Iclevia: Uses, Side Effects and Dosage

What is the most important information I should know about Iclevia ?

Do not use Iclevia if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects 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.

What is Iclevia ?

Iclevia is a birth control pill (oral contraceptive) used by women to prevent pregnancy. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel. Iclevia does not protect against HIV infections (AIDS) and other sexually transmitted infections.

How does Iclevia work for contraception?

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.

Based on the results of clinical studies, about 1 to 5 out of 100 women may get pregnant during the first year they use Iclevia.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Who should not take Iclevia ?

Do not take Iclevia if you:

• smoke and are over 35 years of age
• have or had blood clots in your arms, legs, lungs, or eyes
• had a stroke
• had a heart attack
• have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
• have or had a problem with your blood that makes it clot more than normal
• have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessels problems

• have diabetes

  • and are over the age of 35
  • with high blood pressure
  • with kidney, eye, nerve, or blood vessel damage
  • for more than 20 years
• have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
• have or had breast cancer
• have liver problems, including liver tumors
• have any unexplained vaginal bleeding
• take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

If any of these conditions happen to you while you are taking Iclevia, stop taking Iclevia right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Iclevia.

What should I tell my healthcare provider before taking Iclevia ?

Tell your healthcare provider if you:

• are pregnant or think you may be pregnant
• are scheduled for surgery. Iclevia may increase your risk of blood clots after surgery. You should stop taking Iclevia at least 4 weeks before you have surgery and not restart Iclevia until at least 2 weeks after your surgery.
• are depressed now or have been depressed in the past
• had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy)
• are breastfeeding or plan to breastfeed. Iclevia may decrease the amount of breast milk you make. A small amount of the hormones in Iclevia may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider if you have ever had any of the conditions listed in, “Who should not take Iclevia” above. Your healthcare provider may recommend another method of birth control.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Iclevia may affect the way other medicines work, and other medicines may affect how well Iclevia works.

Some medicines and herbal products may make birth control pills less effective, including:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate

Use a back-up or alternative birth control method when you take medicines that may make birth control pills less effective.

Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose of lamotrigine.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Iclevia ?

Read the Instructions for Use at the end of this Patient Information.

What are the most serious risks of taking Iclevia ?

Like pregnancy, Iclevia may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:

• first start taking birth control pills
• restart the same or different birth control pills after not using them for a month or more

Call your healthcare provider or go to a hospital emergency room right away if you have:

• leg pain that will not go away
• sudden severe shortness of breath
• sudden change in vision or blindness
• chest pain
• a sudden, severe headache unlike your usual headaches
• weakness or numbness in your arm or leg
• trouble speaking
• yellowing of your skin or eyes

Other serious side effects include:

• liver problems, including:

  • rare liver tumors
  • jaundice (cholestasis), especially if you previously had cholestasis of pregnancy.
• high blood pressure. You should see your healthcare provider to check your blood pressure regularly.
• gallbladder problems
• changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
• new or worsening headaches including migraine headaches
• irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking Iclevia .
• depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
• possible cancer in your breast and cervix
• swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema.
• dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking Iclevia. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Iclevia ?

• headache (migraine)
• heavier or longer periods, pain with periods
• nausea
• acne
• breast tenderness
• increase in weight

These are not all the possible side effects of Iclevia. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088.

What else should I know about taking Iclevia ?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking Iclevia. Certain blood tests may be affected by Iclevia.
• Do not skip any pills, even if you do not have sex often.
• Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.
• You should stop Iclevia at least four weeks before you have major surgery and not restart it for at least two weeks after the surgery, due to an increased risk of blood clots.
• If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Iclevia, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk, but this has not caused harmful effects in breastfeeding infants.
• If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your healthcare provider.

How should I store Iclevia ?

• Store Iclevia at room temperature between 20º to 25°C (68° to 77º F). Protect from light.
• Keep Iclevia and all medicines out of the reach of children.

General information about the safe and effective use of Iclevia

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Iclevia for a condition for which it was not prescribed. Do not give Iclevia to other people, even if they have the same symptoms that you have.

This Patient Information summarizes the most important information about Iclevia. You can ask your pharmacist or healthcare provider for information about Iclevia that is written for health professionals.

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

Do birth control pills cause cancer?

It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones. Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What if I want to become pregnant?

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

What should I know about my period when taking Iclevia ?

When you take Iclevia, which has a 91-day extended dosing cycle, you should have 4 scheduled periods a year (bleeding when you are taking the 7 green pills). However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. During the first Iclevia 91-day treatment cycle, about 1 in 3 women may have 20 or more days of unplanned bleeding or spotting. This bleeding or spotting tends to decrease with time. Do not stop taking Iclevia because of this bleeding or spotting. If the spotting continues for more than 7 days in a row or if the bleeding is heavy, call your healthcare provider.

What if I miss my scheduled period when taking Iclevia ?

You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking white pills). Since scheduled periods are less frequent when you are taking Iclevia, notify your healthcare provider that you have missed your period and that you are taking Iclevia. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking Iclevia if it is determined that you are pregnant.

What are the ingredients in Iclevia ?

Active ingredients: Each white pill contains levonorgestrel and ethinyl estradiol.

Inactive ingredients:

White pills: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.

Green pills: anhydrous lactose, croscarmellose sodium, FD &C Blue No.2 Aluminum Lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone.