Imiquimod 37.5 mg/g Cream, 1 bottle
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antivirals class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Imiquimod cream is used to treat certain types of actinic keratoses (flat, scaly growths on the skin caused by too much sun exposure), superficial basal cell carcinoma (a type of skin cancer), and warts on the skin of the genital and anal areas. Imiquimod is in a class of medications called immune response modifiers. It may work by increasing the activity of the body's immune system. Imiquimod cream does not cure warts, and new warts may appear during treatment. It is not known whether imiquimod cream prevents the spread of warts to other people.
Read the full MedlinePlus article ↗- Yes — and that's actually expected. Redness, flaking, and even some crusting or sores at the treatment site are a normal sign that the cream is doing its job. For actinic keratoses...
- How long does it take for imiquimod to work, and will the treated area look worse before it gets better?
- It's important to stick to the schedule your doctor prescribed — not more often. Using it more frequently than directed can make skin reactions much more severe without making trea...
- Can I use imiquimod every day to speed things up?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Imiquimod — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
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Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
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Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
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UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
12 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $107.043 | $802.82 / 7.5 g |
| Medicaid paysCMS SDUD · 12 mo | $78.88 | $591.63 / 7.5 g |
| Medicare drug plans payPart D · Q2 2026 | $132.93 | $996.94 / 7.5 g |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Imiquimod 37.5 mg/g 00093-3133-31 | Teva | 1 bottle | $107.043 | — | Availability likely | — |
| Imiquimod 37.5 mg/gthis 51672-4174-09 | Sun | 1 bottle | $107.043 | AB | Availability likely | — |
| Imiquimod 37.5 mg/g 68682-0272-75 | Oceanside | 1 bottle | — | — | FDA listed | — |
| Zyclara 37.5 mg/g 99207-0270-01 | Bausch | 4 packets | — | — | FDA listed | — |
| Zyclara 37.5 mg/g 99207-0271-01 | Bausch | 1 bottle | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 51672-4174-06 | 28 PACKET in 1 CARTON (51672-4174-6) / .25 g in 1 PACKET (51672-4174-8) | $36.22 / ea | $1,014.10 | 2021-01-26 | Active |
| 51672-4174-09 You're viewing this | 1 BOTTLE, PUMP in 1 CARTON (51672-4174-9) / 7.5 g in 1 BOTTLE, PUMP | $107.04 / g | $802.82 | 2021-10-14 | Active |
This pack accounts for about 27% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 51672-4174-09?
What is the difference between NDC 51672-4174-09 and NDC 51672-4174-06?
What NDC number is used to bill for this package of Imiquimod 37.5 mg/g Cream?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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)
1.1Actinic 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.
1.2External 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 and Administration ▾
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)
2.1Important 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. Prime the imiquimod cream pump bottle before first use by repeatedly depressing the actuator until the cream is dispensed. It is not necessary to repeat this priming process during treatment.
If a imiquimod cream dose is missed, apply the next dose at the regularly scheduled time. Avoid contact with the eyes, lips, nostrils, or inside the anus and vagina. Prescribe no more than 2 boxes (56 packets) or two 7.5 g bottle pumps of imiquimod cream for the entire treatment course for AK or EGW.
Discard partially used packets and do not reuse. Discard pump bottles after completion of a full treatment course.
2.2Dosage and Administration for Actinic Keratosis Use imiquimod cream, 3.75% for the treatment of AK. Apply a thin layer of imiquimod cream once daily before bedtime to the area with AK (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. Rub in until the cream is no longer visible.
Apply up to 0.5 grams (two packets or two full actuations of the pump) of imiquimod cream at each application. Leave imiquimod cream on the skin for approximately 8 hours and then remove with mild soap and water. For local skin reactions, a dosage interruption of several days may be taken if required based on the patient's discomfort or severity of the local skin reaction [see Warnings and Precautions (5.1)].
Do not extend either 2-week treatment cycle due to missed doses or rest periods. Assess response to treatment after resolution of local skin reactions. A transient increase in lesion counts may be observed during treatment; however, continue dosing as prescribed.
Continue treatment for the full treatment course even if all AK appear to be gone.
2.3Dosage and Administration for External Genital Warts Use imiquimod cream, 3.75% for the treatment of EGW. Apply a thin layer of imiquimod cream once daily before bedtime to EGW until total clearance or for up to 8 weeks. To treat the wart area, use up to 0.25 grams (one packet or one full actuation of the pump) at each application.
Leave imiquimod cream on the skin for approximately 8 hours and then remove with mild soap and water. For local skin reactions, a dosage interruption of several days may be taken if required by the patient's discomfort or severity of the local skin reaction; resume treatment once the reaction subsides [see Warnings and Precautions (5.1)]. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.
Inform uncircumcised patients treating warts under the foreskin to retract the foreskin and clean the area daily. Imiquimod cream may weaken condoms and vaginal diaphragms, therefore, concurrent use is not recommended.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Imiquimod cream is a white to faintly yellow cream available as: Cream: 3.75%, in unit-dose packets and pump bottles. Each packet contains 0.25 grams of cream and each pump bottle, when actuated after priming, delivers 0.235 grams of cream. Cream: 3.75% in pump bottles or unit-dose packets. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
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)
5.1Local 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)] . Concomitant use of imiquimod cream and any other imiquimod products, in the same treatment area, may increase the risk for and severity of local skin reactions. Imiquimod cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.
Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling and to urinary retention. Avoid sexual (genital, anal, oral) contact while imiquimod cream is on the skin. To reduce the risk of local skin reactions and manage local skin reactions that occur with imiquimod cream treatment: Avoid concomitant use of imiquimod cream with any other imiquimod product in the same treatment area.
