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Minivelle

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Minivelle

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in labeling:

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.

There were no clinical trials conducted with MINIVELLE. MINIVELLE is bioequivalent to Vivelle®. The following adverse reactions are reported with Vivelle:

Table 1: Summary of Most Frequently Reported Adverse Reactions (Vivelle versus Placebo) Regardless of Relationship Reported at a Frequency > 5 Percent

  Vivelle 0.0375 mg/day†
(N=130) N (%)
Vivelle 0.05 mg/day†
(N=103) N (%)
Vivelle 0.075 mg/day†
(N=46) N (%)
Vivelle 0.1 mg/day†
(N=132) N (%)
Placebo
(N=157) N (%)
Gastrointestinal disorders
Constipation 5 (3.8) 4 (3.9) 3 (6.5) 2 (1.5) 4 (2.5)
Dyspepsia 12 (9.2) 3 (2.9) 2 (4.3) 0 10 (6.4)
Nausea 8 (6.2) 4 (3.9) 0 7(5.3) 5 (3.2)
General disorders and administration site conditions***
Influenza-like illness 6 (4.6) 8 (7.8) 0 3 (2.3) 10 (6.4)
Pain NOS* 8 (6.2) 0 2 (4.3) 7 (5.3) 7(4.5)
Infections and infestations
Influenza 4 (3.1) 6 (5.8) 0 10 (7.6) 14 (8.9)
Nasopharyngitis 16 (12.3) 10 (9.7) 9 (19.6) 11 (8.3) 24 (15.3)
Sinusitis NOS* 17 (13.1) 13 (12.6) 3 (6.5) 7(5.3) 16 (10.2)
Upper respiratory tract infection NoS* 8 (6.2) 11 (10.7) 4 (8.7) 6 (4.5) 9(5.7)
Investigations
Weight increased 5 (3.8) 2 (1.9) 2 (4.3) 0 3 (1.9)
Musculoskeletal and connective tissue disorders
Arthralgia 11 (8.5) 4 (3.9) 2 (4.3) 5 (3.8) 9 (5.7)
Back pain 10 (7.7) 9 (8.7) 4 (8.7) 14 (10.6) 10 (6.4)
Neck pain 4 (3.1) 4 (3.9) 0 6 (4.5) 2 (1.3)
Pain in limb 10 (7.7) 7(6.8) 2 (4.3) 6 (4.5) 9 (5.7)
Nervous system disorders
Headache NOS* 35 (26.9) 32 (31.1) 23 (50.0) 34 (25.8) 37 (23.6)
Sinus headache 12 (9.2) 5 (4.9) 5 (10.9) 2 (1.5) 8 (5.1)
Psychiatric disorders
Anxiety NEC** 5 (3.8) 0 0 2 (1.5) 4 (2.5)
Depression 4 (3.1) 7(6.8) 0 4 (3.0) 6 (3.8)
Insomnia 6 (4.6) 4 (3.9) 2 (4.3) 2 (1.5) 9(5.7)
Reproductive system and breast disorders
Breast tenderness 10 (7.7) 8 (7.8) 3 (6.5) 17 (12.9) 0
Dysmenorrhea 0 0 3 (6.5) 0 0
Intermenstrual bleeding 9 (6.9) 6 (5.8) 0 14 (10.6) 7(4.5)
Respiratory, thoracic and mediastinal disorders
Sinus congestion 4 (3.1) 3 (2.9) 3 (6.5) 6 (4.5) 7(4.5)
Vascular disorders
Hot flushes NOS* 0 3 (2.9) 0 0 6 (3.8)
Hypertension NOS* 0 3 (2.9) 0 0 2 (1.3)
† Represents milligrams of estradiol delivered daily by each system
*NOS represents not otherwise specified
**NEC represents not elsewhere classified
***Application site erythema and application site irritation were observed in 3.2% or less of patients across treatment groups.

During the clinical pharmacology studies with MINIVELLE, 35 percent or less of subjects experienced barely perceptible erythema. No transdermal systems were removed due to irritation. Three subjects (2.2 percent) reported mild discomfort while wearing MINIVELLE (N=136).

Read the Minivelle (estradiol transdermal system) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No drug interaction studies have been conducted for MINIVELLE.

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.

Last reviewed on RxList: 11/30/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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