Balcoltra
levonorgestrel and ethinyl estradiol · KIT · Avion Pharmaceuticals
Balcoltra is a birth control kit containing levonorgestrel and ethinyl estradiol, which are hormones used to prevent pregnancy. It is taken as directed by your healthcare provider.
Key Facts
- Brand Name
- Balcoltra
- Generic Name
- levonorgestrel and ethinyl estradiol
- NDC Code (Product)
75854-602- Manufacturer
- Avion Pharmaceuticals
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA208612
- Marketing Start
- 04/10/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy. Balcoltra is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Take one tablet by mouth at the same time every day. ( 2.1 ) • Take tablets in the order directed on the blister pack. ( 2.1 ) 2.1 How to Start Balcoltra Balcoltra is dispensed in a blister card [see How Supplied/Storage and Handling ( 16 )] . Balcoltra may be started using either a Day 1 start or a Sunday start (see Table 1 ). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. 2.2 How to Take Balcoltra Balcoltra (orange active tablets and blue placebo tablets) is swallowed whole once a day Table 1: Instructions for Administration of Balcoltra Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: •Balcoltra active tablets are orange (Day 1 to Day 21). •Balcoltra placebo tablets are blue (Day 22 to Day 28). Day 1 Start: •Take first orange active tablet on the first d…
Contraindications
4 CONTRAINDICATIONS 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 inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] . - Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] . - Have coronary artery disease [see Warnings and Precautions ( 5.1 )] . - 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 )] . - Have uncontrolled hypertension [see Warnings and Precautions ( 5.4 )] . - Have diabetes mellitus with vascular disease [see Warnings and Precautions ( 5.6 )] . - 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 Warning…
Drug Interactions
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 contraception when enzyme inducers are used with COCs ( 7.1 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and other d…
Adverse Reactions
6 ADVERSE REACTIONS 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%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avion Pharmaceuticals, LLC at 1-888-612-8466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a clinical trial with levonorgestrel …
Frequently Asked Questions
What is Balcoltra used for?
Balcoltra is a birth control kit containing levonorgestrel and ethinyl estradiol, which are hormones used to prevent pregnancy. It is taken as directed by your healthcare provider.
Is Balcoltra a controlled substance?
Balcoltra is not classified as a controlled substance by the DEA.
What is the generic name for Balcoltra?
The generic name for Balcoltra is levonorgestrel and ethinyl estradiol. There are 12 other brand versions of levonorgestrel and ethinyl estradiol.
What is the NDC code for Balcoltra ?
The NDC (National Drug Code) for Balcoltra is 75854-602, listed by Avion Pharmaceuticals.