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LENVIMA is a brand name for Lenvatinib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
, Additional Safety Information from 1L mRCC LENVIMA + Pembrolizumab Clinical Trial Experience, Geriatrics). Although no overall difference in effectiveness was observed between elderly and younger patients treated with LENVIMA + everolimus in the pivotal RCC Phase 2 study, the following common adverse LENVIMA® lenvatinib capsules Page 31 of 106 events occurred at higher rates in patients 65 years of age or greater as compared to younger subjects: cough, dyspnea, lethargy, nausea, peripheral swelling and vomiting.
Elderly patients should be treated with caution and monitored for signs of toxicity. HCC patients of age ≥75 years appear to have demonstrated reduced tolerability to LENVIMA and were more likely to experience hypertension, proteinuria, decreased appetite, asthenia, dehydration, dizziness and hepatic encephalopathy.
Arterial thromboembolic events also occurred at an increased incidence in this age group (see 7 Warnings and Precautions, Cardiovascular, Arterial Thromboembolism). 8. 1. Adverse Reaction Overview The safety data for DTC described below are derived from the pivotal DTC Phase 3 SELECT trial which randomized (2:1) patients with radioactive iodine-refractory differentiated thyroid cancer to LENVIMA (n=261) or placebo (n=131).
The safety data for first line RCC described below are derived from the the CLEAR/E7080-G000- 307/KEYNOTE-581 RCC Phase 3 Study (CLEAR), which randomized (1:1:1) patients with advanced renal cell carcinoma (RCC) to LENVIMA (20 mg orally once daily) in combination with pembrolizumab (200 mg intravenously every 3 weeks) (n=352), or sunitinib (50 mg orally once daily for 4 weeks then off treatment for 2 weeks) (n=340).
The safety data for previously treated RCC described below are derived from the RCC Phase 1b +2 Study 205, which randomized (1:1:1) patients with unresectable advanced or metastatic renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy to LENVIMA 18 mg + everolimus 5 mg (n=62), LENVIMA 24 mg (n=52), or everolimus 10 mg (n=50) once daily.
The safety data for HCC described below are derived from the HCC Phase 3 REFLECT Study 304 in which patients with unresectable hepatocellular carcinoma (HCC) were randomized (1:1) to receive LENVIMA (n=476) or sorafenib (n=475). The safety data of LENVIMA (20 mg orally once daily) in combination with pembrolizumab (200 mg intravenously every 3 weeks) for EC described below are derived from Study 309, a multicenter, open- label, randomized (1:1), active-controlled trial in 827 patients with advanced endometrial carcinoma previously treated with at least one platinum-based chemotherapy regimen in any setting, including in the neoadjuvant and adjuvant settings.
Patients with endometrial carcinoma that is not MSI-H or dMMR received LENVIMA 20 mg orally once daily with pembrolizumab 200 mg intravenously every 3 weeks (n=342); or received doxorubicin or paclitaxel (n= 325). 2. Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
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The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
LENVIMA® lenvatinib capsules Page 32 of 106 Clinical Trial Adverse Reactions in DTC In the pivotal DTC Phase 3 SELECT trial, the LENVIMA and placebo treatment arms were well balanced with respect to demographic and baseline characteristics.
All subjects (100%) underwent prior anti- thyroid cancer surgery. 6% of subjects in the LENVIMA arm had metastatic disease (4 subjects in the LENVIMA arm had locally advanced disease that met the inclusion criteria). The type and frequency of metastatic disease were similar between the 2 treatment arms.
All subjects were documented to be 131I refractory/resistant. 9 months for placebo. Among 261 patients who received LENVIMA in the pivotal DTC Phase 3 SELECT trial, median age was 64 years, 52% were female, 80% were Caucasian, 18% were Asian, and 2% were Black; 4% identified themselves as having Hispanic or Latino ethnicity.
In the pivotal DTC Phase 3 SELECT trial, the most common adverse reactions observed in LENVIMA- treated patients (≥30%) were, in order of decreasing frequency, hypertension, diarrhea, decreased appetite, decreased weight, nausea, fatigue, stomatitis, vomiting, proteinuria, palmar-plantar erythrodysesthesia (PPE) syndrome, abdominal pain, and dysphonia.
The most common serious adverse reactions (at least 2%) were pneumonia (4%), hypertension (3%), renal failure and impairment (3%), and dehydration (3%). Adverse reactions led to dose reductions in 68% of patients receiving LENVIMA and 5% of patients receiving placebo; 18% of patients discontinued LENVIMA and 5% discontinued placebo for adverse reactions.
The most common adverse reactions (at least 10%) resulting in dose reductions of LENVIMA were hypertension (13%), proteinuria (11%), decreased appetite (10%), and diarrhea (10%); the most common adverse reactions (at least 1%) resulting in discontinuation of LENVIMA were hypertension (1%) and asthenia (1%) (see 7 Warnings and Precautions).
4%). Fatal adverse events included myocardial infarction, cardiorespiratory arrest, intracranial tumor, […]