DORYX (doxycycline hyclate)

DORYX (doxycycline hyclate) 

SELF ADMINISTRATION-ORAL

Indication for Prior Authorization:

• Treatment of susceptible infections
• Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term
  travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doryx/Doryx MPC and other antibacterial drugs, Doryx/Doryx MPC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy

Coverage Criteria:

• Patient has a medically appropriate diagnosis, AND
• Chart notes document a medically appropriate reason for use of the tablets and not the preferred agents
  • Preferred agents include doxycycline monohydrate, doxycycline hyclate immediate-release

Dosing:

• Doryx (adult dose):
  • 200 mg on the first day of treatment (administered 100 mg every 12 hours), then a maintenance dose of 100 mg/day
  • For more severe infections: 100 mg every 12 hours is recommended
• Doryx (pediatric patients above 8 years of age):
  • 100 lb or less: 2 mg/lb divided into two doses on the first day, followed by 1 mg/lb given as a single daily dose or divided into two doses on subsequent days
    • For more severe infections up to 2 mg/lb may be used
  •  >100 lbs: usual adult dose should be used
• Doryx MPC (adult dose):
  • 240 mg on the first day of treatment (administered 120 mg every 12 hours) followed by a maintenance dose of 120 mg daily
    • Management of more severe infections (particularly chronic infections of the urinary tract), 120 mg every 12 hours is recommended
• Doryx MPC (pediatric dose):
  • <45 kg with severe or life threatening infections: 2.6 mg per kg every 12 hours
  • 45 kg or more with severe or life threatening infections: usual adult dose should be used
  • Greater than 8 years of age and weighing <45 kg with less severe disease: 5.3 mg per kg divided into two doses on the first day of treatment, then a maintenance dose of 2.6 mg per kg
  • Pediatric patients weighing over 45 kg with less severe disease, the usual adult dose should be used

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Pregnancy: Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity also has been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus
• Breastfeeding: Tetracyclines are excreted in human milk, however, the extent of absorption of tetracyclines including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not contraindicated. The effects of prolonged exposure to doxycycline on breast milk production and breast fed neonates, infants and children are unknown
• Warnings for tooth development, Clostridioides difficile Associated Diarrhea, photosensitivity, potential for microbial overgrowth, severe skin reactions, intracranial hypertension, skeletal development, antianabolic action, malaria, and development of drug-resistant bacteria

Review History:

• 1/4/21- Annual review, format updated
• 7/5/18- Annual review

References: 

• Doryx [package insert]. Rockaway (NJ): Warner Chilcott (US), Inc.; 2007.
• Doryx MPC [package insert]. Greenville (NC): Mayne Pharma; 2020.