Evamist (Page 4 of 8)

6 ADVERSE REACTIONS

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

Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)]
Malignant Neoplasms [see Boxed Warning, Warnings and Precautions ( 5.2)]

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 clinical practice.

In a 12-week, randomized, placebo-controlled trial of Evamist in 454 women, 80 to 90 percent of women randomized to active drug received at least 70 days of therapy and 75 to 85 percent randomized to placebo received at least 70 days of therapy.

The adverse reactions that occurred in at least 5 percent of women in any treatment group are shown in Table 1.

Table 1. Frequency of Adverse Reactions (≥ 5 Percent) in Any Treatment Group in a Controlled Study of Evamist
Frequency n (%)
System Organ Class Preferred Term 1 Spray 2 Sprays 3 Sprays
Placebo (N = 77) Evamist (N = 76) Placebo (N = 76) Evamist (N = 74) Placebo (N = 75) Evamist (N = 76)

Reproductive System and Breast Disorders

Breast tenderness

0 (0)

4 (5)

4 (5)

5 (7)

0 (0)

4 (5)

Nipple pain

0 (0)

2 (3)

0 (0)

5 (7)

0 (0)

1 (1)

Gastrointestinal Disorders

Nausea

5 (7)

1 (1)

1 (1)

2 (3)

4 (5)

2 (3)

Infections and Infestations

Nasopharyngitis

1 (1)

4 (5)

2 (3)

3 (4)

1 (1)

1 (1)

Musculoskeletal and Connective Tissue Disorders

Back pain

1 (1)

2 (3)

2 (3)

4 (5)

1 (1)

2 (3)

Arthralgia

1 (1)

1 (1)

4 (5)

1 (1)

0 (0)

3 (4)

Nervous system

Headache

4 (5)

7 (9)

5 (7)

9 (12)

7 (9)

8 (11)

Application site reactions were reported in 3 out of 226 (1.3%) women treated with Evamist.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Evamist. 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.

Breasts: Breast swelling, breast mass, breast enlargement

Cardiovascular: Heart rate increased

Central nervous system: Dizziness, dysgeusia, paresthesia, lethargy, hypoesthesia

Eyes: Eye irritation, ocular hyperemia

Gastrointestinal: Abdominal pain, diarrhea, constipation, abdominal distension, dry mouth, decreased appetite

Genitourinary system: Vaginal bleeding

Musculoskeletal: Muscle spasms, arthritis

Psychiatric: Insomnia, mood swings, anxiety, irritability, mood altered, depression

Respiratory tract: Cough, dyspnea, dry throat

Skin: Nipple and areola discoloration, usually on the same side of the body as the inner forearm on which Evamist is applied, rash, pruritus, alopecia, urticaria, dry skin, skin discoloration, chloasma

Miscellaneous: Weight increased, malaise, fatigue, asthenia

7 DRUG INTERACTIONS

No drug interaction studies have been conducted for Evamist.

7.1 Metabolic Interactions

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.

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