DROXIDOPA

DROXIDOPA- droxidopa capsule
Bionpharma 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 capsule [see Warnings and Precautions (5.1) ].

1 INDICATIONS AND USAGE

Droxidopa capsule 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 capsule should be assessed periodically.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended starting dose of Droxidopa capsule 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 capsule 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 and after increasing the dose.

Patients who miss a dose of Droxidopa 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 ‘4’ capsules with opaque white body and opaque light blue cap, imprinted with “733” in black ink on cap and “100 mg” in black ink on body, containing off white to light brown powder.
  • 200 mg: Hard gelatin, size ‘2’ capsule, with an opaque white body and opaque light yellow cap, imprinted with “734” in black ink on cap and “200 mg” in black ink on body, containing off white to light brown powder.
  • 300 mg: Hard gelatin, size ‘1’ capsule, with an opaque white body and opaque light green cap, imprinted with “735” in black ink on cap and “300 mg” in black ink on body, containing off white to light brown powder.

4 CONTRAINDICATIONS

Droxidopa capsule is 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 capsule 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 capsule if supine hypertension persists. If supine hypertension is not well-managed, Droxidopa capsule 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 capsule use during post marketing surveillance. Observe patients carefully when the dosage of Droxidopa capsule 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 capsule 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 post marketing experience. Some of these reactions resulted 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 [see Contraindications (4)] .

6 ADVERSE REACTIONS

The following adverse reactions with Droxidopa capsule are included in more detail in the Warnings and Precautions section of the label:

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 capsule 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 capsule 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 capsule group and with at least a 3% greater incidence in the Droxidopa capsule group than in the placebo group) in Droxidopa capsule-treated patients during the three placebo-controlled trials were headache, dizziness, nausea, and hypertension. The most common adverse reactions leading to discontinuation from Droxidopa capsule were hypertension or increased blood pressure and nausea.

Table 1 Most Common Adverse Reactions Occurring More Frequently in the Droxidopa capsule 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 capsule

(N=131)

n (%)

Placebo

(N=108)

n (%)

Droxidopa capsule

(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 capsule group and with at least a 3% greater incidence in the Droxidopa capsule group than in the placebo group were from Study 306.

Long-Term, Open-Label Trials with Droxidopa capsule

In the long-term, open-label extension studies, a total of 422 patients, mean age 65 years, were treated with Droxidopa capsule 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%).

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