Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Warnings and Precautions (5.1) ].
Malignant Neoplasms [see Warnings and Precautions (5.2) ].
The most common adverse reactions with BIJUVA (incidence ≥ 3% of women and greater than placebo) are: breast tenderness, headache, nausea, vaginal bleeding, vaginal discharge and pelvic pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharmaat 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of estradiol and progesterone capsules was assessed in a 1-year trial that included 1,835 postmenopausal women (1,684 were treated with estradiol and progesterone capsules once daily and 151 women received placebo).
Most women (~70%) in the active treatment groups were treated for ≥ 326 days.
Treatment related adverse reactions with an incidence of ≥ 3% in either BIJUVA (estradiol and progesterone) capsules group and numerically greater than those reported in the placebo group are listed in Table
Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 3% and Numerically More Common in Women Receiving BIJUVA (estradiol and progesterone) 0.5 mg/100 mg and 1 mg/100 mg Preferred Term BIJUVA 0.5 mg/100 mg BIJUVA 1 mg/100 mg Placebo (N=151) (N=424) (N=415) Breast tenderness 17 (4.0) 43 (10.4) 1 (0.7) Headache 17 (4.0) 14 (3.4) 1 (0.7) Nausea 15 (3.5) 9 (2.2) 1 (0.7) Vaginal bleeding 10 (2.4) 14 (3.4) 0 Vaginal discharge 8 (1.9) 14 (3.4) 1 (0.7) Pelvic pain 12 (2.8) 13 (3.1) 0 6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of BIJUVA.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5 WARNINGS AND PRECAUTIONS Cardiovascular Disorders: Increased risks of PE, DVT, stroke, and MI are reported with estrogen plus progestin therapy.
Manage risk factors for arterial vascular disease and/or venous thromboembolisum.
Discontinue if an arterial or venous thrombotic or thromboembolic event occurs.
( 5.1 ) Malignant Neoplasms: Assess risk and provide surveillance measures for breast cancer, such as breast examinations and mammography.
( 5.2 ) Estrogens increase the risk of gallbladder disease.
Like all medications, Bijuva can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: