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INDICATION: NEXPLANON is a prescription medication for the prevention of pregnancy in women.
IMPORTANT SAFETY INFORMATION: You should not use NEXPLANON if you are pregnant or think you may be pregnant; have or have had blood clots; have liver disease or a liver tumor; have unexplained vaginal bleeding; have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past; or are allergic to anything in NEXPLANON. Talk to a trained healthcare provider about using NEXPLANON if you have diabetes, high cholesterol or triglycerides, headaches, gallbladder or kidney problems, history of depressed mood, high blood pressure, allergy to numbing medicines (anesthetics) or medicines used to clean your skin (antiseptics). These medicines will be used when the implant is placed into or removed from your arm.

Indication

NEXPLANON is a prescription birth control for the prevention of pregnancy in women.

Important Safety Information

You should not use NEXPLANON if you are pregnant or think you may be pregnant; have or have had blood clots; have liver disease or a liver tumor; have unexplained vaginal bleeding; have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past; or are allergic to anything in NEXPLANON. Talk to a trained healthcare provider about using NEXPLANON if you have diabetes, high cholesterol or triglycerides, headaches, gallbladder or kidney problems, history of depressed mood, high blood pressure, allergy to numbing medicines (anesthetics) or medicines used to clean your skin (antiseptics). These medicines will be used when the implant is placed into or removed from your arm.

SIDE EFFECTS OF NEXPLANON

learn about common side effects, possible risks of using NEXPLANON, and information on who shouldn’t use NEXPLANON

what are the most common side effects of NEXPLANON?

changes in menstrual bleeding patterns (menstrual periods)

In studies, 1 in 10 women stopped using NEXPLANON because of an unfavorable change in their bleeding pattern. You may have:

  • Longer or shorter bleeding during your period
  • No bleeding at all during the time of your period
  • Spotting between your periods
  • Varied amounts of time between your periods

Tell your doctor immediately if you think you may be pregnant or your menstrual bleeding is heavy and prolonged.

Other frequent side effects that cause women to stop using NEXPLANON include:
  • Mood Swings
  • Weight Gain
  • Headaches
  • Acne
  • Depressed Mood
  • Mood Swings
  • Weight Gain
  • Headaches
  • Acne
  • Depressed Mood
Other common side effects of NEXPLANON:
  • Headache
  • Vaginitis (inflammation of the vagina)
  • Weight gain
  • Acne
  • Breast pain
  • Viral infections such as sore throats or flu-like symptoms
  • Stomach pain
  • Painful periods
  • Mood swings, nervousness, or depressed mood
  • Back pain
  • Nausea
  • Dizziness
  • Pain
  • Pain at the site of insertion
  • Headache
  • Vaginitis (inflammation of the vagina)
  • Weight gain
  • Acne
  • Breast pain
  • Viral infections such as sore throats or flu-like symptoms
  • Stomach pain
  • Painful periods
  • Mood swings, nervousness, or depressed mood
  • Back pain
  • Nausea
  • Dizziness
  • Pain
  • Pain at the site of insertion

Implants have been reported to be found in a blood vessel, including a blood vessel in the lung, which can be associated with shortness of breath, cough and/or the coughing up of blood or blood-stained mucus.

This is not a complete list of possible side effects. For more information, ask your healthcare provider for advice about any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

don’t use NEXPLANON if you …

  • Are pregnant or think you may be pregnant

  • Have, or have had blood clots, such as blood clots in your leg (deep vein thrombosis), lungs (pulmonary embolism), eyes (total or partial blindness), heart (heart attack), or brain (stroke)

  • Have liver disease or a liver tumor

  • Have unexplained vaginal bleeding

  • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past

  • Are allergic to anything in NEXPLANON

  • Are pregnant or think you may be pregnant

  • Have, or have had blood clots, such as blood clots in your leg (deep vein thrombosis), lungs (pulmonary embolism), eyes (total or partial blindness), heart (heart attack), or brain (stroke)

  • Have liver disease or a liver tumor

  • Have unexplained vaginal bleeding

  • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past

  • Are allergic to anything in NEXPLANON

tell your doctor if you have or have had any of these conditions

Your doctor can suggest a different method of birth control.

