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Elagolix And Estradiol And Norethisterone

Also known as: Oriahnn

Check Elagolix And Estradiol And Norethisterone Interactions →

6 interactions on record⛔ Black Box Warning

Elagolix And Estradiol And Norethisterone has 6 known drug interactions based on U.S. FDA drug labeling data. Of these, 1 are contraindicated combinations that should be avoided entirely. Notable interactions include combinations with Mao Inhibitors, Digoxin, Midazolam. Patients taking Elagolix And Estradiol And Norethisterone should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 6
Contraindicated: 1
Moderate: 5

Contraindicated (1)

Elagolix And Estradiol And Norethisterone + Mao Inhibitors— OATP1B1 inhibitors that significantly increase elagolix plasma concentrations are contraindicated due to increased risk …

Moderate (5)

Elagolix And Estradiol And Norethisterone + Digoxin— ORIAHNN may increase digoxin plasma concentrations. Increase monitoring of digoxin concentrations and signs of toxicity …
Elagolix And Estradiol And Norethisterone + Midazolam— ORIAHNN may decrease midazolam plasma concentrations. Consider increasing midazolam dose by no more than 2-fold and indi…
Elagolix And Estradiol And Norethisterone + Omeprazole— ORIAHNN may increase omeprazole plasma concentrations. No dose adjustment needed for 40 mg once daily; consider dosage r…
Elagolix And Estradiol And Norethisterone + Rifampin— Rifampin is not recommended with ORIAHNN as concomitant use may decrease elagolix, estradiol, and norethindrone plasma c…
Elagolix And Estradiol And Norethisterone + Rosuvastatin— Statins: rosuvastatin ↓ rosuvastatin Monitor lipid levels and adjust the dose of rosuvastatin, if necessary.

Elagolix And Estradiol And Norethisterone + Mao Inhibitors⛔Contraindicated

OATP1B1 inhibitors that significantly increase elagolix plasma concentrations are contraindicated due to increased risk of elagolix-associated adverse reactions.

Elagolix And Estradiol And Norethisterone + Digoxin🟡Moderate

ORIAHNN may increase digoxin plasma concentrations. Increase monitoring of digoxin concentrations and signs of toxicity when initiating or discontinuing ORIAHNN.

Elagolix And Estradiol And Norethisterone + Midazolam🟡Moderate

ORIAHNN may decrease midazolam plasma concentrations. Consider increasing midazolam dose by no more than 2-fold and individualize therapy based on patient response.

Elagolix And Estradiol And Norethisterone + Omeprazole🟡Moderate

ORIAHNN may increase omeprazole plasma concentrations. No dose adjustment needed for 40 mg once daily; consider dosage reduction for higher doses.

Elagolix And Estradiol And Norethisterone + Rifampin🟡Moderate

Rifampin is not recommended with ORIAHNN as concomitant use may decrease elagolix, estradiol, and norethindrone plasma concentrations and reduce therapeutic effects.

Elagolix And Estradiol And Norethisterone + Rosuvastatin🟡Moderate

Statins: rosuvastatin ↓ rosuvastatin Monitor lipid levels and adjust the dose of rosuvastatin, if necessary.

⛔ FDA Black Box Warning

WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS Estrogen and progestin combinations, including ORIAHNN, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events [see Warnings and Precautions ( 5.1 )] . ORIAHNN is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke and women with uncontrolled hypertension [see Contraindications ( 4 )] . WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS See full prescribing information for complete boxed warning. Estrogen and progestin combinations, including ORIAHNN, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events. ( 5.1 ) ORIAHNN is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events including women over 35 years of age who smoke or women with uncontrolled hypertension. ( 4 )

Contraindications

4 CONTRAINDICATIONS ORIAHNN is contraindicated in women: With a high risk of arterial, venous thrombotic, or thromboembolic disorders [see Boxed Warning and Warnings and Precautions ( 5.1 ) ] . Examples include women over 35 years of age who smoke, and women who are known to have: ○ current or history of deep vein thrombosis or pulmonary embolism ○ vascular disease (e.g., cerebrovascular disease, coronary artery disease, peripheral vascular disease) ○ thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) ○ inherited or acquired hypercoagulopathies ○ uncontrolled hypertension ○ headaches with focal neurological symptoms or have migraine headaches with aura if over age 35 Who are pregnant. Exposure to ORIAHNN early in pregnancy may increase the risk of early pregnancy loss [see Use in Specific Populations ( 8.1 ) ] . With known osteoporosis because of the risk of further bone loss [see Warnings and Precautions ( 5.2 ) ] . With current or history of breast cancer or other hormonally-sensitive malignancies, and with increased risk for hormonally-sensitive malignancies [see Warnings and Precautions ( 5.3 ) ] . With known hepatic impairment or disease [see Warnings and Precautions ( 5.5 ) ] . With undiagnosed abnormal uterine bleeding. With known anaphylactic reaction, angioedema, or hypersensitivity to ORIAHNN or any of its components. Taking inhibitors of organic anion transporting polypeptide (OATP)1B1 (a hepatic uptake transporter) that are known or expected to significantly increase elagolix plasma concentrations [see Drug Interactions ( 7.2 ) ] . High risk of arterial, venous thrombotic, or thromboembolic disorder. ( 4 ) Pregnancy. ( 4 ) Known osteoporosis. ( 4 ) Current or history of breast cancer or other hormonally-sensitive malignancies. ( 4 ) Known liver impairment or disease. ( 4 ) Undiagnosed abnormal uterine bleeding. ( 4 ) Known hypersensitivity to ingr

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Use of ORIAHNN is contraindicated in pregnant women. Exposure to elagolix early in pregnancy may increase the risk of early pregnancy loss. Discontinue ORIAHNN if pregnancy occurs during treatment. The limited human data with the use of elagolix in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage [see Data ]. When pregnant rats and rabbits were orally dosed with elagolix during the period of organogenesis, postimplantation loss was observed in pregnant rats at doses 12 times the maximum recommended human dose (MRHD). Spontaneous abortion and total litter loss were observed in rabbits at doses 4 and 7 times the MRHD. There were no structural abnormalities in the fetuses at exposures up to 25 and 7 times the MRHD for the rat and rabbit, respectively [see Data ] . Data Human Data There was one pregnancy reported in the 453 women who received ORIAHNN in the Phase 3 uterine fibroids clinical trials. The pregnancy resulted in a spontaneous abortion and the estimated fetal exposure to ORIAHNN occurred during the first 18 days of pregnancy. Animal Data Embryofetal development studies were conducted in the rat and rabbit. Elagolix was administered by oral gavage to pregnant rats (25 animals/dose) at doses of 0, 300, 600, and 1200 mg/kg/day and to rabbits (20 animals/dose) at doses of 0, 100, 150, and 200 mg/kg/day during the period of organogenesis (gestation day 6-17 in the rat and gestation day 7-20 in the rabbit). In rats, maternal toxicity was present at all doses and included six deaths and decreases in body weight gain and food consumption. Increased postimplantation losses were present in the mid dose group, which was 12 times the MRHD based on AUC. In rabbits, three spontaneous abortions and a single total litter loss were observed at the highest maternally toxic dose, which was 7 times the MRHD based on AUC. A single total litter loss occurred at a lower non-maternally toxic dose o

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.