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Retsevmo ® ▼ (selpercatinib)
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Could hemorrhagic events occur with Retsevmo® ▼ (selpercatinib)?
Four grade 5 events occurred that were considered not related to selpercatinib. Fewer than 1% of the population had a dose modification due to a hemorrhage event.
UK_cFAQ_SEL415_HEMORRHAGIC_EVENTS
en-GB
Warnings and Precautions
Serious events including fatal haemorrhagic events were reported with selpercatinib. Permanently discontinue selpercatinib in patients with severe or life-threatening haemorrhage.1
Dosing Modifications for Hemorrhagic Events with selpercatinib
Dose Management for Haemorrhagic Events provides dosing modification guidelines for haemorrhagic events.
Grade |
Dose Modification |
Grade 1 or 2 |
|
Grade 3 or 4 |
|
Dose Modifications Because of Haemorrhagic Events in LIBRETTO-001
Fewer than 1% of the LIBRETTO-001 population had a drug interruption because of a haemorrhagic event. Two patients had a dose reduction, one because of eye haemorrhage and another one because of haemorrhage intracranial.
Two patients permanently discontinued selpercatinib because of cerebral haemorrhage, and one patient because of retroperitoneal haematoma.2
Incidence of Haemorrhagic Events in LIBRETTO-001
As of data cutoff June 2021 (N=796), 22% of the LIBRETTO-001 safety population experienced a haemorrhagic event.2
There were no grade 5 haemorrhagic events considered related to selpercatinib.2
Fifty-four preferred terms were included in the haemorrhage analysis.2 Haemorrhagic Events That Occurred in ≥1% of the LIBRETTO-001 Population (N=796)presents haemorrhagic events that occurred in ≥1% of the LIBRETTO-001 population.
Any Causality |
Related to Treatment |
|||
Any Grade |
Any Grade |
Grade ≥3 |
||
Epistaxis |
48 (6) |
0 |
15 (2) |
0 |
Haematuria |
29 (4) |
0 |
3 (<1) |
0 |
Contusion |
19 (2) |
1 (<1) |
3 (<1) |
0 |
Haemoptysis |
19 (2) |
2 (<1) |
1 (<1) |
0 |
Rectal HEM |
10 (1) |
1 (<1) |
0 |
0 |
Haematochezia |
8 (1) |
0 |
2 (<1) |
0 |
Ecchymosis |
5 (1) |
0 |
1 (<1) |
0 |
Petechiae |
5 (1) |
0 |
4 (1) |
0 |
Vaginal HEM |
5 (1) |
0 |
1 (<1) |
0 |
Blood urine present |
4 (1) |
0 |
1 (<1) |
0 |
Gastric HEM |
4 (1) |
4 (1) |
0 |
0 |
Traumatic haematoma |
4 (1) |
1 (<1) |
0 |
0 |
Abbreviations: DIC = disseminated intravascular coagulation; GI = gastrointestinal; HEM = haemorrhage; SDH = subdural haematoma.
aAs of June 2021 data cutoff.
bHemorrhage events that occurred in
c Four grade 4 events such as DIC (n=1), hematemesis (n=1), hemorrhagic stroke (n=1), and hepatic hemorrhage (n=1) were considered not related to selpercatinib.
dFour grade 5 events such as hemoptysis (n=1), postprocedural hemorrhage (n=1), and cerebral hemorrhage (n=2) were considered not related to selpercatinib.
The only haemorrhagic serious adverse event that occurred in ≥1% of the LIBRETTO-001 population was gastric haemorrhage (n=4). The serious adverse events that were considered related to selpercatinib were haemorrhage intracranial (n=2) and retroperitoneal haematoma (n=1).2
LIBRETTO-001 Clinical Trial
LIBRETTO-001 (NCT03157128) phase 1/2, multicenter, open-label, single-arm clinical study evaluated efficacy of selpercatinib in patients with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer (MTC), RET fusion-positive thyroid cancer, and RET fusion-positive tumors other than lung or thyroid.1,3-5
Patients had to have adequate haematologic status including a platelet count ≥75 × 109 per litre not requiring transfusion support for at least 7 days prior to treatment with selpercatinib.2
References
1Retsevmo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Drilon A, Oxnard GR, Tan DSW, et al. Efficacy of selpercatinib in RET fusion–positive non–small-cell lung cancer. N Engl J Med. 2020;383(9):813-824. https://dx.doi.org/10.1056/NEJMoa2005653
4Wirth LJ, Sherman E, Robinson B, et al. Efficacy of selpercatinib in RET-altered thyroid cancers. N Engl J Med. 2020;383(9):825-835. https://dx.doi.org/10.1056/NEJMoa2005651
5Phase 1/2 study of LOXO-292 in participants with advanced solid tumors, RET fusion-positive solid tumors, and medullary thyroid cancer (LIBRETTO-001). ClinicalTrials.gov identifier: NCT03157128. Updated May 23, 2022. Accessed May 25, 2022. https://www.clinicaltrials.gov/ct2/show/NCT03157128
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 20 April 2022
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