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Contrave

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Uses

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.
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History

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Other Information

CONTRAVE extended-release tablets contain naltrexone hydrochloride and bupropion hydrochloride.

Naltrexone hydrochloride, USP, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone.

Naltrexone hydrochloride has the chemical name of morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, hydrochloride, (5α)-. The empirical formula is C20H23NO4•HCl and the molecular weight is 377.86. The structural formula is:

Bupropion Chemical Formula.png

Naltrexone hydrochloride is a white to yellowish, crystalline compound. It is soluble in water to the extent of about 100 mg/mL.

Bupropion hydrochloride is an antidepressant of the aminoketone class. Bupropion hydrochloride closely resembles the structure of diethylpropion. It is designated as (±)-1-(3 chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propranone hydrochloride. It is related to phenylethylamines. The empirical formula is C13H18ClNO•HCl and the molecular weight is 276.2. The structural formula is:

Naltrexone Chemical Formula

Bupropion hydrochloride powder is white, crystalline, and highly soluble in water.

CONTRAVE is available for oral administration as a round, bi-convex, film-coated, extended-release tablet. Each tablet has a trilayer core composed of two drug layers, containing the drug and excipients, separated by a more rapidly dissolving inert layer. Each tablet contains 8 mg of naltrexone hydrochloride and 90 mg of bupropion hydrochloride. Tablets are blue and are debossed with NB-890 on one side. Each tablet contains the following 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.

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Contrave Manufacturers

  • Takeda Pharmaceuticals America, Inc.
    Contrave | Takeda Pharmaceuticals America, Inc.
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    Contrave | Takeda Pharmaceuticals America, Inc.

    Contrave | Takeda Pharmaceuticals America, Inc.
    2.1 Recommended Dosing

    CONTRAVE dosing should be escalated according to the following schedule:

    Morning Dose

    Evening Dose

    Week 1

    1 tablet

    None

    Week 2

    1 tablet

    1 tablet

    Week 3

    2 tablets

    1 tablet

    Week 4 – Onward

    2 tablets

    2 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

    Weight

    (lb)

    125

    130

    135

    140

    145

    150

    155

    160

    165

    170

    175

    180

    185

    190

    195

    200

    205

    210

    215

    220

    225

    (kg)

    56.8

    59.1

    61.4

    63.6

    65.9

    68.2

    70.5

    72.7

    75.0

    77.3

    79.5

    81.8

    84.1

    86.4

    88.6

    90.9

    93.2

    95.5

    97.7

    100. 0

    102. 3

    Height

    (in)

    (cm)

    58

    147.3

    26

    27

    28

    29

    30

    31

    32

    34

    35

    36

    37

    38

    39

    40

    41

    42

    43

    44

    45

    46

    47

    59

    149.9

    25

    26

    27

    28

    29

    30

    31

    32

    33

    34

    35

    36

    37

    38

    39

    40

    41

    43

    44

    45

    46

    60

    152.4

    24

    25

    26

    27

    28

    29

    30

    31

    32

    33

    34

    35

    36

    37

    38

    39

    40

    41

    42

    43

    44

    61

    154.9

    24

    25

    26

    27

    27

    28

    29

    30

    31

    32

    33

    34

    35

    36

    37

    38

    39

    40

    41

    42

    43

    62

    157.5

    23

    24

    25

    26

    27

    27

    28

    29

    30

    31

    32

    33

    34

    35

    36

    37

    38

    38

    39

    40

    41

    63

    160.0

    22

    23

    24

    25

    26

    27

    28

    28

    29

    30

    31

    32

    33

    34

    35

    36

    36

    37

    38

    39

    40

    64

    162.6

    22

    22

    23

    24

    25

    26

    27

    28

    28

    29

    30

    31

    32

    33

    34

    34

    35

    36

    37

    38

    39

    65

    165.1

    21

    22

    23

    23

    24

    25

    26

    27

    28

    28

    29

    30

    31

    32

    33

    33

    34

    35

    36

    37

    38

    66

    167.6

    20

    21

    22

    23

    23

    24

    25

    26

    27

    27

    28

    29

    30

    31

    32

    32

    33

    34

    35

    36

    36

    67

    170.2

    20

    20

    21

    22

    23

    24

    24

    25

    26

    27

    27

    28

    29

    30

    31

    31

    32

    33

    34

    35

    35

    68

    172.7

    19

    20

    21

    21

    22

    23

    24

    24

    25

    26

    27

    27

    28

    29

    30

    30

    31

    32

    33

    34

    34

    69

    175.3

    18

    19

    20

    21

    21

    22

    23

    24

    24

    25

    26

    27

    27

    28

    29

    30

    30

    31

    32

    33

    33

    70

    177.8

    18

    19

    19

    20

    21

    22

    22

    23

    24

    24

    25

    26

    27

    27

    28

    29

    29

    30

    31

    32

    32

    71

    180.3

    17

    18

    19

    20

    20

    21

    22

    22

    23

    24

    24

    25

    26

    27

    27

    28

    29

    29

    30

    31

    31

    72

    182.9

    17

    18

    18

    19

    20

    20

    21

    22

    22

    23

    24

    24

    25

    26

    27

    27

    28

    29

    29

    30

    31

    73

    185.4

    17

    17

    18

    19

    19

    20

    20

    21

    22

    22

    23

    24

    24

    25

    26

    26

    27

    28

    28

    29

    30

    74

    188.0

    16

    17

    17

    18

    19

    19

    20

    21

    21

    22

    23

    23

    24

    24

    25

    26

    26

    27

    28

    28

    29

    75

    190.5

    16

    16

    17

    18

    18

    19

    19

    20

    21

    21

    22

    23

    23

    24

    24

    25

    26

    26

    27

    28

    28

    76

    193.0

    15

    16

    16

    17

    18

    18

    19

    20

    20

    21

    21

    22

    23

    23

    24

    24

    25

    26

    26

    27

    27

    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. There is a lack of adequate information to guide dosing in patients with mild renal impairment [see Use in Specific Population (8.6) and Clinical Pharmacology (12.3)].

    2.3 Dose Adjustment in Patients with Hepatic Impairment

    In patients with hepatic impairment, the maximum recommended daily dose of CONTRAVE is one tablet in the morning [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)].

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