CONTRAVE - med newly approved by FDA Sept 2014

[utahgirll 81]

Contrave

Generic Name: bupropion hydrochloride and naltrexone hydrochloride

Date of Approval: September 10, 2014

Company: Orexigen Therapeutics

Treatment for: Obesity

FDA Approves Contrave

New weight loss option targets both the physiological and behavioral factors associated with obesity.

The U.S. food and Drug Administration has approved Contrave for chronic weight management in addition to a reduced-calorie diet and physical activity. Contrave is a combination of two FDA-approved drugs in an extended-release formulation:

• naltrexone (ReVia, Vivitrol) used to treat alcohol and opioid dependence
• bupropion (Wellbutrin, Zyban) used to treat depression and seasonal affective disorder, and as an aid to smoking cessation treatment.

Contrave is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.

Medication Guide

Read this Medication Guide before you start taking this medicine and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical problems or treatment.

Important information

Contrave can cause serious side effects, including:

• Suicidal thoughts or actions. One of the ingredients 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 this medicine and call a healthcare provider 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
  • new or worse irritability
  • attempts to commit suicide
  • acting aggressive, being angry, or violent
  • new or worse depression
  • acting on dangerous impulses
  • new or worse anxiety
  • an extreme increase in activity and talking (mania)
  • feeling very agitated or restless
  • panic attacks
  • other unusual changes in behavior or mood
  • trouble sleeping (insomnia)

  During treatment, 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 treatment or when your dose changes.
  • Keep all follow-up visits with your health care provider as scheduled. Call your healthcare provider 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.

What is Contrave?

Contrave is a prescription medicine which contains two medicines (naltrexone and bupropion) that may help some obese or over weight adults, who also have weight related medical problems, lose weight and keep the weight off.

• It should be used with a reduced calorie diet and increased physical activity.
• It is not known if it changes your risk of heart problems or stroke or of death due to heart problems or stroke.
• It is not known if it is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.
• It is not known if it is safe and effective in children under 18 years of age.
• It is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation). One of the ingredients, bupropion, is the same ingredient in some other medicines used to treat depression and to help people quit smoking.

Who should not take Contrave?

Do not take this medicine 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 such as methadone or buprenorphine, 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 healthcare provider or pharmacist if you are not sure if you take an MAOI, including linezolid. Do not start treatment until you have stopped taking your MAOI for at least 14 days.
• are allergic to naltrexone or bupropion or any of the other ingredients. See theend of this Medication Guide for a complete list of ingredients.
• are pregnant or planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking Contrave.

Before taking Contrave

Before starting this medicine, tell your healthcare provider 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
• have any other medical conditions
• are breastfeeding or plan to breastfeed. This medicine can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you should continue treatment 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. This medicine may affect the way other medicines work and vice versa, and can cause side effects.

Ask your healthcare provider for a list of these medicines if you are not sure.

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

How should I take Contrave?

How to take Contrave

Morning Dose Evening Dose Starting: Week 1 1 tablet None Week 2 1 tablet 1 tablet Week 3 2 tablets 1 tablet Week 4 Onward 2 tablets 2 tablets

• Take the tablets exactly as your healthcare provider tells you to.
• Do not change your dose without talking with your healthcare provider.
• Your healthcare provider will change your dose if needed.
• Your healthcare provider should tell you to stop taking the tablets if you have not lost a certain amount of weight after 16 weeks of treatment.
• Swallow the tablets whole. Do not cut, chew, or crush. Tell your healthcare provider if you cannot swallow the tablets whole.
• Do not take more than 2 tablets in the morning and 2 tablets in the evening.
• Do not take more than 2 tablets at the same time or more than 4 tablets in 1 day.
• Do not take the tablets with high-fat meals. It may increase your risk of seizures.
• If you miss a dose, wait until your next regular time to take it. Do not take more than one dose at a time.
• If you overdose, call your healthcare provider or go to the nearest emergency room right away.

What should I avoid?

• Do not drink a lot of alcohol during treatment.
• If you drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having a seizure.

Contrave side effects

Serious side effects include:

• See Important information
• Seizures. There is a risk of having a seizure when you take this medicine. The risk of seizure is higher in people who:
  • take higher doses
  • have certain medical conditions
  • take this medicine with certain other medicines

  Do not take any other medicines during treatment unless your healthcare provider has said it is okay to take them.

