How Balcoltra® Works
Balcoltra, like many birth control pills, contains a combination of hormones. These include a progestin called levonorgestrel and an estrogen called ethinyl estradiol.
What Do Progestins Do?
Progestins are a group of synthetic hormones that have similar effects to the natural hormone progesterone. Progestins work to inhibit ovulation, thicken cervical mucus, and thin the endometrium.1
The progestin in birth control pills prevents pregnancy by causing the mucus in the cervix to thicken, making the passage of sperm more difficult.1
Progestin also thins the lining of the uterus, making it harder for a fertilized egg to implant. In some women, progestin may also stop ovulation completely.1
In many birth control methods, including Balcoltra, progestins are used in combination with estrogen.2
What Do Estrogens Do?
Estrogens are a group of hormones that promote the development and maintenance of female characteristics in the human body, such as the regulation of the menstrual cycle and reproductive system.3
The estrogen in birth control pills helps to prevent ovulation and is added to birth control pills to prevent spotting between periods.3
Why Choose Combination Oral Contraceptives?
There are many benefits to using combination oral contraceptives:
They can be highly effective when used correctly2
They can offer cycle control2
You can easily stop if you choose2
What is Balcoltra?
Balcoltra is a prescription birth control pill used for the prevention of pregnancy.
IMPORTANT RISK INFORMATION for Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets)
WARNING TO WOMEN WHO SMOKE
Do not use Balcoltra if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
Who should not take Balcoltra?
Do not use Balcoltra if you have or have had blood clots, history of heart attack or stroke, high blood pressure that medicine cannot control, breast cancer or any cancer that is sensitive to female hormones, liver disease or liver tumors, unexplained bleeding from the vagina, hypersensitivity to any of the components, if you are or may be pregnant, or if you take Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of liver enzymes in the blood.
What else should I know about taking Balcoltra?
Treatment with Balcoltra should be stopped if you have a blood clot, and at least 4 weeks before and through 2 weeks after major surgery. You should not take Balcoltra any earlier than 4 weeks after having a baby. If you are breastfeeding, talk to your doctor before taking Balcoltra. If you experience yellowing of the skin or eyes due to problems with your liver, you should stop taking Balcoltra. If you are prediabetic or diabetic, your doctor should monitor you while using Balcoltra. Your doctor should evaluate you if you have any significant change in headaches or irregular menstrual bleeding. Balcoltra contains FD&C Yellow No. 5 and may cause an allergic reaction, including in those with an allergy to aspirin.
What are the most serious risks of taking Balcoltra?
Balcoltra increases the risk of serious conditions, including blood clots, stroke, and heart attack. These can be life-threatening and require immediate medical care.
What are the possible side effects of Balcoltra?
The most common side effects of Balcoltra are headache, spotting or bleeding between periods or no menstrual bleeding, nausea, breast tenderness or pain, stomach pain, pain during periods, depression, acne, and vaginal infections.
Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‐800‐FDA‐1088.
References: 1. American College of Obstetricians and Gynecologists. Progestin-only hormonal birth control: pill and injection. American College of Obstetricians and Gynecologists Web site. https://www.acog.org/Patients/FAQs/Progestin-Only-Hormonal-Birth-Control-Pill-and-Injection. Updated March 2018. Accessed June 6, 2018. 2. Balcoltra [package insert]. Alpharetta, GA: Avion Pharmaceuticals LLC; 2018. 3. Gebel Berg E. The chemistry of the Pill. ACS Cent Sci. 2015;1(1):5-7. doi:10.1021/ascentsci.5b00066. Published March 25, 2015. Accessed June 8, 2018.