Observational Case Series Evaluation of the Granisetron Transdermal Patch System (Sancuso) for the Management of Nausea/Vomiting of Pregnancy

Abstract

Objective The objective of this study was to observe the efficacy of antiemetic therapy (no emesis/retching episodes and no rescue medication use) when granisetron is administered via a transdermal patch system (TDS) in women who are 6 to 14 weeks pregnant when compared with oral ondansetron by evaluating the frequency of the use of rescue medications for control of nausea/vomiting of pregnancy (NVP).

Methods This was an observational case series study to observe the potential benefits of granisetron TDS compared with oral ondansetron for management of NVP in pregnant patients during the first trimester. Dates of data collection were September 1, 2014, through December 31, 2015. There was no direct contact with patient. The oral ondansetron and granisetron TDS patients were matched by age, 4:1. The proportion of patients who received rescue antiemetics was calculated from those patients who continued to experience NVP. Risk factors for NVP were identified and compared between groups. Descriptive statistics were used to describe study results.

Results Patients were prescribed rescue antiemetics in 0/3 patients in the granisetron TDS group compared with 2/12 patients in the oral ondansetron group.

Conclusion Prospective efficacy studies on the use of granisetron TDS for management of NVP are needed to confirm this clinical observation.

Keywords

nausea/vomiting - pregnancy - antiemetics - granisetron - transdermal patch

• References

• 1 Einarson TR, Piwko C, Koren G. Prevalence of nausea and vomiting of pregnancy in the USA: a meta analysis. J Popul Ther Clin Pharmacol 2013; 20 (02) e163-e170
• 2 Piwko C, Koren G, Babashov V, Vicente C, Einarson TR. Economic burden of nausea and vomiting of pregnancy in the USA. J Popul Ther Clin Pharmacol 2013; 20 (02) e149-e160
• 3 O'Brien B, Naber S. Nausea and vomiting during pregnancy: effects on the quality of women's lives. Birth 1992; 19 (03) 138-143
• 4 Gazmararian JA, Petersen R, Jamieson DJ. , et al. Hospitalizations during pregnancy among managed care enrollees. Obstet Gynecol 2002; 100 (01) 94-100
• 5 Nausea and vomiting of pregnancy. ACOG Practice Bulletin No. 153. American College of Obstetricians and Gynecologists. Obstet Gynecol 2015; 126 (03) e12-e24
• 6 Nausea and vomiting of pregnancy. ACOG Practice Bulletin No. 52. American College of Obstetricians and Gynecologists. Obstet Gynecol 2004; 103: 803-815
• 7 Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernández-Díaz S. ; National Birth Defects Prevention Study. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol 2011; 205 (01) 51.e1-51.e8
• 8 Koren G. Treating morning sickness in the United States--changes in prescribing are needed. Am J Obstet Gynecol 2014; 211 (06) 602-606
• 9 Hamadani M, Chaudhary L, Awan FT. , et al. Management of platinum-based chemotherapy-induced acute nausea and vomiting: is there a superior serotonin receptor antagonist?. J Oncol Pharm Pract 2007; 13 (02) 69-75
• 10 Caritis S, Zhao Y, Chen H-J. , et al. 714: The granisetron patch is effective in reducing nausea and vomiting of pregnancy (NVP). Am J Obstet Gynecol 2015; 212: S348 . Doi: 10.1016/j.ajog.2014.10.920
• 11 Grimes DA, Schulz KF. Compared to what? Finding controls for case-control studies. Lancet 2005; 365 (9468): 1429-1433
• 12 Pasternak B, Svanström H, Hviid A. Ondansetron in pregnancy and risk of adverse fetal outcomes. N Engl J Med 2013; 368 (09) 814-823
• 13 Andersen JT, Jimmenez-Solem E, Andersen NL. Ondansetron use in early pregnancy and the risk of congenital malformations. Int Soc Pharmacoepidermiol 2013; 36 (01) 1-2
• 14 Danielsson B, Wikner BN, Källén B. Use of ondansetron during pregnancy and congenital malformations in the infant. Reprod Toxicol 2014; 50: 134-137
• 15 Julius JM, Tindall A, Moise KJ, Refuerzo JS, Berens PD, Smith JA. Evaluation of the maternal-fetal transfer of granisetron in an ex vivo placenta perfusion model. Reprod Toxicol 2014; 49: 43-47
• 16 Smith JA, Julius JM, Gaikwad A. , et al. Evaluating the potential effect on fetal tissue after exposure to granisetron during pregnancy. Reprod Toxicol 2015; 53: 92-98
• 17 Howell J, Smeets J, Drenth HJ, Gill D. Pharmacokinetics of a granisetron transdermal system for the treatment of chemotherapy-induced nausea and vomiting. J Oncol Pharm Pract 2009; 15 (04) 223-231