Eflornithine

Name: Eflornithine

What brand names are available for eflornithine?

Vaniqa

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Reviewed on 12/22/2015 References Reference: FDA Prescribing Information

Description

VANIQA® is a cream containing 13.9% (139 mg/g) of anhydrous eflornithine hydrochloride as eflornithine hydrochloride monohydrate (150 mg/g).

Chemically, eflornithine hydrochloride is (±) -2-(difluoromethyl) ornithine monohydrochloride monohydrate, with the empirical formula C6H12F2N2O2• HCl•H2O, a molecular weight of 236.65 and the following structural formula:

Anhydrous eflornithine hydrochloride has an empirical formula C6H12F2N2O2• HCl and a molecular weight of 218.65.

Other ingredients include: ceteareth-20; cetearyl alcohol; dimethicone; glyceryl stearate; methylparaben; mineral oil; PEG-100 stearate; phenoxyethanol; propylparaben; stearyl alcohol; and water.

Overdose

Overdosage information with VANIQA® is unavailable. Given the low percutaneous penetration of this drug, overdosage via the topical route is not expected (see CLINICAL PHARMACOLOGY). However, should very high topical doses (e.g., multiple tubes per day) or oral ingestion be encountered (a 30 g tube contains 4.2 g of eflornithine hydrochloride), the patient should be monitored, and appropriate supportive measures administered as necessary.

(Note: Use of an intravenous formulation of eflornithine hydrochloride at high doses (400 mg/kg/day or approximately 24 g/day) for the treatment of Trypanosoma brucei gambiense infection (African sleeping sickness) has been associated with adverse events and laboratory abnormalities. Adverse events in this setting have included hair loss, facial swelling, seizures, hearing impairment, stomach upset, loss of appetite, headache, weakness and dizziness. A variety of hematological toxicities, including anemia, thrombocytopenia and leukopenia have also been observed, but these were usually reversible upon discontinuation of treatment.)

Eflornithine Drug Class

Eflornithine is part of the drug class:

  • Other agents against leishmaniasis and trypanosomiasis

Eflornithine Interactions

This is not a complete list of Eflornithinedrug interactions. Ask your doctor or pharmacist for more information.

What is eflornithine topical (vaniqa)?

Eflornithine interferes with a chemical in the hair follicles of the skin. This results in slower hair growth where eflornithine topical is applied.

Eflornithine topical is used to reduce unwanted facial hair in women. Eflornithine topical does not permanently remove hair or "cure" unwanted facial hair. Eflornithine topical will help you manage your condition and improve your appearance.

Eflornithine topical may also be used for purposes other than those listed in this medication guide.

  • Cyclocort

Read the Vaniqa User Reviews »

© Vaniqa Patient Information is supplied by Cerner Multum, Inc. and Vaniqa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Stability

Storage

Topical

25°C (may be exposed to 15–30°C); do not freeze.1

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad skin irritation.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take eflornithine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to eflornithine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

For the Consumer

Applies to eflornithine topical: topical cream

Some side effects of eflornithine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acne
  • stinging skin
Less common
  • Burning or bleeding skin
  • chapped, red lips
  • chronic acne
  • hair bumps
  • numbness
  • rash
  • reddening of skin
  • swelling of lips
  • tingling skin

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dialysis

Data not available

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