"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOXED WARNING, and WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOXED WARNING, and WARNINGS AND PRECAUTIONS]
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 data described below reflect pooled data from 5 clinical trials of Climara. A total of 614 women were exposed to Climara for 3 months (193 women at 0.025 mg per day, 201 women at 0.05 mg per day, 194 women at 0.1 mg per day) in randomized, double-blind trials of clinical efficacy versus placebo and versus active comparator. All women were postmenopausal, had a serum estradiol level of less than 20 pg/mL, and a minimum of five moderate to severe hot flushes per week or a minimum of 15 hot flushes per week of any severity at baseline. Included in this table are an additional 25 postmenopausal hysterectomized women exposed to Climara 0.025 mg per day for 6 to 24 months (N=16 at 24 months) in a randomized, double-blind, placebo-controlled study of Climara for the prevention of osteoporosis.
Table 1: Treatment-Emergent Adverse Reactions Reported
at a Frequency of ≥5 Percent and More Frequent in Women Receiving Climara
|Body as a Whole||21%||39%||37%||29%|
|Skin and Appendages||19%||12%||12%||15%|
|a Adverse reactions occurring at rate of
≥5 percent in Climara trials of clinical efficacy versus placebo and
versus active comparator; and trial of Climara versus placebo for the
prevention of osteoporosis
b Adverse reactions occurring at rate of ≥5 percent in Climara trials of clinical efficacy versus placebo and versus active comparator
c Adverse reactions occurring in placebo group in Climara trial of clinical efficacy versus placebo
The following adverse reactions have been identified during post-approval use of the Climara transdermal system. 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.
Changes in bleeding pattern, pelvic pain
Vomiting, abdominal pain, abdominal distension, nausea
Visual disturbances, contact lens intolerance,
Central Nervous System
Fatigue, menopausal symptoms, weight increase, application site reaction, anaphylactic reactions
Read the Climara (estradiol transdermal) Side Effects Center for a complete guide to possible side effects
In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's wort (hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/4/2016
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