CONTRAVE®

If you’re new to CONTRAVE, it’s important to follow your doctor’s direction and increase your dose slowly over the first month to help you adjust to the medication. Most patients begin with 1 morning pill during the first week and gradually work their way up to 2 pills twice a day by week 4. This dosing schedule was followed by the patients in the CONTRAVE clinical trials who achieved weight-loss success when CONTRAVE was added to their diet and exercise routine.

Your body needs time to become familiar with medications and increasing your dose over time allows you to adjust to the full dosage. In CONTRAVE clinical trials, most side effects occurred during the dose adjustment period and were mild to moderate in severity.

Remember to always take CONTRAVE exactly as prescribed by your doctor. Know that some people, like those with kidney or liver problems, or those taking other medications, may need to follow a different dosing schedule.

CONTRAVE can cause serious side effects, including:

• Suicidal thoughts or actions. One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.

Stop taking CONTRAVE and call a doctor right away if you, or your family member, have any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood
• trouble sleeping (insomnia)

While taking CONTRAVE, you or your family members should:

• pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes
• keep all follow-up visits with your healthcare provider as scheduled. Call your doctor between visits as needed, especially if you have concerns about symptoms

CONTRAVE has not been studied in and is not approved for use in children under the age of 18.

Who should not take CONTRAVE?

Do not take CONTRAVE if you:

• have uncontrolled hypertension
• have or have had seizures
• use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN, and ZYBAN
• have or have had an eating disorder called anorexia (eating very little) or bulimia (eating too much and vomiting to avoid gaining weight)
• are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal
• drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and you stop using them all of a sudden
• are taking medicines called monoamine oxidase inhibitors (MAOIs). Ask your doctor or pharmacist if you are not sure if you take an MAOI, including linezolid. Do not start CONTRAVE until you have stopped taking your MAOI for at least 14 days
• are allergic to naltrexone or bupropion or any of the ingredients in CONTRAVE. See the Medication Guidefor a complete list of ingredients in CONTRAVE

What should I tell my doctor about other medical conditions I may have?

Before taking CONTRAVE, tell your doctor about all of your medical conditions, including if you:

• have or have had depression or other mental illnesses (such as bipolar disorder)
• have attempted suicide in the past
• have or have had seizures
• have had a head injury
• have had a tumor or infection of your brain or spine (central nervous system)
• have had a problem with low blood sugar (hypoglycemia) or low levels of sodium in your blood (hyponatremia)
• have or have had liver problems
• have high blood pressure
• have or have had a heart attack, heart problems, or have had a stroke
• have kidney problems
• are diabetic taking insulin or other medicines to control your blood sugar
• have or have had an eating disorder
• drink a lot of alcohol
• abuse prescription medicines or street drugs
• are over the age of 65
• are pregnant or plan to become pregnant. Losing weight while pregnant may harm your unborn baby. Stop taking CONTRAVE if you become pregnant. Tell your healthcare provider if you become pregnant or you think you may be pregnant during treatment with CONTRAVE
• are breastfeeding or plan to breastfeed. CONTRAVE can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you should take CONTRAVE or breastfeed. You should not do both

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CONTRAVE may affect the way other medicines work and other medicines may affect the way CONTRAVE works, causing side effects. Ask your doctor for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who:

• take higher doses of CONTRAVE
• have certain medical conditions
• take CONTRAVE with certain other medicines

Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them.

If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away. You should not take CONTRAVE again if you have a seizure.

Risk of opioid overdose. One of the ingredients in CONTRAVE (naltrexone) can increase your chance of having an opioid overdose if you take opioid medicines while taking CONTRAVE.

You can accidentally overdose in 2 ways:

• Naltrexone blocks the effects of opioids, such as heroin, or opioid pain medicines. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death.
• After you take naltrexone, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with naltrexone can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
  • after you have gone through detoxification
  • when your next dose of CONTRAVE is due
  • if you miss a dose of CONTRAVE
  • after you stop CONTRAVE treatment

It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

You or someone close to you should get emergency medical help right away if you:

• have trouble breathing
• become very drowsy with slowed breathing
• have slow, shallow breathing (little chest movement with breathing)
• feel faint, very dizzy, confused, or have unusual symptoms
• Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery.

• Severe allergic reactions. Some people have had a severe allergic reaction to bupropion, one of the ingredients in CONTRAVE. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction:

  • rash
  • itching
  • hives
  • fever
  • swollen lymph glands

  • painful sores in your mouth or around your eyes
  • swelling of your lips or tongue
  • chest pain
  • trouble breathing
• Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE.

• Liver damage or hepatitis. One of the ingredients in CONTRAVE, naltrexone can cause liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems:

  • stomach area pain lasting more than a few days
  • dark urine
  • yellowing of the whites of your eyes
  • tiredness

  Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem.

• Manic episodes. One of the ingredients in CONTRAVE, bupropion can cause some people who were manic or depressed in the past to become manic or depressed again.

• Visual problems (angle-closure glaucoma). One of the ingredients in CONTRAVE, bupropion, can cause some people to have visual problems (angle-closure glaucoma). Signs and symptoms of angle-closure glaucoma may include:

  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

Talk with your healthcare provider to find out if you are at risk for angle-closure glaucoma and to get treatment to prevent it if you are at risk.

• Increased risk of low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines to treat their diabetes. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE.

What are the most common side effects when taking CONTRAVE?

The most common side effects of CONTRAVE include:

These are not all the possible side effects of CONTRAVE. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What can I do to manage the common side effects of CONTRAVE?

If you do experience some of the common side effects, there are things you can do to manage them. For instance:

• Nausea: In general, it is recommended you drink plenty of water when taking CONTRAVE. If you experience nausea, you may also want to eat a small amount of dry toast with CONTRAVE. For most people, this symptom went away within the first 4 weeks of taking CONTRAVE. If symptoms do not improve, please consult with your doctor who may also recommend an over-the-counter anti-nausea medication for you.
• Constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea have also occurred and usually can be managed with over-the-counter products your doctor can recommend.

Call your doctor if you do experience any side effects while taking CONTRAVE that bother you or don’t go away.