BALCOLTRA

AbsorptionNo specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol tablets USP in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavaila...

In a clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets, 1,477 women aged 17-49 years, had 7,720 cycles of use. Eighty-seven percent (87%) of the women were Caucasian. The average weight was 66.4 kg with a range of 38.0-154.2 kg. Among the women in the trial, 5.3% had never used COCs. A total of 5 pregnancies were reported. This represents an overall pregnancy rate of approximately 1 pregnancy per 100 woman-years.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

• Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )]
• Vascular events [see Warnings and Precautions ( 5.1 )]
• Liver disease [see Warnings and Precautions ( 5.2 )] Adverse reactions commonly reported by COC users:
• Irregular uterine bleeding
• Nausea
• Breast tenderness
• Headache Common adverse reactions (≥2% of women): headache (14%), metrorrhag...

Balcoltra is contraindicated in females who are known to have or develop the following conditions:

• A high risk of arterial or venous thrombotic disease. Examples include women who are known to: - Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] . - Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )] . - Have inhe...

• Thrombotic Disorders and Other Vascular Problems : Stop Balcoltra if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding ( 5.1 )
• Liver disease : Discontinue Balcoltra if jaundice occurs ( 5.2 )
• High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Balcoltra if blood pressure rises significantly. ( 5.4 )
• Carbohydrate a...

7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of c...