Vaniqa (Eflornithine) Contraindications/Precautions
- ophthalmic administration
- vaginal administration
- anemia
- bone marrow suppression
- breast-feeding
- children
- hearing impairment
- hematological disease
- human immunodeficiency virus (HIV) infection
- leukopenia
- pregnancy
- renal failure
- renal impairment
- seizure disorder
- thrombocytopenia
Vaniqa (Eflornithine) Contraindications/Precautions
Eflornithine cream is for dermatologic use only; it is not for ophthalmic administration, vaginal administration or oral use. Transient stinging or burning may occur if applied to abraded skin. In clinical trials, patients with severe inflammatory acne were excluded from study. Eflornithine is contraindicated in patients with a previous sensitivity to any components of the product.
There is a risk of infection relapse following treatment with systemic eflornithine for trypanosomiasis. Health care providers should attempt to follow patients for at least 24 months to assure further therapy in case of relapse. Cerebral spinal fluid examinations (via lumbar puncture) are often implemented to evaluate the presence of trypanosomes and/or WBCs.
Myelosuppression (anemia, leukopenia, thrombocytopenia), the most frequent and toxic effect of systemic eflornithine, is usually reversible upon discontinuation of the drug. Myelosuppression, which is an extension of the mechanism of the drug, may be unavoidable in successful treatments. Eflornithine should be used cautiously in patients with bone marrow suppression, human immunodeficiency virus (HIV) infection, and/or other hematological disease. Additionally, a functional immune system is required to kill the growth-arrested trypanosomes; HIV or other immunocompromised patients may not respond optimally to eflornithine. Complete blood count, including platelet count should be monitored at baseline, twice weekly during treatment, and weekly following cessation of treatment until values return to baseline. Decisions to adjust or interrupt treatment should be made on a case-by-case basis, considering response to therapy, presence of hematological disease or immunosuppression, and availability of support facilities.
Seizures have occurred in patients receiving systemic eflornithine. The etiology of the seizure disorder (due to intrinsic meningoencephalitis, eflornithine or the combination) has not been determined. In patients with a previous history of seizures, eflornithine should be used cautiously, realizing that seizures may occur due to the disease itself.
Hearing impairment appears to be a cumulative dose-related, but reversible adverse effect of systemic eflornithine. Hearing loss may be more pronounced in patients that already have a hearing impairment. The health care provider should consider obtaining serial audiograms, if feasible.
Both topical and intravenous eflornithine are classified as FDA pregnancy risk category C. In animal studies, systemic eflornithine has been associated with fetal toxicity and arrested embryonic development. Topical eflornithine, in studies that prevented animal ingestion from application sites, has not been associated with maternal or fetal teratogenic effects at doses up to 29 times the maximum recommended human dose. In clinical trials, 19 pregnancies occurred in women using topical eflornithine, resulting in 9 healthy infants, 4 spontaneous abortions, 5 elective abortions, and 1 Down’s syndrome infant. The manufacturer of topical eflornithine recommends weighing the risk/benefit ratio with serious consideration of avoiding eflornithine therapy during pregnancy.
It is not known if eflornithine is excreted into human milk. Less than 1% of topical eflornithine is absorbed through the skin, however, use caution if topical eflornithine is used during breast-feeding. In a woman receiving systemic eflornithine, a decision should be made whether to discontinue breast-feeding or the drug. The potential exists for serious adverse events in the nursing infant.
Safety and effectiveness in children < 12 years have not been established for topical eflornithine. Clinical studies and case reports have described the use of IV eflornithine in children for trypanosomiasis.
Dosage adjustments of intravenous eflornithine are required in patients with renal impairment or renal failure, although specific guidelines are not available.
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