This product contains FD&C Yellow No. 5 (tartrazine), which may also cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
1. NORTHERA [package insert]. Deerfield, IL: Lundbeck. 2. Data on file. Deerfield, lL: Lundbeck. 3. CFR – Code of Federal Regulations Title 21. U.S. Department of Health & Human Services; U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314&showFR=1&subpartNode=21:126.96.36.199.4.8. Updated September 4, 2018. Accessed July 21 2020. 4. U.S. National Library of Medicine. Clinical Trials website. https://clinicaltrials.gov/ct2/show/results/NCT02586623. Accessed July 21 2020.
Indications and Usage
NORTHERA (droxidopa) is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson’s disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of NORTHERA should be assessed periodically.
Important Safety Information
WARNING: SUPINE HYPERTENSION
Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue NORTHERA.
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
For more information, please see the full Prescribing Information, including Boxed Warning for supine hypertension.