Nexesta Fe: Uses, Side Effects and Dosage

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

Do not use Nexesta 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 Nexesta Fe?

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

How does Nexesta 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 Nexesta 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 Nexesta Fe?

Do not take Nexesta 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 Nexesta Fe, stop taking Nexesta Fe right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Nexesta Fe.

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

Nexesta Fe may affect the way other medicines work, and other medicines may affect how well Nexesta 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 do I take Nexesta Fe?

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

What are the possible serious side effects of Nexesta Fe?

• Like pregnancy, Nexesta 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:

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

What are the most common side effects of Nexesta Fe?

The most common side effects of Nexesta Fe include:

• headache (including migraine)
• nausea and vomiting

• breast problems

  • tenderness, pain and discomfort
  • enlargement and swelling
  • discharge
  • 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 Nexesta 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 Nexesta Fe?

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

How should I store Nexesta Fe?

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

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

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

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

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876

Does hormonal birth control cause cancer?

It is not known if hormonal birth control pills causes 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 Nexesta 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 Nexesta 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 Nexesta Fe?

Active ingredients:

White to off-white pills: norethindrone USP and ethinyl estradiol USP

Brown pills: ferrous fumarate USP

Inactive ingredients:

White to off-white pills: anhydrous lactose, colloidal silicon dioxide, dibasic calcium phosphate, dihydrate, lactose monohydrate, magnesium stearate, nat spearmint, povidone, sodium starch glycolate, and sucralose.

Brown pills: croscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, nat spearmint, povidone, and sucralose.