Hailey 24 Fe (Page 2 of 6)

Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures must be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a white tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

3 DOSAGE FORMS AND STRENGTHS

Hailey™ 24 Fe (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets) is available in blister packs.

Each blister pack (28 tablets) contains in the following order:

24 white, round (active) tablets imprinted with ‘16’ on one side and ‘G’ on other side and each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP.
4 brown, round (non-hormonal placebo) tablets imprinted with ‘17’ on one side and ‘G’ on other side and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

4 CONTRAINDICATIONS

Do not prescribe Hailey 24 Fe to women who are known to have the following conditions:

A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
o
Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
o
Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
o
Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
o
Have cerebrovascular disease [see Warnings and Precautions (5.1)]
o
Have coronary artery disease [see Warnings and Precautions (5.1)]
o
Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
o
Have uncontrolled hypertension [see Warnings and Precautions (5.4)]
o
Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]
o
Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7)]
Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]
Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]
Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]
Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]
Breast cancer or other estrogen-or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11)]
Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]

5 WARNINGS AND PRECAUTIONS

Click here to enter Warnings and Precautions

Thrombotic Disorders and Other Vascular Problems

Stop Hailey 24 Fe if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Stop Hailey 24 Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see Adverse Reactions (6.2)].
If feasible, stop Hailey 24 Fe at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.
Start Hailey 24 Fe no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COCs and when restarting oral contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
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. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.
Use COCs with caution in women with cardiovascular disease risk factors.

Liver Disease

Impaired Liver Function

Do not use Hailey 24 Fe in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications (4)].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. Discontinue Hailey 24 Fe if jaundice develops.

Liver Tumors

Hailey 24 Fe is contraindicated in women with benign and malignant liver tumors [see Contraindications (4)]. 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 risk of liver cancers in COC users is less than one case per million users.

Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue Hailey 24 Fe prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4)]. Hailey 24 Fe can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

High Blood Pressure

Hailey 24 Fe is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4)]. For women with well-controlled hypertension, monitor blood pressure and stop Hailey 24 Fe if blood pressure rises significantly.

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. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis.

Carbohydrate and Lipid Metabolic Effects

Carefully monitor prediabetic and diabetic women who are taking Hailey 24 Fe. COCs may decrease glucose tolerance.

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 Hailey 24 Fe develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Hailey 24 Fe if indicated. Consider discontinuation of Hailey 24 Fe in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).

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