Droxidopa

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.

The exact mechanism of action of NORTHERA in the treatment of neurogenic orthostatic hypotension is unknown. NORTHERA is a synthetic amino acid analog that is directly metabolized to norepinephrine by dopa­-decarboxylase, which is extensively distributed throughout the body. NORTHERA is believed to exert its pharmacological effects through norepinephrine and not through the parent molecule or other metabolites. Norepinephrine increases blood pressure by inducing peripheral arterial and venous vasoconstriction. NORTHERA in humans induces small and transient rises in plasma norepinephrine.

Starting dose is 100 mg three times during the day. Titrate by 100 mg three times daily, up to a maximum dose of 600 mg three times daily. Take consistently with or without food. 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. Take NORTHERA capsule whole

NORTHERA is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients. History of hypersensitivity to the drug or its ingredients

Boxed 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. NORTHERA may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed. Hyperpyrexia and confusion. May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure. Allergic reactions

The following adverse reactions with NORTHERA are included in more detail in the Warnings and Precautions section of the label: Supine Hypertension Hyperpyrexia and Confusion May exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure The most common adverse reactions (>5% and ≥3% compared to placebo) are headache, dizziness, nausea, and hypertension

Use of DOPA decarboxylase inhibitors may require dose adjustments for NORTHERA Drugs that Increase Blood Pressure Administering NORTHERA in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected to increase the risk for supine hypertension.

NORTHERA capsules should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).