Lenvanix 4mg & 10mg – Uses, Side Effects, and More
Jaman
12 Jan, 2025
Lenvanix is an anti-cancer treatment for certain types of cancer, including hepatocellular carcinoma (HCC), differentiated thyroid cancer (DTC), and renal cell carcinoma (RCC). To enable consumers to better grasp Lenvanix, this guide offers comprehensive information on the therapeutic indications, pharmacology, dosage, uses, mechanism of action, side effects, interactions, precautions, and more.
Table of Contents
Therapeutic Class
Anti-cancer
Composition
Lenvanix 4 Capsule: Per capsule contains Lenvatinib Mesylate INN equivalent to Lenvatinib 4 mg.
Lenvanix 10 Capsule: Per capsule contains Lenvatinib Mesylate INN equivalent to Lenvatinib 10 mg.
Indications and Uses of Lenvanix
Lenvanix is primarily indicated for the treatment of:
Differentiated Thyroid Carcinoma (DTC): Of special interest for locally recurrent or metastatic, progressive, radioactive iodine (RAI) – refractory differentiated thyroid cancer. This is used when the cancer has returned after treatment or has spread to other parts of the body and it no longer responds to radioactive iodine treatment.
Renal Cell Carcinoma (RCC): In combination with everolimus for patients with advanced RCC who received one prior anti-angiogenic therapy. In combination with pembrolizumab, as first-line therapy, for advanced RCC.
Unresectable Hepatocellular Carcinoma (HCC): First-line treatment of patients with unresectable Hepatocellular Carcinoma.
Endometrial Carcinoma: With pembrolizumab to treat certain types of Endometrial Cancer that has spread and cannot be removed by surgery or radiation.
Therapeutic Indications:
Lenvanix (lenvatinib) is a kinase inhibitor used to treat several types of cancer:
- Thyroid cancer: Specifically, differentiated thyroid cancer that progressed despite radioactive iodine treatment.
- Kidney cancer: Advanced renal cell carcinoma (RCC), in combination with everolimus or pembrolizumab.
- Liver cancer: Unresectable hepatocellular carcinoma (HCC), as a first-line treatment.
- Endometrial cancer: Advanced endometrial carcinoma, in combination with pembrolizumab.
Clinical Pharmacology of Lenvanix
Drug Classes:
- Tyrosine Kinase Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
Mechanism of Action:
Lenvanix inhibits key cancer-driving proteins known as kinases. Sunitinib inhibits certain kinases responsible for blood vessel formation and for tumor development, and thereby severes the supply lines of the tumor and prevents it from growing. It has been reported as effective in the treatment of a wide range of cancers including thyroid, kidney and liver cancer, as well as endometrial cancer. This stops the growth of (or kills) bacteria, thereby curing the infection. More about Mechanism of Action here.
Mode Of Action:
Lenvatinib, more commonly known as Lenvanix is a multi-targeted tyrosine kinase inhibitor It inhibits a number of receptors related to tumor growth and angiogenesis, among which:
VEGFR (Vascular Endothelial Growth Factor Receptor)
FGFR (Fibroblast Growth Factor Receptor)
PDGFR (Platelet-Derived Growth Factor Receptor)
KIT and RET receptors
Inhibition of these receptors results in decreased tumor blood supply, an anti-tumorigenic effect, and inhibition of metastasis. This process results in diminished tumor persistence and survival in a number of cancers.
Dosage & Administration
Lenvanix dosage depends on the type of infection and how severe it is and the age of the patient and his kidney functions. Following your doctor’s orders and the dosage on the prescription label is critical.
Adult Dose:
The adult dose of Lenvanix (Lenvatinib) depends on the cancer type:
- Thyroid Cancer: 24 mg once daily.
- Hepatocellular Carcinoma: 12 mg orally, once daily (>60 Kg), and 8 mg orally, once daily (<60 Kg).
- Renal Cell Carcinoma: 18 mg Lenvatinib + 5 mg Everolimus, once daily.
- Endometrial Cancer (with Pembrolizumab): 20 mg once daily.
The dose can be modified in case of side effects. It is to be taken once a day, with or without food.
Child Dose:
Lenvanix is a powerful anti-cancer medication, it is not normally administered to children.
