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Lo Loestrin FE

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Lo Loestrin FE

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Thrombotic and Other Vascular Events

Stop Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) if an arterial or deep venous thrombotic event occurs. Although use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The risk is highest during the first year of use of a COC. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.

If feasible, stop Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest in older ( > 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Stop Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

Carcinoma of the Breast and Cervix

Women who currently have or have had breast cancer should not use Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) because breast cancer is a hormonally-sensitive tumor.

There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.

Liver Disease

Discontinue Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded.

Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases per 100,000 COC users. Rupture of hepatic adenomas may cause death through intra- abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term ( > 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.

Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use.

High Blood Pressure

For women with well-controlled hypertension, monitor blood pressure and stop Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.

An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.

Gallbladder Disease

Studies suggest a small increased relative risk of developing gallbladder disease among COC users.

Carbohydrate and Lipid Metabolic Effects

Carefully monitor prediabetic and diabetic women who are taking Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) . COCs may decrease glucose tolerance in a dose-related fashion.

Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COCs.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

Headache

If a woman taking Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) if indicated.

An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.

Bleeding Irregularities and Amenorrhea

Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC.

The clinical trial that evaluated the efficacy of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) also assessed unscheduled bleeding and/or spotting. The participants in this 12-month clinical trial (N=l,582 who had at least one post-treatment evaluation) completed over 15,000 cycles of exposure.

A total of 1,257 women (85.9%) experienced unscheduled bleeding and/or spotting at some time during Cycles 2-13 of this study. The incidence of unscheduled bleeding and/or spotting was highest during Cycle 2 (53%) and lowest at Cycle 13 (36%). Among these women, the mean number of days of unscheduled bleeding and/or spotting during a 28-day cycle ranged from 1.8 to 3.2 days.

Scheduled (withdrawal) bleeding and/or spotting remained fairly constant over the one year study, with an average of less than 2 days per cycle.

Women who are not pregnant and use Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) may experience amenorrhea (absence of scheduled and unscheduled bleeding/spotting). In the clinical trial with Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) , the incidence of amenorrhea increased from 32% in Cycle 1 to 49% by Cycle 13. If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

Some women may experience amenorrhea or oligomenorrhea after stopping COCs, especially when such a condition was preexistent.

COC Use before or during Early Pregnancy

Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) use should be discontinued if pregnancy is confirmed.

Administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy [see Use In Specific Populations].

Depression

Women with a history of depression should be carefully observed and Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) discontinued if depression recurs to a serious degree.

Interference with Laboratory Tests

The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid binding globulin increase with use of COCs.

Monitoring

A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.

Other Conditions

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.

Patient Counseling 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 Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
  • Counsel patients on the Warnings and Precautions associated with COCs.
  • 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 Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) .
  • 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 blue 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

[See WARNINGS AND PRECAUTIONS and Use In Specific Populations]

Use In Specific Populations

Pregnancy

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion.

Women who do not breastfeed should not start COCs earlier than 4 weeks postpartum.

Nursing Mothers

When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing OCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

Pediatric Use

Safety and efficacy of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.

Geriatric Use

Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) has not been studied in postmenopausal women and is not indicated in this population.

Renal Impairment

The pharmacokinetics of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) has not been studied in subjects with renal impairment.

Hepatic Impairment

No studies have been conducted to evaluate the effect of hepatic impairment on the disposition of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) . However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. [See CONTRAINDICATIONS]

Body Mass Index

The safety and efficacy of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) in women with a body mass index (BMI) > 35 kg/m2 has not been evaluated. [See Clinical Studies.]

Last reviewed on RxList: 11/30/2010
This monograph has been modified to include the generic and brand name in many instances.

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