pharmacopeia
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Boxed warning

SUPINE HYPERTENSION 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 droxidopa [see Warnings and Precautions (5.1) ].

Mechanism of action

Sourced from openFDA

The exact mechanism of action of droxidopa in the treatment of neurogenic orthostatic hypotension is unknown. Droxidopa is a synthetic amino acid analog that is directly metabolized to norepinephrine by dopa-decarboxylase, which is extensively distributed throughout the body.

Indications

Sourced from openFDA
  • Droxidopa capsules 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.ICD-10: G20

Contraindications

Sourced from openFDA
  • Droxidopa is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [see Warnings and Precautions (5.4) ].contraindicated

Dosage & administration

Sourced from openFDA

• 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 droxidopa capsule whole (2.1) 2.1 Dosing Information The recommended starting dose of droxidopa capsules 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 droxidopa capsules consistently, either with food or without food. Take droxidopa 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 droxidopa capsules and after increasing the dose. Patients who miss a dose of droxidopa capsules should take their next scheduled dose.

Warnings & precautions

Sourced from openFDA

• Droxidopa may 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) 5.1 Supine Hypertension Droxidopa 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 droxidopa if supine hypertension persists. If supine hypertension is not well-managed, droxidopa may increase the risk of cardiovascular events, particularly stroke. 5.2 Hyperpyrexia and Confusion Postmarketing cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported with droxidopa use during postmarketing surveillance. Observe patients carefully when the dosage of droxidopa 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.

Adverse reactions

Sourced from openFDA

The following adverse reactions with droxidopa are included in more detail in the Warnings and Precautions section of the label: • Supine Hypertension [see Warnings and Precautions (5.1) ] • Hyperpyrexia and Confusion [see Warnings and Precautions (5.2) ] • May exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure [see Warnings and Precautions (5.3) ] The most common adverse reactions (>5% and ≥3% compared to placebo) are headache, dizziness, nausea, and hypertension (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LCC at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety evaluation of droxidopa is based on two placebo-controlled studies 1 to 2 weeks in duration (Studies 301 and 302), one 8-week placebo-controlled study (Study 306), and two long-term, open-label extension studies (Studies 303 and 304). In the placebo-controlled studies, a total of 485 patients with Parkinson's disease, multiple system atrophy, pure autonomic failure, dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy were randomized and treated, 245 with droxidopa and 240 with placebo [see Clinical Studies (14) ] .

Use in specific populations

Sourced from openFDA

• Lactation: Breastfeeding not recommended (8.2) • Patients with Renal Impairment: Dosing recommendations cannot be provided for patients with GFR less than 30 mL/min (8.6) 8.1 Pregnancy Risk Summary There are no available data on use of droxidopa in pregnant women and risk of major birth defects or miscarriage. Droxidopa did not produce significant reproductive toxicity in pregnant female rats or rabbits or in their fetuses. However, when pregnant female rats were dosed during days 7-17 of gestation (the period of fetal organogenesis) with doses of droxidopa corresponding to 0.3, 1 and 3 times the maximum recommended daily dose of 1,800 mg in a 60 kg patient, based on body surface area, and when their male and female offspring (who were exposed only during fetal life) were subsequently bred, the female offspring exhibited a dose-dependent reduction in the number of live fetuses across all three doses and an increased number of embryonic/fetal deaths at the two higher doses (see Data). The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Peak plasma concentrations (C max ) of droxidopa were reached by 1 to 4 hours post-dose (mean of approximately 2 hours) in healthy volunteers. High-fat meals have a moderate impact on droxidopa exposure with C max and area under the plasma concentration-time curve (AUC) decreasing by 35% and 20%, respectively.

Overdosage

Sourced from openFDA

10.1 Symptoms There have been cases of overdose reported during postmarketing surveillance. A patient ingested 7,700 mg of droxidopa and experienced a hypertensive crisis that resolved promptly with treatment. Another patient treated with a total daily dose of 2,700 mg of droxidopa experienced hypertension and an intracranial hemorrhage. 10.2 Treatment There is no known antidote for droxidopa overdosage. In case of an overdose that may result in an excessively high blood pressure, discontinue droxidopa and treat with appropriate symptomatic and supportive therapy. Counsel patients to remain in a standing or seated position until their blood pressure drops below an acceptable limit.

Approval history

Sourced from openFDA
  • Feb 18, 2014NDANDA203202Lundbeck Na Ltd
  • Feb 18, 2021ANDAANDA211652Lupin Pharms
  • Feb 18, 2021ANDAANDA213911Alkem Labs Ltd
  • Feb 18, 2021ANDAANDA211726Annora
  • Feb 18, 2021ANDAANDA214387Aurobindo Pharma Ltd
  • Feb 18, 2021ANDAANDA214384Sun Pharm
  • Feb 18, 2021ANDAANDA211741Msn Pharms Inc
  • Feb 18, 2021ANDAANDA214017Sciegen Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
21,343 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Dizziness2,90714%
  2. 2Death2,15910%
  3. 3Blood Pressure Increased1,8818.8%
  4. 4Drug Ineffective1,6577.8%
  5. 5Headache1,5837.4%
  6. 6Fall1,5007.0%
  7. 7Hypotension1,2545.9%
  8. 8Fatigue1,1945.6%
  9. 9Hypertension1,1475.4%
  10. 10Nausea1,0635.0%
  11. 11Blood Pressure Decreased1,0134.7%
  12. 12Drug Dose Omission9584.5%
  13. 13Loss Of Consciousness8474.0%
  14. 14Malaise8413.9%
  15. 15Blood Pressure Fluctuation7633.6%

Literature

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Recent PubMed references pinned to Droxidopa as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 42 ClinicalTrials.gov registrations naming Droxidopa as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Droxidopa work?
The exact mechanism of action of droxidopa in the treatment of neurogenic orthostatic hypotension is unknown. Droxidopa is a synthetic amino acid analog that is directly metabolized to norepinephrine by dopa-decarboxylase, which is extensively distributed throughout the body.
What is Droxidopa used for?
According to FDA labeling, Droxidopa carries indications including: Droxidopa capsules 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Droxidopa?
Droxidopa is classified as Adrenergic and dopaminergic agents, Increased Blood Pressure, Vasoconstriction.
What are the brand names for Droxidopa?
Droxidopa is marketed under brand names including Northera.
What are the contraindications for Droxidopa?
Droxidopa labeling lists contraindications including: Droxidopa is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [see Warnings and Precautions (5.4) ].. Always consult the full prescribing information and a clinician.
Note. Data for droxidopa is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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