DIABETES

HIGH CHOLESTEROL

HIGH TRIGLYCERIDES

HAVE HEADACHES

GALLBLADDER PROBLEMS

KIDNEY PROBLEMS

HISTORY OF DEPRESSION

HIGH BLOOD PRESSURE

here are some other possible risks with NEXPLANON

improper insertion

The implant may not be placed in your arm due to a failed insertion. If this happens, you may become pregnant.

To ensure NEXPLANON is properly inserted, immediately after insertion, you and your healthcare provider will feel for the implant under your skin. If you can’t feel the implant, be sure to tell your healthcare provider.

location and removal may be difficult

Location and removal of the implant may be difficult or impossible because the implant is not where it should be. Special procedures, including surgery in the hospital, may be needed to remove the implant. If the implant is not removed, the effects of NEXPLANON will continue for a longer period of time.

Implants have been found in the pulmonary artery (a blood vessel in the lung). If the implant cannot be found in the arm, your healthcare provider may use x-rays or other imaging methods on the chest. If the implant is located in the chest, surgery may be needed.

other problems related to insertion and removal
  • Pain, irritation, swelling, or bruising at the insertion site
  • Numbness and tingling at the insertion site
  • Scarring, including a thick scar called a keloid around the insertion site
  • Infection
  • Scar tissue may form around the implant making it difficult to remove
  • The implant may come out by itself. You may become pregnant if the implant comes out by itself. Use a back-up birth control method and call your healthcare provider right away if the implant comes out
  • The need for surgery in the hospital to remove the implant
  • Injury to nerves or blood vessels in your arm
  • The implant breaks making removal difficult
  • Pain, irritation, swelling, or bruising at the insertion site
  • Numbness and tingling at the insertion site
  • Scarring, including a thick scar called a keloid around the insertion site
  • Infection
  • Scar tissue may form around the implant making it difficult to remove
  • The implant may come out by itself. You may become pregnant if the implant comes out by itself. Use a back-up birth control method and call your healthcare provider right away if the implant comes out
  • The need for surgery in the hospital to remove the implant
  • Injury to nerves or blood vessels in your arm
  • The implant breaks making removal difficult
ectopic pregnancy

If you become pregnant while using NEXPLANON, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control.

Unusual vaginal bleeding or lower stomach (abdominal) pain may be a sign of ectopic pregnancy.

Ectopic pregnancy is a medical emergency that often requires surgery.

Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. Call your healthcare provider right away if you think you are pregnant or have unexplained lower stomach (abdominal) pain.

ovarian cysts and breast cancer

Cysts may develop on the ovaries and usually go away without treatment, but sometimes surgery is required to remove them.

It is not known whether NEXPLANON use changes a woman’s risk for breast cancer. If you have breast cancer now, or have had it in the past, do not use NEXPLANON because some breast cancers are sensitive to hormones.

serious blood clots

NEXPLANON may increase your chance of serious blood clots, especially if you have other risk factors such as smoking. 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 embolism)
  • Brain (stroke)
  • Heart (heart attack)
  • Eyes (total or partial blindness)
  • Legs (deep vein thrombosis)
  • Lungs (pulmonary embolism)
  • Brain (stroke)
  • Heart (heart attack)
  • Eyes (total or partial blindness)

The risk of serious blood clots is increased in women who smoke. If you smoke and want to use NEXPLANON, you should quit. Your healthcare provider may be able to help.

Tell your healthcare provider at least 4 weeks before if you are going to have surgery or will need to be on bed rest. You have an increased chance of getting blood clots during surgery or bed rest.

other risks

A few women who use birth control that contains hormones may get:

  • High blood pressure
  • Gallbladder problems
  • Rare cancerous or noncancerous liver tumors

If you feel you have a broken or bent implant, please contact your doctor.

call your doctor immediately if you have …

pain in your lower legThat does not go away
severe chest painOr heaviness in your chest
sudden shortness of breathSharp chest pain or coughing blood
symptoms of severe allergic reactionSuch as swollen face, tongue, or throat or have trouble breathing or swallowing
sudden severe headacheUnlike your usual headaches
weakness or numbnessIn your arm or leg or trouble speaking
sudden blindnessEither partial or complete
yellowing of your skin or whites of your eyesEspecially with fever, tiredness, loss of appetite, dark-colored urine, or light-colored bowel movements
severe pain, swelling or tendernessIn the lower stomach (abdomen)
lump in your breastYou should be checking regularly
problems sleepingOr lack of energy, tiredness, or you feel very sad
heavy menstrual bleedingHeavier than usual
suspect the implant is broken or bentWhile in your arm due to external forces

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Indication
NEXPLANON is a prescription birth control for the prevention of pregnancy in women.

