Elagolix Estradiol Norethindrone acetate

Elagolix Estradiol Norethindrone acetate Brand Name– ORIAHNN

What is Elagolix Estradiol Norethindrone acetate

Elagolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, is used in combination with estradiol (an estrogen), and norethindrone acetate (a progestin) for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Elagolix reduces heavy bleeding, while estradiol and norethindrone are used as “add-back” therapy to help offset hormonal suppression.

The product reduced monthly menstrual blood loss significantly compared with placebo in clinical trials.

Medical therapy provides an alternative to surgical management in premenopausal women.

Use of this combination drug product should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.

This drug combination product was FDA-approved in May 2020

Indications

• uterine leiomyomata

For the management of heavy menstrual bleeding associated with uterine leiomyomata (fibroids) in premenopausal women

Side Effects

1. abdominal pain
2. alopecia
3. amenorrhea
4. angina
5. anxiety
6. arthralgia
7. biliary obstruction
8. bone fractures
9. breakthrough bleeding
10. breast cancer
11. chest pain (unspecified)
12. cholelithiasis
13. cholestasis
14. depression
15. diplopia
16. elevated hepatic enzymes
17. emotional lability
18. fatigue
19. fluid retention
20. headache
21. hot flashes
22. hypercholesterolemia
23. hyperglycemia
24. hyperlipidemia
25. hypertension
26. hypertriglyceridemia
27. hypothyroidism
28. infection
29. influenza
30. irritability
31. jaundice
32. libido decrease
33. menorrhagia
34. migraine
35. myocardial infarction
36. nausea
37. new primary malignancy
38. osteopenia
39. osteoporosis
40. pancreatitis
41. papilledema
42. pulmonary embolism
43. retinal thrombosis
44. stroke
45. suicidal ideation
46. thromboembolism
47. thrombosis
48. vaginal bleeding
49. visual impairment
50. vomiting
51. weight gain

Monitoring Parameters

• blood pressure
• bone mineral density
• pelvic exam
• pregnancy testing
• serum cholesterol profile

Contraindications

• adrenal insufficiency
• atrial fibrillation
• breast cancer
• breast-feeding
• cardiac disease
• cerebrovascular disease
• cervical cancer
• children
• contact lenses
• contraception requirements
• coronary artery disease
• depression
• diabetes mellitus
• endocarditis
• endometrial cancer
• endometrial hyperplasia
• gallbladder disease
• headache
• hepatic disease
• hepatocellular cancer
• hereditary angioedema
• history of angioedema
• hypercholesterolemia
• hyperlipidemia
• hypertension
• hypertriglyceridemia
• hypothyroidism
• infants
• jaundice
• menstrual irregularity
• migraine
• myocardial infarction
• new primary malignancy
• obesity
• osteopenia
• osteoporosis
• ovarian cancer
• pancreatitis
• peripheral vascular disease
• postmenopausal females
• pregnancy
• pregnancy testing
• protein C deficiency
• protein S deficiency
• reproductive risk
• stroke
• suicidal ideation
• surgery
• systemic lupus erythematosus (SLE)
• tartrazine dye hypersensitivity
• thromboembolic disease
• thromboembolism
• thrombophlebitis
• thyroid disease
• tobacco smoking
• uterine cancer
• vaginal bleeding
• vaginal cancer
• valvular heart disease
• visual disturbance

