mg × 30 capsules (calculated based on the chemical formula C21H19ClN4O4)

[Dosage and Administration]

Once daily.

Take one hour before a meal or two hours after a meal.

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

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

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

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

Differentiated Thyroid Cancer

24 mg orally, once daily.

In actual clinical practice, most patients with thyroid cancer take 20 mg per day (i.e., two 10 mg capsules).

Renal Cell Carcinoma

18 mg Lenvatinib + 5 mg Everolimus orally, once daily.

Hepatocellular Carcinoma

The dosage of Lenvatinib for the treatment of hepatocellular carcinoma is based on the patient's body weight:

Body weight ≥ 60 kg: 12 mg/day; Body weight < 60 kg: 8 mg/day; orally, once daily.

Most patients can take 10 mg per day.

Sarcoma

Generally, a dosage of 20 mg or 18 mg is recommended.

A dosage of 14 mg may also be taken, with the choice determined by the individual patient's physical condition.

Indications:

1. Hepatocellular Carcinoma (HCC): For the treatment of patients with unresectable HCC.

2. Differentiated Thyroid Cancer: As monotherapy for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that is refractory to radioactive iodine.

3. Renal Cell Carcinoma: In combination with Everolimus, for the treatment of patients with advanced renal cell carcinoma who have previously received vascular endothelial growth factor (VEGF)-targeted therapy.

Method of Administration

Oral administration. This product should be taken at a fixed time each day, either on an empty stomach or with food.

This product should be swallowed whole. Alternatively, the product (without opening or crushing it) may be mixed with one tablespoon of water or apple juice in a glass to form a suspension. The capsule must remain in the liquid for at least 10 minutes and be stirred for at least 3 minutes to dissolve the capsule shell; the resulting suspension should then be swallowed. After ingestion, an equal amount of water or apple juice (one tablespoon) must be added to the glass, stirred several times, and the entire contents of the glass consumed.

If a patient misses a dose and is unable to take it within 12 hours, the missed dose should not be taken; the next dose should be taken at the regularly scheduled time.

Prior to adjusting the dosage of this product (e.g., by suspending or reducing the dose), adverse reactions such as nausea, vomiting, and diarrhea should be actively treated; gastrointestinal toxicities should be actively managed to minimize the risk of developing renal insufficiency or renal failure (see [Precautions]).

Monitoring, Dosage Adjustment, and Discontinuation: Management of certain adverse reactions may require temporary suspension of administration, dosage adjustment, or discontinuation of treatment with this product.

Mild to moderate adverse reactions (e.g., Grade 1 or 2) generally do not require suspension of administration, unless the patient remains intolerant despite active treatment.

Severe (e.g., Grade 3) or intolerable adverse reactions require suspension of administration until the adverse reaction improves to Grade 0–1 or returns to baseline.

Detailed information regarding dosage adjustments based on adverse reactions can be found in Table 1.

Detailed information regarding monitoring, dosage adjustment, and discontinuation can be found in Table 2.

Special Populations

Patients aged 75 years and older, Caucasian patients, female patients, or patients with more severe hepatic impairment appear to exhibit lower tolerability to this product. With the exception of patients with moderate to severe hepatic impairment or severe renal impairment, all patients with hepatocellular carcinoma should initiate treatment at a recommended starting dose of 8 mg (two 4 mg capsules for patients weighing <60 kg) or 12 mg (three 4 mg capsules for patients weighing ≥60 kg); subsequent dose adjustments should be made based on individual tolerability.

Patients with Hepatic Impairment

Among patients enrolled in clinical studies for hepatocellular carcinoma, no dose adjustment based on hepatic function is required for patients with mild hepatic impairment (Child-Pugh A). Data regarding patients with moderate hepatic impairment (Child-Pugh B) are currently limited; patients with mild to moderate hepatic impairment should use this product with caution under medical supervision and undergo close monitoring of hepatic function. No data are currently available for patients with severe hepatic impairment (Child-Pugh C); therefore, use of this product is not recommended in patients with severe hepatic impairment.

Patients with Renal Impairment

No dose adjustment based on renal function is required for patients with mild or moderate renal impairment. No data are currently available for patients with severe renal impairment; therefore, use of this product is not recommended in patients with severe renal impairment.

Pediatric Patients

No clinical data are currently available regarding the use of this product in children or adolescents under 18 years of age; therefore, use of this product is not recommended in this population.

Geriatric Patients

No adjustment to the starting dose based on age is required; however, data regarding patients aged ≥75 years are limited.

[Contraindications]

Patients with known hypersensitivity to any component of this product. Lactating women (see [Use in Pregnant and Lactating Women]).

[Drug Interactions]

Effects of Other Medicinal Products on Lenvatinib

Chemotherapeutic Agents

The co-administration of lenvatinib, carboplatin, and paclitaxel has no significant effect on the pharmacokinetics of any of these three agents.

Effects of Lenvatinib on Other Medicinal Products

No data are available to rule out the potential risk that this product may act as an inducer of gastrointestinal CYP3A4 or P-gp. This may lead to a decrease in the exposure of orally administered drugs that serve as substrates for CYP3A4/P-gp; therefore, this factor should be carefully considered when such drugs are co-administered to ensure therapeutic efficacy. Consequently, in patients receiving lenvatinib, CYP3A4 substrates known to have a narrow therapeutic index (e.g., astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids [ergotamine, dihydroergotamine]) should be used with caution.

Oral Contraceptives

It is currently unclear whether lenvatinib reduces the efficacy of hormonal contraceptives; therefore, women using oral hormonal contraceptives should employ an additional barrier method of contraception (see [Use in Pregnant and Lactating Women]).

Product Specifications

Product Name: Lenvat 4mg 30s Capsules (Lenvatinib) — 4mg x 30 capsules per box — Natco

Common Name: Lenvatinib

Active Ingredient: Lenvatinib

Dosage Form: Capsules

Specification: 4mg x 30 capsules per bottle

Manufacturer: Natco Pharma Ltd

Indications:

1. Hepatocellular Carcinoma (HCC): For the treatment of patients with unresectable HCC.

2. Differentiated Thyroid Cancer (DTC): As monotherapy for patients with locally recurrent or metastatic, progressive, radioiodine-refractory DTC.

3. Renal Cell Carcinoma (RCC): In combination with everolimus, for the treatment of patients with advanced RCC who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.

Usage and Dosage: Once daily.

Take one hour before a meal or two hours after a meal.

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

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

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 scheduled time and dosage.

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

Differentiated Thyroid Cancer (DTC):

24mg, orally, once daily.

In actual clinical practice, most thyroid cancer patients take 20mg per day (i.e., two 10mg capsules).

Renal Cell Carcinoma (RCC):

18mg Lenvatinib + 5mg Everolimus, orally, once daily.

Hepatocellular Carcinoma (HCC):

The dosage of Lenvatinib for HCC treatment is based on the patient's body weight:

Body weight ≥ 60kg: 12mg/day; Body weight < 60kg: 8mg/day; orally, once daily.

Most patients find that taking 10mg per day is sufficient.

Sarcoma:

Generally, a dosage of 20mg or 18mg is recommended.

A dosage of 14mg may also be taken, with the specific choice determined based on the individual patient's physical condition.