In a 12-month, multicenter, open-label, single-arm clinical trial conducted in the US, 3,667 women, 18 to 40 years old, were enrolled and 3,565 were treated for up to four 91-day cycles, which equates to thirteen 28-day cycles, to assess the safety and efficacy of Fayosim, completing the equivalent of 33,895 28-day cycles of exposure. The racial demographic of those treated was: Caucasian (64%), African-American (19%), Hispanic (11%), Asian (2%), and Other (3%). There were no exclusions for body mass index (BMI) or weight. The weight range of those women treated was 83 to 402 lbs., with a mean weight of 162.5 lbs. Among the women in the trial, 44% were current hormonal contraceptive users, 39% were prior users (who had used hormonal contraceptives in the past), and 17% were new starters. Of treated women, 13.2% were lost to follow-up, 12.8% discontinued due to an adverse event, and 6.1% discontinued by withdrawing their consent.
The pregnancy rate (Pearl Index [PI]) in women aged 18 to 35 years was 3.19 pregnancies per 100 woman-years of use (95% confidence interval 2.49, 4.03), based on 70 pregnancies that occurred after the onset of treatment and up to and including 7 days after the last pill. Cycles in which conception did not occur, but which included the use of backup contraception, were not included in the calculation of the PI. The PI includes patients who did not take the drug correctly.
Fayosim (levonorgestrel and ethinyl estradiol tablets USP, and ethinyl estradiol tablets USP) are available in Extended-Cycle Wallets each containing a 13-week supply of tablets in the following order:
- 42 pink, round, biconvex film-coated tablets, each containing 0.15 mg of levonorgestrel and 0.02 mg ethinyl estradiol: debossed with “LU” on one side and “U19” on the other side.
- 21 white, round, biconvex film-coated tablets, containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol: debossed with “LU” on one side and “U20” on the other side.
- 21 light blue, round, biconvex film-coated tablets, containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol: debossed with “LU” on one side and “V21” on the other side.
- 7 mustard, round, biconvex film-coated tablets, containing 0.01 mg of ethinyl estradiol: debossed with “LU” on one side and “V22” on the other side.
1 extended cycle wallet of 91 tablets which is packed in a pouch (NDC 68180-860-11). Such one pouch is packed in a carton (NDC 68180-860-12).
2 extended cycle wallets of 91 tablets each which is packed in a pouch (NDC 68180-860-11). Such two pouches are packed in a carton (NDC 68180-860-13).
Counsel patients on the following information:
- Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs.
- Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC.
- Fayosim does not protect against HIV-infection (AIDS) and other sexually transmitted infections.
- The Warnings and Precautions associated with COCs.
- Fayosim is not to be used during pregnancy; if pregnancy occurs during use of Fayosim, instruct the patient to stop further intake.
- Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. See WHAT TO DO IF YOU MISS PILLS section of FDA-Approved Patient Labeling.
- Use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
- COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established.
- Women who start COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken a pink tablet for 7 consecutive days.
- Amenorrhea may occur. Consider pregnancy in the event of amenorrhea, and rule out pregnancy if amenorrhea is associated with symptoms of pregnancy, such as morning sickness or unusual breast tenderness.
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
Pithampur (M.P.) – 454 775
November 2017 ID#: 242170
Guide for Using Fayosim™
[levonorgestrel and ethinyl estradiol tablets USP (0.15 mg/0.02 mg, 0.15 mg/0.025 mg and 0.15 mg/0.03 mg), and ethinyl estradiol tablets USP (0.01 mg)]
Do not use Fayosim 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 Fayosim?
Fayosim is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol and a progestin called levonorgestrel.
How Well Does Fayosim Work?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant.
Based on the results of a single clinical study lasting 12 months, 2 to 4 women out of 100 women may get pregnant during the first year they use Fayosim.
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.
1. Take one pill every day at the same time. Take pills in the order directed on the Extended-Cycle wallet.
Do not skip pills or delay taking your pills. 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.
2. You may have spotting or light bleeding, or feel sick to your stomach during the first few months of taking Fayosim. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn’t go away, check with your healthcare provider.
If you vomit or have diarrhea within 4 hours after taking your pill, follow the instructions in “What To Do If You Miss Pills.”
3. 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, you could also feel a little sick to your stomach.
4. If you have trouble remembering to take Fayosim, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.
1. Decide what time of day you want to take your pill. It is important to take it at about the same time every day.
2. Look at your Extended-Cycle Tablet Wallet. Your Extended-Cycle Wallet consists of 3 blister strips that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 42 pink tablets, each containing 0.15 mg of levonorgestrel and 0.02 mg ethinyl estradiol, 21 white tablets containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol, 21 light blue tablets containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 mustard tablets containing 0.01 mg of ethinyl estradiol.
Blister strip 1 contains 4 rows of 7 pink pills.
- Where on the first blister strip in the pack to start taking pills (upper left corner at the start arrow) and
- In what order to take the pills (follow the weeks and arrow).
- Take the first pink pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first pink pill that same day.
- Use another method of birth control (such as condoms and spermicides) as a back-up method if you have sex anytime from the Sunday you start your first pink pill until the next Sunday (first 7 days). If you have been using a different hormonal method of birth control (such as a different pill, the “patch,” or the “vaginal ring”), you need to use another method of birth control (such as condoms and spermicides) each time you have sex after stopping your old method of birth control until you have taken Fayosim for 7 days.
