DROXIDOPA

DROXIDOPA — droxidopa capsule
Lupin Pharmaceuticals, Inc.

WARNING: SUPINE HYPERTENSION

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 droxidopa [see Warnings and Precautions (5.1) ].

1 INDICATIONS AND USAGE

Droxidopa capsules are 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended starting dose of droxidopa capsules are 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 capsules 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.

3 DOSAGE FORMS AND STRENGTHS

Droxidopa capsules are available in 100 mg, 200 mg, and 300 mg strengths as specified below.

  • 100 mg: Hard gelatin, size 3 capsule, with an opaque light blue cap and an opaque white body, printed with “D26” on cap and “LU” on body using black ink and filled with a white to light brown granular powder.
  • 200 mg: Hard gelatin, size 2 capsule, with an opaque light yellow cap and an opaque white body, printed with “D27” on cap and “LU” on body using black ink and filled with a white to light brown granular powder.
  • 300 mg: Hard gelatin, size 1 capsule, with an opaque light green cap and an opaque white body, printed with “D28” on cap and “LU” on body using black ink and filled with a white to light brown granular powder.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

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 capsules 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 capsules use during postmarketing surveillance. Observe patients carefully when the dosage of droxidopa capsules 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.

5.3 Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure

Droxidopa capsules may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure. Careful consideration should be given to this potential risk prior to initiating therapy in patients with these conditions.

5.4 Allergic Reactions

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.

6 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) ]

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) ].

Placebo-Controlled Experience

The most commonly observed adverse reactions (those occurring at an incidence of greater than 5% in the droxidopa group and with at least a 3% greater incidence in the droxidopa group than in the placebo group) in droxidopa -treated patients during the three placebo-controlled trials were headache, dizziness, nausea, and hypertension. The most common adverse reactions leading to discontinuation from droxidopa were hypertension or increased blood pressure and nausea.

Table 1. Most Common Adverse Reactions Occurring More Frequently in the droxidopa Group

Note: n=number of patients. Adverse reactions that were reported in greater than 5% of patients in the droxidopa group and with at least a 3% greater incidence in the droxidopa group than in the placebo group were from Study 306.

Study 301 and Study 302 ( 1 to 2 Weeks Randomized Treatment) Study 306 ( 8 to 10 Weeks Randomized Treatment)
P lacebo ( N=132) n (%) Droxidopa ( N=131) n (%) P lacebo ( N=108) n (%) Droxidopa ( 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)
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