Adult Dosing
Moderate to severe psoriasis
- 15 mg IM qwk for 12-wk period
Notes:- Monitor the CD4+ T lymphocyte counts of patients before initiating therapy and q2 wks throughout the course of the 12-wk dosing regimen. Withhold dosing and institute weekly monitoring if lymphocyte counts are <250 cells/mcL. Discontinue therapy if the counts remain < 250 cells/mcL for 1 month
- May repeat course 12 wk after the end of last course of therapy if normal CD4 counts are observed
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Therapy induces dose-dependent reductions in circulating CD4+ and CD8+ T lymphocyte counts. Avoid initiating therapy in patients having a CD4+ T lymphocyte count below normal
- Monitor the CD4+ T lymphocyte counts of patients q2 wks throughout the course of the 12-wk dosing regimen. Withheld dosing and institute weekly monitoring if lymphocyte counts are <250 cells/mcL. Discontinue therapy if the counts remain <250 cells/mcL for 1 month
- Avoid administration in patients with a history of systemic malignancy. On occurrence of malignancy, discontinue therapy
- Exhibits potential to increase the risk of infection and reactivate latent, chronic infections. Monitor patients for signs and symptoms of infection during or after a course of therapy. Avoid administering to patients with a clinically important infection. Closely monitor new infections. Discontinue therapy on occurrence of serious infection
- Avoid concomitant use in patients receiving other immunosuppressive agents or phototherapy as possibility of excessive immunosuppression exists. The safety and efficacy of vaccines, specifically live or live-attenuated vaccines, administered to patients being treated with this drug have not been established
- Immediately discontinue therapy and initiate appropriate therapy on occurrence of anaphylactic reaction or other serious allergic reaction
- Liver injury, including asymptomatic transaminase elevation, fatty infiltration of the liver, hepatitis, decompensation of cirrhosis with liver failure, and acute liver failure have been reported during post-marketing surveillance. Fully evaluate patients for signs or symptoms of liver injury. Discontinue therapy if patients develop significant clinical signs of liver injury
Cautions: use cautiously in
- Hepatic impairment
- High risk for malignancy
- Concurrent immunosuppressants
- History of recurrent infection
- Latent or chronic infection
- Alcohol use
Supplemental Patient Information
- Advise patients to promptly inform their physicians should any signs of malignancy develop during the course of therapy
- Advise female patients to notify their clinicians if they become pregnant while undergoing a course of treatment
Pregnancy Category:B
Breastfeeding: Safety unknown; as many drugs are excreted in breast milk and because of the potential for serious adverse reactions in nursing infants from Amevive exists, manufacturer advises to make a decision whether to discontinue nursing while taking the drug or to discontinue therapy, taking into account the importance of the drug to the mother.
