Facial hair reduction (females): Topical: Apply thin layer to affected areas of face and areas under the chin twice daily, at least 8 hours apart.
West African trypanosomiasis ( Trypanosoma brucei gambiense infection; sleeping sickness) with confirmed or suspected CNS involvement (off-label use): IV:
Combination therapy: 200 mg/kg/dose every 12 hours for 7 days in combination with nifurtimox (Kappagoda 2011; Priotto 2009; WHO 2019).
Monotherapy (alternative therapy): 100 mg/kg/dose given every 6 hours for 14 days (Kappagoda 2011).
There are no dosage adjustments provided in the manufacturer's labeling.
Injection: Dose should be adjusted although no specific guidelines are available.
There are no dosage adjustments provided in the manufacturer's labeling.
Injection: Dose should be adjusted although no specific guidelines are available.
(For additional information see "Eflornithine (United States: Availability of intravenous preparation limited to CDC and WHO distribution programs): Pediatric drug information")
Reduction of unwanted facial hair: Topical: Cream: Female Children ≥12 years and Adolescents: Apply thin layer of cream to affected areas of face and adjacent chin twice daily, at least 8 hours apart.
Trypanosoma brucei gambiense infection (sleeping sickness); second-stage infection: Limited data available (MSF 2018): Note: Parenteral product only available through special distribution programs; refer to Prescribing Access for additional information.
NECT regimen: Children and Adolescents: IV: 200 mg/kg/dose every 12 hours for 7 days in combination with nifurtimox. NECT is the preferred regimen over monotherapy; it has been found to be safer, easier to administer and complete the course, and less expensive than eflornithine monotherapy (Kansiime 2018).
Monotherapy (difluoromethylornithine [DFMO]):
Children <12 years: IV: 150 mg/kg/dose every 6 hours for 14 days.
Children ≥12 years and Adolescents: IV: 100 mg/kg/dose every 6 hours for 14 days.
Injection: Dose should be adjusted although no specific guidelines are available.
Topical: There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely due to limited systemic absorption.
Topical: There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely due to limited systemic absorption.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as hydrochloride:
Vaniqa: 13.9% (45 g) [contains cetearyl alcohol, methylparaben, propylparaben]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as hydrochloride:
Vaniqa: 13.9% (30 g) [contains cetearyl alcohol, methylparaben, polyethylene glycol 100 stearate, propylparaben]
Injectable eflornithine is donated to the World Health Organization (WHO) by the manufacturer. In the United States, eflornithine injection is available through the Centers for Disease Control (CDC) for treatment of second-stage African trypanosomiasis (caused by Trypanosoma brucei gambiense) with involvement of the CNS. Further information may be found on the WHO website at http://www.who.int/trypanosomiasis_african/diagnosis/en/index.html or by contacting the CDC Drug Service (404-639-3670). Additional information from the CDC is available at https://www.cdc.gov/laboratory/drugservice/formulary.html.
Topical: Cream: For external use only. Apply a thin layer to the affected areas of the face and chin; rub in thoroughly. Hair removal techniques must still be continued; wait at least 5 minutes after removing hair to apply cream. Do not wash affected area for at least 4 hours following application. Makeup and sunscreen may be used over treated area(s) after cream has dried.
IV: Administered IV only; do not administer IM. Dilute prior to use and infuse over 120 minutes; replace IV catheter at least every 48 hours (Priotto 2009; WHO 2019). Not for IM administration.
Parenteral: IV: Administer diluted solution by IV infusion over 120 minutes; not for IM administration (MSF 2016).
Topical: For external use only. Rub in thoroughly. Hair removal techniques must still be continued; wait at least 5 minutes after removing hair to apply cream. Do not wash affected area for at least 4 hours following application. Makeup and sunscreen may be used over treated area(s) after cream has dried.
