Droxidopa

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.

• Starting dose is 100 mg three times during the day (
  2.1 Dosing Information

  The recommended starting dose of droxidopa capsules 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 capsules 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 hours 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.
  )
• Titrate by 100 mg three times daily, up to a maximum dose of 600 mg three times daily (
  2.1 Dosing Information

  The recommended starting dose of droxidopa capsules 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 capsules 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 hours 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.
  )
• Take consistently with or without food (
  2.1 Dosing Information

  The recommended starting dose of droxidopa capsules 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 capsules 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 hours 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.
  )
• To reduce the potential for supine hypertension, elevate the head of the bed and give the last dose at least 3 hours prior to bedtime (
  2.1 Dosing Information

  The recommended starting dose of droxidopa capsules 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 capsules 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 hours 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.
  )
• Take droxidopa capsule whole (
  2.1 Dosing Information

  The recommended starting dose of droxidopa capsules 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 capsules 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 hours 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.
  )

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

• 100 mg: Hard gelatin capsules with “DRX100” on the white opaque body and “ap” logo on the light blue opaque cap
• 200 mg: Hard gelatin capsules with “DRX200” on the white opaque body and “ap” logo on the light yellow opaque cap
• 300 mg: Hard gelatin capsules with “DRX300” on the white opaque body and “ap” logo on the light green opaque cap

• Lactation:
  Breastfeeding not recommended (
  8.2 Lactation

  Risk Summary

  There is no information regarding the presence of droxidopa or its active metabolite(s) in human milk, the effects of droxidopa on the breastfed child, nor the effects of droxidopa on milk production/excretion. Droxidopa is present in rat milk with peak concentrations seen 4 hours after oral drug administration and drug excretion into milk still occurring 48 hours after administration

  (see Data)

  . However, due to species-specific differences in lactation physiology, animal lactation data typically do not reliably predict levels in humans. Because of the potential for serious adverse reactions, including reduced weight gain in breastfed infants, advise a woman not to breastfeed during treatment with droxidopa.

  
  
  

  Data

  Animal Data

  In rats, oral administration of droxidopa resulted in excretion into breast milk with peak concentrations seen 4 hours after administration, and excretion still occurring 48 hours after administration. When the drug was administered to nursing dams during the period of lactation at a dose corresponding to 3 times the maximum recommended daily dose of 1,800 mg in a 60 kg patient when based on body surface area, reduced weight gain and reduced survival were observed in the offspring. Despite the observed decreased weight gain, physical development was normal (with respect to timing and organ morphology).
  )
• Patients with Renal Impairment:
  Dosing recommendations cannot be provided for patients with GFR less than 30 mL/min (
  8.6 Renal Impairment

  Droxidopa 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 droxidopa in patients with severe renal function impairment (GFR less than 30 mL/min) is limited.
  )