  If you have a seizure, 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 (naltrexone) can increase your chance of having an opioid overdose if you take opioid medicines. You can accidentally overdose in 2 ways:
  • Naltrexone blocks the effects of opioids, such as heroin, methadone 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
    • after you stop 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 (including tramadol), cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 10 days before starting Contrave. Using opioids in the 7 to 10 days before you start 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 about all the medications you are taking before a medical procedure or surgery.
• Severe allergic reactions. Some people have had a severe allergic reaction to bupropion, one of the active ingredients. Stop taking this medicine 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
  • painful sores in your mouth or around your eyes
  • itching
  • hives
  • swelling of your lips or tongue
  • fever
  • chest pain
  • swollen lymph glands
  • trouble breathing
• Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking this medicine. 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, naltrexone can cause liver damage or hepatitis. Stop taking this medicine 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 treatment if you get signs or symptoms of a serious liver problem.
• Manic episodes. One of the ingredients, 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, 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 this medicine and during treatment.

The most common side effects include:

• nausea
• dizziness
• constipation
• trouble sleeping
• headache
• dry mouth
• vomiting
• diarrhea

Tell your healthcare provider about any side effect that bothers you or does not go away.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.

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

Storage

Store tablets at room temperature between 59°F to 86°F (15°C to 30°C).

Keep all medicines out of the reach of children.

General information

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms or condition that you have. It may harm them.

If you take a urine drug screening test, Contrave may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking Contrave, they can do a more specific drug screening test that should not have this problem.

This Medication Guide summarizes the most important information. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

Ingredients

Active ingredients: naltrexone hydrochloride and bupropion hydrochloride

Inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, lactose anhydrous, L-cysteine hydrochloride, crospovidone, magnesium stearate, hypromellose, edetate disodium, lactose monohydrate, colloidal silicon dioxide, Opadry II Blue and FD&C Blue #2 aluminum lake

[B-52 7,113]

It can work, similar drugs have worked for people with obessive-compulsive, anxiety addictions such as smoking, gambling, and yes eating.

Personally, I will never know, I, (and just about everybody else on this site) has already had surgery to relieve us from over eating.

Don't see why we would need both.

[WL WARRIOR 692]

I already take these two medications seperately and have for the past year. I don't understand how they do that much for appetite control. I still needed surgery. Maybe my dose is just low.

[utahgirll 81]

(and just about everybody else on this site) has already had surgery to relieve us from over eating.

Don't see why we would need both.

Hi there B52,

MANY people come to this website to look at the POSSIBILITY of surgery, to research questions and to look at complications as well as the positive results of wl surgery. This website is here to answer those questions, assist us in making decisions, help us bond with each other, and for me, after researching here and seeing here, the complications from the surgical methods of weight loss, this website also suggests other possibilities besides surgery. Haven't you seen many that are here on this website for information and questions about surgery, PRIOR to their surgery? I see many. I am one of them.

With your completed surgery, you don't need BOTH surgery and other alternatives, but many people here, after reading complications, problems and issues others are having with their surgeries might want to consider alternative, less invasive bariatric methods of losing their weight. All the methods I have listed and others have listed, including medications, ARE A PART of and under the BARIATRIC HEADING of methods our bariatric doctors use for those wanting to consider weight loss. Some of these methods are experimental in the USA, and some of them are not, but personally, I think it important for everyone to look at what is out there as alternatives, before actually making that permanent surgical step of a major surgery.

Not many places on the internet provide you a comprehensive place to look not only at the different bariatric surgeries available, but also the medications and other, less invasive methods of bariatric weight loss.

One of the admired bariatric doctors said it himself quite succinctly, that in time, these surgical methods will be considered very primitive and the newer non-invasive medical procedures will be used instead.

[utahgirll 81]

I already take these two medications seperately and have for the past year. I don't understand how they do that much for appetite control. I still needed surgery. Maybe my dose is just low.

Hi there,

Please make it clear which meds you are taking for the past year? This medication (CONTRAVE) has only been approved for usage for weight loss by the FDA since September 2014 (at this time, only available 2 months).

Please post under the heading of the medications you are taking, so as not to confuse others that are coming here for research purposes. What are you taking and what strength? If you are, in fact, taking buproprien and naltrexone, separately, which ARE the two that make up this new medication, do let us know the strength, dosage and any side effects that you have had. Very interested to hear about your experience with these two drugs taken together.

Thanks in advance,

Tristan

[WL WARRIOR 692]

I take a buprenorphine/naltroxone (16 mg) mix, also known as Suboxone, and bupropion (200 mg). Naltrexone is very similar to Suboxone and some doctors consider Naltrexone to be a generic form of Suboxone. I had to switch to Naltrexone for a brief time because it was cheaper and my insurance company wouldn't pay for Suboxone since it is terribly expensive. Anyway, I've been on both and never felt much of a difference between the two.

There are a few problems that I have with Bupropion and Naltrexone. Bupropion seems to lose its effectiveness after a long period of time. I took it from 2000-2003 and switched to a SSRI because it just stopped working after a few years (even at a high dose). I have heard many others complain of the same thing. I just started taking it again last Nov. and noticed that it helped my mood improve. The problem with Naltrexone is that it is so addicting after you have been on it for a length of time.

