BELVIQ / BELVIQ XR Film-coated tablet / Extended-release tablet (2018)

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Eisai Inc.

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1. Indications and Usage

BELVIQ/BELVIQ XR is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of: 30 kg/m² ...

2. Dosage and Administration

The recommended dose for BELVIQ is one 10 mg tablet administered orally twice daily. The recommended dose for BELVIQ XR is one 20 mg tablet administered orally once daily. Do not exceed recommended dose ...

3. Dosage Forms and Strengths

BELVIQ 10 mg tablets: blue, film-coated, round, biconvex, debossed with A on one side and 10 on the other side. BELVIQ XR 20 mg extended-release tablets: orange, film-coated, round, biconvex, debossed ...

4. Contraindications

Pregnancy: Weight loss in a pregnant woman offers no benefit and may result in fetal harm [see Use in Specific Populations (8.1)]. Hypersensitivity: BELVIQ/BELVIQ XR is contraindicated in patients ...

5. Warnings and Precautions

5.1 Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions BELVIQ/BELVIQ XR is a serotonergic drug. The development of a potentially life-threatening serotonin syndrome or Neuroleptic ...

6. Adverse Reactions

The following important adverse reactions are described below and elsewhere in labeling: Serotonin Syndrome or NMS-like Reactions [see Warnings and Precautions (5.1)] Valvular Heart Disease ...

6.1. Clinical Trials Experience

In the BELVIQ placebo-controlled clinical database of trials of at least one year in duration, of 6888 patients (3451 BELVIQ vs. 3437 placebo; age range 18-66 years, 79.3% women, 66.6% Caucasians, 19.2% ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably ...

7. Drug Interactions

7.1 Use with Other Agents that Affect Serotonin Pathways Based on the mechanism of action of BELVIQ/BELVIQ XR and the theoretical potential for serotonin syndrome, use with extreme caution in combination ...

8.1. Pregnancy

Risk Summary BELVIQ/BELVIQ XR is contraindicated during pregnancy, because weight loss offers no benefit to a pregnant woman and may result in fetal harm [see Clinical Considerations]. Limited ...

8.2. Lactation

Risk Summary There are no data on the presence of lorcaserin in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions ...

8.4. Pediatric Use

The safety and effectiveness of BELVIQ/BELVIQ XR in pediatric patients below the age of 18 have not been established and the use of BELVIQ/BELVIQ XR is not recommended in pediatric patients.

8.5. Geriatric Use

In the BELVIQ clinical trials, a total of 135 (2.5%) of the patients were 65 years of age and older. Clinical studies of BELVIQ did not include sufficient numbers of subjects aged 65 and over to determine ...

8.6. Renal Impairment

No dose adjustment of BELVIQ/BELVIQ XR is required in patients with mild renal impairment. Use BELVIQ/BELVIQ XR with caution in patients with moderate renal impairment. Use of BELVIQ/BELVIQ XR in patients ...

8.7. Hepatic Impairment

Dose adjustment is not required for patients with mild hepatic impairment (Child-Pugh score 5-6) to moderate hepatic impairment (Child-Pugh score 7-9). The effect of severe hepatic impairment on lorcaserin ...

9.1. Controlled Substance

BELVIQ/BELVIQ XR is listed in Schedule IV of the Controlled Substances Act.

9.2. Abuse

In a human abuse potential study in recreational drug abusers, supratherapeutic oral doses of BELVIQ (40 and 60 mg) produced up to two- to six-fold increases on measures of High, Good Drug Effects, Hallucinations ...

9.3. Dependence

There are no data from well-conducted animal or human studies that evaluate whether lorcaserin can induce physical dependence, as evidenced by a withdrawal syndrome. However, the ability of lorcaserin ...

10. Overdosage

No experience with overdose of BELVIQ/BELVIQ XR is available. In clinical studies that used doses that were higher than the recommended dose, the most frequent adverse reactions associated with BELVIQ ...

11. Description

BELVIQ/BELVIQ XR (lorcaserin hydrochloride) is a serotonin 2C receptor agonist for oral administration used for chronic weight management. Lorcaserin hydrochloride is chemically designated as (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine ...

12.1. Mechanism of Action

Lorcaserin is believed to decrease food consumption and promote satiety by selectively activating 5-HT2C receptors on anorexigenic pro-opiomelanocortin neurons located in the hypothalamus. The ...

12.2. Pharmacodynamics

Cardiac Electrophysiology The effect of multiple oral doses of lorcaserin 15 mg and 40 mg once daily on QTc interval was evaluated in a randomized, placebo- and active- (moxifloxacin 400 mg) controlled ...

12.3. Pharmacokinetics

Absorption BELVIQ Lorcaserin is absorbed from the gastrointestinal tract with peak plasma concentration occurring 1.5-2 hours after oral dosing. The absolute bioavailability of lorcaserin has not been ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

Mutagenesis Lorcaserin was not mutagenic in an in vitro bacterial mutation assay (Ames test), was not clastogenic in an in vitro chromosome aberration assay in Chinese hamster ovary cells, ...

14. Clinical Studies

The safety and efficacy of BELVIQ for chronic weight management in conjunction with reduced caloric intake and increased physical activity were evaluated in 3 randomized, double-blind, placebo-controlled ...

16.1. How Supplied

BELVIQ 10-mg tablets are blue-colored, round, biconvex, film-coated tablets debossed with A on one side and 10 on the other side and are available as follows: NDC 62856-529-60 Bottle of 60 BELVIQ XR 20-mg ...

16.2. Storage and Handling

Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients that BELVIQ/BELVIQ XR is indicated for chronic weight management only in conjunction with a reduced-calorie ...