ICLEVIA (Levonorgestrel And Ethinyl Estradiol) Kit [Aurobindo Pharma Limited]

IcleviaTM
[eye kle’ vee ah]
(levonorgestrel and ethinyl estradiol tablets USP)

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 hormonal 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.

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.

 Figure 3

Who should not take Iclevia?

Do not take Iclevia if you:

  • smoke and are over 35 years of age
  • had blood clots in your arms, legs, lungs, or eyes
  • had a problem with your blood that makes it clot more than normal
  • have certain heart valve problems or irregular heart beat
  • had a stroke
  • had a heart attack
  • have high blood pressure that cannot be controlled by medicine
  • have diabetes with kidney, eye, nerve, or blood vessel damage
  • 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 liver problems, including liver tumors
  • 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.
  • have any unexplained vaginal bleeding
  • are pregnant
  • had breast cancer or any cancer that is sensitive to female hormones

If any of these conditions happen 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 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 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.

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 possible serious side effects of 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

Other serious side effects include:

  • liver problems, including:
    • rare liver tumors
    • jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes.
  • high blood pressure. You should see your healthcare provider for a yearly check of your blood pressure.
  • 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
  • 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)
  • acne
  •  heavier or longer periods, pain with periods
  •  breast tenderness
  •  nausea
  •  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.
  • Iclevia does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store Iclevia?

  • Store Iclevia at room temperature between 20º to 25°C (68° to 77º F).
  • Protect from light.

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?

Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills 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 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.

Instructions For Use

IcleviaTM
[eye kle’ vee ah]
(levonorgestrel and ethinyl estradiol tablets USP)

Important Information about taking Iclevia

  • Take 1 pill every day at the same time. Take the pills in the order directed on your wallet.
  • Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the pack late) you could get pregnant. The more pills you miss, the more likely you are to get pregnant.
  • If you have trouble remembering to take Iclevia, talk to your healthcare provider.
  • When you first start taking Iclevia, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months.
  • You may feel sick to your stomach (nauseous), especially during the first few months of taking Iclevia. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider.
  • Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills (see What should I do if I miss any Iclevia pills? below), you could also feel a little sick to your stomach.
  • It is not uncommon to miss a period. However, if you miss a period and have not taken Iclevia according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking Iclevia.
  • If you have vomiting or diarrhea within 3 to 4 hours of taking a white pill, take another white pill as soon as possible. Continue taking one pill a day until the 91-day course is finished.
  • If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider.
  • Stop taking Iclevia at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms or spermicide) during this time period.

Before you start taking Iclevia:

  • Decide what time of day you want to take your pill. It is important to take it at about the same time every day.
  • Look at your Extended-Cycle Wallet. Your Wallet consists of 3 blister strips that hold 91 individually sealed pills (a 13­-week or 91-day cycle). The 91 pills consists of 84 white and 7 green pills. The blister strips 1 and 2 each contain 28 white pills   (4 rows of 7 pills). See Figure A. The blister strip 3 contains 35 pills consisting of 28 white pills (4 rows of 7 pills) and 7 green pills (1 row of 7 pills). See Figure B. 

figure1

   

figure2
  • Also find:
  • Where on the first blister strip in the pack to start taking pills (upper left corner) and
  • In what order to take the pills (follow the weeks)
  • Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills.

When should I start taking Iclevia?

If you start taking Iclevia and you have not used a hormonal birth control method before:

  • Take the first white pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first white pill that same day.
  • Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first white pill until the next Sunday (first 7 days).

If you start taking Iclevia and you are switching from another birth control pill:

  • Start your new Iclevia pack on the same day that you would start the next pack of your previous birth control method.
  • Do not continue taking the pills from your previous birth control pack.

If you start taking Iclevia and previously used a vaginal ring:

  • Start using Iclevia on the day you would have reapplied the next ring.

If you start taking Iclevia and previously used a transdermal patch:

  • Start using Iclevia on the day you would have started a new cycle (first patch application).

If you start taking Iclevia and you are switching from a progestin-only method such as an implant or injection:

  • Start taking Iclevia on the day of removal of your implant, or on the day when you would have had your next injection.

If you start taking Iclevia and you are switching from an intrauterine device or system (IUD or IUS):

  • Start taking Iclevia on the day of removal of your IUD or IUS.
  • You do not need back-up contraception if your IUD or IUS is removed on the first day (Day 1) of your period. If your IUD or IUS is removed on any other day, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take Iclevia.

Keep a calendar to track your period: If this is the first time you are taking birth control pills, read, “When should I start taking Iclevia?” above. Follow these instructions for a Sunday Start.

Instructions for using your Iclevia Extended-Cycle Wallet:

 

Sunday Start:

  • Take pill 1 on the Sunday after your period starts. To remove your pill from the wallet, press the pill through the hole in the bottom of the wallet. See Figure C.

figure4

  • If your period starts on a Sunday, take pill “1” that same day.
  • Take 1 pill at about the same time every day until you have taken the last pill in the wallet.
  • After taking the last green pill on Day 91 from the wallet, start taking the first white pill from a new Extended-Cycle Wallet on the very next day (this should be a Sunday). Take the first pill in the new pack whether or not you are having your period.
  • Use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days of the first cycle that you take Iclevia.

What should I do if I miss any Iclevia pills?

If you miss 1 white pill, follow these steps:

  • Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
  • Then continue taking 1 pill every day until you finish the pack.
  • You do not need to use a back-up birth control method if you have sex.

If you miss 2 white pills in a row, follow these steps:

  • Take 2 pills on the day you remember and 2 pills the next day.
  • Then continue to take 1 pill every day until you finish the pack.
  • You could become pregnant if you have sex in the 7 days after you miss two pills. You must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.

If you miss 3 or more white pills in a row, follow these steps:

  • Do not take the missed pills. Keep taking 1 pill every day until you have completed all of the remaining pills in the pack. For example, if you start taking the pill on Thursday, take the pill under “Thursday” and do not take the missed pills. You may have bleeding during the week following the missed pills.
  • You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. You must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the green pills, call your healthcare provider because you may be pregnant.

If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India

Revised: 08/2018

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