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NORTHERA™ (droxidopa) capsules
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NORTHERA 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
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Starting dose is 100 mg three times during the day (2.1)
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Titrate by 100 mg three times daily, up to a maximum dose of 600 mg three times daily (2.1)
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Take consistently with or without food (2.1)
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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)
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Take NORTHERA capsule whole (2.1)
DOSAGE FORMS AND STRENGTHS
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100 mg, 200 mg, and 300 mg capsules (3)
WARNINGS AND PRECAUTIONS
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NORTHERA can cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed (5.1).
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Hyperpyrexia and confusion (5.2)
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May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure (5.3)
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Allergic reactions (5.4)
ADVERSE REACTIONS
Headache, dizziness, nausea, hypertension, and fatigue (greater than 5%) (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Use of DOPA decarboxylase inhibitors may require dose adjustments for NORTHERA (7.2)
USE IN SPECIFIC POPULATIONS
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Nursing Mothers: Choose nursing or NORTHERA (8.3)
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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: 8/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
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
2.1 Dosing Information
The recommended starting dose of NORTHERA is 100 mg, taken orally three times daily: upon arising in the morning, at midday, and in the late afternoon at least 3 hours prior to bedtime (to reduce the potential for supine hypertension during sleep). Administer NORTHERA consistently, either with food or without food. Take NORTHERA capsule whole. Titrate to symptomatic response, in increments of 100 mg three times daily every 24 to 48 hours up to a maximum dose of 600 mg three times daily (i.e., a maximum total daily dose of 1,800 mg).
Monitor supine blood pressure prior to initiating NORTHERA and after increasing the dose.
Patients who miss a dose of NORTHERA should take their next scheduled dose.
3 DOSAGE FORMS AND STRENGTHS
NORTHERA capsules are available in 100 mg, 200 mg, and 300 mg strengths as specified below.
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100 mg: Hard gelatin capsules with “Northera” on the white body and “100” on the light blue cap
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200 mg: Hard gelatin capsules with “Northera” on the white body and “200” on the light yellow cap
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300 mg: Hard gelatin capsules with “Northera” on the white body and “300” on the light green cap
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Supine Hypertension
NORTHERA therapy may cause or exacerbate supine hypertension in patients with NOH. Patients should be advised to elevate the head of the bed when resting or sleeping. Monitor blood pressure, both in the supine position and in the recommended head-elevated sleeping position. Reduce or discontinue NORTHERA if supine hypertension persists. If supine hypertension is not well-managed, NORTHERA may increase the risk of cardiovascular events.
5.2 Hyperpyrexia and Confusion
Post-marketing cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported with NORTHERA use during post-marketing surveillance in Japan. Observe patients carefully when the dosage of NORTHERA is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.
NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia, muscle rigidity, involuntary movements, altered consciousness, and mental status changes. The early diagnosis of this condition is important for the appropriate management of these patients.
5.3 Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure
NORTHERA may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure. Careful consideration should be given to this potential risk prior to initiating therapy in patients with these conditions.
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