Eculizumab

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Headache and miscarriage: case report A 38-year-old woman experienced headache and had a miscarriage during treatment with eculizumab for paroxysmal nocturnal haemoglobinuria (PNH). The woman was diagnosed with PNH in August 2016. One year after this diagnosis, conceding to her desire for being pregnant and the potential increased risk, treatment with eculizumab was proposed despite no signs of haemolysis. Before starting the treatment, she was given antibiotic prophylaxis for subsequent vaccination against meningococcus. In August 2017, she was initiated with eculizumab 600mg per week for the first 4 weeks and 900mg every 14 days thereafter [route not stated]. She did not receive any antithrombotic prophylactic treatment. Once induction phase was over, she had a clear clinical improvement with disappearance of chest pain, oesophageal spasm episodes and asthenia. She tolerated the medication well; however a mild headache was reported 24 hours post-infusion. D-dimer and LDH values returned to normal. In January 2018, 6 months after the initiation of eculizumab treatment, she presented to the emergency department because of abdominal pain and heavy vaginal bleeding. She had received a total of 16 doses of eculizumab until that moment. She was at 6+4 weeks of amenorrhoea. Her physical examination showed normal genitalia with vaginal remains after Valsalva; and these were sent for pathological anatomy analysis. Her ultrasound scan showed a 17mm endometrium with two anechoic images of 2 and 4mm, respectively (with normal right and left annexes). The value of β-Human chorionic gonadotropin (βHCG) was found to be 910.5 IU/L. Initially, she was diagnosed with either miscarriage or early/ectopic pregnancy. On the basis of these findings, hormonal monitoring was decided; 2 days and 1 week later, βHCG values were found to be 409.9 IU/L and 13.1 IU/L, respectively. A diagnosis of miscarriage in the first trimester was confirmed by sample results and hormone level changes. Menstruation following the miscarriage was heavy, with pre-syncopal episode. At the time of report, the woman continued eculizumab treatment and was haematologically stable, with no clinical symptoms or haemolysis. Author comment: "In August 2017, eculizumab treatment was administered. . .Tolerance was good, with only a mild headache 24hr post-infusion." "Six months after her eculizumab treatment, the patient experienced spontaneous abortion in her first trimester. The direct relation between eculizumab and the miscarriage is not clear." "A recent publication assessed the safety and efficacy of eculizumab in 61 pregnant patients with PNH. Six spontaneous abortions occurred". Rodriguez-Ferreras A, et al. Eculizumab-related abortion in a woman with paroxysmal nocturnal hemoglobinuria: A case report. Journal of Reproduction and Infertility 20: 252-255, No. 4, Oct-Dec 2019. Available from: URL: http:// 803434923 www.jri.ir/article/60062 - Spain

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