Bijuva
Generic: ESTRADIOL AND PROGESTERONE
Basic Information
Manufacturer
Mayne Pharma
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
59eadb88-c9f3-4871-b176-7ddd98faf9bc
Indications & Usage
1 INDICATIONS AND USAGE BIJUVA is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.
( 1.1 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
( 1.1 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
Adverse Reactions
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 1.
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.
Gastrointestinal disorders Abdominal pain and discomfort, abdominal distention, diarrhea, nausea, vomiting.
General disorders and administration site conditions Fatigue, feeling abnormal, malaise.
Investigations Weight increased.
Metabolism and nutrition disorders Fluid retention.
Musculoskeletal and connective tissue disorders Muscle spasms, pain in extremity.
Nervous system disorders Dizziness, headache, somnolence.
Psychiatric disorders Insomnia, sleep disorder.
Reproductive system and breast disorders Breast pain, breast tenderness, uterine bleeding.
Skin and subcutaneous tissue disorders Night sweats, pruritus.
Vascular disorders Hot flush.
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 1.
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.
Gastrointestinal disorders Abdominal pain and discomfort, abdominal distention, diarrhea, nausea, vomiting.
General disorders and administration site conditions Fatigue, feeling abnormal, malaise.
Investigations Weight increased.
Metabolism and nutrition disorders Fluid retention.
Musculoskeletal and connective tissue disorders Muscle spasms, pain in extremity.
Nervous system disorders Dizziness, headache, somnolence.
Psychiatric disorders Insomnia, sleep disorder.
Reproductive system and breast disorders Breast pain, breast tenderness, uterine bleeding.
Skin and subcutaneous tissue disorders Night sweats, pruritus.
Vascular disorders Hot flush.