Retsevmo ® (selperkatinib)

För fullständig produktresumé för Retsevmo se FASS.

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

Är muntorrhet vanligt med Retsevmo® ▼ (selperkatinib)?

Även om xerostomi var den vanligaste biverkan i studien, var det mycket få dosmodifieringar och inga avbrott på grund av muntorrhet.

LIBRETTO-001 Clinical Trial

LIBRETTO-001 is a multicenter, open-label, phase 1/2 study of selpercatinib administered orally to patients with RET fusion-positive solid tumors, RET-mutant MTC, and other tumors with RET activation.1-4

Overall Occurrence of Dry Mouth

Dry mouth was the most common AE reported in the overall population in the LIBRETTO-001 trial (N = 746) with 300 patients (40%) reporting the event.2,5 Severity of the events was grade 1 (89%) and grade 2 (11%).5

Dry mouth occurred more often in the NSCLC cohort (43%) compared to the MTC cohort (39%).5

Selpercatinib-Related Dry Mouth

Selpercatinib-related dry mouth was reported in 265 patients (36%). Drug-related dry mouth occurred more frequently in the NSCLC cohort (40%) compared to the MTC cohort (33%).5

Dosage Modification

Selpercatinib-related dose modifications in the overall population (N = 746) included 2 patients having a drug interruption and 6 patients having a dose reduction due to dry mouth.5

No patients discontinued selpercatinib due to dry mouth.5

Concomitant Local Oral Treatment

As of data cut-off December 2019, 110 (16%) patients used a concomitant local oral treatment (Table 1). There were 53 (8%) patients that reported ‘other’ unspecified products used.5

Table 1. Concomitant Local Oral Treatments Reported in LIBRETTO-001ab5

Lidocaine hydrochloride, lidocaine

Magic mouthwash formulation

Sodium chloride

Sialin

Benzydamine hydrochloride

Sodium gualenate hydrate

Biotene

---

Calcium lactate with glucose oxidase

Aluminum hydroxide with diphenhydramine

Glucose oxidase with lactoferrin

---

Caphosol

First BLM

Glycol thymoline

---

a Names of products are written as reported.

b Data cut-off December 2019.

Treatment Guidelines for Dry Mouth

Lilly is unable to provide treatment guidelines or recommendations. Table 2 provides a sampling of resources that may provide helpful information for management of dry mouth. Common themes found on these websites include the importance of

  • regular dental visits

  • frequent teeth brushing and flossing, and

  • staying hydrated.

Other information regarding management of dry mouth including nutrition, diet, and artificial saliva is also available on these sites.6-10

Table 2. Internet Resources for Management of Dry Mouth6-10

Resourcea

Website

CancerCare

https://www.cancercare.org

CancerConnect

https://news.cancerconnect.com

Cancer.Net

https://www.cancer.net

Chemocare.com

http://chemocare.com

OncoLink

https://www.oncolink.org

a Lilly does not promote or recommend 1 website over another.

References

1. Phase 1/2 study of LOXO-292 in patients with advanced solid tumors, RET fusion-positive solid tumors, and medullary thyroid cancer (LIBRETTO-001). ClinicalTrials.gov identifier: NCT03157128. Updated July 2, 2020. Accessed January 25, 2020. https://www.clinicaltrials.gov/ct2/show/NCT03157128

2. Retsevmo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

3. Wirth 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

4. Drilon 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

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

6. Dry mouth (xerostomia). OncoLink. Published February 7, 2020. Accessed March 10, 2020. https://www.oncolink.org/cancer-treatment/radiation/side-effects-of-radiation-therapy/dry-mouth-xerostomia

7. Weaver CH. Dry mouth or xerostomia. Cancer.Net. Published May 2018. Accessed March 10, 2020. https://www.cancer.net/coping-with-cancer/physical-emotional-and-social-effects-cancer/managing-physical-side-effects/dry-mouth-or-xerostomia

8. Dry mouth-xerostomia. CancerConnect. Published March 18, 2019. Accessed March 10, 2020. https://news.cancerconnect.com/treatment-care/dry-mouth-xerostomia-uLP3i3Dq-EKO0rHSfOVBKw

9. Dry mouth. Chemocare. Accessed March 10, 2020. http://chemocare.com/chemotherapy/side-effects/dry-mouth.aspx

10. The importance of dental health. CancerCare. Published March 17, 2016. Accessed March 10, 2020. https://www.cancercare.org/publications/269-the_importance_of_dental_health

Glossary

AE = adverse event

Lilly = Eli Lilly and Company

MTC = medullary thyroid cancer

NSCLC = non-small cell lung cancer

RET = rearranged during transfection

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.

Datum fӧr senaste ӧversyn 2021 M01 21


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