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Systemic Lupus Erythematosus
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Maria A. Giraldo-Isaza, Bettina F. Cuneo
Hydroxychloroquine sulfate was originally an antimalarial drug. 400 mg orally daily or divided bid. Maximum dose 5 mg/kg/day. Safe in pregnancy [18]. No increased risk of miscarriage, stillbirth, pregnancy loss, and congenital anomalies (including ocular abnormalities) in exposed pregnancies when compared to non-exposed group [19–21]. This is currently the safest and most effective therapy for SLE pregnant women who need therapy. Important not to stop drug periconception [11, 19, 22]. Hydroxychloroquine therapy is desirable in all pregnant SLE patients, for maternal and fetal benefit. If stable with no recent flares on hydroxychloroquine, it is recommended to continue it in pregnancy and postpartum. If not previously taking, consider initiating hydroxychloroquine therapy, unless contraindicated. Hydroxychloroquine >200 mg/d initiated prior to 10 weeks and continued through pregnancy decreases C-NLE recurrence by greater than 50% in women with prior affected offspring [23–25]. See CHB Prevention later in the chapter. Compatible with breastfeeding.
Photoexacerbated Dermatoses
Published in Henry W. Lim, Nicholas A. Soter, Clinical Photomedicine, 2018
Therapy should begin with 200–400 mg/day of hydroxychloroquine sulfate. If a response is not seen in 6–8 weeks, quinacrine hydrochloride 100 mg/day may be added. An attempt should be made to taper or to discontinue the antimalarials as early as possible. Cosmesis may be of benefit in some patients: makeup to cover depigmented lesions and wigs to cover scalp lesions. Excision of lesions is contraindicated because the disease will generally recur within the scar.
Acute and subacute oral toxicity of artemisinin-hydroxychloroquine sulfate tablets in beagle dogs
Published in Drug and Chemical Toxicology, 2023
Xiaobo Li, Jianjia Feng, Yueming Yuan, Shouya Zhang, Zhiyong Xu, Qin Xu, Jianping Song, Li Ru, Zheng Yuan, Wanting Wu
Hydroxychloroquine sulfate is a derivative of chloroquine, belonging to the 4-aminoquinolines, with similar effects to chloroquine, such as treating malaria, regulating immunity, antibacterial (Ben-Zvi et al. 2012). But chloroquine has serious drug resistance and side effects, leading to limited clinical application (Marques et al. 2014). Hydroxychloroquine, which is relatively less toxic than chloroquine, is currently one of the first-line drugs for the treatment of rheumatoid arthritis, but it is rarely used as an antimalarial in clinic (Hu et al. 2017, Jorge et al. 2018). Recently, we developed artemisinin-hydroxychloroquine sulfate tablets (AH) to treat malaria. Our previous studies have demonstrated that the combination of artemisinin and hydroxychloroquine sulfate has many benefits, including improving the therapeutic efficacy of malaria, decreasing the dose of both, reducing the toxic side effects of hydroxychloroquine, and postponing the progress of single drug resistance (unpublished data). In addition to being antimalarial, hydroxychloroquine and artemisinin are also antivirals with broad activity, such as anti-flavivirus and anti-coronavirus (Andreani et al. 2020, Cao et al. 2020, Liu et al. 2020, Wang et al. 2020). Recent reports showed they have been used in many clinical trials to treat COVID-19 (Nicol et al.2020, Lewis et al. 2021, Li et al.2021a). Hence, as a combination of hydroxychloroquine and artemisinin, AH has great potential in treating many diseases, particularly coronavirus infection.
Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?
Published in The American Journal of Bioethics, 2021
Holly Fernandez Lynch, Arthur Caplan, Patricia Furlong, Alison Bateman-House
FDA’s first EUA for COVID-19 therapeutics was issued jointly for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) (U.S. Food and Drug Administration 2020h). Atypically, these products were already approved for other uses; the EUA was needed to allow them to be distributed from the strategic national stockpile. In addition to a hefty dose of political pressure (Bright 2020), the EUA was based on very low-quality evidence—in vitro data and case reports—as well as the misguided notion that products already in use for other indications must be reasonably safe for any patient population. Hype and related demand soared amongst both clinicians and patients, making it challenging to run robust, randomized trials of HCQ/CQ for COVID-19, as well as trials of other possible therapeutics. High levels of interest resulted in a proliferation of HCQ/CQ trials, but these were often poorly designed and duplicative, ultimately using resources that could have been devoted to more promising products (Herper and Riglin 2020). In time, research demonstrated that HCQ/CQ were not effective treatments for COVID-19 and that they posed safety concerns without countervailing benefits (Schluger 2020), leading FDA to revoke the EUA after just a few months (U.S. Food and Drug Administration 2020i). Ultimately, patients got rapid access, but not to an effective COVID-19 therapy.
Formulation and stability study of hydroxychloroquine sulfate oral suspensions
Published in Pharmaceutical Development and Technology, 2021
Sarah El Mershati, Agathe Thouvenin, Philippe-Henri Secretan, Pascale De Lonlay, Caroline Tuchmann-Durand, Salvatore Cisternino, Joël Schlatter
Hydroxychloroquine sulfate (HCQ), chemically known as 7-chloro-4-[4-(N-ethyl-N-b-hydroxyethylamino)-1-methylbutylamino]quinoline sulfate, is a known antimalarial drug indicated for the treatment of uncomplicated malaria and rheumatic diseases such as systemic lupus erythematosus, and rheumatoid arthritis (FDA: Plaquenil summary of product characteristics). Recently it gained more attention since it was proposed in COVID-19 therapy. The mechanism of action of HCQ is complex and remains unresolved. In systemic autoimmune disease, HCQ decreases the pro-inflammatory cytokine secretion and impairs immune cell function (Casian et al. 2018; Schreiber et al. 2018). HCQ markedly suppresses the Toll-like receptors 9 (TLR9)-mediated human B cell functions during inflammatory processes (Torigoe et al. 2018). HCQ reversed platelet activation induced by human antiphospholipid antibodies and protected the annexin A5 anticoagulant shield from disruption by antiphospholipid antibodies (Espinola et al. 2002; Rand et al. 2010; Miranda et al. 2019).