药物信息为Activella (Novo Nordisk): ADVERSE REACTIONS

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  • See BOXED WARNINGS, WARNINGS and PRECAUTIONS.

    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 adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

    Adverse events reported with Activella 1.0 mg/0.5 mg by investigators in the Phase 3 studies regardless of causality assessment are shown in Table 6.

    TABLE 6: ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF =5% WITH ACTIVELLA 1.0 MG/0.5 MG

    Endometrial Hyperplasia Study

    (12-Months)

    Vasomotor Symptoms Study

    (3-Months)

    Osteoporosis Study

    (2 years)
    Activella 1.0 mg/0.5 mg1 mg E2Activella 1.0 mg/0.5 mgPlaceboActivella 1.0 mg/0.5 mgPlacebo
    (n=295)(n=296)(n=29)(n=34)(n=47)(n=48)
    Body as a Whole
    Back Pain 6% 5% 3% 3% 6%4%
    Headache16%16%17%18%11%6%
    Digestive System
    Nausea 3% 5%10%0%11%0%
    Gastroenteritis 2% 2%0%0%6%4%
    Nervous System
    Insomnia 6% 4% 3% 3%0%8%
    Emotional Lability 1% 1% 0% 0%6%0%
    Respiratory System
    Upper Respiratory Tract Infection18%15%10% 6%15%19%
    Sinusitis 7%11% 7% 0%15%10%
    Metabolic and Nutritional
    Weight Increase0%0%0%0%9%6%
    Urogenital System
    Breast Pain24%10%21% 0%17%8%
    Post-Menopausal Bleeding 5%15%10% 3%11%0%
    Uterine Fibroid 5% 4% 0% 0%4%8%
    Ovarian Cyst 3% 2% 7% 0%0%8%
    Resistance mechanism
    Infection Viral4%6%0%3%6%6%
    Moniliasis Genital4%7%0%0%6%0%
    Secondary Terms
    Injury Accidental4%3%3%0%17%including one upper extremity fracture in each group4%
    Other Events2%3%3%0%6%4%

    Adverse events reported with Activella 0.5 mg/0.1 mg by investigators during the Phase 3 study regardless of causality assessment are shown in Table 7.

    TABLE 7: ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF =5% WITH ACTIVELLA 0.5 MG/0.1 MG

    Activella 0.5 mg/0.1 mg

    Placebo

    (n=194)(n=200)
    Body as a Whole
    Back Pain10%4%
    Headache22%19%
    Pain in extremity5%4%
    Digestive System
    Nausea5%4%
    Diarrhea6%6%
    Respiratory System
    Nasopharyngitis21%18%
    Urogenital System
    Endometrial thickening10%4%
    Vaginal hemorrhage26%12%

    The following adverse reactions have been reported with estrogen and/or progestin therapy:

  • 1. Genitourinary system

  • Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; pre-menstrual-like syndrome; cystitis-like syndrome; ovarian cancer; endometrial hyperplasia; endometrial cancer.

  • 2. Breasts

  • Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

  • 3. Cardiovascular

  • Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction, stroke; increase in blood pressure.

  • 4. Gastrointestinal

  • Nausea, vomiting; changes in appetite; cholestatic jaundice; abdominal pain/cramps, flatulence, bloating; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.

  • 5. Skin

  • Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; seborrhea; hirsutism; itching; skin rash; pruritus.

  • 6. Eyes

  • Retinal vascular thrombosis, intolerance to contact lenses.

  • 7. Central nervous system

  • Headache; migraine; dizziness; mental depression; chorea; insomnia; nervousness; mood disturbances; irritability; exacerbation of epilepsy; probable dementia.

  • 8. Miscellaneous

  • Increase or decrease in weight; aggravation of porphyria; edema; leg cramps; changes in libido; fatigue; reduced carbohydrate tolerance; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; back pain; arthralgia; myalgia.

  • Drug Information Provided by National Library of Medicine (NLM).
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