Dosing & Uses
Dosage Forms & Strengths
cream
- 13.9%
Reduction of Facial Hair in Women
Apply to affected area twice daily at least 8 hours apart
Dosage Forms & Strengths
cream
- 13.9%
Reduction of Facial Hair in Women
<12 years: Safety & efficacy not established
>12 years: Apply to affected area twice daily at least 8 hours apart
Adverse Effects
Frequency Not Defined
Acne
Pseudofolliculitis barbae
Burning
Stinging
Dry, and/or tingling skin
Erythema
Anorexia
Neutropenia
Injection site reaction
Myalgia/arthralgia
Rash
Pruritus
Alopecia
Fever
Arrhythmia
Chest pain
Headache
Dizziness
Dyspepsia
Warnings
Contraindications
Hypersensitivity
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 use of the product
Pregnancy & Lactation
Pregnancy
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 or not eflornithine hydrochloride is excreted in human milk; caution should be exercised when therapy is administered to a nursing woman
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
May inhibit ornithine decarboxylase (ODC), an enzyme that catalyzes biosynthesis of intracellular polyamines required for cell division & differentiation, which in turn can affect hair growth
Pharmacokinetics
Absorption: < 1%
Half-life: 8 hr
Excretion: Urine (primarily)
Onset of action: 4-8 weeks (decreased hair growth)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Vaniqa topical - | 13.9 % cream |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
eflornithine topical
EFLORNITHINE - TOPICAL
(eh-FLOOR-nith-een)
COMMON BRAND NAME(S): Vaniqa
USES: This medication is used to slow down the growth of unwanted hair on the face and under the chin in women. It should not be used for hair on other parts of the body. It blocks a certain natural substance (an enzyme) that is needed for hair growth in the skin. This effect slows hair growth and may also make the hair finer and lighter. It does not remove hair or cause the hair to fall out.This drug is not for use in children younger than 12 years.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using eflornithine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Apply a thin layer of this medication only to the affected areas of the face and chin as directed by your doctor, usually twice daily (at least 8 hours apart). Rub the medication in well. Do not apply for at least 5 minutes after hair removal (such as plucking, shaving). Do not wash the treated area for at least 4 hours.Wash hands immediately after using this product. This medication is for use on the skin only. Avoid getting the product in your eyes, nose, or mouth. If the medication gets in these areas, rinse immediately with clean water. If this drug gets in your eyes, rinse thoroughly with water and contact your doctor.Wait until the medication has dried completely before applying cosmetics, moisturizers, or sunscreens over the treated areas.This product is not a hair removal product. Continue to use hair removal techniques (such as shaving, plucking) while using this medication. If you stop using this product, hair growth will return.You should see some improvement in 4 to 8 weeks. This medication works slowly. Use exactly as directed. Do not use more of this product or use it more often. Your condition will not improve faster, and the risk of side effects will increase. Tell your doctor if your skin becomes red or irritated. Your doctor may direct you to apply the medication only once a day or stop the medication.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Acne or burning, stinging, tingling, and redness of the skin may occur. If any of these effects last or get worse, tell your doctor.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: small red bumps on the skin (folliculitis).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to eflornithine; or if you have any other allergies. This product may contain inactive ingredients (such as methylparaben), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: cuts/infections/sores on face.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.
MISSED DOSE: If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not apply more to catch up.
STORAGE: Store at room temperature. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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