6/10/2023

Janusmed kön och genus

Janusmed kön och genus – Fluorouracil Sandoz

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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C! C!
C! C!

Fluorouracil - intravenöst

Fluorouracil - intravenöst

Klass: C!

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Efudix, Efudix 5% cream, Efudix MEDA Pharma, Efudix MED......

Efudix, Efudix 5% cream, Efudix MEDA Pharma, Efudix MEDA Pharma GmbH, Efudix Meda, Efudix cream, Fluorouracil Accord, Fluorouracil Sandoz, Fluorouracil Teva, Fluorouracil-Teva, Flurablastin, Tolak
ATC-koder

L01BC02

L01BC02
Substanser

fluorouracil, fluorouracilnatrium

fluorouracil, fluorouracilnatrium
Sammanfattning

Kvinnligt kön är korrelerat med högre risk för biverkningar av 5-fluorouracil (5-FU). Könsskillnader i farmakokinetiken för 5-FU som infusion har noterats och några studier pekar på ökad exponering för 5-FU hos kvinnor. Någon könsrelaterad skillnad i utfall har dock inte setts för 5-FU ensamt eller i kombinationsbehandling.

Kvinnligt kön är korrelerat med högre risk för biverkningar av 5-fluorouracil (5-FU). Könsskillnader i farmakokinetiken för 5-FU som infusion har noterats och några studier pekar på ökad exponering för 5-FU hos kvinnor. Någon könsrelaterad skillnad i utfall har dock inte setts för 5-FU ensamt eller i kombinationsbehandling.
Background

Since chemotherapeutic agents share some adverse effects, evaluation of a particular agent’s safety during combination chemotherapy is complicated.

Pharmacokinetics and dosing
A pharmacokinetic study on patients (301 men, 79 women) showed a wide variability in the clearance rate of 5-FU (L/h/m2) among both men and women, and a significantly faster clearance rate in men (median 179; range 29-739, vs median 155; range 56-466) [1] .

Results of a prospective population pharmacokinetic study showed sex-specific elimination of continuous-infusional 5-FU in patients with gastrointestinal malignancies (21 men, 10 women). Men had a 26% higher elimination of 5-FU, and lower AUC of 5-FU compared to women (18 vs. 22 mg h/L) [2].

Effects
A pooled analysis from five5 randomized clinical trials of metastatic colorectal cancer patients (1925 men, 1298 women) who were mainly treated with FOLFOX (folinic acid, fluorouracil, and oxaliplatin)-based regimens found no difference in overall survival, or progression-free survival between men and women [3].

Adverse effects
An analysis of five randomiz......

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Since chemotherapeutic agents share some adverse effects, evaluation of a particular agent’s safety during combination chemotherapy is complicated. # Pharmacokinetics and dosing A pharmacokinetic study on patients (301 men, 79 women) showed a wide variability in the clearance rate of 5-FU (L/h/m2) among both men and women, and a significantly faster clearance rate in men (median 179; range 29-739, vs median 155; range 56-466) [1] . Results of a prospective population pharmacokinetic study showed sex-specific elimination of continuous-infusional 5-FU in patients with gastrointestinal malignancies (21 men, 10 women). Men had a 26% higher elimination of 5-FU, and lower AUC of 5-FU compared to women (18 vs. 22 mg h/L) [2]. # Effects A pooled analysis from five5 randomized clinical trials of metastatic colorectal cancer patients (1925 men, 1298 women) who were mainly treated with FOLFOX (folinic acid, fluorouracil, and oxaliplatin)-based regimens found no difference in overall survival, or progression-free survival between men and women [3]. # Adverse effects An analysis of five randomized clinical trials of metastatic colorectal cancer patients found that women had a higher rate of gastrointestinal and hematologic toxicities than men. Women were also more likely to experience alopecia, diarrhea, nausea and vomiting, anemia, and neutropenia [3]. Patients with stage II and stage III colon cancer were randomly allocated to receive leucovorin and fluorouracil with irinotecan biweekly (FOLFIRI, 351 men, 247 women) or without irinotecan biweekly (LV/5-FU, 340 men, 254 women) after curative surgery. Women compared to men had a higher risk for grade III-IV neutropenia in the FOLFIRI arm (OR 2.2, 95% CI: 1.8-2.8), but not in the LV/5-FU arm [4, 5]. # Reproductive health issues Fetal defects and miscarriages have been reported. Women of childbearing potential and their partner should be advised against becoming pregnant and advised to use effective contraception during and 6 months after treatment with 5-FU. If the medicine is used during pregnancy or if the patient becomes pregnant while taking the medicine, she should be given complete information about the potential danger to the fetus; genetic counseling is recommended [6]. For more information regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Försäljning på recept

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Läkemedel innehållande fluorouracil (ATC-kod L01BC02) används huvudsakligen på sjukhus och därför saknas könsspecifika användningsdata [7].
Referenser

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  1. Milano G, Etienne MC, Cassuto-Viguier E, Thyss A, Santini J, Frenay M et al. Influence of sex and age on fluorouracil clearance. J Clin Oncol. 1992;10(7):1171-5.

  2. Mueller F, Büchel B, Köberle D, Schürch S, Pfister B, Krähenbühl S, Froehlich TK, Largiader CR, Joerger M. Gender-specific elimination of continuous-infusional 5-fluorouracil in patients with gastrointestinal malignancies: results from a prospective population pharmacokinetic study. Cancer Chemother Pharmacol. 2013;71(2):361-70.

  3. Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019;18(2):110-115.

  4. Van Cutsem E, Labianca R, Bodoky G, Barone C, Aranda E, Nordlinger B et al. Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3. J Clin Oncol. 2009;27(19):3117-25.

  5. Tejpar S, Yan P, Piessevaux H, Dietrich D, Brauchli P, Klingbiel D et al. Clinical and pharmacogenetic determinants of 5-fluorouracyl/leucovorin/irinotecan toxicity: Results of the PETACC-3 trial. Eur J Cancer. 2018;99:66-77.

  6. Fluorouracil Accord (fluorouracil). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2020-12-16, cited 2021-06-03]

  7. Concise (INSIKT). Kalmar: eHälsomyndigheten. 2018 [cited 2019-03-14.]

  1. Milano G, Etienne MC, Cassuto-Viguier E, Thyss A, Santini J, Frenay M et al. Influence of sex and age on fluorouracil clearance. J Clin Oncol. 1992;10(7):1171-5.
  2. Mueller F, Büchel B, Köberle D, Schürch S, Pfister B, Krähenbühl S, Froehlich TK, Largiader CR, Joerger M. Gender-specific elimination of continuous-infusional 5-fluorouracil in patients with gastrointestinal malignancies: results from a prospective population pharmacokinetic study. Cancer Chemother Pharmacol. 2013;71(2):361-70.
  3. Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019;18(2):110-115.
  4. Van Cutsem E, Labianca R, Bodoky G, Barone C, Aranda E, Nordlinger B et al. Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3. J Clin Oncol. 2009;27(19):3117-25.
  5. Tejpar S, Yan P, Piessevaux H, Dietrich D, Brauchli P, Klingbiel D et al. Clinical and pharmacogenetic determinants of 5-fluorouracyl/leucovorin/irinotecan toxicity: Results of the PETACC-3 trial. Eur J Cancer. 2018;99:66-77.
  6. Fluorouracil Accord (fluorouracil). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2020-12-16, cited 2021-06-03]
  7. Concise (INSIKT). Kalmar: eHälsomyndigheten. 2018 [cited 2019-03-14.]
Uppdaterat

Litteratursökningsdatum 3/6/2021

Litteratursökningsdatum 3/6/2021