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CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)

The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

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Clinical Trials

Three 56-week studies have shown that patients who took CONTRAVE® lost approximately 2–4x more weight than with diet and exercise alone

COR-I Study

Patients lost 4 times more weight on average when CONTRAVE® was part of their diet and exercise approach

CONTRAVE + diet and exercise produced statistically significant mean weight loss as early as 4 weeks1,2

Peak mean weight loss was observed at 36 weeks and sustained through at least 56 weeks with CONTRAVE + diet and exercise

*In the 56-week, multicenter, double-blind COR-I Trial, obese patients (BMI ≥30 kg/m2), or overweight patients (BMI ≥27 kg/m2) with at least 1 comorbidity (hypertension or dyslipidemia), were randomized to CONTRAVE 32 mg/360 mg per day or placebo. The co-primary endpoints were percent change from baseline body weight and the proportion of patients achieving at least a 5% reduction in body weight at Week 56.

  ITT analysis included all randomized patients who had a baseline body weight measurement and at least one postbaseline body weight measurement during the defined treatment phase. CONTRAVE: N=539; placebo: n=536. Missing data were imputed using last observation carried forward (LOCF). Mean baseline weight: CONTRAVE 220 lb; placebo 219 lb.

Difference from placebo, P<0.001.

4x more weight loss with CONTRAVE + diet and exercise
  • 49% of patients in the CONTRAVE group and 50% of patients in the placebo group withdrew from the COR-I Trial prior to Week 56. The majority of these patients discontinued within the first 12 weeks of treatment1
  • Patients participated in a program consisting of1:
    • Advice to follow a reduced-calorie diet
    • Behavioral counseling
    • Advice to increase physical activity

Significantly more patients achieved reductions in percent body weight with CONTRAVE at Week 561,2

Percent weight loss

P<0.001 vs placebo.

§Based on last observation carried forward (LOCF) in all randomized subjects who had a baseline body weight measurement and at least one postbaseline body weight measurement during the defined treatment phase. All available body weight data during the double-blind treatment phase are included in the analysis, including data collected from subjects who discontinued study drug.

Significantly greater reductions in average waist circumference with CONTRAVE at 56 weeks (secondary endpoint)||1,2

Reduction in waist circumference after CONTRAVE + diet and exercise
  • Significantly greater reductions were also observed with CONTRAVE in the ITT population (CONTRAVE: –2.4 inches; placebo: –1.0 inches)||¶1

||P<0.001 between groups.

Average initial waist circumference was 43 inches for CONTRAVE and 43 inches for placebo.

Based on LOCF.

Review the COR-I abstract

COR-BMOD Study

Patients who took CONTRAVE® for 56 weeks with an intensive behavioral modification (BMOD) program lost an average of 25 pounds

CONTRAVE + BMOD produced statistically significant results as early as 4 weeks1,2

Peak mean weight loss was observed at 36 weeks and sustained through at least 56 weeks with CONTRAVE + BMOD

*In the 56-week, multicenter, double-blind COR-BMOD Trial, 793 obese patients (BMI ≥30 kg/m2), or overweight patients (BMI ≥27 kg/m2) with at least 1 comorbidity (hypertension or dyslipidemia), were randomized to CONTRAVE 32 mg/360 mg per day or placebo. The co-primary endpoints were percent change from baseline body weight and the proportion of patients achieving at least a 5% reduction in body weight at Week 56.

  ITT analysis included all randomized patients who had a baseline body weight measurement and at least one postbaseline body weight measurement during the defined treatment phase. CONTRAVE: n=565; placebo: n=196. Missing data were imputed using last observation carried forward (LOCF). Mean baseline weight: CONTRAVE 221 lb; placebo 224 lb.

Difference from placebo, P<0.001.

Completers lost 25 lb on average with CONTRAVE + BMOD
  • 42% of patients in the CONTRAVE group and 42% of patients in the placebo group withdrew from the COR-BMOD Trial prior to Week 56. The majority of these CONTRAVE patients discontinued within the first 12 weeks of treatment1
  • Patients participated in a BMOD program for 56 weeks consisting of1:
    • Up to 28 group counseling sessions
    • Individualized daily caloric goals
    • Advice to follow prescribed exercise regimen

Significantly more patients achieved reductions in percent body weight with CONTRAVE at Week 561,2

Percent weight loss

P<0.001 vs placebo.

§Based on last observation carried forward (LOCF) in all randomized subjects who had a baseline body weight measurement and at least one postbaseline body weight measurement during the defined treatment phase. All available body weight data during the double-blind treatment phase are included in the analysis, including data collected from subjects who discontinued study drug.

