Eflornithine Cream

Eflornithine cream is a prescription medication indicated for the reduction of unwanted facial hair in women.

• Eflornithine cream is available under the following different brand names: Vaniqa.

Common side effects of Eflornithine cream include:

• application site skin reactions (burning, stinging, tingling, and redness, and rash) of the skin
• acne
• hair bumps (folliculitis)

Serious side effects of Eflornithine cream include:

• hives
• difficult breathing 
• swelling of the face, lips, tongue, or throat
• severe irritation of treated skin
• redness or crusting around your hair follicles

Rare side effects of Eflornithine cream include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Cream

• 13.9%

Reduction of facial hair in women

Adult dosage

• Apply to the affected area twice daily at least 8 hours apart

Pediatric dosage

• Children younger than 12 years: Safety & efficacy not established
• Children older than 12 years: Apply to the affected area twice daily at least 8 hours apart

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Eflornithine cream has no noted severe interactions with any other drugs
• Eflornithine cream has no noted serious interactions with any other drugs
• Eflornithine cream has no noted moderate interactions with any other drugs
• Eflornithine cream has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Eflornithine cream?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Eflornithine cream?”

Cautions

• For external use only
• Transient stinging or burning may occur when applied to abraded or broken skin
• This medication is not a depilatory, but rather appears to retard hair growth to improve the condition and the patient’s appearance; patients will likely need to continue using a hair removal method (eg, shaving, plucking, etc.) in conjunction with the drug
• Onset of improvement reported after as little as 4-8 weeks of treatment in the 24-week clinical trials; the condition may return to pretreatment levels 8 weeks after discontinuing treatment
• If skin irritation or intolerance develops, direct the patient to temporarily reduce the frequency of application (eg, once a day); if irritation continues, the patient should discontinue the use of the product

Pregnancy and Lactation

• Although this drug was not formally studied in pregnant patients, 22 pregnancies occurred during the trials; nineteen of these pregnancies occurred while patients were receiving therapy; of the 19 pregnancies, there were 9 healthy infants, 4 spontaneous abortions, 5 induced/elective abortions, and 1 birth defect (Down’s Syndrome to a 35-year-old); because there are no adequate and well-controlled studies in pregnant women, the risk/benefit ratio of using this drug in women with unwanted facial hair who are pregnant should be weighed carefully with serious consideration for either not implementing or discontinuing use
• Lactation
  • It is not known whether eflornithine hydrochloride is excreted in human milk; caution should be exercised when therapy is administered to a nursing woman