- Research: There hasn’t been enough research done on whether Lenvanix is safe or effective in children. The majority of studies have concentrated on adults.
- Possible risk factors of the drug: Children may be more susceptible to high blood pressure, protein in the urine, and slow healing of wounds by the drug Lenvanix.
- Alternative treatments: There are generally other available treatments for children with cancer that have been more thoroughly researched and shown to be safe and effective.
Miss a dose:
Take it as soon as you remember if you miss a dose. However, if your next scheduled dose is almost due, skip the missed dose and follow your regular dosing schedule. Do not take a double dose to compensate for a missed dose.
Overdosage:
Lenvanix does not have a specific antidote in case of overdose. Moreover, because of the high plasma protein binding, we would not be expecting Lenvanix to be dialyzable. The adverse reactions observed in these patients dosed with Lenvatinib single doses up to 40 mg were similar in nature to the adverse events observed for DTC and RCC at the recommended dosing in the clinical studies. For a drug overdose, get medical help right away or call a poison control center.
Side Effects of Lenvanix
As with all medicines, Lenvanix can cause side effects. Most side effects are mild and temporary, but some may be serious and need medical treatment.
Regular Side Effects:
- High blood pressure
- Protein in the urine
- Bleeding problems
- Gastrointestinal problems (diarrhea, nausea, vomiting, and mouth sores)
- Changes in liver function
- Headache
- Tiredness
- Weight loss
- Muscle or joint pain
- Skin problems
Non-Regular Side Effects:
- Heart problems
- Blood clots
- Liver problems
- Kidney problems
- Gastrointestinal perforation
- Problems with wound healing
- Changes in voice
- Reversible posterior leukoencephalopathy syndrome (RPLS)
Rare Side Effects:
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
- Osteonecrosis of the Jaw (ONJ)
- Severe Bleeding (Hemorrhage)
- Severe Hypothyroidism or Thyroid Crisis
- Heart Attack or Stroke
- Pulmonary Embolism (Blood Clot in Lungs)
- Liver Failure
- Pancreatitis
- Severe Allergic Reactions (Anaphylaxis)
- Fistula formation
- Pneumomediastinum
If you experience any severe or persistent side effects, consult your doctor immediately.
Use In Specific Populations
Pregnancy
Lenvanix is absolutely contraindicated in pregnancy. This means that it should not be used by women who are pregnant or who may become pregnant. It can also harm the fetus when given to pregnant women.
Lactation
Risk Summary: Unknown if Lenvanix is present in human milk. However, Lenvanix is found in the rat milk and its metabolite concentrations exceed maternal. Due to the potential for serious adverse reactions in nursing infants related to Lenvanix, advise women not to lactate during treatment with Lenvanix.
Precautions & Warnings
Hypertension
Blood pressure had to be controlled before starting Lenvatinib. •Lenvatinib Hold Grade 3 Hypertension On Optimal Anti-Hypertensive Treatment STOP for malignant hypertension.
Cardiac Failure
Monitor for clinical signs of cardiac decompensation. Grade 3 cardiac dysfunction: Withhold Lenvatinib. Withdrawn for Grade 4 cardiac dysfunction.
Arterial Thromboembolic Events
Lenvatinib should be discontinued in patients experiencing an arterial thromboembolic event.
Hepatotoxicity
Liver function tests: Monitor prior to initiation and periodically throughout treatment. DOSE MODIFICATIONS Hepatic Impairment Withhold Lenvatinib for Grade 3 or greater liver impairment Do not use in hepatic failure.
Proteinuria
Assess for proteinuria prior to initiation of and periodically throughout treatment with Lenvatinib. Lenvatinib should be withheld for 24 hours for 2 g proteinuria. Hold for nephrotic syndrome
Diarrhea
May be severe and recurrent. Give symptomatic anti-diarrheal treatment. In the case of Diarrhea with Grade 3 reduce the dose while for Grade 4 Lenvatinib must be discontinued.
Adverse Reactions
In DTC, the most common adverse drug reactions (frequency ≥30%) of Lenvatinib are hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight decreased, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.
For RCC, the most frequent adverse reactions (≥30%) reported with Lenvatinib + Everolimus were diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal pain, dyspnea, rash, weight decreased, hemorrhagic events, and proteinuria.