Significantly greater reductions in average waist circumference with CONTRAVE at 56 weeks (secondary endpoint)||1,2

Reduction in waist circumference after CONTRAVE + BMOD
  • Significantly greater reductions were also observed with CONTRAVE in the ITT population (CONTRAVE: –3.9 inches; placebo: –2.7 inches)||¶1

||P<0.001 between groups.

Average initial waist circumference was 43 inches for CONTRAVE and 43 inches for placebo.

Based on LOCF.

Review the COR-BMOD abstract

COR-Diabetes Study

For patients with weight-related comorbidities, CONTRAVE® may offer additional health benefits

CONTRAVE significantly improved A1C in patients with type 2 diabetes

Mean A1C reduction from baseline at 56 weeks

*In the 56-week, multicenter, double-blind COR-Diabetes Trial, 505 overweight or obese patients (BMI ≥27 kg/m2) with type 2 diabetes with or without hypertension and/or dyslipidemia were randomized to CONTRAVE 32 mg/360 mg per day or placebo. COR-Diabetes evaluated patients with type 2 diabetes not achieving glycemic goal of an HbA1c less than 7% either with oral antidiabetic agents or with diet and exercise alone. The co-primary endpoints were percent change from baseline body weight and the proportion of patients achieving at least a 5% reduction in body weight. Based on last observation carried forward while on study drug. Mean baseline A1C: CONTRAVE 8.0%; placebo 8.0%.

P<0.001 vs placebo.

  • Significantly more patients achieved ≥5% weight loss with CONTRAVE (36%) vs placebo (18%) at 56 weeks (P<0.001; ITT-LOCF analysis)1
  • Patients lost significantly more weight with CONTRAVE (3.7%) vs placebo (1.7%) at 56 weeks (P<0.001; ITT-LOCF analysis)1
Review the COR-Diabetes abstract

COR-BMOD and COR-I

CONTRAVE had a positive impact on some cardiometabolic health parameters

Changes in cardiometabolic risk factors were observed (secondary endpoint)1,2

Changes in trigkycerides, HDL-C, LDL-C, systolic and diastolic blood pressure, waist circumference

In the 56-week, multicenter, double-blind COR-BMOD Trial, 793 obese patients (BMI ≥30 kg/m2), or overweight patients (BMI ≥27 kg/m2) with at least 1 comorbidity (hypertension or dyslipidemia), were randomized to CONTRAVE 32 mg/360 mg per day or placebo. COR-BMOD included an intensive behavioral modification program consisting of 28 group counseling sessions over 56 weeks, as well as a prescribed diet and exercise regimen. The co-primary endpoints were percent change from baseline body weight and the proportion of patients achieving at least a 5% reduction in body weight.

§Based on last observation carried forward while on study drug.

||In the 56-week, multicenter, double-blind COR-I Trial, obese patients (BMI ≥30 kg/m2), or overweight patients (BMI ≥27 kg/m2) with at least 1 comorbidity (hypertension or dyslipidemia), were randomized to CONTRAVE 32 mg/360 mg per day or placebo. COR-I included a program consisting of a reduced-calorie diet, behavioral counseling, and increased physical activity. The co-primary endpoints were percent change from baseline body weight and the proportion of patients achieving at least a 5% reduction in body weight.

Patient Profiles

RESULTS FROM REAL PATIENTS

See how real patients did after adding CONTRAVE to their diet and exercise plan.

Important Safety Information for CONTRAVE
(naltrexone HCl and bupropion HCl) extended-release tablets

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Suicidality and Antidepressant Drugs

CONTRAVE® is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients.

Contraindications

CONTRAVE is contraindicated in: uncontrolled hypertension; seizure disorder or a history of seizures; use of other bupropion-containing products; bulimia or anorexia nervosa, which increase the risk for seizure; chronic opioid or opiate agonist (eg, methadone) or partial agonist (eg, buprenorphine) use, or acute opiate withdrawal; patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; use during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs), as there is an increased risk of hypertensive reactions when CONTRAVE is used concomitantly with MAOIs, including reversible MAOIs such as linezolid or intravenous methylene blue; known allergy to any component of CONTRAVE, as anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; and pregnancy.

WARNINGS AND PRECAUTIONS

Suicidal Behavior and Ideation

All patients being treated with antidepressants for any indication should be monitored and observed for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of suicidality, anxiety, agitation, irritability, unusual changes in behavior, and other symptoms, and to report such symptoms immediately to healthcare providers.

Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment

CONTRAVE is not approved for smoking cessation. Serious neuropsychiatric adverse events have been reported in patients taking bupropion for smoking cessation. These postmarketing reports have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.

Some patients who stopped smoking may have been experiencing symptoms of nicotine withdrawal, including depressed mood. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these adverse events occurred in patients taking bupropion who continued to smoke.

Neuropsychiatric adverse events occurred in patients without and with pre-existing psychiatric disease; some patients experienced worsening of their psychiatric illnesses. Observe patients for the occurrence of neuropsychiatric adverse events. Advise patients and caregivers that the patient should stop taking CONTRAVE and contact a healthcare provider immediately if agitation, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of bupropion was reported. However, the symptoms persisted in some cases, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

Depression, suicide, attempted suicide, and suicidal ideation have been reported in the postmarketing experience with naltrexone used in the treatment of opioid dependence. No causal relationship has been demonstrated.

Seizures

The risk of seizure is dose-related. Discontinue treatment and do not restart CONTRAVE in patients who experience a seizure. Use caution when prescribing CONTRAVE to patients with an elevated risk of seizure, including: history of head trauma or prior seizure, severe stroke, arteriovenous malformation, central nervous system tumor or infection, or metabolic disorders (eg, hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia); excessive use of alcohol or sedatives, addiction to cocaine or stimulants, or withdrawal from sedatives; patients with diabetes treated with insulin and/or oral diabetic medications (sulfonylureas and meglitinides) that may cause hypoglycemia; concomitant administration of medications that may lower the seizure threshold, including other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, and systemic steroids.

Clinical experience with bupropion suggests that the risk of seizure may be minimized by adhering to the recommended dosing recommendations, including the avoidance of high-fat meals while taking CONTRAVE.

Patients Receiving Opioid Analgesics

CONTRAVE should not be administered to patients receiving chronic opioids. If chronic opiate therapy is required, CONTRAVE treatment should be stopped. In patients requiring intermittent opiate treatment, CONTRAVE therapy should be temporarily discontinued and lower doses of opioids may be needed. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after CONTRAVE treatment is discontinued.

An opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids, and those patients transitioning from buprenorphine or methadone may need as long as two weeks. Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid use.

Increase in Blood Pressure (BP) and Heart Rate (HR)

CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. These events were observed in both patients with and without evidence of preexisting hypertension. In clinical practice with other bupropion-containing products, hypertension, in some cases severe and requiring acute treatment, has been reported. Blood pressure and pulse should be monitored at regular intervals.

Allergic Reactions

Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock. Instruct patients to discontinue CONTRAVE and consult a healthcare provider if they develop an allergic or anaphylactoid/anaphylactic reaction.

Hepatotoxicity

Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Warn patients of the risk of hepatic injury and advise them to discontinue CONTRAVE if they experience symptoms of acute hepatitis.

Activation of Mania

CONTRAVE treatment can precipitate a manic, mixed, or hypomanic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (eg, family history of bipolar disorder, suicide, or depression). CONTRAVE is not approved for use in treating bipolar depression.

Angle-Closure Glaucoma

The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Hypoglycemia with Use of Antidiabetic Medications

Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (eg, sulfonylureas). Measurement of blood glucose levels prior to starting CONTRAVE and during CONTRAVE treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for antidiabetic medications that are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.

Adverse Reactions

Most common adverse reactions (≥5%) include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).

Drug Interactions

Use caution when prescribing CONTRAVE concomitantly with dopaminergic drugs (levodopa and amantadine), drugs metabolized by CYP2D6, or drugs that lower the seizure threshold. Avoid concomitant use with MAOIs and CYP2B6 inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors. CONTRAVE can cause false positive urine test results for amphetamines.

Indication

CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

  • 30 kg/m2 or greater (obese) or
  • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)

Limitations of Use

The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Please see accompanying Full Prescribing Information for complete Boxed Warning and Medication Guide for CONTRAVE.

References

  1. CONTRAVE (naltrexone HCl and bupropion HCl) Prescribing Information, Orexigen Therapeutics.
  2. Data on file, Orexigen Therapeutics.
  3. Hollander P, Gupta AK, Plodkowski R, et al. Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes. Diabetes Care. 2013;36:4022-4029.

Important Safety Information, including Boxed Warning

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Suicidality and Antidepressant Drugs

CONTRAVE® is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients.

