Xelria Fe is indicated for use by females of reproductive potential to prevent pregnancy.

Xelria Fe is available in cartons of 3 blister packs.

Each blister pack contains 28 tablets in the following order:

• 21 yellow, round, uncoated flat (active) tablets debossed with “226” on one side of the tablet and plain on the other side and each containing 0.4 mg norethindrone and 0.035 mg ethinyl estradiol.

• 7 brown, round (non-hormonal placebo) tablets debossed with “291” on one side of the tablet and plain on the other side and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

Xelria Fe is contraindicated in females who are known to have or develop the following conditions:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:

o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]

o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]

o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]

o Have cerebrovascular disease [see Warnings and Precautions (5.1)]

o Have coronary artery disease [see Warnings and Precautions (5.1)]

o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]

o Have uncontrolled hypertension [see Warnings and Precautions (5.4)]

o Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]

o Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7)]

• Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]

• Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]

• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]

• Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]

• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.11)]

• Hypersensitivity to any of the components.

• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

• Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)]

• Vascular events [see Warnings and Precautions (5.1)]

• Liver disease [see Warnings and Precautions (5.2)]

The following adverse reactions are commonly reported by COC users. Because these reactions are voluntarily reported by from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

• Irregular uterine bleeding

• Nausea

• Breast tenderness

• Headache

6.2 Post Marketing Experience

Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use.

Figure 1. Risk of Breast Cancer with Combined Oral Contraceptive Use

RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

Xelria Fe is a combinational contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. The packaging includes 21 yellow tablets composed of norethindrone and ethinyl estradiol followed by 7 brown ferrous fumarate (placebo) tablets. The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural formulas are:

The active yellow norethindrone and ethinyl estradiol tablets (chewable) contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D & C Yellow No.10 Aluminium Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, maltodextrin, povidone K-30, sodium starch glycolate, spearmint flavor and sucralose.

The brown tablets contain ferrous fumarate, colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, magnesium stereate, microcrystalline cellulose and povidone K-90.The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay.

USP Dissolution Test is pending.

The data presented in Section 14 are from a clinical trial conducted with norethindrone 0.4 mg/ethinyl estradiol 0.035 mg tablets. Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are bioequivalent to these norethindrone/ethinyl estradiol tablets.

In a multicenter open-label clinical trial, 1,970 women, 98% of whom were 16 to 39 years of age, were studied for up to 31 cycles (28 days per cycle) to assess the efficacy of norethindrone /ethinyl estradiol tablets, completing the equivalent of 20,230 cycles of exposure. The racial demographic of all enrolled women was: Caucasian (56%), African-American (14%), and Other (30%) (Hispanic, Native American, etc.). Of treated women, 10% were lost to follow-up, 11% discontinued related to cycle control and 7% discontinued due to other adverse events

The pregnancy rate (Pearl Index [PI]) in all 1,970 women was 1.48 pregnancies per 100 women-years of use (95% confidence interval 0.94 to 2.22), based on 23 pregnancies that occurred after the onset of treatment of norethindrone /ethinyl estradiol tablets.

See 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)].

• Xelria Fe does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

• Xelria Fe is not to be used during pregnancy; if pregnancy occurs during use of Xelria 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 (2.3)].

• Use a back-up or alternative method of contraception when enzyme inducers are used with Xelria 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 (8.3)].

• A woman who starts COCs postpartum and who has not yet had a period should use an additional method of contraception until she has taken a yellow 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)].

Xelria Fe (Norethindrone and Ethinyl Estradiol Tablets, USP (Chewable) and Ferrous Fumarate Tablets (Chewable))

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

Do not use Xelria Fe if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) 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 Xelria Fe?

Xelria Fe is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Xelria 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 of one clinical study of a 28-day regimen of norethindrone 0.4 mg/ethinyl estradiol 0.035 mg tablets, about 1 to 2 out of 100 women may get pregnant during the first year they use Xelria 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 Xelria Fe?

Do not take Xelria 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

• are pregnant

• had breast cancer or any cancer that is sensitive to female hormones

• 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 Xelria Fe, stop taking Xelria Fe right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Xelria Fe.

What should I tell my healthcare provider before taking Xelria 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. Xelria Fe may decrease the amount of breast milk you make. A small amount of the hormones in Xelria 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.

Xelria Fe may affect the way other medicines work, and other medicines may affect how well Xelria Fe work.

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

How do I take Xelria Fe?

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

What are the possible serious side effects of Xelria Fe?

• Like pregnancy, Xelria 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

• a sudden, severe headache unlike your usual headaches

• sudden severe shortness of breath

• weakness or numbness in your arm or leg

• sudden change in vision or blindness

• trouble speaking

• chest pain

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 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 Xelria Fe. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Xelria Fe?

