HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NORTHERA™ (droxidopa) safely and effectively. See full prescribing information for NORTHERA.
NORTHERA (droxidopa) capsules, for oral use
Initial U.S. Approval: 2014
WARNING: SUPINE HYPERTENSION
See full prescribing information for complete boxed warning.
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 [see Warnings and Precautions (5.1)]
INDICATIONS AND USAGE
NORTHERA 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 caused by primary autonomic failure (Parkinson's disease, 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 demonstrated. The continued effectiveness of NORTHERA should be assessed periodically. (1)
DOSAGE AND ADMINISTRATION
•Starting dose is 100 mg three times during the day (2.1)
•Titrate by 100 mg three times daily, up to a maximum dose of 600 mg three times daily (2.1)
•Take consistently with or without food (2.1)
•To reduce the potential for supine hypertension, elevate the head of the bed and give the last dose at least 3 hours prior to bedtime (2.1)
•Take NORTHERA capsule whole (2.1)
DOSAGE FORMS AND STRENGTHS
•100mg,200mg,300mg capsules (3)
CONTRAINDICATIONS
•None (4)
WARNINGS AND PRECAUTIONS
•NORTHERA can cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed. (5.1)
•Hyperpyrexia and confusion (5.2)
•May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure (5.3)
•Allergic reactions (5.4)
ADVERSE REACTIONS
Headache, dizziness, nausea, hypertension, and fatigue (greater than 5%) (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Chelsea Therapeutics, Inc. 1-855-351-2879 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•Use of DOPA decarboxylase inhibitors may require dose adjustments for NORTHERA (7.2)
USE IN SPECIFIC POPULATIONS
•Nursing Mothers: Choose nursing or NORTHERA (8.3)
•Patients with Renal Impairment: Dosing recommendations cannot be provided for patients with GFR less than 30 mL/min (8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
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FULL PRESCRIBING 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 [see Warnings and Precautions (5.1)]
1. INDICATIONS AND USAGE
NORTHERA 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.
2. DOSAGE AND ADMINISTRATION
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