Cyramza ® (ramucirumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Cyramza Summary of Product Characteristics (SmPC)

Cyramza® (ramucirumab): Weight Based Dosing

In Cyramza (ramucirumab) clinical trials, actual body weight, not ideal body weight, was used in calculating the dose for individual patients.

Dose Calculation in Clinical Trials

In ramucirumab clinical trials, actual body weight, not ideal body weight, was used to calculate the appropriate dose for individual patients. There were no restrictions or dose adjustments for obese patients. No maximum weight or dose was specified.1-3

Dose Modification for Weight Change

The initial dose of ramucirumab or placebo was dependent upon the patient’s baseline body weight in kilograms. Recalculation of this dose was required in the event of a ≥10% change in body weight from the previous dose calculation; recalculation of dose was permitted in cases of a <10% change in body weight.1-3

Dose Modification for Fluid Drainage

In RELAY, for patients undergoing repeated palliative drainage procedures to remove pleural or peritoneal fluid, dry weight was defined as weight obtained after the drainage procedure and before fluid reaccumulation. In this circumstance, dry weight was used for dose calculation if obtained within 30 days prior to dose. If no recent dry weight was available, actual weight was used.2

Population Pharmacokinetic Analysis by Baseline Body Weight

A meta-analysis was conducted to evaluate the PK parameters of ramucirumab in patients (n=1639) with various tumor types (CRC [27%], gastric cancer [24%], NSCLC [27%], HCC [19%], mBC [<1%], and other solid tumors [2%]). Data from 11 studies (phase 1b, 2, and 3) were collected to provide 6427 ramucirumab serum concentration observations. In these studies, ramucirumab was administered as an IV infusion at either 8 mg/kg every 2 weeks or 10 mg/kg every 3 weeks over 1 hour.4

Among the patients included in this analysis, average baseline body weight was 70.5 kg and the range was 31.9 to 143 kg. A positive correlation was observed between patient weight and ramucirumab clearance and central compartment volume. Patient weights were further grouped into quartiles and significant overlap was observed between groups when distribution of ramucirumab exposure was evaluated. This PK analysis demonstrated that body-weight normalized dosing is appropriate for ramucirumab.4

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669. https://doi.org/10.1016/S1470-2045(19)30634-5

3. Zhu AX, Kang YK, Yen CJ, et al. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(2):282-296. http://dx.doi.org/10.1016/S1470-2045(18)30937-9

4. O'Brien L, Westwood P, Gao L, Heathman M. Population pharmacokinetic meta-analysis of ramucirumab in cancer patients. Br J Clin Pharmacol. 2017;83(12):2741-2751. https://doi.org/10.1111/bcp.13403

Glossary

CRC = colorectal cancer

HCC = hepatocellular carcinoma

IV = intravenous

mBC = metastatic breast cancer

NSCLC = non-small cell lung cancer

PK = pharmacokinetic(s)

Date of Last Review: July 15, 2020

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