have a question about nextstellis?

NEXTSTELLIS is a birth control pill (oral contraceptive) used by females to prevent pregnancy.¹

Do not use NEXTSTELLIS if you smoke cigarettes and are over 35 years old.¹ 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.¹ The risk increases with age and the number of cigarettes you smoke.¹

You should not take NEXTSTELLIS if you:¹

• Smoke and are 35 years of age and older
• Have or have had blood clots in your arms, legs, lungs, or eyes
• Have a problem with your blood that makes it clot more than normal
• Have certain heart valve problems or an irregular heart beat that increases your risk of having blood clots
• Had a stroke
• Have had a heart attack
• Have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessel problems
• Have diabetes
  • With high blood pressure or kidney, eye, nerve, or blood vessel damage, or
  • Have had diabetes for more than 20 years
• Have certain kinds of severe migraine headaches with aura
• Have liver problems, including liver tumors
• Have any unexplained vaginal bleeding
• Have or have had breast cancer or any cancer that is sensitive to female hormones
• Have kidney disease or kidney failure
• Have reduced adrenal gland function (adrenal insufficiency)
• 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 NEXTSTELLIS, stop taking NEXTSTELLIS right away and talk to your healthcare provider.¹ Use non-hormonal contraception when you stop taking NEXTSTELLIS.¹

1. Take your first pink (active) pill on the first day of your next period¹
2. Take one pink pill every day for 24 days, in the order shown on the pack¹
3. Then take the 4 white (inactive) pills to finish your monthly pack¹

If you start taking NEXTSTELLIS on any day other than the first day of your natural menstrual period, use a backup non-hormonal birth control method (such as condoms or spermicide) until you have taken 1 pink (active) pill every day for 7 days.¹

Please see Instructions for Use for additional information.

• Store NEXTSTELLIS at room temperature between 68°F to 77°F (20°C to 25°C)¹
• Throw away unused NEXTSTELLIS through a take-back option, if available. You may also visit www.fda.gov/drugdisposal for FDA instructions for throwing away medicine in your household trash. Do not flush NEXTSTELLIS down the toilet¹
• Keep NEXTSTELLIS and all medicines out of the reach of children¹

The most common side effects of NEXTSTELLIS include:¹ 

1. Irregular vaginal bleeding (including absence of period)
2. Pain with your periods
3. Mood changes
4. Acne
5. Headache
6. Weight gain
7. Breast tenderness, pain, and discomfort
8. Decreased sex drive

NEXTSTELLIS 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, have high blood pressure, have diabetes, have high cholesterol, 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:

• High potassium levels in your blood (hyperkalemia). Certain medicines and conditions can also increase the potassium levels in your blood. Your healthcare provider may check the potassium levels in your blood during treatment with NEXTSTELLIS. Call your healthcare provider or go to a hospital emergency room right away if you have signs or symptoms of high potassium levels in your blood including:
  • Weakness or numbness in an arm or leg
  • Palpitations (feel like your heart is racing or fluttering) or irregular heartbeat
  • Nausea
  • Vomiting
  • Severe pain in your chest
  • Shortness of breath
• High blood pressure. You should see your healthcare provider to check your blood pressure regularly
• New or worsening headaches including migraine headaches
• Possible cancer that is sensitive to female hormones, such as breast cancer, skin cancer (melanoma), lung cancer, and brain cancer
• Liver problems, including:
  • An increase in liver enzymes in the blood
  • Rare liver tumors
  • Jaundice. Call your healthcare provider if you have yellowing of your skin or eyes
• Changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
• Gallbladder problems (cholestasis), especially if you previously had cholestasis of pregnancy.
• Irregular or unusual vaginal bleeding or spotting between your menstrual periods, especially during the first 4 months of taking NEXTSTELLIS, or the absence of menstrual periods
• Depression
• Possible cancer in your cervix
• Swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider right away 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). Females who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking NEXTSTELLIS. Use sunscreen if you have to be in the sunlight

These are not all of the possible side effects of NEXTSTELLIS.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may stop taking NEXTSTELLIS whenever you wish.¹ Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking NEXTSTELLIS.¹

Irregular vaginal bleeding or spotting may happen while you are taking NEXTSTELLIS, especially during the first 4 months of use.¹

If the irregular vaginal bleeding or spotting continues or happens again after you have had regular menstrual cycles, talk to your healthcare provider. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.¹

Some women miss periods on hormonal birth control, even when they are not pregnant.¹ However, if you go 2 or more months in a row without a period, or you miss your period after a month where you did not take all of your NEXTSTELLIS correctly, call you healthcare provider because you may be pregnant.¹

Also call your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking NEXTSTELLIS if you are pregnant.¹

Missing pills can affect how well NEXTSTELLIS works.¹

Here’s a quick guide:¹

If you miss 1 pink (active) pill in Weeks 1, 2 or 3:

• Take it as soon as you remember
• Then take your next pill at the usual time (you may take 2 pills in one day)
• You do not need back-up birth control

If you miss 2 or more pink (active) pills in Week 1 or Week 2:

• Take the most recent missed pill as soon as possible
• Take your next pill at the usual time (you may take 2 pills in one day)
• Throw away the other missed pills
• Continue taking 1 pill a day until the pack is finished
• Use back-up birth control (like condoms) for 7 days

If you miss 2 pink active pills in a row in week 3:

• Take 1 missed pill as soon as possible
• Take your next pill at the usual time (you may take 2 pills in one day)
• Throw away the other missed pills
• Continue taking 1 pill a day until you finish the pink active pills in the pack and throw away the inactive white pills
• Start a new pack of pills the next day
• If you miss your next period, contact your healthcare provider
• You could become pregnant if you have sex during the first 7 days after you restart your pills. You should use a back-up non-hormonal birth control method (such as condoms or spermicide) if you have sex during the first 7 days after you restart your pills

If you miss any white (inactive) pills:

• Skip the missed pills and continue as usual

For full instructions and all scenarios, please refer to the Patient Information Leaflet (PIL) included with your prescription or here.

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