The most common side effects of Xelria Fe include:

• headache (including migraine)

• nausea and vomiting

• breast problems

o tenderness, pain and discomfort

o enlargement and swelling

o discharge

o nipple pain

• belly pain

• pain with your periods (menstrual cycle)

• mood changes, including depression

• acne

• vaginal infections

• bloating

• weight gain

These are not all the possible side effects of Xelria 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 Xelria Fe?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking Xelria Fe. Certain blood tests may be affected by Xelria Fe.

• Xelria Fe does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store Xelria Fe?

• Store Xelria Fe at room temperature between 20° to 25°C (68° to 77°F).

• Keep Xelria Fe and all medicines out of the reach of children.

• Store away from light.

General information about the safe and effective use of Xelria Fe.

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

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

For more information, call Xiromed, LLC at 1-844-XIROMED (1-844-947-6633).

Does hormonal birth control 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 Xelria 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 Xelria 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 Xelria Fe?

Active ingredients:

Yellow pills: norethindrone and ethinyl estradiol

Brown pills: ferrous fumarate

Inactive ingredients:

Yellow pills: colloidal silicon dioxide, dibasic calcium phosphate, D & C Yellow No.10 Aluminium Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, maltodextrin, povidone K-30, sodium starch glycolate, spearmint flavor and sucralose

Brown pills: colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, magnesium stereate, microcrystalline cellulose and povidone K-90

INSTRUCTIONS FOR USE
Xelria Fe (Norethindrone and Ethinyl Estradiol Tablets, USP (Chewable) and Ferrous Fumarate Tablets (Chewable))

Important Information about taking Xelria Fe.

• Take 1 pill every day at the same time. Take the pills in the order directed on your blister pack.

• Both the yellow pills and the brown pills may be swallowed whole or chewed and swallowed. If the pill is chewed, drink a full glass (8 ounces) of liquid immediately after swallowing.

• 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 Xelria Fe, talk to your healthcare provider. When you first start taking Xelria 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 Xelria 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 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 Xelria 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 Xelria Fe.

• If you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack. If you do not have an extra blister pack, take the next pill in your blister pack. Continue taking all your remaining pills in order. Start the first pill of your next blister pack the day after finishing your current blister pack. 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 Xelria 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 Xelria 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 pack.

• Have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed.

When should I start taking Xelria Fe?

If you start taking Xelria 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 Xelria Fe. You do not need back-up contraception if you use the Day 1 Start.

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

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

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

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

• Start taking Xelria 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 Xelria Fe and you are switching from an intrauterine device or system (IUD or IUS):

• Start taking Xelria 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 Xelria 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 Xelria 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 pack at the same time each day for 28 days.

• After taking the last pill on Day 28 from the blister pack, 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 Xelria 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 pack, at the same time each day, for 28 days.

• After taking the last pill on Day 28 from the blister pack, 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 pill pack:

Step 1.

Look at your Xelria Fe pill pack. See Figure A.

The Xelria Fe pill pack has:

• 21 yellow (active) pills with hormone for Week 1 through Week 3.

• 7 brown (inactive) pills without hormones for Week 4.

Step 2.

Find:

• where on your pack to start taking pills

• in what order to take your pills (follow the arrows)

• the week numbers

Step 3.

Remove the yellow pill by pressing the pill through the foil in the bottom of the pill pack. See Figure B. Continue taking the yellow pills for 21 days.

Step 4.

On the first day of Week 4 start taking the brown pills. Take the brown pill for 7 days. Your period should start during this time.

Step 5.

When you have taken all of the brown pills in your pill pack, get a new pill pack and start taking the yellow pills.

• For a Day 1 start:
   
  Begin your next pill pack on the same day of the week as your first cycle pill pack.
   

• For a Sunday Start:
   
  Begin your next pill pack on Sunday.

What should I do if I miss any Xelria Fe pills?

If you miss 1 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 pills 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 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, 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 have any questions or are unsure about the information in this leaflet, call your healthcare provider.

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

Manufactured for:
Xiromed, LLC
Florham Park, NJ 07932

Product of India

Code No.: GUJ-DRUGS/G/28/1297

PI-308-00

Revised: 10/2024

NDC 70700-308-85

Rx only

Xelria Fe (Norethindrone and Ethinyl Estradiol Tablets USP (Chewable) andFerrous Fumarate Tablets (Chewable))*

0.4 mg /0.035 mg

3 pouches, each pouch contains one blister pack of 28 tablets