Effexor

Efficacy Profile

Efficacy Profile

Remission rates in depression shown to be significantly superior to placebo (secondary endpoint)1*

Remission rates

Remission rates in depression shown to be significantly superior to placebo (secondary endpoint)

Long-term efficacy demonstrated to help reduce the risk of relapse (6 months) after an initial response in depression2§

Cumulative probability of continued effectiveness

Long-term efficacy demonstrated to help reduce the risk of relapse (6 months) after an initial response in depression

* Double-blind, placebo-controlled, 12-week trial in outpatients randomized to EFFEXOR XR 75-225 mg/day (n=122), fluoxetine 20-60 mg/day (n=119), or placebo (n=118). Primary efficacy variables were the final scores during therapy for the 21-item Hamilton Rating Scale for Depression (HAM-D), the Hamilton Rating Scale for Anxiety (HAM-A) total, and the Clinical Global Impression (CGI) improvement rating scales. Remission was defined as a total score of ≤7 on the first 17 items of the HAM-D at the end of treatment.

§ Cumulative probability of relapse was 28% with EFFEXOR XR vs. 52% for placebo at 26 weeks (p<0.001). Patients who responded to venlafaxine XR during 8 weeks were randomized to receive continuation therapy of their same dose or placebo for 26 weeks. Patients were judged to be ‘‘responders’’ if they had a Clinical Global Impression scale-Severity of Illness item (CGI-S) score ≤3 (‘‘mildly ill’’) and a HAM-D21 score ≤10. Relapse was defined by a combination of the reappearance of major depressive disorder (DSM-IV criteria) and a CGI-S score ≥4 (‘‘moderately ill’’), two consecutive CGI-S scores ≥4, or a final CGI-S score ≥4 for any patient who withdrew from the study for any reason.

References:

  1. Silverstone PH, Ravindran A. Once-daily venlafaxine extended release (XR) compared with fluoxetine in outpatients with depression and anxiety. Venlafaxine XR 360 Study Group. J Clin Psychiatry. 1999;60(1):22-28.
  2. Simon JS, et al. Extended-release venlafaxine in relapse prevention for patients with major depressive disorder. J Psychiatr Res. 2004;38(3):249-257.

Safety Profile

Safety Profile

Most commonly observed adverse events (AEs) (incidence ≥5% and at least twice that of placebo)1

Major Depressive Disorder: Most commonly observed adverse events incidence ≥5% and at least twice that of placebo)

Adapted from Product Monograph1

Reference:

  1. Upjohn Canada ULC. EFFEXOR Product Monograph. Available from:https://www.pfizer.ca/sites/default/files/202005/EFFEXOR-XR_PM_E_237819_2020.05.13.pdf

Dosing

Dosing

Recommended dosing1

  • Recommended dose: 75 mg once daily
  • For some patients, it may be desirable to start at 37.5 mg/day for 4-7 days to allow new patients to adjust to the medication before increasing to 75 mg/day
  • Depending on tolerability and the need for further clinical effect, the dose should be increased by up to 75 mg/day up to a maximum of 225 mg once daily for moderately depressed outpatients
  • Dose increments should be made at intervals of approximately ≥2 weeks, but not <4 days
  • When treating a pregnant woman with EFFEXOR XR during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. 
  • No dose adjustment is recommended for elderly patients solely on the basis of their age. As with any antidepressant or anxiolytic, drug for treatment of social anxiety disorder, or panic disorder, however, caution should be exercised in treating the elderly. When individualizing the dosage, extra care should be taken when increasing the dose. 
  • The total daily dose should be reduced by about 50% in patients with mild to moderate hepatic impairment. For such patients, it may be desirable to start at 37.5 mg/day. Because of individual variability in clearance in these patients, individualization of dosage may be desirable. Since there was much individual variability in clearance between patients with cirrhosis, it may be necessary to reduce the dose by even more than 50%, and individualization of dosing may be desirable in some patients. 
  • In patients with renal impairment (GFR = 10-70 mL/min) compared to normal subjects, the total daily dose should be decreased by 25%-50%. In patients undergoing hemodialysis, the total daily dose must be reduced by 50% and the dose be withheld until the dialysis treatment is completed (4 hrs). For such patients, it may be desirable to start at 37.5 mg/day. Since there is so much individual variability in clearance among patients with renal impairment, individualization of dosing may be desirable. 

Available doses

Effexor, Venlafaxine, HCI, 37.5, grey cap and peach body capsule

Effexor, Venlafaxine, HCI, 75, peach cap and body capsule

Effexor, Venlafaxine, HCI, 150, dark orange cap and body capsule

Please refer to the Product Monograph for complete dosing instructions.

Reference:

  1. Upjohn Canada ULC. EFFEXOR Product Monograph. Available from:https://www.pfizer.ca/sites/default/files/202005/EFFEXOR-XR_PM_E_237819_2020.05.13.pdf