Contraindications

CONTRAVE is contraindicated in: uncontrolled hypertension; seizure disorder or a history of seizures; use of other bupropion-containing products; bulimia or anorexia nervosa, which increase the risk for seizure; chronic opioid or opiate agonist (eg, methadone) or partial agonist (eg, buprenorphine) use, or acute opiate withdrawal; patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; use during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs), as there is an increased risk of hypertensive reactions when CONTRAVE is used concomitantly with MAOIs, including reversible MAOIs such as linezolid or intravenous methylene blue; known allergy to any component of CONTRAVE, as anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; and pregnancy.

WARNINGS AND PRECAUTIONS

Suicidal Behavior and Ideation

All patients being treated with antidepressants for any indication should be monitored and observed for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of suicidality, anxiety, agitation, irritability, unusual changes in behavior, and other symptoms, and to report such symptoms immediately to healthcare providers.

Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment

CONTRAVE is not approved for smoking cessation. Serious neuropsychiatric adverse events have been reported in patients taking bupropion for smoking cessation. These postmarketing reports have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.

Some patients who stopped smoking may have been experiencing symptoms of nicotine withdrawal, including depressed mood. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these adverse events occurred in patients taking bupropion who continued to smoke.

Neuropsychiatric adverse events occurred in patients without and with pre-existing psychiatric disease; some patients experienced worsening of their psychiatric illnesses. Observe patients for the occurrence of neuropsychiatric adverse events. Advise patients and caregivers that the patient should stop taking CONTRAVE and contact a healthcare provider immediately if agitation, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of bupropion was reported. However, the symptoms persisted in some cases, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

Depression, suicide, attempted suicide, and suicidal ideation have been reported in the postmarketing experience with naltrexone used in the treatment of opioid dependence. No causal relationship has been demonstrated.

Seizures

The risk of seizure is dose-related. Discontinue treatment and do not restart CONTRAVE in patients who experience a seizure. Use caution when prescribing CONTRAVE to patients with an elevated risk of seizure, including: history of head trauma or prior seizure, severe stroke, arteriovenous malformation, central nervous system tumor or infection, or metabolic disorders (eg, hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia); excessive use of alcohol or sedatives, addiction to cocaine or stimulants, or withdrawal from sedatives; patients with diabetes treated with insulin and/or oral diabetic medications (sulfonylureas and meglitinides) that may cause hypoglycemia; concomitant administration of medications that may lower the seizure threshold, including other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, and systemic steroids.

Clinical experience with bupropion suggests that the risk of seizure may be minimized by adhering to the recommended dosing recommendations, including the avoidance of high-fat meals while taking CONTRAVE.

Patients Receiving Opioid Analgesics

CONTRAVE should not be administered to patients receiving chronic opioids. If chronic opiate therapy is required, CONTRAVE treatment should be stopped. In patients requiring intermittent opiate treatment, CONTRAVE therapy should be temporarily discontinued and lower doses of opioids may be needed. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after CONTRAVE treatment is discontinued.

An opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids, and those patients transitioning from buprenorphine or methadone may need as long as two weeks. Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid use.

Increase in Blood Pressure (BP) and Heart Rate (HR)

CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. These events were observed in both patients with and without evidence of preexisting hypertension. In clinical practice with other bupropion-containing products, hypertension, in some cases severe and requiring acute treatment, has been reported. Blood pressure and pulse should be monitored at regular intervals.

Allergic Reactions

Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock. Instruct patients to discontinue CONTRAVE and consult a healthcare provider if they develop an allergic or anaphylactoid/anaphylactic reaction.

Hepatotoxicity

Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Warn patients of the risk of hepatic injury and advise them to discontinue CONTRAVE if they experience symptoms of acute hepatitis.

Activation of Mania

CONTRAVE treatment can precipitate a manic, mixed, or hypomanic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (eg, family history of bipolar disorder, suicide, or depression). CONTRAVE is not approved for use in treating bipolar depression.

Angle-Closure Glaucoma

The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Hypoglycemia with Use of Antidiabetic Medications

Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (eg, sulfonylureas). Measurement of blood glucose levels prior to starting CONTRAVE and during CONTRAVE treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for antidiabetic medications that are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.

Adverse Reactions

Most common adverse reactions (≥5%) include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).

Drug Interactions

Use caution when prescribing CONTRAVE concomitantly with dopaminergic drugs (levodopa and amantadine), drugs metabolized by CYP2D6, or drugs that lower the seizure threshold. Avoid concomitant use with MAOIs and CYP2B6 inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors. CONTRAVE can cause false positive urine test results for amphetamines.

Indication

CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

  • 30 kg/m2 or greater (obese) or
  • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)

Limitations of Use

The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Please see accompanying Full Prescribing Information for complete Boxed Warning and Medication Guide for CONTRAVE.