Product image of Kisplyx (Lenvatinib) supplied by GNH India

Kisplyx

Active Ingredient:
Lenvatinib
Origin:
EU

Kisplyx (Lenvatinib)

Lenvatinib, the active ingredient in Kisplyx, is a tyrosine kinase inhibitor presented as an oral tablet for oral administration. It is indicated for the treatment of several advanced solid tumours, such as differentiated thyroid carcinoma, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma, in adult patients.

GNH India supplies Kisplyx as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to oncology centres, hospitals and pharmacies worldwide from its EU‑origin market. All batches are manufactured under EU GMP standards and undergo rigorous quality testing before distribution.

Manufacturer / TM Owner

Eisai Gmbh

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Indications & Clinical Uses

Lenvatinib is a multi‑targeted tyrosine kinase inhibitor used in the management of several solid tumours.

  • Differentiated thyroid carcinoma: improves progression‑free survival in patients with radioactive‑iodine refractory disease.
  • Renal cell carcinoma: reduces tumour growth and extends overall survival in advanced clear‑cell RCC.
  • Hepatocellular carcinoma: delays disease progression in patients with unresectable HCC.
  • Endometrial carcinoma: provides disease control in advanced or recurrent endometrial cancer.

How It Works

  • Lenvatinib exerts its antineoplastic activity by inhibiting multiple receptor tyrosine kinases involved in angiogenesis and tumour cell proliferation, including VEGFR1‑3, FGFR1‑4, PDGFRα, KIT and RET. Blockade of these pathways reduces endothelial cell signalling, suppresses new blood‑vessel formation and directly impairs tumour cell growth, leading to tumour regression. The combined inhibition also interferes with the tumour microenvironment and may enhance the efficacy of concurrent therapies.

Side Effects

Lenvatinib is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Hypertension: elevated blood pressure often requiring medication.
  • Diarrhoea: watery stools that may cause dehydration.
  • Fatigue: persistent tiredness affecting daily activities.
  • Nausea: feeling of sickness that can reduce appetite.

Serious or Rare Side Effects

  • Hepatotoxicity: liver enzyme elevations or liver failure.
  • Cardiac failure: signs of reduced cardiac function such as dyspnoea and edema.
  • Gastrointestinal perforation: severe abdominal pain indicating possible perforation.
  • Severe haemorrhage: bleeding events including gastrointestinal or intracranial bleeding.

Precautions & Warnings

When prescribing Lenvatinib, clinicians should consider several precautionary measures to minimise risks.

  • Blood pressure monitoring: check baseline and regularly during therapy.
  • Liver function tests: assess hepatic enzymes before starting and periodically.
  • Cardiac assessment: evaluate cardiac history and monitor for signs of heart failure.
  • Proteinuria screening: perform urine analysis to detect protein loss.
  • Pregnancy and lactation: avoid use in pregnant or breastfeeding women unless benefits outweigh risks.
  • Store at ambient temperature: keep tablets below 25 °C in the original container, protected from moisture and light.

Avoid Interactions

Lenvatinib may interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers: agents such as rifampicin can markedly reduce lenvatinib exposure.
  • Anticoagulants: concurrent use may increase risk of severe bleeding.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors: drugs like ketoconazole may increase lenvatinib plasma levels.
  • Antihypertensive agents: may require dose adjustment due to additive blood‑pressure effects.
  • Diuretics: can exacerbate electrolyte disturbances when combined with lenvatinib.

Frequently Asked Questions

Kisplyx contains the active ingredient lenvatinib and is prescribed for adult patients with advanced solid tumours, specifically differentiated thyroid carcinoma that is refractory to radioactive iodine, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma. It is used when disease progression requires systemic therapy.

Lenvatinib blocks multiple receptor tyrosine kinases such as VEGFR1‑3, FGFR1‑4, PDGFRα, KIT and RET. By inhibiting these signalling pathways, it reduces angiogenesis, limits tumour blood‑supply, and directly suppresses tumour cell proliferation, leading to slowed tumour growth and possible regression.

The prescribed dose of Kisplyx is determined by the treating physician based on the specific cancer type, disease stage, patient weight, renal and hepatic function, and any concomitant medications. Dosing regimens are individualized and should follow the prescriber’s instructions.

Safety data for lenvatinib in pregnancy and lactation are limited. The drug is generally avoided in pregnant or nursing women because potential risks to the fetus or infant are unknown. Women of child‑bearing potential should use effective contraception during treatment and for a period after discontinuation as advised by their clinician.

To request Kisplyx, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

The primary alternative to lenvatinib in many indications is sorafenib, another multi‑kinase inhibitor. While both target VEGFR pathways, lenvatinib additionally inhibits FGFR1‑4, which may offer broader anti‑angiogenic activity. Clinical trials have shown differences in efficacy and side‑effect profiles, so the choice depends on the specific tumour type, patient tolerance and physician judgment.

Kisplyx tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack or container. Keep the product away from moisture, direct sunlight and excessive heat. Do not refrigerate or freeze the tablets.

Kisplyx is taken orally as a whole tablet with a glass of water. It is usually taken once daily, preferably at the same time each day, and may be taken with or without food as directed by the prescriber. Swallow the tablet whole; do not crush or chew it.

Serious adverse events associated with lenvatinib include hepatotoxicity (significant liver enzyme elevation or liver failure), cardiac failure (shortness of breath, swelling, reduced exercise tolerance), severe haemorrhage (gastrointestinal or intracranial bleeding), and gastrointestinal perforation. Patients should be monitored regularly for these conditions and report any concerning symptoms promptly.

Kisplyx should not be used in patients with severe hepatic impairment, uncontrolled hypertension, or known hypersensitivity to lenvatinib or any tablet excipients. It is also contraindicated during pregnancy and breastfeeding, and should be avoided in individuals with a history of serious bleeding or recent major surgery unless the prescriber decides otherwise.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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