10 Capsules 4mg Lenvatinib Hepatocellular Carcinoma Medication

【Drug Name】
Generic name: Lenvatinib mesylate capsules

Product name: LENVIMA®

English name: Lenvatinib Mesilate Capsules

Chinese Pinyin: Jiahuangsuan Lunfatini Jiaonang

【Indications】

This product is suitable for:

1. Patients with unresectable hepatocellular carcinoma who have not received systemic therapy in the past. Pivotal studies of this product excluded patients with hepatocellular carcinoma who were candidates for local therapy and for whom no study data are available.

2. Patients with progressive, locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.

【Dosage】

Recommended dosage

hepatocellular carcinoma

For patients weighing <60 kg, the recommended daily dose of this product is 8 mg (two 4 mg capsules) once daily; for patients weighing ≥ 60 kg, the recommended daily dose of this product is 12 mg (three 4 mg capsules) ), once a day. Treatment should be continued until disease progression or intolerable toxicity occurs.

differentiated thyroid cancer

The recommended daily dose of this product 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.

Dosing method

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

This product should be swallowed whole, or you can form a suspension by mixing this product (do not open or crush it) with a tablespoon of water or apple juice in a glass. The capsules must remain in the liquid for at least 10 minutes, stir for at least 3 minutes to dissolve the capsule shell, and then swallow the suspension. After drinking, you must add the same amount of water or apple juice (one tablespoon) to the glass, stir several times, and then drink all the liquid in the glass.

If a patient misses a dose and cannot take it within 12 hours, there is no need to take a missed dose and the next dose should be taken at the regular dosing time.

Before dose adjustment (suspension, reduction) of this product, adverse reactions such as nausea, vomiting and diarrhea should be actively treated; gastrointestinal toxic reactions should be actively treated to reduce the risk of renal insufficiency or renal failure (see instructions [ Precautions】).

【Dosage】

Recommended dosage

hepatocellular carcinoma

For patients weighing <60 kg, the recommended daily dose of this product is 8 mg (two 4 mg capsules) once daily; for patients weighing ≥ 60 kg, the recommended daily dose of this product is 12 mg (three 4 mg capsules) ) , once a day. Treatment should be continued until disease progression or intolerable toxicity occurs.

differentiated thyroid cancer

The recommended daily dose of this product 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.

Dosing method

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

This product should be swallowed whole, or you can form a suspension by mixing this product (do not open or crush it) with a tablespoon of water or apple juice in a glass. The capsules must remain in the liquid for at least 10 minutes, stir for at least 3 minutes to dissolve the capsule shell, and then swallow the suspension. After drinking, you must add the same amount of water or apple juice (one tablespoon) to the glass, stir several times, and then drink all the liquid in the glass.

If a patient misses a dose and cannot take it within 12 hours, there is no need to take a missed dose and the next dose should be taken at the regular dosing time.

Before dose adjustment (suspension, reduction) of this product, adverse reactions such as nausea, vomiting and diarrhea should be actively treated; gastrointestinal toxic reactions should be actively treated to reduce the risk of renal insufficiency or renal failure (see instructions [ Precautions ]) .

【Adverse reactions】
hepatocellular carcinoma

The most common adverse reactions observed in lenvatinib-treated patients (≥20%) are as follows, in descending order of frequency:

High blood pressure (45%), fatigue (44%), diarrhea (39%), decreased appetite (34%), weight loss (31%), joint pain/myalgia (31%), abdominal pain (30%), palmar pain plantar erythrodysesthesia syndrome (27%), proteinuria (26%), dysphonia (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 mucosa inflammation, headache, vomiting, proteinuria, palmoplantar erythrodysesthesia 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.