BELVIQ XR Extended Release Extended Release (Page 4 of 8)

6.2 Post-Marketing Experience

The following adverse reactions have been identified during post approval use of lorcaserin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: drug hypersensitivity

7 DRUG INTERACTIONS

7.1 Use with Other Agents that Affect Serotonin Pathways

Based on the mechanism of action of lorcaserin and the theoretical potential for serotonin syndrome, use with extreme caution in combination with other drugs that may affect the serotonergic neurotransmitter systems, including, but not limited to, triptans, monoamine oxidase inhibitors (MAOIs, including linezolid, an antibiotic which is a reversible non-selective MAOI), selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), dextromethorphan, tricyclic antidepressants (TCAs), bupropion, lithium, tramadol, tryptophan, and St. John’s Wort [s ee Warnings and Precautions (5.1)].

7.2 Cytochrome P450 (2D6) substrates

Use caution when administering BELVIQ XR together with drugs that are CYP 2D6 substrates, as BELVIQ XR can increase exposure of these drugs [see Clinical Pharmacology (12.3)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

BELVIQ XR is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm [see Clinical Considerations ] . Limited data on lorcaserin use in pregnant women are not sufficient to determine a drug-associated risk of major congenital malformations or miscarriage. No adverse developmental effects were observed when lorcaserin was administered to pregnant rats and rabbits during organogenesis at exposures up to 44- and 19-times the 20mg/day clinical dose, respectively. In rats, maternal exposure to lorcaserin in late pregnancy resulted in lower body weight in offspring which persisted to adulthood [see Data ] . Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryofetal risk

A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.

Data

Animal Data

Reproduction studies were performed in pregnant rats and rabbits that were administered lorcaserin hydrochloride during the period of embryofetal organogenesis. Plasma exposures up to 44 and 19 times the 20mg clinical dose in pregnant rats and rabbits, respectively, did not reveal evidence of teratogenicity or embryolethality with lorcaserin hydrochloride.

In a pre- and postnatal development study, maternal rats were dosed from gestation through post-natal day 21 at 5, 15, and 50mg/kg lorcaserin hydrochloride; pups were indirectly exposed in utero and throughout lactation. Stillborns and lower pup viability was observed at 50mg/kg, or 44 times the 20mg clinical dose, based on AUC. All other doses lowered pup body weight similarly at birth which persisted to adulthood; however, no developmental abnormalities were observed and reproductive performance was not affected.

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 in a breastfed infant, advise women that use of BELVIQ XR is not recommended while breastfeeding.

8.4 Pediatric Use

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

8.5 Geriatric Use

In lorcaserin clinical trials, a total of 135 (2.5%) of the patients were 65 years of age and older. Clinical studies of lorcaserin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Since elderly patients have a higher incidence of renal impairment, use of BELVIQ XR in the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Elderly patients with normal renal function should require no dose adjustment.

8.6 Renal Impairment

No dose adjustment of BELVIQ XR is required in patients with mild renal impairment. Use BELVIQ XR with caution in patients with moderate renal impairment. Use of BELVIQ XR in patients with severe renal impairment or end stage renal disease is not recommended [s ee Clinical Pharmacology (12.3)].

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 was not evaluated. Use lorcaserin with caution in patients with severe hepatic impairment [s ee Clinical Pharmacology (12.3)].

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Lorcaserin 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 immediate-release lorcaserin hydrochloride (40 and 60 mg) produced up to two- to six-fold increases on measures of “High”, “Good Drug Effects”, “Hallucinations” and “Sedation” compared to placebo. These responses were similar to those produced by oral administration of the positive control drugs, zolpidem (15 and 30 mg) and ketamine (100 mg). In this study, the incidence of the adverse reaction of euphoria following lorcaserin administration (40 and 60 mg; 19%) is similar to the incidence following zolpidem administration (13-16%), but less than the incidence following ketamine administration (50%). The duration of euphoria following lorcaserin administration persisted longer (> 9 hours) than that following zolpidem (1.5 hours) or ketamine (2.5 hours) administration.

Overall, in short-term studies with healthy individuals, the rate of euphoria following oral administration of lorcaserin was 16% following 40 mg (n = 11 of 70) and 19% following 60 mg (n = 6 of 31). However, in clinical studies with obese patients with durations of 4 weeks to 2 years, the incidence of euphoria and hallucinations following oral doses of lorcaserin up to 40 mg was low (< 1.0%).

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 to produce hallucinations, euphoria, and positive subjective responses at supratherapeutic doses suggests that lorcaserin may produce psychic dependence.

10 OVERDOSAGE

No experience with overdose of lorcaserin is available. In clinical studies that used doses that were higher than the recommended dose, the most frequent adverse reactions associated with lorcaserin were headache, nausea, abdominal discomfort, and dizziness. Single 40- and 60-mg doses of immediate-release lorcaserin hydrochloride caused euphoria, altered mood, and hallucination in some subjects. Treatment of overdose should consist of lorcaserin discontinuation and general supportive measures in the management of overdosage. Lorcaserin is not eliminated to a therapeutically significant degree by hemodialysis.

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