From the FDA Drug Label
Weight Gain Weight gain has been observed with use of atypical antipsychotics, including VRAYLAR Monitor weight at baseline and frequently thereafter. Table 4. Change in Body Weight (kg) in 6-Week Schizophrenia Trials VRAYLAR* Placebo(N=573)1. 5 - 3 mg/day(N=512)4.5 - 6mg/day(N=570)9 - 12⸰ mg/day(N=203) Mean Change at Endpoint+0.3+0. 8+1+1 Proportion of Patients with Weight Increase (≥7%)5%8%8%17% In long-term, uncontrolled trials with VRAYLAR in schizophrenia, the mean changes from baseline in weight at 12,24, and 48 weeks were 1.2 kg, 1.7 kg, and 2.5 kg, respectively.
Weight gain is a potential side effect of Vraylar (cariprazine). The proportion of patients with weight increase (≥7%) ranged from 1% to 17% in various trials. Mean changes in body weight were also observed, with increases ranging from 0.2 kg to 2.5 kg in different trials and durations of treatment 1.
From the Research
Vraylar (cariprazine) is associated with a low risk of weight gain, with an average increase of approximately 2.4 kg over the treatment period, as shown in a recent study 2. The weight effects of Vraylar appear to be modest, with most patients not experiencing clinically significant weight gain or loss. Some key points to consider:
- The majority of patients (82.8%) did not experience clinically significant weight gain (≥7%) after starting cariprazine 2.
- Average predicted weight changes were +0.8 kg, +1.1 kg, and +1.4 kg at months 3,6, and 12, respectively 2.
- Cariprazine has a favorable weight and metabolic profile compared to other antipsychotic medications 3.
- Regular monitoring of weight and maintaining healthy diet and exercise habits are recommended for patients taking Vraylar.
- If weight gain becomes problematic, the doctor may consider adjusting the dose or switching medications, but it's essential not to stop taking Vraylar without consulting a healthcare provider, as abrupt discontinuation can lead to symptom recurrence. The most recent and highest-quality study 2 provides the best evidence for the weight effects of Vraylar, and its findings should be prioritized in clinical decision-making.