Facial hair reduction: Reduce unwanted hair in females from the face and adjacent areas under the chin
West African trypanosomiasis (Trypanosoma brucei gambiense infection; sleeping sickness) with confirmed or suspected CNS infection
Vaniqa may be confused with Viagra
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Injection (Priotto 2009):
>10%:
Cardiovascular: Cardiac arrhythmia (22%), hypertension (13%), chest pain (11%)
Central nervous system: Headache (46%), dizziness (17%)
Dermatologic: Pruritus (19%), skin rash (14%)
Gastrointestinal: Abdominal pain (30%), diarrhea (29%), nausea (20%), vomiting (20%), anorexia (14%)
Hematologic & oncologic: Neutropenia (33%)
Infection: Infection (2% to 16%)
Local: Injection site reaction (11%)
Neuromuscular & skeletal: Arthralgia (≤30%), myalgia (≤30%), weakness (20%)
Miscellaneous: Fever (43%)
1% to 10%:
Cardiovascular: Edema (4%), hypotension (≤3%), shock (≤3%)
Central nervous system: Insomnia (10%), seizure (9%), anxiety (8%), peripheral neuropathy (1% to 4%), coma (2%), amnesia (1%), ataxia (1%), confusion (1%), depression (1%), hallucination (1%), lethargy (1%)
Endocrine & metabolic: Dehydration (2%)
Gastrointestinal: Dysphagia (9%), xerostomia (5%), constipation (4%), dysgeusia (2%), hiccups (2%)
Genitourinary: Urinary frequency (≤4%), urinary urgency (≤4%), urinary incontinence (3%), change in creatinine (1%)
Hematologic & oncologic: Anemia (9%), leukopenia (4%), thrombocytopenia (4%)
Hepatic: Abnormal bilirubin levels (5%), increased serum transaminases (3%)
Local: Extravasation (8%)
Neuromuscular & skeletal: Tremor (1%)
Otic: Inner ear disturbance (5%)
Respiratory: Cough (10%), epistaxis (2%), dyspnea (1%), respiratory distress (1%)
Topical:
>10%: Dermatologic: Acne vulgaris (11% to 21%), pseudofolliculitis barbae (5% to 16%)
1% to 10%:
Central nervous system: Headache (4%), tingling of skin (2% to 4%), dizziness (1% to 2%)
Dermatologic: Stinging of the skin (4% to 8%), burning sensation of skin (4%), pruritus (3% to 4%), skin rash (2% to 3%), xeroderma (2% to 3%), erythema (1% to 3%), alopecia (1% to 2%), skin irritation (1% to 2%), folliculitis (≤1%), ingrown hair (≤1%)
Gastrointestinal: Dyspepsia (2% to 3%), anorexia (1%)
<1%, postmarketing, and/or case reports: Acne rosacea, cheilitis, contact dermatitis, dermal hemorrhage, facial edema, herpes simplex infection, nausea, numbness, swelling of lips, vertigo, weakness
Hypersensitivity to eflornithine or any component of the formulation
Dosage form specific issues:
• Cream: Appropriate use: For topical use by females only; discontinue if hypersensitivity occurs.
• Injection: For IV use only; not for IM administration. Must be diluted before use; frequent monitoring for myelosuppression should be done; use with caution in patients with a history of seizures and in patients with renal impairment; serial audiograms should be obtained; due to the potential for relapse, patients should be followed up for at least 24 months.
None known.
There are no known significant interactions.
Information related to the use of eflornithine for facial hair reduction during pregnancy is limited.
Information related to the use of nifurtimox for the treatment of West African trypanosomiasis in pregnancy is limited (Schmid 2012); other agents may be preferred when therapy cannot be postponed until after delivery. Eflornithine should not be used during pregnancy unless treatment is considered life-saving for the mother (WHO 2019).
It is not known if eflornithine is present in breast milk.
The manufacturer recommends that caution be exercised when administering topical eflornithine to breastfeeding women.
Information related to the use of eflornithine for the treatment of West African trypanosomiasis in breastfeeding women is limited (Schmid 2012). However, breastfeeding may continue when eflornithine is used for the treatment of West African trypanosomiasis in lactating women (WHO 2019).
Injection: CBC with platelet counts; hearing loss.
Cream: Eflornithine inhibits the enzyme ornithine decarboxylase (ODC) which inhibits cell division and synthetic functions and thereby affects the rate of hair growth.
Injection: Eflornithine exerts antitumor and antiprotozoal effects through specific, irreversible (“suicide”) inhibition of the enzyme ornithine decarboxylase (ODC). ODC is the rate-limiting enzyme in the biosynthesis of putrescine, spermine, and spermidine, the major polyamines in nucleated cells. Polyamines are necessary for the synthesis of DNA, RNA, and proteins and are, therefore, necessary for cell growth and differentiation. Although many microorganisms and higher plants are able to produce polyamines from alternate biochemical pathways, all mammalian cells depend on ornithine decarboxylase to produce polyamines. Eflornithine inhibits ODC and rapidly depletes animal cells of putrescine and spermidine; the concentration of spermine remains the same or may even increase. Rapidly dividing cells appear to be most susceptible to the effects of eflornithine.
Onset of action: Decreased hair growth: 4 to 8 weeks
Duration of action: Decreased hair growth: Continues until ~8 weeks after discontinuing treatment
Absorption: Topical: <1%
Half-life elimination: IV: 3 to 3.5 hours; Topical: 8 hours
Excretion: Primarily urine (as unchanged drug)
Cream (Vaniqa External)
13.9% (per gram): $4.43
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