HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use YAZ
safely and effectively. See full prescribing information for YAZ.
YAZ (drospirenone/ethinyl estradiol) tablets, for oral use
Initial U.S. Approval: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS
CARDIOVASCULAR EVENTS
See full prescribing information for complete boxed warning
Women over 35 years old who smoke should not use Yaz (4).
Cigarette smoking increases the risk of serious cardiovascular
events from combination oral contraceptive (COC) use. (4)
------------------------------RECENT MAJOR CHANGES----------------------
Warnings and Precautions, Thromboembolic Disorders (5.1) 4/2012
----------------------------INDICATIONS AND USAGE---------------------------
Yaz is an estrogen/progestin COC, indicated for use by women to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for women
who choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for women at least 14 years old only if the patient
desires an oral contraceptive for birth control. (1.3)
----------------------DOSAGE AND ADMINISTRATION-----------------------
Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the blister pack. (2.1)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
Yaz consists of 28 film-coated, biconvex tablets in the following order (3):
24 light pink tablets, each containing 3 mg drospirenone (DRSP) and 0.02
mg ethinyl estradiol (EE) as betadex clathrate
4 white inert tablets
-------------------------------CONTRAINDICATIONS------------------------------
Renal impairment (4)
Adrenal insufficiency (4)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Pregnancy (4)
-----------------------WARNINGS AND PRECAUTIONS------------------------
Vascular risks: Stop Yaz if a thrombotic event occurs. Stop at least 4
weeks before and through 2 weeks after major surgery. Start no earlier
than 4 weeks after delivery, in women who are not breastfeeding. (5.1)
COCs containing DRSP may be associated with a higher risk of venous
thromboembolism (VTE) than COCs containing levonorgestrel or some
other progestins. Before initiating Yaz in a new COC user or a woman
who is switching from a contraceptive that does not contain DRSP,
consider the risks and benefits of a DRSP-containing COC in light of her
risk of a VTE. (5.1)
Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in
patients predisposed to hyperkalemia. Check serum potassium
concentration during the first treatment cycle in women on long-term
treatment with medications that may increase serum potassium
concentration. (5.2, 7.3)
Liver disease: Discontinue Yaz if jaundice occurs. (5.4)
High blood pressure: Do not prescribe Yaz for women with uncontrolled
hypertension or hypertension with vascular disease. (5.5)
Carbohydrate and lipid metabolic effects: Monitor prediabetic and
diabetic women taking Yaz. Consider an alternate contraceptive method
for women with uncontrolled dyslipidemia. (5.7)
Headache: Evaluate significant change in headaches and discontinue
Yaz if indicated. (5.8)
Uterine bleeding: Evaluate irregular bleeding or amenorrhea. (5.9)
------------------------------ADVERSE REACTIONS-------------------------------
The most frequent adverse reactions (≥ 2%) in contraception and acne
clinical trials were: headache/migraine (6.7%), menstrual irregularities
(4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%) and
mood changes (2.2%). (6.1)
The most frequent adverse reactions (≥ 2%) in PMDD clinical trials
were: menstrual irregularities (24.9%), nausea (15.8%), headache
(13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%),
decreased libido (2.8%), increased weight (2.5%), and affect lability
(2.1%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bayer
HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-
FDA-1088 or www.fda.gov/medwatch
------------------------------DRUG INTERACTIONS-------------------------------
Drugs or herbal products that induce certain enzymes (for example, CYP3A4)
may decrease the effectiveness of COCs or increase breakthrough bleeding.
Counsel patients to use a back-up or alternative method of contraception when
enzyme inducers are used with COCs. (7.1)
-----------------------USE IN SPECIFIC POPULATIONS------------------------
Nursing Mothers: Not recommended; can decrease milk production. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-
approved patient labeling.
Revised: 4/2012
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CIGARETTE SMOKING AND SERIOUS
CARDIOVASCULAR EVENTS
1 INDICATIONS AND USAGE
1.1 Oral Contraceptive
1.2 Premenstrual Dysphoric Disorder (PMDD)
1.3 Acne
2 DOSAGE AND ADMINISTRATION
2.1 How to Take Yaz
2.2 How to Start Yaz
2.3 Advice in Case of Gastrointestinal Disturbances
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolic Disorders and Other Vascular Problems
5.2 Hyperkalemia
5.3 Carcinoma of the Breasts and Reproductive Organs
5.4 Liver Disease
5.5 High Blood Pressure
5.6 Gallbladder Disease
5.7 Carbohydrate and Lipid Metabolic Effects
5.8 Headache
5.9 Bleeding Irregularities
5.10 COC Use Before or During Early Pregnancy
5.11 Depression
5.12 Interference with Laboratory Tests
5.13 Monitoring
5.14 Other Conditions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Combined Oral Contraceptives
7.2 Effects of Combined Oral Contraceptives on Other Drugs
7.3 Interference with Laboratory Tests
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatic Use
8.6 Patients with Renal Impairment
8.7
Patients with Hepatic Impairment
8.8 Race
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Oral Contraceptive Clinical Trial
14.2 Premenstrual Dysphoric Disorder Clinical Trials
14.3 Acne Clinical Trials
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING