Lenvima hard capsules 4mg Eisai cancer treatment (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Lenvatinib

Ingredient

Composition information	Content
Lenvatinib	4mg

Uses

Indications

Lenvima drugs are indicated in the following cases:

Treatment of differential thyroid cancer (DTC).

Lenvatinib is a kinase inhibitor inhibiting the activity of the enzyme kinase on blood vessel growth factors (VEGF) at VEGFR1 receptors (FLT1), VEGFR2 (KDR) and VEGFR3 (FLT4). Lenvatinib inhibits other kinase related to the process of pathogenic formation, tumor growth and the progression of cancer in addition to their normal cell function, including fibrous cell growth factors (FGF) FGFR 1, 2, 3, and 4; The growth factor of the Alpha receptor platelet (PDGFRα), KIT and RET.

Lenvatinib also shows anti -proliferation activity in liver cell carcinoma cell lines depending on the FGFR signal activated with inhibition simultaneously the process of fgF 2α receptor receptor.

In the mouse tumor models, Lenvatinib reduces tumor-related macrophages, increases enabled cytotoxic T cells, and proves a larger anti-tumor activity in combination with PD-1 single-line antibodies compared to simple treatment.

The combination of lenvatinib and Everolimus shows that antibiotics increase and tumor anti -activity is shown by a decrease in human hyperplasia, the formation of tubular and VEGF signals in the test tube, and due to a decrease in tumor volume in the Xenograph mouse model on renal cancer cells in users 2 types larger than those who use only one type.

pharmacokinetic

absorption

The time for the drug reaches a maximum plasma concentration (TMAX) usually occurs from 1 to 4 hours after the last dose.

Interaction with food.

Use a high -fat meal (approximately 900 calories of which about 55% are from fat, 15% from protein and 30% from carbohydrates) does not affect the level of absorption, but reduces the speed of absorption and slows the average TMAX from 2 hours to 4 hours.

Distribution

The distribution model is predicted by the distribution volume of 97 L (% CV, 30.2%). Linking with lenvatinib protein is 97% to 99%, regardless of concentration and is not affected by liver or kidney function. The ratio of plasma blood concentration ranges from 0.59 to 0.61 at a concentration of 0.1 to 10 µg / ml in vitro.

Elimination

Lenvatinib's last sale time is approximately 28 hours.

Metabolism

The main metabolic paths of lenvatinib in humans are identified as enzyme dependent processes (CYP3A and aldehyde oxidase) and enzyme -dependent processes.

Excretion

10 days after only one -time Lenvatinib is used for radioactive isotopes, approximately 64% and 25% of radioactive isotopes are excreted through feces and urine.

Before taking Lenvima hard capsules 4mg Eisai cancer treatment (2 blisters x 10 tablets)

How to use

lenvima oral use.

Dosage

Single dose:

Differentiate thyroid cancer treatment (DTC): The recommended dose is 24mg/time daily.

Treatment of liver cell carcinoma (HCC): recommended dose based on actual body weight: 12mg/time for drinking daily for patients greater than or equal to 60kg or 8mg/time per day for patients under 60kg.

Treatment of endometrial carcinoma (EC): The recommended dose is 20mg/taken daily when combined with Pembrolizumab 200mg indicated in the form of intravenous injection for more than 30 minutes every 3 weeks.

Treatment of renal cell carcinoma (RCC): The recommended dose is:

20mg/Take daily with Pembrolizumab 200mg indicated in the form of intravenous injection for more than 30 minutes every 3 weeks.

18mg/Take every day with Everolimus 5mg/Take every day.

Adjust the recommended dose suitable for patients with liver function and impaired renal function.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Death from multi -organ dysfunction occurs in some patients using single dose of lenvima 120mg oral.

What to do when forgetting a dose? If it is nearly time to take the next dose, skip the forgotten dose and take medicine at the next recommended dose. Do not take double dose to compensate for the forgotten dose.

Side Effects

When using lenvima, you may experience unwanted effects (ADR)

In DTC, the most common side effects (ratio ≥ 20%) for lenvima are hypertension, fatigue, diarrhea, joint pain/muscle pain, reduced cravings, weight loss, nausea, stomatitis, headache, vomiting, proteinuria, leg syndrome, abdominal pain and shortness of breath.

