In a 24 month oral carcinogenicity study in mice dosed with 10 mg/kg/day DRSP alone or 1 + 0.01, 3 + 0.03 and 10 + 0.1 mg/kg/day of DRSP and EE, 0.1 to 2 times the exposure (AUC of DRSP) of women taking a contraceptive dose, there was an increase in carcinomas of the harderian gland in the group that received the high dose of DRSP alone. In a similar study in rats given 10 mg/kg/day DRSP alone or 0.3 + 0.003, 3 + 0.03 and 10 + 0.1 mg/kg/day DRSP and EE, 0.8 to
10 times the exposure of women taking a contraceptive dose, there was an increased incidence of benign and total (benign and malignant) adrenal gland pheochromocytomas in the group receiving the high dose of DRSP. Mutagenesis studies for DRSP were conducted in vivo and in vitro and no evidence of mutagenic activity was observed.
In the clinical efficacy studies of up to 2 years duration, 2,629 subjects completed 33,160 cycles of use without any other contraception. The mean age of the subjects was 25.5 ± 4.7 years. The age range was 16 to 37 years. The racial demographic was: 83% Caucasian, 1% Hispanic, 1% Black, <1% Asian, <1% other, <1% missing data, 14% not inquired and <1% unspecified. Pregnancy rates in the clinical trials were less than one per 100 woman-years of use.
1. Dinger JC, Heinemann LAJ, et al: The safety of a drospirenone-containing oral contraceptive: final results from the European active surveillance study on oral contraceptives based on 142,475 women-years of observation. Contraception 2007;75:344-354.
2. Seeger JD, Loughlin J, Eng PM, et al: Risk of thromboembolism in women taking ethinyl estradiol/drospirenone and other oral contraceptives. Obstetrics & Gynecology 2007;110(3):587-593.
3. van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke JP, et al: The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ 2009;339:b2921.
4. Lidegaard O, Lokkegaard E, Svendsen AL, et al: Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009; 339:b2890.
Yasmin (drospirenone/ethinyl estradiol) tablets are available in blister packs (54868-4590-0).
The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with DO or DP.
Each blister pack contains 28 film-coated tablets in the following order:
- 21 round, biconvex, yellow, film-coated tablets with embossed “DO” in a regular hexagon on one side each containing 3 mg drospirenone and 0.03 mg ethinyl estradiol
- 7 round, biconvex, white, film-coated tablets with embossed “DP” in a regular hexagon on one side
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
See “FDA-approved patient labeling (Patient Information).”
- Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs.
- Counsel patients that the increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC.
- Counsel patients that Yasmin does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
- Counsel patients on Warnings and Precautions associated with COCs.
- Counsel patients that Yasmin contains DRSP. Drospirenone may increase potassium. Patients should be advised to inform their healthcare provider if they have kidney, liver or adrenal disease because the use of Yasmin in the presence of these conditions could cause serious heart and health problems. They should also inform their healthcare provider if they are currently on daily, long-term treatment (NSAIDs, potassium-sparing diuretics, potassium supplementation, ACE inhibitors, angiotensin-II receptor antagonists, heparin or aldosterone antagonists) for a chronic condition.
- Inform patients that Yasmin is not indicated during pregnancy. If pregnancy occurs during treatment with Yasmin, instruct the patient to stop further intake.
- Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. See “What to Do if You Miss Pills” section in FDA-Approved Patient Labeling .
- Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
- Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established.
- Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a yellow tablet for 7 consecutive days.
- Counsel patients that amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles.
Manufactured for Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470
Manufactured in Germany
©2012 Bayer HealthCare Pharmaceuticals Inc. All Rights Reserved
Bayer HealthCare Pharmaceuticals Inc.
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
PLACE DAY LABEL HERE
3 MG/0.03 MG
(DROSPIRENONE & ETHINYL ESTRADIOL TABLETS)
(drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg
This product (like all oral contraceptives) is
intended to prevent pregnancy. It does not
protect against HIV infection (AIDS) and other
sexually transmitted diseases.
Store at 25°C with excursions permitted between
15–30°C. [See USP Controlled Room Temperature].
To the Dispenser: This unit contains two pieces of
information intended for the patient, which are
combined in a single booklet. This informational
piece is to be provided to the patient with each
Rx onlyimage of package label
| YASMIN |
drospirenone and ethinyl estradiol kit
|Labeler — Physicians Total Care, Inc. (194123980)|
|Physicians Total Care, Inc.||194123980||relabel|
Revised: 03/2012 Physicians Total Care, Inc.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.