Blisovi 24 Fe: Package Insert and Label Information (Page 4 of 5)

16.2 Storage Conditions

• Store at 20° C to 25° C (68° F to 77° F); excursions permitted from 15 to 30° C (59 to 86° F) [see USP Controlled Room Temperature].
• Protect from light. Keep this drug and all drugs out of the reach of children.

17 PATIENT COUNSELING INFORMATION

Counsel patients to read the FDA-approved Patient Labeling (Patient Information and Instructions for Use).

Counsel patients about 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 [see BOXED WARNING].
• 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 [see WARNINGS AND PRECAUTIONS (5.1)].
• Blisovi 24 Fe does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
• Blisovi 24 Fe is not to be used during pregnancy; if pregnancy occurs during use of Blisovi 24 Fe instruct the patient to stop further use [see WARNINGS AND PRECAUTIONS (5.9)].
• Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed [see DOSAGE AND ADMINISTRATION (2.2)].
• Use a back-up or alternative method of contraception when enzyme inducers are used with Blisovi 24 Fe [see DRUG INTERACTIONS (7.1)].
• COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see USE IN SPECIFIC POPULATIONS (8.2)].
• Women who start COCs postpartum, and who has not yet had a period, must use an additional method of contraception until she has taken a white tablet for 7 consecutive days [see DOSAGE AND ADMINISTRATION (2.2)].
• Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see WARNINGS AND PRECAUTIONS (5.8)].

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) — 454 775

INDIA

Revised: February 2023

PATIENT INFORMATION

Blisovi^™ 24 Fe (bli-SO-vee EFF-EE)

(norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets)

What is the most important information I should know about Blisovi 24 Fe?

Do not use Blisovi 24 Fe 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 Blisovi 24 Fe?

Blisovi 24 Fe is a birth control pill (hormonal contraceptive) used by women to prevent pregnancy.

How does Blisovi 24 Fe 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 from the clinical study, about 1 to 4 out of 100 women may get pregnant during the first year they use Blisovi 24 Fe.

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 Blisovi 24 Fe?

Do not take Blisovi 24 Fe 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 that increases your risk of having blood clots
• 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
• have any unexplained vaginal bleeding
• had breast cancer
• 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 while you are taking Blisovi 24 Fe, stop taking Blisovi 24 Fe right away and talk to your healthcare provider. Use non-hormonal contraception (such as condoms and spermicide) when you stop taking Blisovi 24 Fe.

What should I tell my healthcare provider before taking Blisovi 24 Fe?

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. Blisovi 24 Fe may decrease the amount of breast milk you make. A small amount of the hormones in Blisovi 24 Fe 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.

Blisovi 24 Fe may affect the way other medicines work, and other medicines may affect how well Blisovi 24 Fe 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 Blisovi 24 Fe?

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

What are the possible serious side effects of Blisovi 24 Fe?

• Like pregnancy, Blisovi 24 Fe 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
• 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 if 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 Blisovi 24 Fe. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Blisovi 24 Fe?

• headache
• vaginal infections
• nausea
• menstrual cramps
• breast tenderness
• mood changes
• acne
• weight gain

These are not all the possible side effects of Blisovi 24 Fe. 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 Blisovi 24 Fe?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking Blisovi 24 Fe. Certain blood tests may be affected by Blisovi 24 Fe.
• Blisovi 24 Fe does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store Blisovi 24 Fe?

• Store Blisovi 24 Fe at room temperature between 68°F to 77°F (20°C to 25°C).
• Store away from light.
• Keep Blisovi 24 Fe and all medicines out of the reach of children.

General information about the safe and effective use of Blisovi 24 Fe .

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Blisovi 24 Fe for a condition for which it was not prescribed. Do not give Blisovi 24 Fe to other people.

This Patient Information summarizes the most important information about Blisovi 24 Fe. You can ask your pharmacist or healthcare provider for information about Blisovi 24 Fe that is written for health professionals.

For more information, call Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or visit our website at www.lupinpharmaceuticals.com.

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 Blisovi 24 Fe?

Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Blisovi 24 Fe, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.

What are the ingredients in Blisovi 24 Fe?