Interactions

• Abacavir; Dolutegravir; Lamivudine
• Acarbose
• Acetaminophen; Butalbital
• Acetaminophen; Butalbital; Caffeine
• Acetaminophen; Butalbital; Caffeine; Codeine
• Acetaminophen; Caffeine; Dihydrocodeine
• Acetaminophen; Codeine
• Acetaminophen; Hydrocodone
• Acetaminophen; Oxycodone
• Acetaminophen; Propoxyphene
• Acetaminophen; Tramadol
• Acetohexamide
• Acitretin
• Albiglutide
• Alfentanil
• Aliskiren; Amlodipine
• Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
• Alogliptin
• Alogliptin; Metformin
• Alogliptin; Pioglitazone
• Alpha-glucosidase Inhibitors
• Alprazolam
• Amikacin
• Aminoglycosides
• Amiodarone
• Amlodipine
• Amlodipine; Atorvastatin
• Amlodipine; Benazepril
• Amlodipine; Celecoxib
• Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
• Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
• Amlodipine; Olmesartan
• Amlodipine; Telmisartan
• Amlodipine; Valsartan
• Amobarbital
• Amoxicillin
• Amoxicillin; Clarithromycin; Lansoprazole
• Amoxicillin; Clarithromycin; Omeprazole
• Amoxicillin; Clavulanic Acid
• Ampicillin
• Ampicillin; Sulbactam
• Amprenavir
• Anastrozole
• Apalutamide
• Aprepitant, Fosaprepitant
• Aripiprazole
• Armodafinil
• Artemether; Lumefantrine
• Aspirin, ASA; Butalbital; Caffeine
• Aspirin, ASA; Butalbital; Caffeine; Codeine
• Aspirin, ASA; Caffeine; Dihydrocodeine
• Aspirin, ASA; Carisoprodol; Codeine
• Aspirin, ASA; Omeprazole
• Aspirin, ASA; Oxycodone
• Atazanavir
• Atazanavir; Cobicistat
• Atropine; Hyoscyamine; Phenobarbital; Scopolamine
• Avanafil
• Avapritinib
• Axitinib
• Azelastine; Fluticasone
• Azithromycin
• Aztreonam
• Bacitracin
• Barbiturates
• Beclomethasone
• Bedaquiline
• Belladonna Alkaloids; Ergotamine; Phenobarbital
• Betamethasone
• Betrixaban
• Bexarotene
• Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
• Bismuth Subsalicylate; Metronidazole; Tetracycline
• Boceprevir
• Bosentan
• Brigatinib
• Bromocriptine
• Brompheniramine; Guaifenesin; Hydrocodone
• Brompheniramine; Hydrocodone; Pseudoephedrine
• Budesonide
• Budesonide; Formoterol
• Bupivacaine; Lidocaine
• Buprenorphine
• Buprenorphine; Naloxone
• Buspirone
• Butabarbital
• Calaspargase pegol
• Calcium
• Canagliflozin
• Canagliflozin; Metformin
• Capmatinib
• Carbamazepine
• Carbapenems
• Carbenicillin
• Carbinoxamine; Hydrocodone; Phenylephrine
• Carbinoxamine; Hydrocodone; Pseudoephedrine
• Cariprazine
• Cefaclor
• Cefadroxil
• Cefazolin
• Cefdinir
• Cefditoren
• Cefepime
• Cefiderocol
• Cefixime
• Cefotaxime
• Cefotetan
• Cefoxitin
• Cefpodoxime
• Cefprozil
• Ceftaroline
• Ceftazidime
• Ceftazidime; Avibactam
• Ceftibuten
• Ceftizoxime
• Ceftolozane; Tazobactam
• Ceftriaxone
• Cefuroxime
• Cenobamate
• Cephalexin
• Ceritinib
• Charcoal
• Chenodiol
• Chloramphenicol
• Chlorpheniramine; Codeine
• Chlorpheniramine; Dihydrocodeine; Phenylephrine
• Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
• Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
• Chlorpheniramine; Hydrocodone
• Chlorpheniramine; Hydrocodone; Phenylephrine
• Chlorpheniramine; Hydrocodone; Pseudoephedrine
• Chlorpropamide
• Ciclesonide
• Cimetidine
• Ciprofloxacin
• Cisapride
• Citalopram
• Clarithromycin
• Clindamycin
• Clobazam
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Codeine; Guaifenesin
• Codeine; Phenylephrine; Promethazine
• Codeine; Promethazine
• Colchicine
• Colchicine; Probenecid
• Colistimethate, Colistin, Polymyxin E
• Conivaptan
• Corticosteroids
• Cortisone
• Cosyntropin
• Cyclosporine
• Dabigatran
• Dabrafenib
• Daclatasvir
• Dalbavancin
• Danazol
• Dantrolene
• Dapagliflozin
• Dapagliflozin; Metformin
• Dapagliflozin; Saxagliptin
• Daptomycin
• Daratumumab; Hyaluronidase
• Darunavir
• Darunavir; Cobicistat
• Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
• Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
