Northera Blue Flamingo
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NORTHERA trials, data, and experience

Northera Blue Flamingo
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NORTHERA trials, data, and experience

Real-World Experience

Observational study of patients prescribed NORTHERA followed up to 6 months1

Study design1-3

  • A non-interventional, US-based, prospective cohort study of adult patients aged ≥18 years with a diagnosis of primary autonomic failure (PD, MSA, PAF), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy, who were newly prescribed NORTHERA® (droxidopa) (no treatment in the prior year) for symptomatic nOH
  • Patients were enrolled through a central hub (HUB) by Lash Specialty Pharmacy Network, and continuation of NORTHERA beyond 2 weeks was at the prescriber's discretion
  • Continued participation in the study was not a condition for continuing treatment with NORTHERA

Patient sample/sample characteristics1

  • The 179 patients who completed the baseline surveys had a mean age of 62.8 years
  • The mean total daily maintenance dose for NORTHERA was 1014.5 mg
  • Baseline medication usage in >5% of patients included midodrine, fludrocortisone acetate, levodopa-carbidopa, pyridostigmine, dopamine agonists, pseudoephedrine or ephedrine, monoamine oxidase B inhibitors, carbidopa/levodopa/entacapone; however, information concerning continuation of baseline medications was not collected

Treatment continuation data

 

  • Not all patients who completed the questionnaire at Month 6 also did at baseline, Month 1, and Month 3. Similarly, not all patients who completed the questionnaire at Month 3 did at baseline and Month 13

Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of NORTHERA should be assessed periodically. The RESTORE clinical study to assess the sustained effects of NORTHERA therapy in adult patients with symptomatic nOH is ongoing.2,4

Discontinuations1

  • The most common reasons for discontinuation were adverse events, patient or prescriber choice, treatment with alternative medication, and other/unknown

Limitations1

  • Recruitment and enrollment of patients were conducted by identifying eligible patients via the HUB. Patients who consented and were enrolled in the study may be different from those who did not consent
  • 53 of the 232 patients enrolled in the study were lost to follow-up before completion of the baseline survey, which may have affected the observations of the study
  • Observations relied on patient self-report, which could have resulted in recall bias or misclassification
  • This was an uncontrolled study and no conclusions of statistical or clinical significance can be drawn
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Find out more about adverse reactions reported during clinical trials and other safety considerations.2

 

SEE SAFETY CONSIDERATIONS
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Find out how NORTHERA is metabolized in the body.

SEE PHARMACOLOGY

References:

1. Francois C, Shibao CA, Biaggioni I, et al. Mov Disord Clin Pract. 2019;6(3):235-242. 2. NORTHERA [package insert]. Deerfield, IL: Lundbeck. 3. Data on file. Deerfield, IL: Lundbeck. 4. U.S. National Library of Medicine. Sustained effect of droxidopa in symptomatic neurogenic orthostatic hypotension (RESTORE). Clinical Trials website. https://clinicaltrials.gov/ct2/show/results/NCT02586623. Accessed July 21, 2020.

Please see Important Safety Information, including Boxed Warning for supine hypertension.

For more information, see the full Prescribing Information.

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.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

  • Supine Hypertension: NORTHERA therapy may cause or exacerbate supine hypertension in patients with nOH, which may increase the risk of cardiovascular events if not well managed, particularly stroke.
  • Hyperpyrexia and Confusion: Cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported with NORTHERA use during post-marketing surveillance. 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.
  • Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure: NORTHERA therapy may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure. Careful consideration should be given to this potential risk prior to initiating therapy.
  • Allergic Reactions: Hypersensitivity reactions, including anaphylaxis, angioedema, bronchospasm, urticaria, and rash have been reported in post-marketing experience, with some resulting in emergency treatment. If a hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy.
  • 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.

ADVERSE REACTIONS

  • The most common adverse reactions (>5% and ≥3% difference compared to placebo) were headache, dizziness, nausea, and hypertension.

DRUG INTERACTIONS

  • 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.
  • Dopa-decarboxylase inhibitors may require dose adjustments for NORTHERA.
  • 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.

USE IN SPECIFIC POPULATIONS

  • There are no available data on use of NORTHERA in pregnant women and risk of major birth defects or miscarriage. Because of the potential for serious adverse reactions, including reduced weight gain in breastfed infants, advise a woman not to breastfeed during treatment with NORTHERA.
  • The safety and effectiveness of NORTHERA in pediatric patients have not been established. No overall differences in safety or effectiveness were observed between patients aged 75 years and older and younger patients in clinical trials, but greater sensitivity of some older individuals cannot be ruled out.
  • Clinical experience with NORTHERA in patients with severe renal function impairment (GFR <30 mL/min) is limited; therefore, dosing recommendations cannot be provided for these patients.

For more information, please see the full Prescribing Information, including Boxed Warning for supine hypertension.