"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.
CombiPatch is indicated in a woman with a uterus for:
- Treatment of moderate to severe vasomotor symptoms due to menopause.
- Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
- Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
DOSAGE AND ADMINISTRATION
Generally, when estrogen therapy is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus generally does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin. Use of estrogen-alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be reevaluated periodically as clinically appropriate to determine whether treatment is still necessary. Adequate diagnostic measures, such as directed or random endometrial sampling, when indicated, should be undertaken to rule out malignancy in a postmenopausal woman with a uterus with undiagnosed persistent or recurring abnormal genital bleeding.
Initiation Of Therapy
Patients should be started at the lowest dose. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. The lowest effective dose of CombiPatch has not been determined in clinical trials.
Women not currently using continuous estrogen or combination estrogen plus progestin therapy may start therapy with CombiPatch at any time. However, women currently using continuous estrogen or combination estrogen plus progestin therapy should complete the current cycle of therapy, before initiating CombiPatch therapy.
Women often experience withdrawal bleeding at the completion of the cycle. The first day of this bleeding would be an appropriate time to begin CombiPatch therapy.
Combination estrogen plus progestin regimens are indicated for women with an intact uterus. Two CombiPatch (estradiol/NETA) transdermal delivery systems are available: 0.05 mg estradiol with 0.14 mg NETA per day (9 cm²) and 0.05 mg estradiol with 0.25 mg NETA per day (16 cm²). The lowest effective dose should be used. For all regimens, women should be reevaluated at 3-to 6-month intervals to determine if changes in hormone therapy or if continued hormone therapy is appropriate.
Continuous Combined Regimen
CombiPatch 0.05 mg estradiol/0.14 mg NETA per day (9 cm²) matrix transdermal system is used for continuous uninterrupted treatment applied twice weekly on the lower abdomen. A new system should be applied to the skin every 3 to 4 days (twice weekly) during a 28-day cycle.
Additionally, a dose of 0.05 mg estradiol/0.25 mg NETA (16 cm² system) is available if a greater progestin dose is desired. Irregular bleeding may occur particularly in the first six months, but generally decreases with time, and often to an amenorrheic state.
Continuous Sequential Regimen
CombiPatch can be applied as a sequential regimen in combination with an estradiol-only transdermal delivery system.
In this treatment regimen, a 0.05 mg per day (nominal delivery rate) estradiol transdermal system (Vivelle-Dot®) is worn for the first 14 days of a 28-day cycle, replacing the system every 3 to 4 days (twice weekly) according to product directions.
For the remaining 14 days of the 28-day cycle, CombiPatch 0.05 mg estradiol/0.14 mg NETA per day (9 cm²) transdermal system should be worn continuously on the lower abdomen. The CombiPatch system should be replaced every 3 to 4 days (twice weekly) during this 14-day period in the 28-day cycle.
Additionally, a dose of 0.05 mg estradiol/0.25 mg NETA (16 cm² system) is available if a greater progestin dose is desired. Women should be advised that monthly withdrawal bleeding often occurs.
Application of the System
CombiPatch should be placed on a smooth (fold-free), clean, dry area of the skin on the lower abdomen. CombiPatch should not be applied to or near the breasts. The area selected should not be oily (which can impair adherence of the system), damaged, or irritated. The waistline should be avoided, since tight clothing may rub the system off or modify drug delivery. The sites of application must be rotated, with an interval of at least one week allowed between applications to the same site.
After opening the pouch, remove 1 side of the protective liner, taking care not to touch the adhesive part of the transdermal delivery system with the fingers. Immediately apply the transdermal delivery system to a smooth (fold-free) area of skin on the lower abdomen. Remove the second side of the protective liner and press the system firmly in place with the hand for at least 10 seconds, making sure there is good contact, especially around the edges.
Care should be taken that the system does not become dislodged during bathing and other activities. If a system should fall off, the same system may be reapplied to another area of the lower abdomen. If necessary, a new transdermal system may be applied, in which case, the original treatment schedule should be continued. Only 1 system should be worn at any 1 time during the 3-to 4-day dosing interval.
Once in place, the transdermal system should not be exposed to the sun for prolonged periods of time.
Removal of the System
Removal of the system should be done carefully and slowly to avoid irritation of the skin. Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes. Then gently rub the area with an oil-based cream or lotion to remove the adhesive residue.
CombiPatch estradiol/NETA transdermal delivery system is available in:
|System Size||Nominal Delivery Rate* Estradiol/NETA||Presentation||NDC||Markings|
|9 cm²||0.05/0.14 mg per day||8 systems per carton||68968-0514-8||CombiPatch 0.05/0.14 mg per day|
|Cartons of 2 patient packs of 8 systems||68968-0514-4|
|16 cm²||0.05/0.25 mg per day||8 systems per carton||68968-0525-8||CombiPatch 0.05/0.25 mg per day|
|Cartons of 2 patient packs of 8 systems||68968-0525-4|
|*Nominal delivery rate described. See DESCRIPTION for more details regarding drug delivery.|
Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing to the patient, CombiPatch can be stored at room temperature between 20°C to 25°C (66°F to 77°F) for up to 6 months. For the Pharmacist: When CombiPatch is dispensed to the patient, place an expiration date on the label. The date should not exceed either 6 months from the date of sale or the expiration date, whichever comes first.
Store the systems in the sealed foil pouch.
Do not store the system in areas where extreme temperatures can occur.
Keep this and all medicines out of the reach of children.
Manufactured by: Noven Pharmaceuticals Inc. Miami, FL 33186. Distributed by: Noven Therapeutics, LLC Miami, FL 33186. Revised: May 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/27/2015
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