Droxidopa

Oral Administration

Administer upon arising in the morning, at midday, and in the late afternoon at least 3 hr prior to bedtime (to reduce the potential for supine hypertension during sleep)

Administer consistently, either with food or without food

Swallow capsule whole; do not chew, open, or dissolve contents

Monitor supine blood pressure prior to initiating and after increasing the dose

Patients who miss a dose should take their next scheduled dose; do not double the dose to make up for a missed dose

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Serious side effects have been reported. See "Precautions" section.

Common side effects include:

• headache
• dizziness
• nausea
• high blood pressure
• fatigue

This is not a complete list of side effects. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of droxidopa, there are no specific foods that you must exclude from your diet when receiving this medication.

However, you should always take droxidopa the same way, either with or without food.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Droxidopa is usually taken 3 times per day, as follows. First dose in the morning when you wake up; second dose at mid-day; third dose in the late afternoon or at least 3 hours before you go to bed. The timing of your doses is very important in helping to maintain a healthy blood pressure while you are taking droxidopa. Follow your doctor's dosing instructions very carefully.

You may take droxidopa with or without food, but take it the same way each time.

Do not crush, chew, break, or open a droxidopa capsule. Swallow it whole.

Droxidopa can increase your blood pressure even while you are lying down or sleeping (when blood pressure is usually lowest). Long-term high blood pressure (hypertension) can lead to heart attack or stroke, which may be fatal.

Follow your doctor's instructions about the best way to position your body while you are laying down or sleeping. You may need to keep your head elevated to help prevent high blood pressure.

Your blood pressure will need to be checked before and during treatment with droxidopa, or whenever your dose is changed. Check your blood pressure while you are lying down, and check it again with your head elevated.

Your doctor will need to check your progress at regular visits if you use droxidopa for longer than 2 weeks.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Symptomatic Neurogenic Orthostatic Hypotension (NOH)

Management of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in patients with symptomatic NOH caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, or pure autonomic failure), dopamine β-hydroxylase deficiency, or non-diabetic autonomic neuropathy.1 2 3 4 5 8 9 16 17

Has been designated an orphan drug by FDA for treatment of symptomatic NOH in patients with primary autonomic failure, dopamine β-hydroxylase deficiency, or nondiabetic autonomic neuropathy.2

Efficacy in symptomatic NOH beyond 2 weeks not established; reassess continued benefit periodically during therapy.1 3

General

Restricted Distribution

• Available only through a specialty pharmacy.10 For more information, contact manufacturer at 844-601-0101 or .10

Administration

Oral Administration

Administer orally 3 times daily: upon arising in the morning, at midday, and in the late afternoon at least 3 hours before bedtime.1 Take consistently, either with food or without food.1 Swallow capsules whole.1

Monitor supine BP prior to initiating droxidopa, periodically during treatment, and after dosage increases.1 (See Supine Hypertension under Cautions.)

If a dose is missed, skip the dose and take the next dose at the regularly scheduled time.1

Dosage

Adults

Initially, 100 mg 3 times daily.1 May increase dosage based on symptomatic response and tolerance in increments of 100 mg 3 times daily at intervals of 24–48 hours.1

Efficacy beyond 2 weeks not established; periodically reassess continued benefit.1

Prescribing Limits

Adults

600 mg 3 times daily (1.8 g daily).1

Special Populations

Renal Impairment

Mild or moderate renal impairment when GFR >30 mL/minute: Dosage adjustment not necessary.1

Limited experience in patients with severe renal impairment (GFR <30 mL/minute); no dosage recommendations provided by manufacturer.1

Geriatric Patients

Manufacturer makes no special dosage recommendations.1

Take droxidopa exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Take droxidopa the same way every day. This means take it at the same time and take it consistently, either with or without food.

Swallow the capsule whole. Do not crush, break, or chew it.

Dosing

The dose of droxidopa will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of droxidopa. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For neurogenic orthostatic hypotension:
    • Adults—At first, 100 milligrams (mg) three times a day (taken upon waking up in the morning, at noon, and in the late afternoon at least 3 hours before bedtime). Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of droxidopa, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• It is used to treat dizziness or the feeling that you are about to black out.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Northera: 100 mg, 200 mg [contains fd&c blue #2 (indigotine)]

Northera: 300 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, tartrazine (fd&c yellow #5)]

GFR >30 mL/minute: No dose adjustments necessary.

GFR ≤30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea. Have patient report immediately to prescriber severe headache, severe dizziness, passing out, vision changes, or signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, severe headache, confusion, change in thinking, tachycardia, abnormal heartbeat, or sweating a lot) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Applies to droxidopa: oral capsule

Cardiovascular

Common (1% to 10%): Hypertension (greater than 5%)
Frequency not reported: Supine hypertension, exacerbation of existing heart disease, arrhythmias, and congestive heart failure[Ref]

Gastrointestinal

Common (1% to 10%): Nausea[Ref]

Genitourinary

Very common (10% or more): Urinary tract infections (15% in the elderly)[Ref]

Musculoskeletal

Very common (10% or more): Falls (24% in the elderly)[Ref]

Nervous system

Very common (10% or more): Headache (up to 15%), syncope (13% in the elderly), dizziness (up to 11%)[Ref]

Some side effects of droxidopa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.