The Food and Drug Administration (FDA) has approved updated labeling for Northera (droxidopa capsules; Lundbeck) to include new information regarding hypersensitivity reactions and potential drug interactions.
Northera, a norepinephrine prodrug, is indicated to treat 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. The approved sNDA contains revisions to the Contraindications, Warnings and Precautions, Drug Interactions, and Specific Populations sections.
A new Contraindication has been added to state the following: “Northera is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients.”
Under Warnings and Precautions, the following text was added: “Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria and rash have been reported in postmarketing experience. Some of these reactions resulted in emergency treatment. If a hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy.”
Under Drug Interactions, a new section on non-selective MAO inhibitors was added: “The concomitant use of selective MAO-B inhibitors, such as rasagiline or selegiline, was permitted in the Northera clinical trials. However, based on mechanism of action, the use of non-selective MAO inhibitors and linezolid should be avoided as there is a potential for increased blood pressure when taken with Northera.”
Northera is available as 100mg, 200mg, and 300mg strength capsules in 90-count bottles.
For more information call (866) 337-6996 or visit Northera.com.