Iclevia

ICLEVIA- levonorgestrel and ethinyl estradiol
Aurobindo Pharma Limited

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This 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 [see Contraindications (4)].

1 INDICATIONS AND USAGE

IcleviaTM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Iclevia

Iclevia is dispensed in an Extended-Cycle Wallet [see How Supplied/Storage and Handling (16)]. Iclevia should be started on a Sunday (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. Instruct patients to take Iclevia once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, Iclevia should be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see FDA-approved patient labeling.

2.2 How to Take Iclevia

Table 1: Instructions for Administration of Iclevia
Starting COCs in women not currently using hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color:
  • Iclevia active tablets are white (Day 1 to Day 84).
  • Iclevia inactive tablets are green (Day 85 to Day 91).
Sunday Start: For each 91-day course, take in the following order:
  • Take the first white tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first 7 days of treatment.
  • Take subsequent white tablets once daily at the same time each day for a total of 84 days.
  • Take one green tablet (inert) daily for the following 7 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 7 days that the green tablets are taken.
  • Begin the next and all subsequent 91-day courses of Iclevia without interruption on the same day of the week (i.e., Sunday) on which the patient began her first dose. Follow the same schedule as the initial 91-day course: a white tablet once a day for 84 days, and a green tablet once a day for 7 days. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a white tablet daily for 7 consecutive days.
Switching to Iclevia from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started.
Switching from another contraceptive method to Iclevia Start Iclevia:
• Transdermal patch
  • On the day when the next application would have been scheduled.
• Vaginal ring
  • On the day when the next insertion would have been scheduled.
• Injection
  • On the day when the next injection would have been scheduled.
• Intrauterine contraceptive (IUD)
  • On the day of removal.
  • If the IUD is not removed on first day of the patient’s menstrual cycle, additional non- hormonal contraception (such as condoms or spermicide) is needed for the first seven days of the first 91-day course.
• Implant
  • On the day of removal.
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-approved patient labeling.

Starting Icleviaafter Abortion or Miscarriage

First-trimester

  • After a first-trimester abortion or miscarriage, Iclevia may be started immediately. An additional method of contraception is not needed if Iclevia is started immediately.
  • If Iclevia is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first 91-day course of Iclevia.

Second-trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Iclevia following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first 91-day course of Iclevia [see Contraindications (4), Warnings and Precautions (5.1), and FDA-approved Patient Labeling].

Starting Icleviaafter Childbirth

Wallet I nstructions:

  • The Wallet consists of 3 blister strips that hold 91 individually sealed pills (a 13-week, or 91-day, cycle). The 91 pills consist of 84 white pills (active pills with hormones) and 7 green pills (inactive pills without hormone).
  • The blister strips 1 and 2 each contain 28 white pills (4 rows of 7 pills). See Figure A.

figure1
(click image for full-size original)

  • 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.

figure2

  • Advise the patient to remove the first pill in the upper left corner by pushing down on the pill. The pill will come out through a hole in the back of the Wallet.
  • Advise the patient to wait 24 hours to take the next pill, and continue to take one pill each day until all the pills have been taken.
  • Advise the patient, after taking the last green pill, to start taking the first white pill from a new Wallet the very next day, regardless of when their period started.
figure1figure2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.