• Deferasirox
• Deflazacort
• Delafloxacin
• Delavirdine
• Demeclocycline
• Dexamethasone
• Diazepam
• Dicloxacillin
• Dienogest; Estradiol valerate
• Digoxin
• Dihydrocodeine; Guaifenesin; Pseudoephedrine
• Diltiazem
• Dipeptidyl Peptidase-4 Inhibitors
• Diphenhydramine; Hydrocodone; Phenylephrine
• Disopyramide
• Docetaxel
• Dolutegravir
• Dolutegravir; Lamivudine
• Dolutegravir; Rilpivirine
• Doravirine
• Doravirine; Lamivudine; Tenofovir disoproxil fumarate
• Doripenem
• Doxycycline
• Drospirenone
• Drospirenone; Estradiol
• Drospirenone; Ethinyl Estradiol
• Drospirenone; Ethinyl Estradiol; Levomefolate
• Dulaglutide
• Duloxetine
• Efavirenz
• Efavirenz; Emtricitabine; Tenofovir
• Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
• Elbasvir; Grazoprevir
• Elexacaftor; tezacaftor; ivacaftor
• Eltrombopag
• Elvitegravir
• Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
• Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
• Empagliflozin
• Empagliflozin; Linagliptin
• Empagliflozin; Linagliptin; Metformin
• Empagliflozin; Metformin
• Emtricitabine; Rilpivirine; Tenofovir alafenamide
• Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
• Enasidenib
• Encorafenib
• Entrectinib
• Enzalutamide
• Eravacycline
• Erdafitinib
• Erlotinib
• Ertapenem
• Ertugliflozin
• Ertugliflozin; Metformin
• Ertugliflozin; Sitagliptin
• Erythromycin
• Erythromycin; Sulfisoxazole
• Eslicarbazepine
• Estradiol
• Estradiol Cypionate; Medroxyprogesterone
• Estradiol; Levonorgestrel
• Estradiol; Norethindrone
• Estradiol; Norgestimate
• Ethinyl Estradiol
• Ethinyl Estradiol; Desogestrel
• Ethinyl Estradiol; Ethynodiol Diacetate
• Ethinyl Estradiol; Etonogestrel
• Ethinyl Estradiol; Levonorgestrel
• Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
• Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
• Ethinyl Estradiol; Norelgestromin
• Ethinyl Estradiol; Norethindrone
• Ethinyl Estradiol; Norethindrone Acetate
• Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
• Ethinyl Estradiol; Norethindrone; Ferrous fumarate
• Ethinyl Estradiol; Norgestimate
• Ethinyl Estradiol; Norgestrel
• Ethotoin
• Exemestane
• Exenatide
• Fedratinib
• Felbamate
• Fentanyl
• Fidaxomicin
• Flibanserin
• Fluconazole
• Fludrocortisone
• Flunisolide
• Fluoxetine
• Fluoxetine; Olanzapine
• Fluticasone
• Fluticasone; Salmeterol
• Fluticasone; Umeclidinium; Vilanterol
• Fluticasone; Vilanterol
• Formoterol; Mometasone
• Fosamprenavir
• Fosphenytoin
• Fostemsavir
• Gemfibrozil
• Gemifloxacin
• Gentamicin
• Glasdegib
• Glecaprevir; Pibrentasvir
• Glimepiride
• Glimepiride; Pioglitazone
• Glimepiride; Rosiglitazone
• Glipizide
• Glipizide; Metformin
• Glyburide
• Glyburide; Metformin
• Glycylcyclines
• grapefruit juice
• Griseofulvin
• Guaifenesin; Hydrocodone
• Guaifenesin; Hydrocodone; Pseudoephedrine
• Guanfacine
• Hemin
• Homatropine; Hydrocodone
• Hyaluronidase
• Hyaluronidase, Recombinant; Immune Globulin
• Hydantoins
• Hydralazine
• Hydralazine; Hydrochlorothiazide, HCTZ
• Hydralazine; Isosorbide Dinitrate, ISDN
• Hydrocodone
• Hydrocodone; Ibuprofen
• Hydrocodone; Phenylephrine
• Hydrocodone; Potassium Guaiacolsulfonate
• Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
• Hydrocodone; Pseudoephedrine
• Hydrocortisone
• Ibuprofen; Oxycodone
• Icosapent ethyl
• Idelalisib
• Imatinib
• Imipenem; Cilastatin
• Imipenem; Cilastatin; Relebactam
• Incretin Mimetics
• Indinavir
• Insulin Degludec; Liraglutide
• Insulin Glargine; Lixisenatide
• Insulins
• Isavuconazonium
• Isoniazid, INH; Pyrazinamide, PZA; Rifampin
• Isoniazid, INH; Rifampin
• Isotretinoin
• Itraconazole
• Ivabradine
• Ivosidenib
• Kanamycin
• Ketoconazole
• Lamotrigine
• Lansoprazole
• Lansoprazole; Naproxen
• Lapatinib
• Lefamulin
• Leflunomide
• Lemborexant
• Lenalidomide
• Lesinurad
• Lesinurad; Allopurinol
