Vaniqa (Eflornithine) Indications… Dosage
- hirsutism
- Pneumocystis carinii †
- pneumonia †
- Trypanosoma brucei gambiense
- trypanosomiasis
† non-FDA-approved indication
Vaniqa (Eflornithine) Indications...Dosage
The following organisms are generally considered susceptible to eflornithine in vitro: Giardia lamblia † , Pneumocystis carinii † , Trichomonas vaginalis † , Trypanosoma brucei gambiense, Trypanosoma brucei rhodesiense † , Trypanosoma sp † .
For the reduction of unwanted facial hair in females, including hirsutism of the face:
Topical Dosage (Vaniqa™ cream):
Adult, elderly and adolescent females: Apply a thin layer twice daily, at least 8 hours apart, to affected facial area(s). Rub the cream into the skin thoroughly. Do not wash the treated area for >= 4 hours. If skin irritation occurs, apply only once per day until irritation is resolved. If irritation continues, discontinue use of the product. In clinical trials, onset of improvement was seen within 4-8 weeks but returned to pretreatment levels 8 weeks after discontinuing therapy. Unpublished studies note marked improvement in unwanted facial hair by week 8 in 20%-40% of females applying topical eflornithine, versus 8% of females using placebo vehicle. Subgroup analysis revealed that whites had a significantly greater response to eflornithine than non-whites (37% vs. 22%, respectively).
Children: Safe and effective use has not been established.
For the treatment of the protozoal infection trypanosomiasis (African sleeping sickness), caused by Trypanosoma brucei gambiense:
- for initial treatment of new cases of Trypanosoma brucei gambiense:
NOTE: The FDA has designated eflornithine IV an orphan drug for trypanosomiasis. The IV form is not commercially available in the US. Direct requests for eflornithine IV to: Executive Director, World Health Organization, Communicable Diseases Cluster, 1211 Geneva 27, Switzerland (F. Kuzoe, personal communication, 4/24/2001).
Intravenous infusion dosage:
Adults, including the elderly: 100 mg/kg IV infusion every 6 hours for 14 days, each dose administered over a period of at least 45 minutes. In Uganda, the treatment regimen for new cases of trypanosomiasis have extremely high failure rates, possibly due to resistant strains. For new cases in Cote d’Ivoire, DRC and Congo, the 14 day regimen has been highly effective.
- for the treatment of relapsing † cases of Trypanosoma brucei gambiense unresponsive to other therapy:
Intravenous infusion dosage:
Adults, including the elderly: 100 mg/kg IV infusion every 6 hours for 7 or 14 days, each dose administered over a period of at least 45 minutes. NOTE: The shorter 7 day course of therapy has been shown to be ineffective for new cases of Trypanosoma brucei gambiense. If the 7 day course is used for relapsing cases, close follow-up of patients is required to identify relapses. Relapsing cases respond better to eflornithine than new cases, perhaps because of better CSF penetration of the drug in patients with an impaired blood-brain barrier as well as low probability of having positive lymph node aspirates.
Children and adolescents: 125 mg/kg IV infusion every 6 hours for 14 days, each dose administered over a period of at least 45 minutes. NOTE: Some studies that have included pediatric populations have used the same weight-based dose as adults (i.e., 100 mg/kg IV). Due to higher failure rates in children, one study suggests children should be given a higher dosage per kg than adults. Compared with adults, children <= 12 years had mean CSF and serum eflornithine levels that were, respectively, only 36% and 56% of those of adults. Pending additional pharmacokinetic data, the higher dose of 125 mg/kg IV is recommended in those < 20 years of age.
Oral dosage:
Adults, including the elderly: 50-100 mg/kg PO every 6 hours for 6 weeks. Late stage sleeping sickness may respond better to doses in the upper end of the dosage range.
For the treatment of Pneumocystis carinii pneumonia † (PCP) in patients unresponsive to other standard treatments:
NOTE: Systemic eflornithine is not commercially available in the US.
Intravenous and oral dosage:
Adults, including the elderly: 100 mg/kg IV infusion every 6 hours for 14 days, each dose administered over a period of at least 45 minutes, then 75 mg/kg PO every 6 hours for 4 to 6 weeks.
Oral dosage:
Adults, including the elderly: 2 g/m2 PO every 8 hours for 8 weeks. If toxicity occurs, use a lower dose of 1.3 g/m2 PO every 8 hours for 8 weeks.
Maximum Dosage Limits:
- Adults: 400 mg/kg/day IV.
- Elderly: 400 mg/kg/day IV.
- Adolescents: 500 mg/kg/day IV.
- Children: 500 mg/kg/day IV.
Patients with hepatic impairment:
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with renal impairment:
Dosage adjustment is needed in renal impairment; however, specific guidelines are not available. Use reduced initial dosage and adjust gradually according to clinical response and tolerance.
† non-FDA-approved indication
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