Important Safety Information

You should not use NEXPLANON if you are pregnant or think you may be pregnant; have or have had blood clots; have liver disease or a liver tumor; have unexplained vaginal bleeding; have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past; or are allergic to anything in NEXPLANON.

Talk to your healthcare professional about using NEXPLANON if you have diabetes, high cholesterol or triglycerides, headaches, gallbladder or kidney problems, history of depressed mood, high blood pressure, allergy to numbing medicines (anesthetics) or medicines used to clean your skin (antiseptics). These medicines will be used when the implant is placed into or removed from your arm.

Immediately after the NEXPLANON implant has been placed, you and your healthcare professional should check that the implant is in your arm by feeling for it. If at any time you cannot feel the NEXPLANON implant, contact your healthcare professional immediately and use a non-hormonal birth control method (such as condoms) until your healthcare professional confirms that the implant is in place. You may need special tests to check that the implant is in place or to help find the implant when it is time to take it out.

The implant may not be actually in your arm due to failed insertion. If this happens, you may become pregnant. Removal of the implant may be very difficult or impossible if the implant is not where it should be. Special procedures, including surgery in the hospital, may be needed to remove the implant. If the implant is not removed, then the effects of NEXPLANON will continue for a longer period of time. Other problems related to insertion and removal may also occur, including vasovagal reactions (such as a drop in blood pressure, dizziness, or fainting), pain, irritation, swelling, bruising, numbness and tingling, scarring, infection, injury to the nerves or blood vessels, and breaking of the implant. Additionally, the implant may come out by itself. You may become pregnant if the implant comes out by itself. Use a back-up birth control method and call your healthcare professional right away if the implant comes out.

The most common side effect of NEXPLANON is a change in your normal menstrual bleeding pattern. In studies, one out of ten women stopped using the implant because of an unfavorable change in their bleeding pattern. You may experience longer or shorter bleeding during your periods or have no bleeding at all. The time between periods may vary, and you may also have spotting in between periods.

If you become pregnant while using NEXPLANON, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control. Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. Call your healthcare professional right away if you think you are pregnant or have unexplained lower stomach (abdominal) pain.

The use of NEXPLANON may also increase your chance of serious blood clots, especially if you have other risk factors, such as smoking. If you smoke and want to use NEXPLANON, you should quit. Serious blood clots can occur within blood vessels of different parts of the body, including legs (deep vein thrombosis), lungs (pulmonary embolism), brain (stroke), heart (heart attack), and eyes (total or partial blindness). It is possible to die from a problem caused by a blood clot, such as a heart attack or stroke. Tell your healthcare professional at least 4 weeks before if you are going to have surgery or will need to be on bed rest, because you have an increased chance of getting blood clots during surgery or bed rest.

Cysts may develop on the ovaries and usually go away without treatment, but sometimes surgery is needed to remove them.

Besides changes in menstrual bleeding patterns, other common side effects reported in women using NEXPLANON include: headaches; vaginitis (inflammation of the vagina); weight gain; acne; breast pain; viral infection such as sore throats or flu-like symptoms; stomach pain; painful periods; mood swings, nervousness, or depressed mood; back pain; nausea; dizziness; pain and pain at the site of insertion. Implants have been reported to be found in a blood vessel, including a blood vessel in the lung.

Call your healthcare professional right away if you have pain in your lower leg that does not go away; severe chest pain or heaviness in the chest; sudden shortness of breath, sharp chest pain, or coughing blood; symptoms of a severe allergic reaction, such as swollen face, tongue or throat, trouble breathing or swallowing; sudden severe headaches unlike your usual headaches; weakness or numbness in your arm, leg, or trouble speaking; sudden partial or complete blindness; yellowing of your skin or whites of your eyes, especially with fever, tiredness, loss of appetite, dark-colored urine, or light-colored bowel movements; severe pain, swelling, or tenderness in the lower stomach (abdomen); lump in your breast; problems sleeping, lack of energy, tiredness, or you feel very sad; heavy menstrual bleeding; or if you feel that the implant may have broken or bent while in your arm.

NEXPLANON does not protect against HIV or other STDs.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Patient Information for NEXPLANON and discuss it with your healthcare professional. The physician Prescribing Information also is available.