What patient education is recommended for Contrave (bupropion and naltrexone)?

From the Guidelines

Patients taking Contrave should be educated on its proper use, potential side effects, and importance of lifestyle modification to achieve optimal weight loss results, as evidenced by a 56-week multicenter, randomized, double-blind, placebo-controlled trial 1. When taking Contrave, patients should start with a low dose and gradually increase to the target dose of two tablets twice daily by week four, as this dosing regimen has been shown to be effective in achieving significant weight loss 1. Key points to emphasize in patient education include:

• Taking Contrave with food to minimize gastrointestinal side effects
• Swallowing tablets whole without cutting, crushing, or chewing them
• Common side effects such as nausea, constipation, headache, and dizziness
• Importance of a reduced-calorie diet and increased physical activity to achieve best results
• Potential interactions with other medications, including monoamine oxidase inhibitors and opioids
• Avoiding alcohol consumption due to increased risk of seizures and potential effects on naltrexone's mechanism of action
• Regular follow-up appointments to monitor progress and potential side effects, particularly in patients with a history of depression or other conditions that may be affected by bupropion 1. Ideal candidates for Contrave may include patients with concomitant depression, those trying to quit smoking or reduce alcohol intake, or individuals who experience cravings for food and/or addictive behaviors related to food 1.

From the FDA Drug Label

Instruct patients, their families, and/or their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Instruct patients to discontinue bupropion hydrochloride extended-release tablets (XL) and contact a healthcare professional if they experience such symptoms Educate patients on the symptoms of hypersensitivity and to discontinue bupropion hydrochloride extended-release tablets (XL) if they have a severe allergic reaction. Instruct patients to discontinue and not restart bupropion hydrochloride extended-release tablets (XL) if they experience a seizure while on treatment Advise patients that the excessive use or the abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid the use of alcohol Patients should be advised that taking bupropion hydrochloride extended-release tablets (XL) can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Educate patients that bupropion hydrochloride extended-release tablets (XL) contains the same active ingredient (bupropion) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that bupropion hydrochloride extended-release tablets (XL) should not be used in combination with ZYBAN or any other medications that contain bupropion hydrochloride Advise patients that any CNS-active drug like bupropion hydrochloride extended-release tablets (XL) may impair their ability to perform tasks requiring judgment or motor and cognitive skills Advise patients that until they are reasonably certain that bupropion hydrochloride extended-release tablets (XL) do not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. Bupropion hydrochloride extended-release tablets (XL) treatment may lead to decreased alcohol tolerance Counsel patients to notify their healthcare provider if they are taking or plan to take any prescription or over-the-counter drugs, because bupropion hydrochloride extended-release tablets (XL) and other drugs may affect each other’s metabolism Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with bupropion hydrochloride extended-release tablets (XL) Instruct patients to swallow bupropion hydrochloride extended-release tablets (XL) whole so that the release rate is not altered. Instruct patients if they miss a dose, not to take an extra tablet to make up for the missed dose and to take the next tablet at the regular time because of the dose-related risk of seizure Instruct patients that bupropion hydrochloride extended-release tablets (XL) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride extended-release tablets (XL) should be administered in the morning and may be taken with or without food.

The patient education for Contrave (which is a combination of bupropion and naltrexone) is not explicitly mentioned in the provided label, however the label is for bupropion. Key points for patient education on bupropion include:

• Monitoring for suicidal thoughts and behaviors
• Reporting any changes in mood or behavior
• Avoiding alcohol and other CNS-active drugs
• Notifying their healthcare provider if they become pregnant or intend to become pregnant
• Swallowing the tablets whole and not crushing, dividing, or chewing them
• Taking the tablets in the morning with or without food
• Not taking an extra tablet if a dose is missed 2

From the Research

Patient Education on Contrave

• Contrave is a combination of naltrexone and bupropion, approved for weight loss in adults with a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher with at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol 3, 4, 5.
• The medication works by increasing feelings of fullness and reducing hunger, as well as improving mood and reducing cravings for food 5, 6.
• Clinical trials have shown that Contrave can lead to significant weight loss, with an average weight loss of 4.25% over 56 weeks, compared to placebo 4.
• Common side effects of Contrave include nausea, constipation, headache, and vomiting, but serious adverse effects are rare 3, 4, 6.
• Patient education on Contrave should include information on the proper use of the medication, potential side effects, and the importance of combining the medication with a healthy diet and regular exercise 7.
• Healthcare providers should also educate patients on the potential benefits of Contrave, including improved weight-related health outcomes, such as reduced blood pressure, improved blood sugar control, and increased high-density lipoprotein (HDL) cholesterol 3, 6.

Important Considerations

• Patients should be informed that Contrave is not a substitute for a healthy lifestyle, but rather a tool to help support weight loss efforts 3, 4.
• Patients should also be aware of the potential risks and side effects associated with Contrave, and should report any concerns or adverse effects to their healthcare provider 3, 4, 6.
• Healthcare providers should carefully select patients for treatment with Contrave, taking into account individual factors such as medical history, current medications, and potential contraindications 7.