Minivelle
FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex »
"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.
Dyspareunia"...
Read the FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex article »
Minivelle
SIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in labeling:
- Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Endometrial Cancer [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.
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.
Additional Minivelle Information
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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