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The following serious adverse reactions are discussed elsewhere in the labeling:

• Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
• Malignant Neoplasms [see BOXED WARNING, 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.

In a 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or Vagifem 10 mcg tablets. Adverse reactions with an incidence of ≥ 5 percent in the Vagifem 10 mcg group and greater than those reported in the placebo group are listed in Table 1.

Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 5 Percent in Women Receiving Vagifem 10 mcg

In a 12-week, randomized, double-blind, placebo-controlled study, 138 postmenopausal women were randomized to receive either placebo or Vagifem 25 mcg tablets. Adverse reactions with an incidence of ≥ 5 percent in the Vagifem 25 mcg group and greater than those reported in the placebo group are listed in Table 2.

Table 2: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 5 Percent in Women Receiving Vagifem 25 mcg

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Vagifem 25 mcg. 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.

Genitourinary System

Endometrial cancer, endometrial hyperplasia, vaginal irritation, vaginal pain, vaginismus, vaginal ulceration

Breast

Breast cancer

Cardiovascular

Deep vein thrombosis

Gastrointestinal

Diarrhea

Skin

Urticaria, erythematous or pruritic rash, genital pruritus

Central Nervous System

Aggravated migraine, depression, insomnia

Miscellaneous

Fluid retention, weight increase, drug ineffectiveness, hypersensitivity, blood estrogen increase

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.

No drug-drug interaction studies have been conducted for Vagifem.

Metabolic Interactions

In-vitro and in-vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3 A4 (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.

Last reviewed on RxList: 5/3/2012
This monograph has been modified to include the generic and brand name in many instances.