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Antineoplastic Drugs during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
Hydroxyurea (Hydrea) inhibits DNA synthesis. It is approved to treat chronic myelocytic leukemia, ovarian carcinoma, head and neck cancers, and melanoma. No studies have been published on the use of hydroxyurea during pregnancy in humans.
Sickle Cell Disease
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Hydroxyurea (also known as hydroxycarbamide) is recommended for adults with sickle cell disease, in particular for those with three or more crises per year, pain or chronic anemia interfering with daily life, or severe or recurrent episodes of ACS. Data in pregnancy is limited; however available case series do not appear to demonstrate an increased risk of congenital malformations. If hydroxyurea was beneficial prior to pregnancy, its continual use could be considered during pregnancy.
Antimetabolites
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
In the UK, hydroxycarbamide is recommended by NICE for the treatment of polycythemia vera, essential thrombocythemia, chronic myeloid leukemia, and cervical cancer. In the noncancer area, because it induces fetal hemoglobin production, hydroxyurea (SiklosTM) is also used to treat sickle cell anemia (sickle cell disease). The most common toxic effects are myelosuppression, nausea, and skin reactions.
Evaluation of pharmacological efficacy and safety of hydroxyurea in sickle cell disease: Study of a pediatric cohort from Chhattisgarh, India
Published in Pediatric Hematology and Oncology, 2023
Harsha Lad, Shoma Naskar, S. K. D. B. Punyasri Pasupuleti, Rakesh Nahrel, Pradeep Sihare, Giriraj R. Chandak, Pradeep K. Patra
Some trials have reported a successful treatment effect upon long-term usage of hydroxyurea on mortality and morbidity among newborns and adults with sickle cell disease. Initially, hydroxyurea was used to induce HbF pharmacologically which indeed improved the survival order over a 10-year follow-up of treated patients.14 In phase III randomized clinical trials in children, HU has shown to diminish VOC events.7 However, there is a limited short-term correlation between the observed clinical benefits. Hydroxyurea is the solitary accessible medication to date that modulates the process and prognosis of SCD, its use has been limited due to various concerns regarding its side effects in children. Moreover, whether the use of HU can modulate the clinical severity in children is still an unsettled question.
Pregnancy and sickle cell disease: an overview of complications and suggested perinatal care
Published in Expert Review of Hematology, 2022
Nour M. Moukalled, Rayan Bou Fakhredin, Ali T. Taher
For women on hydroxyurea, counseling should be provided regarding the need to discontinue therapy prior to conception [32]. The Sickle Cell Disease Implementation Consortium reported data on the use of hydroxyurea and pregnancy outcomes among 1285 women (1788 pregnancies), where use during conception and pregnancy led to an increase in the risk of miscarriage or stillbirths (OR 2.21; 1.40–3.47), a risk which was not confirmed when use of hydroxyurea was limited to time of conception [33]. These results provide evidence that the use of hydroxyurea might be safe until conception, while caution should be advised regarding its continued use during pregnancy. In addition, prenatal diagnosis and genetic counseling should be offered to all couples. Diagnostic procedures include chorionic villous sampling during the first trimester, amniocentesis or cordocentesis during the second trimester [34]. Multiple additional prenatal diagnostic procedures in addition to preimplantation genetic diagnosis can also be utilized for optimal decision making.
A critical evaluation of crizanlizumab for the treatment of sickle cell disease
Published in Expert Review of Hematology, 2022
Nabin Raj Karki, Katherine Saunders, Abdullah Kutlar
The SUSTAIN study was a multicenter, multinational, double-blind, randomized, placebo-controlled, phase 2 trial designed to assess safety and efficacy of two different doses of crizanlizumab in patients aged 16–65 years with sickle cell disease [31]. Eligible participants had sickle cell disease of all genotypes and 2 to 10 VOE in the preceding 12 months before enrollment. Patients taking stable dose of hydroxyurea therapy were allowed in the study, but no dose alteration was allowed during the study period of 52 weeks and new initiation of hydroxyurea was not allowed. Patients receiving chronic red cell transfusions were excluded. A total of 198 participants underwent 1:1:1 randomization into placebo, low-dose crizanlizumab (2.5 mg/kg) or high-dose crizanlizumab (5 mg/kg) subgroups. Two loading doses of the assigned agent 2 weeks apart followed by maintenance doses every 4 weeks through week 50 for a total of 14 doses were administered. High dose crizanlizumab resulted in 45.3% lower median annual crisis rates compared with placebo (median, 1.63 versus 2.98). High-dose crizanlizumab also delayed the occurrence of first crisis as well as second crisis compared to placebo (median time, 4.07 vs 1.38 months and 10.32 vs 5.09 months respectively). The median rate of uncomplicated crises per year was 63.9% lower with high dose crizanlizumab when compared to placebo (median, 1.08 vs 2.98). These efficacy end points validate clinically significant reduction of total crises as well as postponement of crises.