Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal


Klassificering: C!

Preparat: Gemcitabin Actavis, Gemcitabin Ebewe, Gemcitabin Fresenius Kabi, Gemcitabin Hospira, Gemcitabin Pfizer, Gemcitabin Sandoz, Gemcitabin SUN, Gemcitabine Accord, Gemcitabine Vianex, Gemkabi, Gemzar®, Gitrabin

ATC kod: L01BC05

Substanser: gemcitabin, gemcitabinhydroklorid


Kvinnor kan ha mer nytta än män av gemcitabinbaserade kombinationskemoterapier men är mer benägna att utveckla kräkningar. Användning av gemcitabin under graviditet kan orsaka fosterskador.

Additional information

Pharmacokinetics and dosing

The clearance of gemcitabine is 25-48% lower in women than men, with more pronounced difference at higher age and resulting in higher concentrations [1]. According to the product information, the clearance for women is about 25% lower than for men, but the recommended gemcitabine dose of 1000 mg per square meter of body surface area does not need to be reduced for women [2].


Pancreatic cancerOutcome of chemoradiotherapy for unresectable pancreatic cancer in 103 men and 77 women was analyzed retrospectively: Multivariate analysis showed that male sex , lower performance status, and higher posttreatment CA 19-9 level predicted worse overall survival [3].  Data on Japanese patients with nonresectable pancreatic cancer receiving gemcitabine-based chemotherapy (306 men, 225 women) collected to generate a nomogram to predict survival and patient´s sex was not a significant factor [4].A single-arm prospective, multicenter, open-label phase II study (25 men, 21 women) evaluated the combination of erlotinib and weekly fixed dose-rate gemcitabine, in previously untreated patients with locally advanced, inoperable, or metastatic pancreatic cancer. Female sex was a predictor of longer progression free survival (HR 2.99, 05%CI 1.13-7.90), but not overall survival [5].

Biliary tract cancerBetween 2010 and 2016, 740 Korean patients (425 men, 315 women) with cholangiocarcinoma and gallbladder cancer were treated with first-line gemcitabine plus cisplatin. In multivariate analysis, male sex was associated with lower overall survival (HR 0.83) [6].

Urothelial cancerA total of 174 men and 54 women with metastatic urothelial carcinoma undergoing systemic chemotherapy were included in a multi-institutional study. The gemcitabine plus cisplatin regimen was administered as first-line chemotherapy to 131 patients. Of all patients, 119 received at least 2 different regimens and 22 underwent resection of metastases. The median overall survival (OS) time was 17 months. One of the favorable prognostic factors was female sex [7]. Median survival was 16 months for men and 27 months for women (HR 0.48) [7].

Non-small cell lung cancer (NSCLC)A retrospective study included 235 men and 83 women with advanced NSCLC treated with first-line gemcitabine-based chemotherapy. No difference in terms of progression-free survival or overall survival according to sex, age, stage, chemotherapy (single-agent versus combination chemotherapy) and thrombocytosis was observed [8].

Adverse effects

Female sex predicts a greater risk for acute emesis and poor antiemetic control [9].A total of 120 patients (74 men, 46 women) with biliary tract cancer were enrolled in a study to evaluate acid suppressants’ efficacy in prevention of chemotherapy-induced nausea and vomiting. It showed that the treatment was not associated with nausea incidence. Female sex was a predictive factor for onset of all-grade nausea in association with cisplatin and gemcitabine treatment [10].

Reproductive health issues

Gemcitabine may cause fetal harm. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Försäljning på recept

Läkemedel innehållande gemcitabin (ATC-kod L01BC05) används huvudsakligen på sjukhus och därför könsspecifika användningsdata [11].

Uppdaterat: 2022-11-08

Litteratursökningsdatum: 2022-10-14


  1. Food and Drug Administration (FDA). Drug label - GEMZAR (gemcitabine). Drugs@FDA [www]. [updated 2005-04-20, cited 2022-10-14]. länk
  2. Gemcitabine Accord (gemcitabine). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2022-10-24, cited 2022-11-08]
  3. Zhou J, Fang CX, Shen J, Schipper MJ, Zalupski MM, Minter RM et al. Definitive Chemoradiation With Full-dose Gemcitabine for Unresectable Pancreatic Cancer: Efficacy of Involved-Field Radiotherapy. Am J Clin Oncol. 2017;40(5):517-522. PubMed
  4. Hamada T, Nakai Y, Yasunaga H, Isayama H, Matsui H, Takahara N et al. Prognostic nomogram for nonresectable pancreatic cancer treated with gemcitabine-based chemotherapy. Br J Cancer. 2014;110(8):1943-9. PubMed
  5. Vaccaro V, Bria E, Sperduti I, Gelibter A, Moscetti L, Mansueto G et al. First-line erlotinib and fixed dose-rate gemcitabine for advanced pancreatic cancer. World J Gastroenterol. 2013;19(28):4511-9. PubMed
  6. Kim BJ, Hyung J, Yoo C, Kim KP, Park SJ, Lee SS et al. Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients. Cancer Chemother Pharmacol. 2017;80(1):209-215. PubMed
  7. Abe T, Ishizaki J, Kikuchi H, Minami K, Matsumoto R, Harabayashi T et al. Outcome of metastatic urothelial carcinoma treated by systemic chemotherapy: Prognostic factors based on real-world clinical practice in Japan. Urol Oncol. 2017;35(2):38e1-38e8. PubMed
  8. Canova S, Cicchiello F, Agustoni F, Bianchini G, Abbate MI, Bidoli P et al. Gemcitabine-induced thrombocytosis as a potential predictive factor in non-small cell lung cancer: analysis of 318 patients. Tumori. 2017;103(2):143-147. PubMed
  9. Gralla RJ, Osoba D, Kris MG, Kirkbride P, Hesketh PJ, Chinnery LW et al. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines American Society of Clinical Oncology. J Clin Oncol. 1999;17(9):2971-94. PubMed
  10. Saito Y, Takekuma Y, Komatsu Y, Sugawara M. Evaluation of risk factors for chemotherapy-induced nausea and vomiting in cisplatin and gemcitabine treatment for biliary tract cancer: acid suppressants do not prevent nausea. Pharmazie. 2022;77(6):196-201. PubMed
  11. Concise (INSIKT). Kalmar: eHälsomyndigheten. 2018 [cited 2019-03-14.] länk

Författare: Alan Fotoohi

Faktagranskat av: Diana Rydberg, Carl-Olav Stiller

Godkänt av: Karin Schenck-Gustafsson