Balcoltra

Balcoltra is a prescription birth control medication used to prevent pregnancy.

It is a single product containing 3 medications: levonorgestrel, ethinyl estradiol, and ferrous bisglycinate.

Levonorgestrel and ethinyl estradiol belongs to a group of drugs called hormonal contraceptives. These hormones prevent pregnancy by stopping ovulation and by altering cervical mucus and the lining of the uterus. Ferrous bisglycinate is a form of iron for iron replacement.

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects of Balcoltra include headache and abnormal bleeding from the uterus.

Balcoltra is a prescription birth control medication used by women to prevent pregnancy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Balcoltra. See the “Balcoltra Precautions” section.

Common side effects of Balcoltra include the following:

• headache
• abnormal bleeding from the uterus
• painful periods or cramping
• nausea
• abdominal pain
• breast pain or tenderness
• mood changes
• acne
• depression
• absence of menstrual cycle
• vaginal yeast infection

This is not a complete list of Balcoltra side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Some medications may decrease how effective Balcoltra is and require the use of back-up method of contraception. Especially tell your doctor if you take:

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, topiramate, aprepitant, St John's wort, bosentan, felbamate, and griseofulvin
• colesevelam
• medications that block a protein in the body (CYP3A4) such as some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole)
• hepatitis C virus (HCV) medications
• human immunodeficiency virus (HIV) medications

This is not a complete list of Balcoltra drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Balcoltra including the following:

• thrombotic disorders, or clots. Tell your healthcare provider if you have loss of vision or double vision. You should also tell your healthcare provider if you plan on having surgery.
• high blood pressure. Your healthcare provider will monitor your blood pressure.
• gallbladder disease. Your healthcare provider will monitor you for this.
• liver disease or damage. Tell your healthcare provider if you have yellowing of your skin or the whites of your eyes.
• carbohydrate and lipid metabolic effects. Persons with prediabetes, diabetes, and high cholesterol will be monitored by a healthcare provider.
• headache. Tell your healthcare provider if you have an increase in frequency or severity of headache.
• irregular or abnormal bleeding. Tell your healthcare provider if you have any bleeding or spotting outside of your cycle. This can be normal during the first three months of Balcoltra use. If scheduled bleeding does not occur when Balcoltra is stopped, talk to your healthcare provider.
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, including chest pain, rash, difficulty breathing or swallowing, and swelling of the face, eyes, lips, tongue, arms, or legs.

Do not take Balcoltra if you:

• smoke and are over the age of 35
• are allergic to Balcoltra or to any of its ingredients
• have a high risk of clots or have had clots
• have liver tumors or liver disease
• undiagnosed uterine bleeding that is abnormal
• are pregnant
• have breast cancer or history of breast cancer
• have other estrogen or progestin-sensitive cancer or history of it
• are taking hepatitis C virus (HCV) medication that is a combination of ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Viekira)

Grapefruit and grapefruit juice may interact with Balcoltra and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Balcoltra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Balcoltra or to any of its ingredients
• ever had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
• ever had a stroke or heart attack
• have heart valve problems or heart rhythm abnormalities 
• have an inherited problem with your blood that makes it clot more than normal
• have high blood pressure
• have or have had migraine headaches
• ever had breast cancer or any cancer that is sensitive to female hormones
• have diabetes
• have liver problems
• have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy)
• smoke
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Balcoltra should not be used during pregnancy. Stop Balcoltra if pregnancy occurs.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Balcoltra has been detected in human breast milk. Balcoltra can decrease milk production. Women who are breastfeeding should be advised to use different methods of contraception while breastfeeding. 

• Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.

How to take Balcoltra

1. Be sure to read these directions before you start taking your pills or anytime you are not sure what to do.
2. The right way to take the pill is to take one pill every day at the same time in the order directed on the package. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
3. Many women have spotting or light bleeding at unexpected times, or may feel sick to their stomach during the first 1-3 packs of pills. If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your healthcare provider.
4. Missing pills can also cause spotting or light bleeding, even when you make up these missed pills. On the days you take two pills, to make up for missed pills, you could also feel a little sick to your stomach.
5. If you have vomiting (within 3 to 4 hours after you take your pill), you should follow the instructions for "What To Do If You Miss Pills." If you have diarrhea or if you take certain medicines, including some antibiotics and some herbal products such as St. John's Wort, your pills may not work as well. Use a back-up method (such as condoms and spermicides) until you check with your healthcare provider.
6. If you have trouble remembering to take the pill, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.

