Pronunciation:

lee-voe-nor-JES-trel, ETH-i-nil es-tra-DYE-ol, FER-us bis-GLYE-sin-ate KEY-late

Brand Names:

• Balcoltra

Dosage Forms:

• Tablet

Warnings:

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. The risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke .

Uses of This Medicine:

Levonorgestrel, ethinyl estradiol, and ferrous bisglycinate combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, levonorgestrel and ethinyl estradiol, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

This medicine also contains ferrous bisglycinate. Ferrous bisglycinate is an iron supplement.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of levonorgestrel, ethinyl estradiol, and ferrous bisglycinate combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Older adults—

Appropriate studies on the relationship of age to the effects of levonorgestrel, ethinyl estradiol, and ferrous glycinate combination have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Baloxavir Marboxil
• Belzutifan
• Betamethasone
• Bexarotene
• Bictegravir
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dimercaprol
• Dipyrone
• Dolutegravir
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Eltrombopag
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Ethinyl Estradiol
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Magnesium Sulfate
• Mavacamten
• Mephobarbital
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Raltegravir
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acitretin
• Amitriptyline
• Atazanavir
• Atorvastatin
• Carbidopa
• Cefdinir
• Ciprofloxacin
• Clomipramine
• Delafloxacin
• Demeclocycline
• Diazepam
• Doxepin
• Doxycycline
• Etoricoxib
• Gatifloxacin
• Ginseng
• Grepafloxacin
• Imipramine
• Lamotrigine
• Levodopa
• Levofloxacin
• Levothyroxine
• Licorice
• Liothyronine
• Lomefloxacin
• Lorazepam
• Methyldopa
• Minocycline
• Moxifloxacin
• Mycophenolate Mofetil
• Mycophenolic Acid
• Norfloxacin
• Ofloxacin
• Omadacycline
• Omeprazole
• Parecoxib
• Penicillamine
• Perampanel
• Roflumilast
• Selegiline
• Tacrine
• Temafloxacin
• Temazepam
• Tetracycline
• Tipranavir
• Triazolam
• Troleandomycin
• Trovafloxacin Mesylate
• Valdecoxib
• Voriconazole
• Warfarin
• Zinc

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine
• Dairy Food
• Phytic Acid Containing Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, active or history of or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems) or
• Heart rhythm problems (atrial fibrillation) or
• Hypertension (high blood pressure), uncontrolled or
• Liver disease, including tumors or cancer or
• Migraine headache, new or worse or a new kind of headache or
• Problems with circulation or blood clots, now or in the past or
• Stroke, history of—Should not be used in patients with these conditions.

• Angioedema (swelling of the face, tongue, or throat), inherited or
• Cervical cancer or intraepithelial neoplasia or
• Chloasma gravidarum (skin disorder during pregnancy), history of or
• Cholestasis (bile problem) during pregnancy, history of or
• Depression, history of or
• Diabetes or
• Dyslipidemia (high cholesterol or fats in the blood), uncontrolled or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diarrhea or
• Vomiting—May decrease the absorption of levonorgestrel and ethinyl estradiol combination in the body.

Proper Use of This Medicine:

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception (eg, condom, spermicide, or diaphragm) for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day. Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, treat this as a missed dose and follow the instructions in the patient leaflet or call your doctor.

If you are switching from another birth control method to using Balcoltra™:

• Transdermal patch, vaginal ring, or injection—Start Balcoltra™ on the day that you would usually apply, insert, or inject the medicine.
• Implant—Start Balcoltra™ on the day of removing the implant.
• Intrauterine device (IUD)—Start Balcoltra™ on the day of removing the IUD. Use a second form of birth control for the first 7 days if the IUD has not been removed on the first day of your menstrual cycle.

If you have a miscarriage or an abortion in the first trimester of your pregnancy, you may start using this medicine right away. You do not need a second form of birth control. If you start this medicine 5 days or more after the miscarriage or abortion, you should use a second form of non-hormonal birth control for the first 7 days of your first pill cycle. If you have a miscarriage or abortion after the second trimester, you should wait for 4 weeks before starting this medicine. Use another form of birth control for the first 7 days of your first pill cycle if you use this medicine on a Sunday.

Do not drink grapefruit juice while you are using this medicine. Grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 Start) or on the first Sunday after your menstrual period starts (called Sunday Start). When you begin on a certain day, it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

• For oral dosage forms (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—One orange tablet (active) taken at the same time each day for 21 consecutive days followed by one blue (inert) tablet daily for 7 days per menstrual cycle.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

• If you miss one orange active tablet in weeks 1, 2, or 3: Take the tablet as soon as possible and take the next tablet at your regular schedule. Continue taking one tablet a day until you finish the pack.
• If you miss two orange active tablets in week 1 or 2: Take the two tablets as soon as possible and the next two tablets the next day. Continue taking one tablet a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
• If you miss two orange active tablets in week 3, or you miss three or more orange active tablets in a row in weeks 1, 2, or 3:
  • Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.
• You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.
• Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

You might have some light bleeding or spotting during the first 3 months of use. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than a few days in a row, call your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using this medicine, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Cramps

headache

heavy bleeding

pain

Less common

Absent, missed, or irregular menstrual periods

breast pain

change in the color, amount, or odor of vaginal discharge

Incidence not known

Anxiety

chest pain

cough

diarrhea

difficult or labored breathing

dizziness or lightheadedness

fainting

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

fever

headache, severe and throbbing

heavy non-menstrual vaginal bleeding

joint or muscle pain

longer or heavier menstrual periods

nausea

numbness or tingling of the face, hands, or feet

pain, redness, or swelling in the arm or leg

redness and soreness of the eyes

redness of the face, neck, arms, and occasionally, the upper chest

skin rash

sores in the mouth

stomach pain

sudden sweating

swelling of the feet or lower legs

tightness in the chest

troubled breathing

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acne

crying

delusions of persecution, mistrust, suspiciousness, or combativeness

discouragement

false or unusual sense of well-being

feeling of unreality

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

quick to react or overreact emotionally

rapidly changing moods

sense of detachment from self or body

tiredness

trouble concentrating

trouble sleeping

Incidence not known

Back pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty in moving

headache

injury

muscle pain, spasm, or stiffness

pain in the arms, legs, or joints

sleepiness or unusual drowsiness

sore throat

stuffy or runny nose

unusual tiredness or weakness

weight decreased

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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