Ospemifene Brand Name– Osphena
What is Ospemifene
Ospemifene is an oral estrogen receptor agonist/antagonist (selective estrogen-receptor modulator, or SERM) that is used to treat women experiencing moderate to severe vaginal dryness and dyspareunia, symptoms of vulvar and vaginal atrophy due to menopause.
Ospemifene is not a hormone and is an alternative to estrogen therapy in menopausal women with exclusive genitourinary menopausal symptoms.
The drug’s labeling carries a boxed warning alerting that the drug can stimulate endometrial hyperplasia; consider the addition of a progestin to reduce this risk in women with an intact uterus.
Similar to estrogens, there is also a warning regarding the risk for thrombotic and hemorrhagic strokes and deep venous thrombosis; however, thrombotic events occur at incidence rates that are low (3.39 per thousand women or less) compared with the known risks associated with estrogen-based hormone replacement therapy.
Treatment with ospemifene should be individualized, and prescribed for the shortest duration consistent with treatment goals and risks.
Ospemifene was FDA approved in 2013.
Indications
- atrophic vaginitis
- dyspareunia
For the treatment of moderate to severe vaginal dryness and dyspareunia, symptoms of atrophic vaginitis due to menopause
Side Effects
- angioedema
- endometrial cancer
- endometrial hyperplasia
- headache
- hot flashes
- hyperhidrosis
- muscle cramps
- myocardial infarction
- new primary malignancy
- night sweats
- pruritus
- pulmonary embolism
- rash
- stroke
- thromboembolism
- thrombosis
- urticaria
- vaginal bleeding
- vaginal discharge
Monitoring Parameters
- pelvic exam
Contraindications
- breast cancer
- breast-feeding
- children
- diabetes mellitus
- dysfunctional uterine bleeding
- endometrial cancer
- hepatic disease
- hypercholesterolemia
- hypertension
- infants
- labor
- myocardial infarction
- neonates
- new primary malignancy
- obesity
- ovarian cancer
- pregnancy
- stroke
- surgery
- systemic lupus erythematosus (SLE)
- thromboembolic disease
- thromboembolism
- tobacco smoking
- vaginal bleeding
Interactions
- Amiodarone
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amprenavir
- Apalutamide
- Atazanavir
- Atazanavir; Cobicistat
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Boceprevir
- Bosentan
- Carbamazepine
- Ceritinib
- Clarithromycin
- Cobicistat
- Conjugated Estrogens
- Conjugated Estrogens; Bazedoxifene
- Conjugated Estrogens; Medroxyprogesterone
- Dabrafenib
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Delavirdine
- Dienogest; Estradiol valerate
- Diethylstilbestrol, DES
- Drospirenone; Estradiol
- Drospirenone; Ethinyl Estradiol
- Drospirenone; Ethinyl Estradiol; Levomefolate
- Elagolix; Estradiol; Norethindrone acetate
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Enzalutamide
- Esterified Estrogens
- Esterified Estrogens; Methyltestosterone
- Estradiol
- Estradiol Cypionate; Medroxyprogesterone
- Estradiol; Levonorgestrel
- Estradiol; Norethindrone
- Estradiol; Norgestimate
- Estradiol; Progesterone
- Estrogens
- Estropipate
- 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
- Fluconazole
- Fosamprenavir
- Fosphenytoin
- Glyburide
- Glyburide; Metformin
- Indinavir
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ketoconazole
- Letermovir
- Lopinavir; Ritonavir
- Mestranol; Norethindrone
- Mitotane
- Ombitasvir; Paritaprevir; Ritonavir
- Phenobarbital
- Phenytoin
- Primidone
- Raloxifene
- Ribociclib
- Ribociclib; Letrozole
- Rifampin
- Ritonavir
- Rucaparib
- Segesterone Acetate; Ethinyl Estradiol
- St. John’s Wort, Hypericum perforatum
- Tamoxifen
- Telaprevir
- Telithromycin
- Toremifene
- Tucatinib
- Voriconazole
- Warfarin