Before You Start Taking Your Pills:

1. Decide what time of the day you want to take your pill. It is important to take Balcoltra in the order directed on the package at the same time every day.
2. Look at your pill pack. It has 28 pills. The Balcoltra-pill pack has 21 orange tablets (with hormones) to be taken for 21 days, followed by 7 blue pills (without hormones) to be taken for the next seven days.
3. Also look for where on the pack to start taking pills and in what order to take the pills.
4. Be sure you have a back-up method of birth control (such as condoms and spermicides) to use in case you miss pills.
5. Be sure you have an extra, full pill pack.

When to Start the First Pack of Pills:

You have a choice for which day to start taking your first pack of pills. Decide with your healthcare provider which is the best day for you.
Pick a time of day which will be easy to remember.

Day 1 Start:

1. Take the first orange pill of the pack during the first 24 hours of your period.
2. Then take one of the orange active tablets once daily at the same time each day.
3. After taking all the orange tablets, take one blue placebo tablet once daily at the same time each day.
4. You will not need to use a back-up method of birth control, since you are starting the Pill at the beginning of your period. However, if you start Balcoltra later than the first day of your period, you should use another method of birth control (such as a condom and spermicide) as a back-up method until you have taken 7 orange pills.

Sunday Start: 

1. Take the first orange active tablet of the pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
2. Then take one of the orange active tablets once daily at the same time each day.
3. After taking all the orange tablets, take one blue placebo tablet once daily at the same time each day.
4. Use another method of birth control (such as a condom and spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). This also applies if you start Balcoltra after having been pregnant, and you have not had a period since your pregnancy.

When You Switch From a Different Birth Control Pill:

1. When switching from another birth control pill, Balcoltra should be started on the same day that a new pack of the previous birth control pill would have been started.

When You Switch From Another Type of Birth Control Method:

• When switching from a transdermal patch or vaginal ring, Balcoltra should be started when the next application would have been due.
• When switching from an injection, Balcoltra should be started when the next dose would have been due.
• When switching from an intrauterine contraceptive or an implant, Balcoltra should be started on the day of removal.

What to Do During the Month:

1. Take one pill at the same time every day until the pack is empty. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often.
2. When you finish a pack of pills, start the next pack on the day after your last white pill. Do not wait any days between packs.

What to Do if You Miss Pills:

If you miss 1 orange pill of your pack:

1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take two pills in one day.
2. You do not need to use a back-up birth control method if you have sex. 

If you miss 2 orange pills in a row in Week 1 or Week 2 of your pack:

1. Take two pills on the day you remember and two pills the next day.
2. Then take one pill a day until you finish the pack.
3. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as a condom and spermicide) as a back-up for those 7 days.

If you miss 2 yellow pills in a row in Week 3 or Week 4 of your pack:

• If you are a Day 1 Starter: Throw out the rest of the pill pack and start a new pack that same day. 
• If you are a Sunday Starter: Keep taking one pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.
• You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as a condom and spermicide) as a back-up for those 7 days.
• You may not have your period this month but this is expected. However, if you miss your period two months in a row, call your healthcare provider because you might be pregnant.

If you miss 3 or more orange pills in a row during any week:

• If you are a Day 1 Starter: Throw out the rest of the pill pack and start a new pack that same day. 
• If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.
• You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as condoms and spermicides) as a back-up for those 7 days.
• Call your healthcare provider if you miss your period, because you might be pregnant. 

If you miss any of the 7 blue pills in Week 4. 

• Throw away the pills you missed. Keep taking one pill each day until the pack is empty. You do not need a back-up method. 

Finally, if you are still not sure what to do about the pills you have missed: Use a back-up method (such as condoms and spermicides) anytime you have sex.

Take this medication exactly as prescribed by your doctor. 

The recommended dose of Balcoltra is one tablet once daily at the same time every day.

If you take too much Balcoltra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Balcoltra at room temperature between 68° to 77°F (20° to 25°C).
• Protect Balcoltra from direct light.
• Keep this and all medicines out of the reach of children.
• Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
• Do not skip any pills, even if you do not have sex often.
• If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant.

Contact your healthcare provider for advice if you:

• think you are pregnant.
• miss one period and have not taken your birth control pills every day.
• miss two periods in a row.
• are planning on having surgery. You should stop Balcoltra at least four weeks before you have major surgery and not restart it until at least two weeks after the surgery due to an increased risk of blood clots.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS 

• Balcoltra is contraindicated in women over 35 years old who smoke.
• Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use.