Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Cyramza® (ramucirumab): Viktbaserad Dosering

I kliniska studier med Cyramza (ramucirumab) användes faktisk kroppsvikt, inte ideal kroppsvikt, vid beräkning av dosen för enskilda patienter.



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

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

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 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.2

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.2  

References

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

2. 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)

Datum fӧr senaste ӧversyn 2017 M10 26

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