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Northera

"The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associate"...

Northera

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Supine Hypertension

NORTHERA 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 NORTHERA if supine hypertension persists. If supine hypertension is not well-managed, NORTHERA may increase the risk of cardiovascular events.

Hyperpyrexia And Confusion

Postmarketing cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported with NORTHERA use during post-marketing surveillance in Japan. 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 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.

Allergic Reactions

This product contains FD+C Yellow No. 5 (tartrazine) which may 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies have been conducted at dosages up to 1000 mg/kg/day in mice and up to 100 mg/kg/day in rats with no indication of carcinogenic effects. Based on dose per unit body surface area, these two doses correspond to approximately 3 and 0.5 times, respectively, the maximum recommended total daily dose of 1800 mg in a 60 kg patient. Droxidopa was clastogenic in Chinese hamster ovary cells (chromosome aberration assay), but was not mutagenic in bacteria (Ames assay), and was not clastogenic in a mouse micronucleus assay.

Studies in rats show that droxidopa has no effect on fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well controlled trials in pregnant women.

Following consecutive oral administration at doses of 60, 200, and 600 mg/kg/day to pregnant Sprague Dawley rats, increased incidences of lower body weight and occurrence of undulant rib were noted in fetuses, but they were slight and spontaneously reversed after birth. Based on dose per unit body surface area, these three doses correspond to approximately 0.3, 1 and 3 times, respectively, the maximum recommended total daily dose of 1800 mg in a 60 kg patient. Shortening of the gestation period was observed in rats at 600 mg/kg/day. Low incidences of renal lesions (cysts, indentations or renal pelvic dilation) were observed on the surface of the kidneys of female rats treated with droxidopa during the period of fetal organogenesis. No other potentially teratogenic effects have been observed in rats or rabbits.

Nursing Mothers

Choose nursing or NORTHERA. In rats, droxidopa is excreted in breast milk, and when the drug was administered to the nursing dams during the period of lactation, reduced weight gain and reduced survival were observed in the offspring.

Pediatric Use

The safety and effectiveness of NORTHERA in pediatric patients have not been established.

Geriatric Use

A total of 197 patients with symptomatic NOH aged 75 years or above were included in the NORTHERA clinical program. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Patients With Renal Impairment

NORTHERA and its metabolites are primarily cleared renally. Patients with mild or moderate renal impairment (GFR greater than 30 mL/min) were included in clinical trials and did not have a higher frequency of adverse reactions. Clinical experience with NORTHERA in patients with severe renal function impairment (GFR less than 30 mL/min) is limited.

Last reviewed on RxList: 2/27/2014
This monograph has been modified to include the generic and brand name in many instances.

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