Cyramza® (Ramucirumab)

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Ramucirumab: Bleeding

Ramucirumab should be permanently discontinued in patients who experience grade 3-4 bleeding.

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Label Information

Ramucirumab is an antiangiogenic therapy and may increase the risk of severe bleeding. Severe GI hemorrhage was reported in patients with gastric cancer treated with ramucirumab in combination with paclitaxel, and in patients with CRC treated with ramucirumab in combination with FOLFIRI.1

Incidence of Bleeding

Clinical Studies

The incidence of any grade and grade ≥3 bleeding/hemorrhage in the phase 3 studies is summarized in Incidence of Any Grade and Grade ≥3 Bleeding/Hemorrhage in Phase 3 Studies.

Incidence of Any Grade and Grade ≥3 Bleeding/Hemorrhagea in Phase 3 Studies1-5

Any Grade (%)

Grade ≥3 (%)

REGARD (second-line gastric cancer)

Ramucirumab (n=236)

13

3

Placebo (n=115)

11

3

RAINBOW (second-line gastric cancer)

Ramucirumab + Paclitaxel (n=327)

41.9

4.3

Paclitaxel + Placebo (n=329)

17.9

2.4

REVEL (second-line NSCLC)

Ramucirumab + Docetaxel (n=627)

29

2

Docetaxel + Placebo (n=618)

15

2

RAISE (second-line CRC)

Ramucirumab + FOLFIRI (n=529)

43.9b

2.5

FOLFIRI + Placebo (n=528)

22.7

1.7

REACH-2 (second-line HCC)

Ramucirumab (n=197)

24

5

Placebo (n=95)

13

3

RELAY (first-line EGFR mutation+ NSCLC)

Ramucirumab + Erlotinib (n=221)c

54.8

1.8

Placebo + Erlotinib (n=225)

26.2

1.8

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.

aBleeding/hemorrhage is a consolidated, Medical Dictionary for Regulatory Activities-preferred term.

bp<.05.

cOne death occurred on study and was because of a pulmonary hemorrhage event of hemothorax.

Systematic Review and Meta-Analysis

A systematic review and meta-analysis of eligible phase 2 and 3 studies was conducted to assess the risk of bleeding associated with the use of ramucirumab for the treatment of patients with solid tumors (n=5694). Of the 11 studies that were included in the analysis, a total of 3103 patients received ramucirumab and were included in the incidence analysis. Nine studies reported bleeding (all grades) and the incidence ranged from 13% to 44% (relative risk [ramucirumab vs control]: 1.98 [95% CI: 1.77-2.21; p<.0001]). The relative risk of high-grade bleeding was 1.08 (95% CI: 0.78-1.5).6

Management of Bleeding

Permanently discontinue ramucirumab in patients who experience grade 3 or 4 bleeding.1

References

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

2Garon 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

3Fuchs 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

4Zhu 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

5Nakagawa 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

6Abdel-Rahman O, ElHalawani H. Risk of cardiovascular adverse events in patients with solid tumors treated with ramucirumab: a meta analysis and summary of other VEGF targeted agents. Crit Rev Oncol Hematol. 2016;102:89-100. http://dx.doi.org/10.1016/j.critrevonc.2016.04.003.

Glossary

CRC = colorectal cancer

FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil

GI = gastrointestinal

Fecha de la última revisión: 2019 M10 15


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