• Letermovir
• Letrozole
• Leuprolide; Norethindrone
• Levofloxacin
• Levonorgestrel
• Levothyroxine
• Levothyroxine; Liothyronine (Porcine)
• Levothyroxine; Liothyronine (Synthetic)
• Lidocaine
• Lidocaine; Prilocaine
• Linagliptin
• Linagliptin; Metformin
• Lincomycin
• Lincosamides
• Linezolid
• Liothyronine
• Liraglutide
• Lixisenatide
• Lomitapide
• Loperamide
• Loperamide; Simethicone
• Lopinavir; Ritonavir
• Lorlatinib
• Lumacaftor; Ivacaftor
• Lumacaftor; Ivacaftor
• Lumateperone
• Lurbinectedin
• Meglitinides
• Melatonin
• Mephobarbital
• Meropenem
• Meropenem; Vaborbactam
• Mestranol; Norethindrone
• Metformin
• Metformin; Pioglitazone
• Metformin; Repaglinide
• Metformin; Rosiglitazone
• Metformin; Saxagliptin
• Metformin; Sitagliptin
• Methadone
• Methohexital
• Methylprednisolone
• Metreleptin
• Metronidazole
• Metyrapone
• Midazolam
• Mifepristone
• Miglitol
• Miltefosine
• Mineral Oil
• Minocycline
• Minoxidil
• Mitotane
• Mivacurium
• Modafinil
• Mometasone
• Morphine
• Morphine; Naltrexone
• Moxifloxacin
• Nafcillin
• Nanoparticle Albumin-Bound Paclitaxel
• Nefazodone
• Nelfinavir
• Neomycin
• Neratinib
• Nevirapine
• Nilotinib
• Nisoldipine
• Nitrofurantoin
• Nitroprusside
• Norethindrone
• Norfloxacin
• Norgestrel
• Obeticholic Acid
• Ofloxacin
• Olaparib
• Omadacycline
• Ombitasvir; Paritaprevir; Ritonavir
• Omeprazole
• Omeprazole; Amoxicillin; Rifabutin
• Omeprazole; Sodium Bicarbonate
• Oral Contraceptives
• Oritavancin
• Ospemifene
• Oxacillin
• Oxcarbazepine
• Oxycodone
• Paromomycin
• Pegaspargase
• Pemigatinib
• Penicillin G
• Penicillin G Benzathine
• Penicillin G Benzathine; Penicillin G Procaine
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Perampanel
• Perindopril; Amlodipine
• Pexidartinib
• Phenobarbital
• Phentermine; Topiramate
• Phenytoin
• Pimavanserin
• Piperacillin
• Piperacillin; Tazobactam
• Pitolisant
• Plazomicin
• Polymyxin B
• Polymyxins
• Posaconazole
• Pramlintide
• Prasterone, Dehydroepiandrosterone, DHEA (Dietary Supplements)
• Prasterone, Dehydroepiandrosterone, DHEA (FDA-approved)
• Praziquantel
• Prednisolone
• Prednisone
• Primidone
• Propoxyphene
• Pyrimethamine; Sulfadoxine
• Rabeprazole
• Raloxifene
• Ranolazine
• Ribociclib
• Ribociclib; Letrozole
• Rifabutin
• Rifampin
• Rifamycins
• Rifapentine
• Rilpivirine
• Riluzole
• Rimegepant
• Ritonavir
• Rituximab; Hyaluronidase
• Rivaroxaban
• Roflumilast
• Ropinirole
• Rosuvastatin
• Rufinamide
• Saquinavir
• Sarilumab
• Saxagliptin
• Secobarbital
• Segesterone Acetate; Ethinyl Estradiol
• Selpercatinib
• Selumetinib
• Semaglutide
• SGLT2 Inhibitors
• Sildenafil
• Siltuximab
• Simeprevir
• Simvastatin; Sitagliptin
• Siponimod
• Sirolimus
• Sitagliptin
• Sofosbuvir; Velpatasvir
• Sofosbuvir; Velpatasvir; Voxilaprevir
• Solifenacin
• Somatropin, rh-GH
• Sonidegib
• St. John’s Wort, Hypericum perforatum
• Streptogramins
• Streptomycin
• Succinylcholine
• Sufentanil
• Sugammadex
• Sulfadiazine
• Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
• Sulfasalazine
• Sulfisoxazole
• Sulfonamides
• Sulfonylureas
• Sunitinib
• Tacrine
• Tacrolimus
• Talazoparib
• Tazemetostat
• Tedizolid
• Telaprevir
• Telavancin
• Telithromycin
• Teriflunomide
• Testolactone
• Tetracycline
• Thalidomide
• Thiazolidinediones
• Thiopental
• Thyroid hormones
• Ticarcillin
• Ticarcillin; Clavulanic Acid
• Tigecycline
• Tinidazole
• Tipranavir
• Tizanidine
• Tobramycin
• Tocilizumab
• Tolazamide
• Tolbutamide
• Topiramate
• Topotecan
• Toremifene
• Tramadol
• Trandolapril; Verapamil
• Tranexamic Acid
• Trastuzumab; Hyaluronidase
• Triamcinolone
• Tricyclic antidepressants
• Trimethoprim
• Tucatinib
• Ubrogepant
• Ulipristal
• Ursodeoxycholic Acid, Ursodiol
• Vancomycin
• Venetoclax
• Verapamil
• Voriconazole
• Voxelotor
• Warfarin
• Zafirlukast
• Zanubrutinib
• Zolpidem