Interaction of Lenvanix
Lenvanix can interact with certain medications, including:
Drug Interactions
- Strong CYP3A4 Inducers: Rifampin, phenytoin, carbamazepine and other medications that induce the enzyme CYP3A4, which is responsible for Lenvatinib metabolism in the liver, may reduce the activity of Lenvatinib.
- Strong CYP3A4 Inhibitors: Medicines that reduce the rate that Lenvatinib is broken down in the body (called CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin) may increase amounts of Lenvatinib in the body, increasing possible side effects.
- QT Prolonging Drugs: Lenvatinib has potential to prolong the QT interval (an aspect of your heart’s rhythm on an EKG). Using it with other drugs known to have the same effect (for example, some antibiotics, antipsychotics) can increase the risk for a rare but serious heart rhythm problem called Torsades de Pointes.
Food Interactions
Minor interaction: Lenvatinib can be taken with or without food, as food does not significantly affect its absorption.
Herbal Supplements and Other Substances
Limited knowledge: There is limited knowledge on interaction between Lenvatinib with herbal supplements and other substances. Perhaps it’s best to be cautious and tell your doctor about all the supplements and over-the-counter medications you’re taking.
Important Notes
- Always inform your doctor: When visiting the doctor or pharmacist, always give a full list of all the medications, supplements and herbal remedies you take. That will help them spot potential interactions and modify your treatment plan accordingly.
- Monitoring: If you are taking medications that interact with Lenvatinib, you may need to be monitored more closely or have your dosage adjusted.
- Don’t self-medicate: Don’t start or stop taking any medications without first talking to your doctor.
Presentation & Packaging
Lenvanix 4 MG: Per commercial box contain 30 capsules in a Pot.
Lenvanix 10 MG: Per commercial box contain 30 capsules in a Pot.
Storage Conditions
Store Lenvanix in a cool, dry place, away from direct sunlight and moisture. Keep it out of the reach of children.
Manufactured by:
Lenvanix specifically is manufactured and marketed by Beacon Pharmaceuticals Limited in Bangladesh.
Beacon Pharmaceuticals has the license to produce Lenvatinib under the brand name Lenvanix, likely due to patient exemptions for Bangladeshi companies that allow them to manufacture patented drugs to increase access to essential medicines.
However, Lenvatinib is originally developed and marketed by Eisai Co., Ltd., a Japanese pharmaceutical company. If you have Lenvanix, it was manufactured by Beacon Pharmaceuticals.
FAQ
- How does Lenvanix work?
Lenvanix is a type of kinase inhibitor. It does so by interrupting certain proteins that encourage tumors to grow and spread. This slows or stops the cancer from growing.
- How is Lenvanix taken?
Lenvanix is in the form of a capsule and is taken by mouth once a day, with or without food. That’s the dosage, which depends on the type of cancer being treated and the patient’s weight. You must follow your doctor’s instructions exactly, and you should not alter the dose or stop taking the medication without talking to him or her in advance.
- How long will I need to take Lenvanix?
How long you take Lenvanix depends on several factors, including the type of cancer being treated, how well the cancer responds to the treatment and the side effects you may have. Your doctor will explain this point to you, and will regularly monitor your progress.
- Can I take Lenvanix with other medications?
Some medications may interact with Lenvanix to increase the risk of side effects or decrease effectiveness. It’s important to inform your doctor about any and all medications you’re taking, including prescription drugs, over-the-counter medications, vitamins and herbal supplements.
- What should I avoid while taking Lenvanix?
Grapefruit and grapefruit juice can interact with Lenvanix and increase the risk of side effects. It can cause dizziness and fatigue, so be cautious when driving or operating machinery until you know how it affects you.
- Does Lenvanix cure cancer?
Lenvanix can work really well in treating certain cancers, but it isn’t seen as a cure. It is intended to slow or halt the progression of the cancer while alleviating symptoms. Sometimes it makes tumors shrink or keep them from spreading.
- Where can I find more information about Lenvanix?
The official website provides detailed information about the medication, including prescribing information and patient resources.
Disclaimer: This information is provided solely for educational reasons and should not be considered medical advice. Always consult with your doctor or healthcare professional before taking any drug.