- If you have recently given birth and have not yet had a period, use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken Fayosim for 7 days.
1. Take one pill at the same time every day until you have taken the last pill in the Extended-Cycle wallet.
- Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea).
- Do not skip pills even if you do not have sex very often.
- Do not skip the mustard pills because they are not placebo pills (“sugar pills”). They contain ethinyl estradiol.
- After taking the last mustard pill, start taking the first pink pill from a new Extended-Cycle Wallet the very next day (this should be on a Sunday) regardless of when your period started.
If you MISS 1 pink, white or light blue pill:
1. 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.
2. You do not need to use a back-up birth control method if you have sex.
If you MISS 2 pink, white or light blue pills in a row:
1. Take 2 pills on the day you remember, and 2 pills the next day.
2. Then take 1 pill a day until you finish the pack.
3. You could become pregnant if you have sex in the 7 days after you miss two pills. You MUST use another birth control method (such as condoms and spermicide) as a back up for the 7 days after you restart your pills.
If you MISS 3 OR MORE pink, white or light blue pills in a row:
1. Do not take the missed pills. Keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. For example: If you resume taking the pill on Thursday, take the pill under “Thursday” and do not take the missed pills. You may experience bleeding during the week following the missed pills.
2. You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills.
3. You MUST use a non-hormonal birth control method (such as condoms and 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 mustard pills, call your healthcare provider because you may be pregnant.
If you MISS ANY of the 7 mustard colored pills:
1. Take the next scheduled pill at the scheduled time.
2. You do not need a back-up method of birth control.
Finally, if you are still not sure what to do about the pills you have missed
1. Use a back-up method anytime you have sex.
2. Keep taking one pill each day until you contact your healthcare provider.
Who Should Not Take Fayosim?
Your healthcare provider will not give you Fayosim if you have:
- Ever had breast cancer or any cancer that is sensitive to female hormones
- Liver disease, including liver tumors
- Been prescribed 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
- Ever had blood clots in your arms, legs, eyes, or lungs
- Ever had a stroke
- Ever had a heart attack
- Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
- An inherited problem with your blood that makes it clot more than normal
- High blood pressure that medicine can’t control
- Diabetes with kidney, eye, nerve or blood vessel damage
- Ever had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headaches if you are over age 35
- Smoke and are over 35 years old
- Are pregnant
- Have any unexplained bleeding from the vagina
Tell your healthcare provider if you have ever had any of the above conditions (your healthcare provider may recommend another method of birth control.)
Birth control pills do notprotect you against any sexually transmitted infection, including HIV, the virus that causes AIDS.
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 Fayosim 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 Fayosim, may decrease the amount of milk you make. A small amount of the pill’s hormones pass into breast milk.
Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:
- St. John’s wort
If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms and spermicide, until you check with your healthcare provider.
Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone.
Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.
It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:
- Legs (deep vein thrombosis)
- Lungs (pulmonary embolus)
- Eyes (loss of eyesight)
- Heart (heart attack)
- Brain (stroke)
- High blood pressure
- Gallbladder problems
- Rare cancerous or noncancerous liver tumors
Call your healthcare provider right away if you have:
- Persistent leg pain
- Sudden shortness of breath
- Sudden blindness, partial or complete
- Severe pain or pressure in your chest
- Sudden, severe headache unlike your usual headaches
- Weakness or numbness in an arm or leg, or trouble speaking
- Yellowing of the skin or eyeballs
The most common side effects of birth control pills are:
- Spotting or bleeding between menstrual periods
- Breast tenderness
Less common side effects are:
- Less sexual desire
- Bloating or fluid retention
- Blotchy darkening of the skin, especially on the face
- High blood sugar, especially in women who already have diabetes
- High fat (cholesterol, triglyceride) levels in the blood
- Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
- Problems tolerating contact lenses
- Weight gain
No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.
Birth control pills do not appear 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 Should I Know About My Period When Taking Fayosim?
When you take Fayosim, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 mustard pills). Each period is likely to last about 3 to 4 days. 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. This bleeding or spotting tends to decrease with each additional cycle. Do not stop taking Fayosim because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider.
What If I Miss My Scheduled Period When Taking Fayosim?
You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking mustard pills). Because scheduled periods are less frequent when you are taking Fayosim, notify your healthcare provider that you have missed your period and that you are taking Fayosim. 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 Fayosim if it is determined that you are pregnant.
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.
General Advice About Fayosim
Your healthcare provider prescribed Fayosim for you. Do not share Fayosim with anyone else. Keep Fayosim out of the reach of children.
If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare provider for a more detailed label written for medical professionals.
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
Pithampur (M.P.) – 454 775
November 2017 ID#: 242171
1 extended cycle wallet of 91 tablets in a carton (NDC 68180-860-12).
2 extended cycle wallets of 91 tablets in a carton (NDC 68180-860-13)
Pouch Label (NDC 68180-860-11)
Wallet Label (NDC 68180-860-11)
|FAYOSIM levonorgestrel and ethinyl estradiol and ethinyl estradiol kit|
|Labeler — Lupin Pharmaceuticals, Inc. (089153071)|
|Registrant — LUPIN LIMITED (675923163)|
|LUPIN LIMITED||650582310||MANUFACTURE (68180-860), PACK (68180-860)|
Revised: 12/2019 Lupin Pharmaceuticals, Inc.
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.