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

När ska Cyramza® (ramucirumab) sättas ut före, och återinsättas efter, en operation?

De flesta studier med ramucirumab krävde minst 28 dagar mellan kirurgi och randomisering eller återinättning av behandling, eller avbrott av behandling med ramucirumab i minst 28 dagar före ingrepp. För specifika studier, se nedan.

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SE_cFAQ_RAM079_Y1_SURGERY_WOUND_HEALING
en-GB

Ramucirumab can Adversely Affect Wound Healing

Ramucirumab is an antiangiogenic therapy that potentially affects wound. Ramucirumab treatment should be withheld prior to scheduled surgery. The decision to resume ramucirumab following surgical intervention should be based on clinical judgment of adequate wound healing.1

The impact of ramucirumab has not been evaluated in patients with serious or nonhealing wounds. In a study conducted on animals, ramucirumab did not impair wound healing.1

Surgery During Treatment

The below Study-specific requirements relating to surgery and wait time, before and after the procedure. shows the requirements in our studies with ramucirumab relating to surgery and wait time, before and after the procedure.1,2

Study-specific requirements relating to surgery and wait time, before and after the procedure.1,2

Study

Time-lapse from surgery to Cyramza treatment

Time-lapse from Cyramza treatment to surgery

Additional recommendations or requirements

REGARD

Major surgery to be performed >28 days prior to randomization when possible1

Major surgery to be postponed until ≥28 days after study completion when possible1 

If subcutaneous venous access device  (SVAD)  placement was required during therapy, it was recommended that a 7-day treatment-free period occur both prior to and following placement.1

RAISE

Patients could resume all study treatment ≥28 days following surgical resection, provided the recovery was adequate1

 

Following surgery, radiologic evaluation of disease was required before study treatment.1

REVEL and RELAY

Patients could resume all study treatment ≥28 days following a required surgery (palliative surgery or medically indicated by the investigator), provided the recovery was adequate.1,2

The time of study treatment interruption before surgery was to be ≥28 days following the last dose of study treatment.

The patient was to undergo a radiologic evaluation of the disease before and after surgery.

Elective surgery was strongly discouraged during study participation.1,2  

REACH-2

In the event of postsurgical or other wound complications, study treatment was delayed until the wound was fully healed.

After surgery, study treatment could be resumed based on clinical judgment. Ramucirumab dosing could be delayed (for up to 21 days) in the case of any post-surgical or other wound complications until the wound was fully healed.1

If surgery was required during the study, study treatment was withheld prior to planned surgery.1  


Study Eligibility Criteria Related to Surgery and Wound Healing

Patients were excluded from participation in the REGARD, RAINBOW, REVEL, RAISE, REACH-2, and RELAY studies if

  • patient had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization, or
  • patient has undergone major surgery (including major dental procedures) within 28 days prior to randomization, or SVAD placement within 7 days prior to randomization.1-6

Patients were excluded from participation in the REGARD, RAISE, REVEL, and REACH-2 studies if an elective or planned major surgery was scheduled during the course of the trial.3,5-7

Additionally, in the REVEL and RELAY studies, patients with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months were excluded from participation.

In the REACH-2 study, patients with hepatic locoregional surgery following sorafenib or within 28 days prior to randomization were excluded from participation.2,5,7

References

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

2Nakagawa 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

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

4Wilke 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

5Garon 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

6Tabernero 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

7Zhu 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

Datum fӧr senaste ӧversyn October 22, 2019


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