Because of treprostinils inhibiting effect on platelet aggregation, there is an increased risk of bleeding, especially among patients who are also taking anticoagulants. It is not known whether treprostinil is excreted in breast milk. Caution is advised when administering this medication to nursing women. Caution is advised when administering treprostinil to patients who have impaired kidney or liver function.Common side effects depending on route of administration:

85% of patients report pain or other reaction at the infusion site. Other side effects may include headache, cough, throat irritation, diarrhea, nausea, rash, jaw pain, vasodilatation, dizziness, edema (swelling), pruritus (itching), and hypotension.Warnings:

Abrupt interruption of the treprostinil infusion can lead to worsening of pulmonary hypertension symptoms, and should be avoided. Pharmacology
Mechanism of action
Treprostinil binds to the IP receptor in the lung tissue which will cause G protein activation and lead to three major effects: vasodilation, decreased cell proliferation and inhibition of platelet aggregation. Pharmacokinetics
The pharmacokinetics of continuous subcutaneous treprostinil are linear over the dose range of 1.25 to 125 ng/kg/min (corresponding to plasma concentrations of about 15 pg/mL to 18,250 pg/m) and can be described by a two-compartment model. Dose proportionality at infusion rates greater than 125 ng/kg/min has not been studied. Treprostinil is substantially metabolized by the liver, but the involved enzymes are not currently known. Five metabolites (HU1 through HU5) have been described thus far. Based on the results of in vitro human hepatic cytochrome P450 studies, Remodulin does not inhibit CYP-1A2, 2C9, 2C19, 2D6, 2E1, or 3A. Whether Remodulin induces these enzymes has not been studied.
History
Elagolix/estradiol/norethindrone acetate was approved for medical use in the United States in May 2020.The efficacy of elagolix/estradiol/norethindrone acetate was established in two clinical trials in which a total of 591 premenopausal women with heavy menstrual bleeding received the drug or placebo for six months. Heavy menstrual bleeding at baseline was defined as having at least two menstrual cycles with greater than 80 mL (about a third of a cup) of menstrual blood loss (MBL). The primary endpoint was the proportion of women who achieved MBL volume less than 80 mL at the final month and 50% or greater reduction in MBL volume from the start of the study (baseline) to the final month. In the first study, 68.5% of participants who received elagolix/estradiol/norethindrone acetate achieved this endpoint (compared to 8.7% of participants who received placebo). In the second study, 76.5% of participants who received elagolix/estradiol/norethindrone acetate achieved this endpoint (compared to 10.5% of participants who received placebo).The approval of Oriahnn was granted to AbbVie Inc.

References
External links
"Elagolix". Drug Information Portal. U.S. National Library of Medicine. "Estradiol". Drug Information Portal. U.S. National Library of Medicine. "Norethindrone acetate". Drug Information Portal. U.S. National Library of Medicine. Clinical trial number NCT02654054 for "Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women" at ClinicalTrials.gov
Clinical trial number NCT02691494 for "Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)" at ClinicalTrials.gov