Active ingredients:

White pills: norethindrone acetate and ethinyl estradiol

Inactive ingredients:

Brown pills: ferrous fumarate

INSTRUCTIONS FOR USE

Blisovi™ 24 Fe (bli-SO-vee EFF-EE)

(norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets)

Important Information about taking Blisovi 24 Fe

• Take 1 pill every day at the same time. Take the pills in the order directed on your blister.
• 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 Blisovi 24 Fe, talk to your healthcare provider.
• When you first start taking Blisovi 24 Fe, 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 Blisovi 24 Fe. 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 Blisovi 24 Fe 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 Blisovi 24 Fe according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking Blisovi 24 Fe.
• If you have vomiting or diarrhea within 3 to 4 hours of taking a white active pill, take another white pill from your extra blister. If you do not have an extra blister, take the next white pill in your blister. Continue taking all your remaining pills in order. Start the first pill of your next blister the day after finishing your current blister. This will be 1 day earlier than originally scheduled. Continue on your new schedule.
• 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 and a spermicide, until you check with your healthcare provider.
• Stop taking Blisovi 24 Fe 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 and spermicide) during this time period.

Before you start taking Blisovi 24 Fe:

• Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on your blister.
• Have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed.

When should I start taking Blisovi 24 Fe?

If you start taking Blisovi 24 Fe and you have not used a hormonal birth control method before:

• There are 2 ways to start taking your birth control pills. You can either start on a Sunday (Sunday Start) or on the first day (Day 1) of your natural menstrual period (Day 1 Start). Your healthcare provider should tell you when to start taking your birth control pill.
• If you use the Sunday Start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take Blisovi 24 Fe. You do not need back-up contraception if you use the Day 1 Start.

If you start taking Blisovi 24 Fe and you are switching from another birth control pill:

• Start your new Blisovi 24 Fe 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 Blisovi 24 Fe and previously used a vaginal ring or transdermal patch:

• Start using Blisovi 24 Fe on the day you would have reapplied the next ring or patch.

If you start taking Blisovi 24 Fe and you are switching from a progestin-only method such as an implant or injection:

• Start taking Blisovi 24 Fe on the day of removal of your implant or on the day when you would have had your next injection.

If you start taking Blisovi 24 Fe and you are switching from an intrauterine device or system (IUD or IUS):

• Start taking Blisovi 24 Fe 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 and spermicide for the first 7 days that you take Blisovi 24 Fe.

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 Blisovi 24 Fe? ” above. Follow these instructions for either a Sunday Start or a Day 1 Start.

Sunday Start:

You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday.

• Take pill 1 on the Sunday after your period starts.
• If your period starts on a Sunday, take pill “1 ” that day and refer to Day 1 Start instructions below.
• Take 1 pill every day in the order on the blister at the same time each day for 28 days.
• After taking the last pill on Day 28 from the blister, start taking the first pill from a new pack, on the same day of the week as the first pack (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 and spermicide for the first 7 days of the first cycle that you take Blisovi 24 Fe.

Day 1 Start:

You will use a Day 1 Start if your doctor told you to take your first pill (Day 1) on the first day of your period.

• Take 1 pill every day in the order of the blister, at the same time each day, for 28 days.
• After taking the last pill on Day 28 from the blister, start taking the first pill from a new pack, on the same day of the week as the first pack. Take the first pill in the new pack whether or not you are having your period.

Instructions for using your blister:

The Blisovi 24 Fe blister has 24 “active” white pills (with hormones) to be taken for 24 days, followed by 4 “reminder” brown pills (without hormones) to be taken for the next 4 days.

Look for:

• Where on the pack to start taking pills
• In what order to take the pills. Follow the arrows shown in Figure A.
• The week numbers as shown in Figure A.

What if should I do if I miss any Blisovi 24 Fe white pills?

If you miss 1 white pill in Weeks 1, 2, or 3, 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 in Week 1 or Week 2 of your pack, follow these steps:

• Take the 2 missed pills as soon as possible and the next 2 pills the next day.
• Then continue to take 1 pill every day until you finish the pack.
• Use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after missing your pills.

If you miss 2 white pills in a row in Week 3 or Week 4, or you miss 3 or more white pills in a row at any time, follow these steps:

• If you are a Day 1 Starter:
  • Throw out the rest of the pill pack and start a new pack that same day.
• If you are a Sunday Starter:
  • Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.
• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.
• You could become pregnant if you have sex during the first 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.

If you miss any of the 4 brown “reminder” pills in Week 4 , throw away the pills you missed and keep taking 1 pill each day until the pack is empty. You do not need to use a back-up method of birth control.

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

Blisovi^™ 24 Fe is a trademark of Lupin Pharmaceuticals, Inc.

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) — 454 775

INDIA

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

Revised: February 2023 ID#: 272868