I read the Contrave clinical trials because I was curious how much weight people lost on it. I wasn't surprised by what I read. Most people notice that their mood improves and the average amount of weight loss was 5-15 pounds. It does seem to be a safer option than other prescription weight loss drugs.

[utahgirll 81]

Warrior,

Thank you so much for sharing! I really appreciate your experience and hearing how it went for you.

Triss

[WL WARRIOR 692]

I have to chime in again about this drug. I talked to someone today that is actually taking this drug and we had a disagreement about whether this drug was addictive. It ends up that Naltrexone (one of the ingredients in Contrave) is NOT addictive according to the drug's insert pamphlet and released info. from the FDA. I think I was being a little judgmental and should have remembered that we are all different when it comes to how our body reacts to weight loss medication. Many people may benefit from this medication and a doctor is a better source to determine if it is right for you.

[avriddle 4]

I tried Contrave just as it first came out. The Wellbutrin portion of Contrave improved my mood, and the Naltrexone portion of Contrave helped relieve general aches & pains. Contrave also completely relieved any of my food cravings and appetite, however, I could not stay on it long because I am one of the rare individuals who ended up with a Parkinsonian-like response from the drug. I was odd, expressionless, and felt like I could not move or function; like moving through quicksand. I also got a very bad Migraine after the fourth day on the lowest dose, so had to quit after the first week. I have tried all the new and old obesity medications, but the side effects are bad for me every time, not to mention the cost on some of the newer ones like Belviq. Thank you to the help of BariatricPal, I had the mini gastric bypass one week ago with Dr. Zavalza in Mexico. Best decision I've ever made, and cheaper in the long run than taking the medications for even just 1 1/2 years.

[peteyrulz 82]

Because I may never ever never ever ever get approved for this surgery, today my PCP suggested I try this. She is a fantastic doc IMHO & she carefully explained its ins, outs, & warning signs of problems. I'm starting it in a few days after I decrease my current ADs. I started this journey almost a year ago, and for the first time in a loonngg time I'm starting to see light! My insurance won't cover it [sURPRISE!!] but she signed me up for the rx program.

Sooo, I'll let you know how it turns out. If Contrave doesn't work for me, she says she'll see me post-op should I go to Mexico. Yay!

[Mel24 51]

I started it last Wednesday, it took a month of back and forth with insurance to cover it. But they are! I am in pre surgery phase as well, but my dr said this will be good while I am waiting. So far, I am not eating as mindlessly as I was before. Whether that is a placebo effect or not, Who knows. My dr said the part that starts with the N works right away, versus the B takes about a month to build up in your system. I do have slight nausea on it.

[Tonileigh 17]

I have been taking Contrave for 5 weeks. I am not able to take the full dosage due to nausea. It definitely helped with my appetite at first but I have pretty much stopped taking it due to feeling sick on it.

[theother_onefoot 122]

I took Contrave for a full month, getting all the way past titration up to the full dose. Shortly after starting my second bottle and second month, I had to discontinue the medicine.

It's possible I could have had such a strong reaction to it at the time due to strong school- and work-related stressors, but one day when I took my dose in the morning I just started having what I can only imagine as a manic episode! I was shaky and I couldn't focus and all of the things I was stressing about seemed amplified and I just couldn't stop crying from the intense feelings of stress almost to the point of hyperventilating. I also told my doctor that during this episode I felt very "in my head", which is kind of hard to describe, but just think of it like your inner-thoughts-voice in your head having a rambling monologue. The only way I was able to calm myself down was taking a Clonazepam (anti-anxiety medicine) so that I could function.

I waited until two days after that to try the Contrave dose again and had similar manic effects. It was terrible. I called my doctor's office and let them know and they told me to stop taking it completely immediately. The problem with that however, as with various drugs, when you stop cold turkey it can make you feel..."off". Not bad, or not necessarily in a specific way, but just generally unwell in mind and body. It might have been two weeks before I felt almost 100% again.

The doctors assume the components of the Contrave just didn't do well for me based on a history of anxiety, depression, or slight bi-polar disorder. I don't know what I'm technically diagnosed as having or if I'm just predispositioned to certain things, but regardless, Contrave just didn't do well with me even though the first month had been fine with decreased cravings and no nausea. ):

If it works for you, congratulations! But if it doesn't, you'll know. Always let your doctor know how a medication makes you feel.

[Mrs.Jackson76 1]

Belviq

[livvsmum 2,369]

I take this mainly because I need the Wellbutrin part of it, but am terrified of taking a depression/anxiety medication on its own because of potential weigh gain side effects. My doctor thought this would be a good fit because I would still get the wellbutrin benefit without having to worry about weight gain. So far so good and I was able to lose the last 10 pounds I wanted to get off.