HUMIRA® (adalimumab) Risk Evaluation and Mitigation Strategy (REMS)
A Risk Evaluation and Mitigation Strategy (REMS) is a plan to manage the serious
risks associated with a drug or biologic product. The Food and Drug Administration
requires REMS for certain medications like TNF alpha blockers, including HUMIRA,
to ensure that the benefits of a drug or biologic product outweigh its risks.
Serious side effects, which sometimes lead to death, have happened in patients taking
HUMIRA. The goals of the HUMIRA REMS are:
- Alerting and warning healthcare providers about unrecognized histoplasmosis and
other invasive fungal infections associated with Tumor Necrosis Factor (TNF) blocker
use.
- Educating patients about the serious risks associated with HUMIRA therapy.
Abbott has developed educational materials that are available on this website, including
a Dear Healthcare Provider Letter and Invasive Fungal Infection Awareness Educational
Brochure, which should be reviewed in addition to the Prescribing Information and Medication Guide. Healthcare providers can utilize all
of these materials to counsel patients and caregivers about the risks of HUMIRA.
Patients are urged to read the Medication Guide and discuss any questions with their healthcare
provider.
Should you have any questions or require further information regarding the use of
HUMIRA, please contact Abbott's Medical Information Department at 1-800-633-9110.
Healthcare providers can also contact Abbott’s Medical Information Department via
the web at http://www.abbottmedinfo.com.