4mg Lenvatinib Mesilate Capsules Gastric Cancer Treatment Drugs

【Drug Name
Generic Name: Lenvatinib Mesylate Capsules

Trade name:Lenvima® LENVIMA®

English name: Lenvatinib Mesilate Capsules

Hanyu Pinyin: Jiahuangsuan Lunfatini Jiaonang

Indications

This product is suitable for:

1. patients with unresectable hepatocellular carcinoma who have not received prior systemic systemic therapy. The pivotal study of this product excluded patients with hepatocellular carcinoma that could be treated locally, for which there are no available study data.

2. patients with progressive, locally advanced or metastatic radioiodine-refractory differentiated thyroid cancer.

[Usage and Dosage

Recommended Dosage

Hepatocellular carcinoma

The recommended daily dose is 8 mg (two 4 mg capsules) once daily for patients <60 kg and 12 mg (three 4 mg capsules) once daily for patients ≥60 kg. Treatment should be continued until disease progression or intolerable toxicity occurs.

Differentiated Thyroid Cancer

The recommended daily dose is 24 mg (two 10 mg capsules and one 4 mg capsule) once daily. Treatment should be continued until disease progression or intolerable toxicity occurs.

Method of administration

This product is for oral use. It should be taken at a fixed time of day, either on an empty stomach or with food (see [Pharmacokinetics] in the leaflet).

The product should be swallowed whole, or it may be mixed (not opened or crushed) with a tablespoon of water or apple juice in a glass to form a suspension. The capsules must be left in the liquid for at least 10 minutes, stirred for at least 3 minutes to dissolve the capsule shell, and then the suspension swallowed. The same amount of water or apple juice (one tablespoon) must be added to the glass, stirred several times, and then all the liquid in the glass must be drunk.

If a patient misses a dose and is unable to take it within 12 hours, there is no need to make up the dose and the next dose should be taken at the regular dosing time.

Adverse reactions such as nausea, vomiting, and diarrhea should be treated aggressively before making dose adjustments (suspensions, reductions) to this product; gastrointestinal toxicity reactions should be treated aggressively to reduce the risk of renal insufficiency or renal failure (see Instruction Manual [PRECAUTIONS]).


Special Populations

Elderly patients

Patients 75 years of age and older, white patients, female patients, or patients with more severe hepatic insufficiency appear to be less tolerant of this product. Except for patients with moderate or severe hepatic insufficiency or severe renal insufficiency, all patients with hepatocellular carcinoma should begin treatment with the recommended starting dose of 8 mg (two 4 mg capsules, body weight <60 kg) or 12 mg (three 4 mg capsules, body weight ≥60 kg), after which the dose should be further adjusted based on individual tolerability.

Patients 75 years of age and older, patients of Asian ethnicity, patients with comorbidities (e.g., hypertension, hepatic insufficiency, or renal insufficiency), or patients weighing less than 60 kg appear to be less tolerant of this product. All patients with differentiated thyroid cancer, except those with severe hepatic or renal insufficiency, should start treatment at the recommended dose of 24 mg, after which the dose should be further adjusted according to individual tolerance.

Patients with hepatic insufficiency

In patients enrolled in clinical studies in hepatocellular carcinoma, in patients with mild hepatic insufficiency (Child-Pugh A), no dosage adjustment is required based on liver function, and there are limited data from studies in patients with moderate hepatic insufficiency (Child-Pugh B), so patients with mild-to-moderate hepatic insufficiency should be treated with caution and liver function should be closely monitored under the supervision of a physician. There are no studies in patients with severe hepatic insufficiency.

(There is no research data on patients with severe hepatic insufficiency (Child-Pugh C), and this product is not recommended for patients with severe hepatic insufficiency.

In patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic insufficiency, there is no need to adjust the starting dose based on liver function. In patients with severe hepatic insufficiency (Child-Pugh C), the recommended starting dose is 14 mg once daily. Further dose adjustments may be required based on individual tolerability.

Patients with Renal Insufficiency

In patients with mild or moderate renal insufficiency, no dose adjustment based on renal function is necessary. No study data are available for patients with severe renal insufficiency, and this product is not recommended for patients with severe renal insufficiency.

In patients with mild or moderate renal insufficiency, no starting dose adjustment is required based on renal function. For patients with severe renal insufficiency, the recommended starting dose is 14 mg once daily. Further dose adjustments may be required based on individual tolerability. No studies have been conducted in patients with end-stage renal disease; therefore, this product is not recommended for these patients.

Pediatric Patients

There are no clinical data on the use of this product in pediatric or adolescent patients under the age of 18 years and it is not recommended.

Adverse Reactions
Hepatocellular carcinoma

The most common adverse reactions observed in patients (≥20%) treated with lenvatinib are listed below in descending order of frequency:

Hypertension (45%), fatigue (44%), diarrhea (39%), decreased appetite (34%), weight loss (31%), arthralgia/myalgia (31%), abdominal pain (30%), palmar-plantar erythema syndrome (27%), proteinuria (26%), dyspraxia (24%), bleeding events (23%), hypothyroidism (21%), and nausea (20%).

Differentiated thyroid cancer

The most common adverse reactions (>30%) observed in patients treated with lenvatinib were (in descending order of frequency) hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight loss, nausea, oral mucositis, headache, vomiting, proteinuria, palmar-plantar erythema syndrome (PPE), abdominal pain, and dysphonia. The most common serious adverse reactions (at least 2%) were pneumonia (4%), hypertension (3%), and dehydration (3%).


[Storage].
Store at no more than 30°C.