Imiquimod
Generic Name: imiquimod
Brand Names:
Imiquimod
11 DESCRIPTION Imiquimod Cream, 3.75% is for topical administration. Each gram contains 37.5 mg of imiquimod in an off-white oil-in-water vanishing cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum. Chemically, imiquimod is 1-(2-methylpropyl)-1 H -imidazol[4,5-c]quinolin-4-amine.
Overview
11 DESCRIPTION Imiquimod Cream, 3.75% is for topical administration. Each gram contains 37.5 mg of imiquimod in an off-white oil-in-water vanishing cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum. Chemically, imiquimod is 1-(2-methylpropyl)-1 H -imidazol[4,5-c]quinolin-4-amine.
Uses
1 INDICATIONS AND USAGE Imiquimod cream, 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. (1.1) • Imiquimod cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. (1.2) 1.1 Actinic Keratosis Imiquimod cream, 3.75% is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. 1.2 External Genital Warts Imiquimod cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age and older.
Dosage
2 DOSAGE AND ADMINISTRATION For topical use only; not for oral, ophthalmic, intra-anal or intravaginal use. (2.1) AK: Apply a thin layer once daily at bedtime to affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. Apply up to 0.5 grams at each application. (2.2) EGW: Apply a thin layer once daily at bedtime until total clearance or up to 8 weeks. Apply up to 0.25 grams at each application. (2.3) 2.1 Important Dosage and Administration Instructions Imiquimod cream is for topical use only. Imiquimod cream is not for oral, ophthalmic, intra-anal or intravaginal use. Instruct patients on proper application technique. Wash hands before and after applying imiquimod cream.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Local Skin Reactions [see Warnings and Precautions (5.1)] • Systemic Reactions [see Warnings and Precautions (5.2)] Most common adverse reactions (≥4%) are local skin reactions (erythema, scabbing/crusting, flaking/scaling/dryness, edema, erosion/ulceration, exudate,), headache, application site pain, application site irritation, application site pruritus, fatigue, influenza-like illness, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling.
Warnings
5 WARNINGS AND PRECAUTIONS Local Skin Reactions: Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosage interruption may be required. Severe vulvar swelling may occur and lead to urinary retention; interrupt dosing or discontinue for severe vulvar swelling. (2.2, 2.3,5.1) Systemic Reactions: Flu-like signs and symptoms have occurred. Consider dosage interruption for systemic reactions. (5.2) Ultraviolet Light Exposure Risks: Avoid or minimize exposure to sunlight and sunlamps. Wear protective clothing. (5.3) 5.1 Local Skin Reactions Local skin reactions including skin weeping or erosion have been reported with use of imiquimod cream and can occur after a few applications [see Adverse Reactions (6)] . 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from case reports and case series have not established a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes when imiquimod is used during pregnancy. There are no controlled or large-scale epidemiologic studies and no exposure registries with imiquimod use in pregnant women.
Storage
Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Avoid freezing Store imiquimod cream pump bottles upright.
Frequently Asked Questions
What is Imiquimod used for?▼
1 INDICATIONS AND USAGE Imiquimod cream, 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. (1.1) • Imiquimod cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. (1.2) 1.1 Actinic Keratosis Imiquimod cream, 3.75% is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. 1.2 External Genital Warts Imiquimod cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age and older.
What are the side effects of Imiquimod?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Local Skin Reactions [see Warnings and Precautions (5.1)] • Systemic Reactions [see Warnings and Precautions (5.2)] Most common adverse reactions (≥4%) are local skin reactions (erythema, scabbing/crusting, flaking/scaling/dryness, edema, erosion/ulceration, exudate,), headache, application site pain, application site irritation, application site pruritus, fatigue, influenza-like illness, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling.
Can I take Imiquimod during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from case reports and case series have not established a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes when imiquimod is used during pregnancy. There are no controlled or large-scale epidemiologic studies and no exposure registries with imiquimod use in pregnant women.
What are the important warnings for Imiquimod?▼
5 WARNINGS AND PRECAUTIONS Local Skin Reactions: Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosage interruption may be required. Severe vulvar swelling may occur and lead to urinary retention; interrupt dosing or discontinue for severe vulvar swelling. (2.2, 2.3,5.1) Systemic Reactions: Flu-like signs and symptoms have occurred. Consider dosage interruption for systemic reactions. (5.2) Ultraviolet Light Exposure Risks: Avoid or minimize exposure to sunlight and sunlamps. Wear protective clothing. (5.3) 5.1 Local Skin Reactions Local skin reactions including skin weeping or erosion have been reported with use of imiquimod cream and can occur after a few applications [see Adverse Reactions (6)] . 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.