Cyramza® (Ramucirumab)

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Ramucirumab: Proteinuria

Permanently discontinue ramucirumab if the urine protein level is >3 g/24 hours or in the setting of nephrotic syndrome.

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Incidence of Proteinuria

The incidence of any grade and grade ≥3 proteinuria in phase 3 clinical trials are presented in Incidence of Any Grade and Grade ≥3 Proteinuria in the Phase 3 Clinical Studies.

Incidence of Any Grade and Grade ≥3 Proteinuria in the Phase 3 Clinical Studies1-6

Proteinuria

Any Grade (%)

Grade ≥3 (%)

REGARD (second-line gastric cancer)

Ramucirumab (n=236)

3

<1

Placebo (n=115)

3

0

RAINBOW (second-line gastric cancer)

Ramucirumab + Paclitaxel (n=327)

17

1

Paclitaxel + Placebo (n=329)

6

0

REVEL (second-line NSCLC)

Ramucirumab + Docetaxel (n=627)

3

<1

Docetaxel + Placebo (n=618)

1

0

RAISE (second-line CRC)a

Ramucirumab + FOLFIRI (n=529)

17

3

FOLFIRI + Placebo (n=528)

5

<1

REACH-2 (second-line HCC)

Ramucirumab (n=197)

20

2

Placebo (n=95)

4

0

RELAY (first-line EGFR mutation+ NSCLC)

Ramucirumab + Erlotinib (n=221)

34

3

Erlotinib + Placebo (n=225)

8

0

Abbreviations: CRC = colorectal cancer; EGFR = epidermal growth factor receptor; FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil; HCC = hepatocellular carcinoma; NSCLC = non-small cell lung cancer.

aProteinuria includes proteinuria and nephrotic syndrome.

Monitoring for Proteinuria

Monitor for the development or worsening of proteinuria during ramucirumab therapy. If the urine protein level is ≥2+, perform a 24-hour urine collection.7

Clinical Trial Protocols

In the REGARD trial, urinalysis was performed every 6 weeks, and in the RAINBOW and REACH-2 trials, urinalysis was performed prior to each ramucirumab treatment (days 1 and 15 of a 28-day cycle). In the REVEL trial, routine dipstick measurements were done within 72 hours prior to treatment on day 1 of every second cycle (screening period, before cycle 3, cycle 5, and every 2 cycles thereafter). In the RAISE trial, urinalysis was done at baseline and prior to every third cycle. In the RELAY trial, urinalysis was done at baseline and prior to every cycle. A patient’s urinary protein was measured by routine urinalysis or dipstick in clinical trials.1,2,5-7

Proteinuria and Dose Adjustments

Ramucirumab dose modifications for proteinuria are summarized in Dose Modifications for Proteinuria.

Dose Modifications for Proteinuria7

If the urine protein is…

And…

Then…

And reinitiate treatment when…

>2g/24 hours

is occurring for the first time in a patient receiving 8 mg/kg

interrupt ramucirumab treatment

urine protein level returns to <2g/24 hours at 6 mg/kg

is occurring for the first time in a patient receiving 10 mg/kg

urine protein level returns to <2g/24 hours at 8 mg/kg

is reoccurring for the second time in a patient who originally received 8 mg/kg and is currently receiving 6 mg/kg

urine protein level returns to <2g/24 hours at 5 mg/kg

is reoccurring for the second time in a patient who originally received 10 mg/kg and is currently receiving 8 mg/kg

urine protein level returns to <2g/24 hours at 6 mg/kg

>3g/24 hours

not applicable 

permanently discontinue ramucirumab treatment

not applicable

Any level

patient has nephrotic syndrome

permanently discontinue ramucirumab treatment

not applicable


References

1Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31-39. http://dx.doi.org/10.1016/S0140-6736(13)61719-5

2Wilke H, Muro K, Van Cutsem E, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224-1235. http://dx.doi.org/10.1016/S1470-2045(14)70420-6

3Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673. http://dx.doi.org/10.1016/S0140-6736(14)60845-X

4Tabernero J, Yoshino T, Cohn AL, et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015;16(5):499-508. http://dx.doi.org/10.1016/S1470-2045(15)70127-0

5Zhu 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

6Nakagawa 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

7Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Fecha de la última revisión: 2019 M10 07


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