In RCC:

The most common side effects (≥ 20%) for Lenvima and PembroLizumab are fatigue, diarrhea, musculoskeletal pain, hypothyroidism, hypertension, stomatitis, reduction of appetite, rash, nausea, weight loss, dyspnea, protein, hand syndrome, leg pain, hemorrhage, chestnut, acute pain, acute pain.

The most common side effect (≥ 30%) for lenvima and Everolimus is diarrhea, fatigue, joint pain/muscle pain, reducing cravings, nausea, vomiting, stomatitis, hypertension, peripheral edema, cough, pain, rash, weight loss, bleeding and protein.

In HCC, the most common side effect (≥ 20%) for Lenvima is hypertension, fatigue, diarrhea, reducing cravings, joint pain/muscle pain, weight loss, abdominal pain, hands - feet, protein, hemorrhage, hemorrhagic and nausea.

In the EC, the most common side effect (≥ 20%) for Lenvima and PembroLizumab are hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, reduced cravings, vomiting, stomatitis, weight loss, abdominal pain, urinary tract infections, protein, constipation, headache, hemorrhoids, storms, stiffness, stiffness.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Lenvima drug is contraindicated in cases of hypersensitivity to any component of the drug.

Precautions when using

Hypertension

Control blood pressure before treatment and monitoring during treatment. Temporarily stop with hypertension in 3rd despite optimizing the treatment of hypertension. Stop use for hypertension at level 4.

Heart dysfunction

Monitor clinical symptoms and signs of heart dysfunction. Temporarily suspend or stop use for cardiac dysfunction of degree 3. Stop use for cardiac dysfunction 4.

arterial thrombosis: Stop use after arterial thrombosis.

toxicity on the liver

Monitor liver function before treatment and periodic treatment during treatment. Temporarily suspend or stop use if toxicity on liver 3 or 4. Stop used for liver failure.

Kidney failure or impaired renal function: temporarily suspended or stopped treatment for renal failure or impaired renal function of 3 or 4.

proteinuria

monitor proteinuria before treatment and periodically during treatment. Temporarily suspend if proteinuria from 2 g or more every 24 hours. Stop treatment for nephrotic syndrome.

diarrhea

may be serious and relapse. Quickly start management for serious diarrhea. Temporarily stop or stop based on the severity of the disease.

Formation of fistula and gastrointestinal perforation: Stop for patients developing level 3 or 4 fistula or any level of gastrointestinal perforation.

extends the range of qt

Monitor and adjust electrolyte abnormalities. Pause if the QT range is greater than 500 ms or from 60 ms or more for standard QT interval.

Lower blood calcium

Monitor the blood calcium concentration at least every month and adjust the calcium level as needed. Temporarily suspend or stop use based on severity.

The following brain circulatory disorder syndrome (RPLS): The suspension until the RPLLA is completely solved or stopped using.

Bleeding

Temporarily suspend or stop use based on severity.

impaired hormonal inhibition function stimulates thyroid/thyroid dysfunction

Monitor the thyroid function before treatment and during treatment each month.

impaired wound healing function

Pause Lenvima at least 1 week before surgery. Do not use at least 2 weeks after major surgery and until the wound is fully healed. The safety of the use of lenvima after resolving wound healing complications has not been published.

jaw bone tumor

Consider dental prevention before treatment with lenvima. Avoid invasive dental procedures, if possible, especially in high -risk patients.

Toxicity on embryos

can be harmful to the fetus. It is necessary to ask for advice for any potential risk for pregnancy when and the use of effective contraception.

The ability to drive and operate machinery

Lenvima 4mg pills can cause side effects that can affect the ability to drive or use your machine. Avoid driving or using machines if you feel dizzy or tired.

Pregnancy

can be harmful to the fetus when used for pregnant subjects. Need advice to pregnant women about the risk of fetus.

Breastfeeding period

It is not known whether the drug is excreted through breast milk. However, women who are taking the drug should stop breastfeeding, at least 1 week after the last dose.

Medicinal interaction

Lenvima has been reported as capable of causing extension of QT. Therefore, avoiding use with drugs that can cause extension of QT.

Storage

Store room temperature, from 20 to 250C.

Other drugs

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