Contrave Extended-Release

CONTRAVE EXTENDED-RELEASE- naltrexone hydrochloride and bupropion hydrochloride tablet, extended release
PD-Rx Pharmaceuticals, Inc.

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 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 [see Warnings and Precautions ( 5.1), Use in Specific Populations ( 8.4)] .

1 INDICATIONS AND USAGE

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/m 2 or greater (obese) or
  • 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

CONTRAVE dosing should be escalated according to the following schedule:

Morning Dose Evening Dose
Week 1 1 tabletNone
Week 2 1 tablet1 tablet
Week 3 2 tablets1 tablet
Week 4 – Onward 2 tablets2 tablets

A total daily dosage of two CONTRAVE 8 mg/90 mg tablets twice daily (32 mg/360 mg) is reached at the start of Week 4.

CONTRAVE should be taken by mouth in the morning and in the evening. The tablets should not be cut, chewed, or crushed. Total daily doses greater than 32 mg/360 mg per day (two tablets twice daily) are not recommended. In clinical trials, CONTRAVE was administered with meals. However, CONTRAVE should not be taken with a high-fat meal because of a resulting significant increase in bupropion and naltrexone systemic exposure [see Warnings and Precautions ( 5.3) and Clinical Pharmacology ( 12.3)] .

Patients may develop elevated blood pressure or heart rate during CONTRAVE treatment; the risk may be greater during the initial three months of therapy [see Warnings and Precautions ( 5.6)] . Because patients with hypertension may be at increased risk for developing blood pressure elevations, such patients should be monitored for this potential effect when initiating treatment with CONTRAVE.

Response to therapy should be evaluated after 12 weeks at the maintenance dosage. If a patient has not lost at least 5% of baseline body weight, discontinue CONTRAVE, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

BMI is calculated by dividing weight (in kg) by height (in meters) squared. A BMI chart for determining BMI based on height and weight is provided in Table 1.

Table 1. BMI Conversion Chart

Table 1
(click image for full-size original)

2.2 Dose Adjustment in Patients with Renal Impairment

In patients with moderate or severe renal impairment, the maximum recommended daily dose for CONTRAVE is two tablets (one tablet each morning and evening). CONTRAVE is not recommended for use in patients with end-stage renal disease [see Use in Specific Population ( 8.6) and Clinical Pharmacology ( 12.3)] .

2.3 Dose Adjustment in Patients with Hepatic Impairment

In patients with moderate hepatic impairment, the maximum recommended daily maintenance dose of CONTRAVE is two tablets (one tablet each morning and evening). CONTRAVE is not recommended for use in patients with severe hepatic impairment [see Use in Specific Population ( 8.7) and Clinical Pharmacology ( 12.3)] .

2.4 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant

At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with CONTRAVE. Conversely, at least 14 days should be allowed after stopping CONTRAVE before starting an MAOI antidepressant [see Contraindications ( 4) and Drug Interactions ( 7.1)] .

2.5 Concomitant Use with CYP2B6 Inhibitors

During concomitant use with CYP2B6 inhibitors (e.g., ticlopidine or clopidogrel), the maximum recommended daily dose of CONTRAVE is two tablets (one tablet each morning and evening) [see Drug Interactions ( 7.4) and Clinical Pharmacology ( 12.3)] .

3 DOSAGE FORMS AND STRENGTHS

CONTRAVE extended-release tablets: 8 mg/90 mg are blue, round, bi-convex, film-coated, and debossed with “NB-890” on one side.

4 CONTRAINDICATIONS

CONTRAVE is contraindicated in

  • Uncontrolled hypertension [see Warnings and Precautions ( 5.5)]
  • Seizure disorder or a history of seizures [see Warnings and Precautions ( 5.3)]
  • Use of other bupropion-containing products (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN and ZYBAN)
  • Bulimia or anorexia nervosa, which increase the risk for seizure [see Warnings and Precautions ( 5.3)]
  • Chronic opioid or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal [see Warnings and Precautions ( 5.4) and Drug Interactions ( 7.2)]
  • Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.3) and Drug Interactions ( 7.7)]
  • Concomitant administration of monoamine oxidase inhibitors (MAOI). At least 14 days should elapse between discontinuation of MAOI and initiation of treatment with CONTRAVE. There is an increased risk of hypertensive reactions when CONTRAVE is used concomitantly with MAOIs. Starting CONTRAVE in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated [see Dosage and Administration ( 2.4), Drug Interactions ( 7.1)]
  • Known allergy to bupropion, naltrexone or any other component of CONTRAVE. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported with bupropion [see Warnings and Precautions ( 5.6)]

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