Important Safety Information
Patients should be counseled that this product does not protect against HIV infection (AIDS) and
other sexually transmitted diseases.
INDICATIONS AND USAGE
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the
- Known or suspected pregnancy
- Known or suspected carcinoma of the breast
- Undiagnosed abnormal genital bleeding
- Hypersensitivity to any component of this product
- Benign or malignant liver tumors
- Acute liver disease
1. ECTOPIC PREGNANCY
Cigarette smoking increases the risk of serious cardiovascular disease. Women who use
contraceptives should be strongly advised not to smoke.
Healthcare professionals should be alert to the possibility of an ectopic pregnancy in
women who become pregnant or complain of lower abdominal pain while on progestin-only
2. DELAYED FOLLICULAR ATRESIA/OVARIAN CYSTS
If follicular development occurs, atresia of the follicle is sometimes delayed and the
follicle may continue to grow beyond the size it would attain in a normal cycle.
Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic;
in some cases they are associated with mild abdominal pain. Rarely they may twist or
rupture, requiring surgical intervention.
3. IRREGULAR GENITAL BLEEDING
Irregular menstrual patterns are common among women using progestin-only oral
If genital bleeding is suggestive of infection, malignancy, or other abnormal
conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea
occurs, the possibility of pregnancy should be evaluated.
4. CARCINOMA OF THE BREAST AND REPRODUCTIVE ORGANS
Some epidemiological studies of oral contraceptive users have reported an increased
relative risk of developing breast cancer, particularly at a younger age and apparently
related to duration of use. These studies have predominantly involved combined oral
contraceptives, and there is insufficient data to determine whether the use of POPs
similarly increases the risk.
Women with breast cancer should not use oral contraceptives because the role of female
hormones in breast cancer has not been fully determined.
Some studies suggest that oral contraceptive use has been associated with an increase in
the risk of cervical intraepithelial neoplasia in some populations of women.
However, there continues to be controversy about the extent to which such findings may be
due to differences in sexual behavior and other factors. There is insufficient data to
determine whether the use of POPs increases the risk of developing cervical
5. HEPATIC NEOPLASIA
Benign hepatic adenomas are associated with combined oral contraceptive use, although
of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may
cause death through intraabdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in combined
oral contraceptive users. However, these cancers are rare in the U.S. There is
insufficient data to determine whether POPs increase the risk of developing hepatic
INFORMATION FOR THE PATIENT
The following points should be discussed with prospective users before prescribing
progestin-only oral contraceptives:
DOSAGE AND ADMINISTRATION
- The necessity of taking pills at the same time every day, including throughout all
- The need to use a backup method such as condoms and spermicides for the next 48
a progestin-only oral contraceptive is taken 3 or more hours late.
- The potential side effects of progestin-only oral contraceptives, particularly
- The need to inform the healthcare professional of prolonged episodes of bleeding,
severe abdominal pain.
- The importance of using a barrier method in addition to progestin-only oral
contraceptives if a
woman is at risk of contracting or transmitting STDs/HIV.
To achieve maximum contraceptive effectiveness, Lyza must be taken exactly as directed.
One tablet is taken every day, at the same time. Administration is continuous, with no
interruption between pill packs.
prescribing information. Charleston, SC: Afaxys Inc. January 2017.
Please see full prescribing information