FDA

Droxidopa

Approved 18 Feb 2021OralCapsule

The FDA lists this product in 48 strengths and forms.

Indications

Droxidopa capsules 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 droxidopa capsules should be assessed periodically. Droxidopa capsule is indicated for the treatment of orthostatic dizziness, light headedness, 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 Droxidopa capsules should be assessed periodically ( 1 ).

Contraindications

Droxidopa capsules is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [see Warnings and Precautions ( 5.4 )]. History of hypersensitivity to the drug or its ingredients ( 4 )

Warnings and precautions

Droxidopa capsules 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 )

5.1Supine Hypertension

Droxidopa capsules 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 capsules if supine hypertension persists. If supine hypertension is not well-managed, droxidopa capsules may increase the risk of cardiovascular events , particularly stroke.

At a glance

Brand name: Droxidopa
Route: Oral
Dosage form: Capsule
Applicant: Alkem Labs LTD
Status: Prescription
FDA approval: 18 Feb 2021
Application: ANDA213911-001

Indications

Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of Droxidopa capsules should be assessed periodically ( 1 ).

Warnings and precautions

5.1Supine Hypertension

Adverse reactions

The following adverse reactions with droxidopa capsules 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 Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 capsules 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 capsules and 240 with placebo [see Clinical Studies ( 14 )] . Placebo-Controlled Experience The most commonly observed adverse reactions (those occurring at an incidence of greater than 5% in the droxidopa capsules group and with at least a 3% greater incidence in the droxidopa capsules group than in the placebo group) in droxidopa capsules -treated patients during the three placebo-controlled trials were headache, dizziness, nausea, and hypertension.

The most common adverse reactions leading to discontinuation from droxidopa capsules were hypertension or increased blood pressure and nausea. Table 1. Most Common Adverse Reactions Occurring More Frequently in the droxidopa capsules Group Study 301 and Study 302 (1 to 2 Weeks Randomized Treatment) Study 306 (8 to 10 Weeks Randomized Treatment) Placebo (N=132) n (%) Droxidopa capsules (N=131) n (%) Placebo (N=108) n (%) Droxidopa capsules (N=114) n (%) Headache 4 (3.0) 8 (6.1) 8 (7.4) 15 (13.2) Dizziness 2 (1.5) 5 (3.8) 5 (4.6) 11 (9.6) Nausea 2 (1.5) 2 (1.5) 5 (4.6) 10 (8.8) Hypertension 0 2 (1.5) 1 (0.9) 8 (7.0) Note: n=number of patients.

Adverse reactions that were reported in greater than 5% of patients in the droxidopa capsules group and with at least a 3% greater incidence in the droxidopa capsules group than in the placebo group were from Study 306. Long-Term, Open-Label Trials with droxidopa capsules In the long-term, open-label extension studies, a total of 422 patients, mean age 65 years, were treated with droxidopa capsules for a mean total exposure of approximately one year.

The commonly reported adverse events were falls (24%), urinary tract infections (15%), headache (13%), syncope (13%), and dizziness (10%).

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of droxidopa capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: Chest pain Eye Disorders: Blurred vision Gastrointestinal Disorders: Pancreatitis, abdominal pain, vomiting, diarrhea General Disorders and Administration Site Conditions: Fatigue Nervous System Disorders: Cerebrovascular accident Psychiatric Disorders: Psychosis, hallucination, delirium, agitation, memory disorder

Droxidopa

Indications

Contraindications

Warnings and precautions

5.1Supine Hypertension

At a glance

Two medicines in one question?

Droxidopa

Indications

Contraindications

Warnings and precautions

5.1Supine Hypertension

At a glance

Two medicines in one question?

5.3Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure

5.4Allergic Reactions

Interactions

7.2Parkinson's Medications

7.3Non-selective MAO Inhibitors

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information