Droxidopa - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Droxidopa. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
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 ]. 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 capsules [ see Warnings and Precautions ].
5 WARNINGS AND PRECAUTIONS Droxidopa may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed Hyperpyrexia and confusion May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure Allergic reactions 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.
5.3 Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure Droxidopa 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.
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