Avoid application of imiquimod cream to skin that is not intact (i.e., any area with an abrasion, cut, burn, rash, infection, or other condition that has altered skin integrity). An interruption of dosing may be required for local skin reactions [see Dosage and Administration (2.2, 2.3)] . Interrupt dosing or discontinue imiquimod cream for severe vulvar swelling [see Dosage and Administration (2.3)].
If severe local skin reactions occur, instruct patients to remove imiquimod cream by washing the treatment area with mild soap and water.
5.2Systemic Reactions Flu-like signs and symptoms have been reported with use of imiquimod cream andmay accompany, or even precede, local skin reactions [see Adverse Reactions (6)]. Signs and symptoms may include fatigue, nausea, fever, myalgias, arthralgias, malaise and chills. Concomitant use of imiquimod cream and any other imiquimod products may increase the risk for and severity of systemic reactions.
Lymphadenopathy occurred in 2% of subjects with AK treated with imiquimod cream, 3.75% and in no patients in the vehicle arm [see Adverse Reactions (6.1)] . This reaction resolved in all subjects by 4 weeks after completion of treatment. Consider an interruption of dosing if systemic reactions occur.
5.3Ultraviolet Light Exposure Risks Imiquimod cream may cause heightened sunburn susceptibility. Avoid or minimize exposure to sunlight (including sunlamps) during use of imiquimod cream. Instruct patients to use sunscreen and wear protective clothing (e.g., a hat). Advise patients not to use imiquimod cream until fully recovered from a sunburn.
5.4Immune Cell Activation in Autoimmune Disease Imiquimod activates immune cells [see Clinical Pharmacology (12.2)]. Carefully monitor patients with pre-existing autoimmune conditions who are using imiquimod cream.
🤒 Adverse Reactions ▾
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.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Actinic Keratosis The data described below reflect exposure to imiquimod cream or vehicle in 479 subjects with AK enrolled in two double-blind, vehicle-controlled trials (Studies AK1 and AK2) [see Clinical Studies (14.1)]. Subjects applied up to two packets of imiquimod cream, 3.75%, or vehicle once daily, to the skin of the affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no treatment period.
Selected adverse reactions are listed in Table 1. Table 1: Selected Adverse Reactions Occurring in ≥ 2% of Imiquimod-Treated Subjects with AK and at a Greater Frequency than Vehicle in Studies AK1 and AK2 Adverse Reaction Imiquimod Cream, 3.75% (N=160) Imiquimod Cream, 2.5% (N=160) Vehicle (N=159) Headache 10 (6%) 3 (2%) 5 (3%) Application site pruritus 7 (4%) 6 (4%) 1 (<1%) Fatigue 7 (4%) 2 (1%) 0 Nausea 6 (4%) 1 (1%) 2 (1%) Application site irritation 5 (3%) 4 (3%) 0 Application site pain 5 (3%) 2 (1%) 0 Pyrexia 5 (3%) 0 0 Anorexia 4 (3%) 0 0 Dizziness 4 (3%) 1 (<1%) 0 Herpes simplex 4 (3%) 0 1 (<1%) Lymphadenopathy 3 (2%) 4 (3%) 0 Diarrhea 3 (2%) 2 (1%) 0 Arthralgia 2 (1%) 4 (3%) 0 Influenza like illness 1 (<1%) 6 (4%) 0 Oral herpes 0 4 (3%) 0 Cheilitis 0 3 (2%) 0 Local skin reactions were recorded as adverse reactions if they extended beyond the treatment area, or required any medical intervention, or resulted in patient discontinuation from the trial.
The incidence and severity of selected local skin reactions are shown in Table 2. Table 2: Local Skin Reactions in the Treatment Area in Imiquimod-Treated Subjects with AK as Assessed by the Investigator in Studies AK1 and Ak2 In the AK trials, 11% (17/160) of subjects in the imiquimod cream, 3.75% arm, 7% (11/160) of subjects in the imiquimod cream, 2.5% arm, and 0% in the vehicle arm required rest periods due to adverse local skin reactions. Other adverse reactions observed in subjects treated with imiquimod cream included: application site bleeding, application site swelling, chills, dermatitis, herpes zoster, insomnia, lethargy, myalgia, pancytopenia, pruritus, squamous cell carcinoma, and vomiting.
External Genital Warts In two double-blind, placebo-controlled trials 602 subjects with EGW applied up to one packet of imiquimod cream, 3.75% or vehicle to all warts once daily for up to 8 weeks (Studies EGW1 and EGW2) [see Clinical Studies (14.2)]. The most frequently reported adverse reactions were application site reactions and local skin reactions. Selected adverse reactions are listed in Table 3.
Table 3: Selected Adverse Reactions Occurring in ≥ 2% of Imiquimod-Treated Subjects with EGW and at a Greater Frequency than Vehicle in Studies EGW1 and EGW 2 *Percentage based on female population of 6/216 for imiquimod cream, 3.75% and 2/106 for vehicle Local skin reactions were recorded as adverse reactions if they extended beyond the treatment area, or required any medical intervention, or resulted…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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. In animal reproduction studies, there were no adverse developmental effects observed after oral administration of imiquimod in pregnant rats and intravenous administration of imiquimod in pregnant rabbits during organogenesis at doses up to 28 times and 115 times, respectively, the maximum recommended human dose (MRHD) (see Data).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data The MRHD was set at two packets per treatment of imiquimod cream, 3.75%, (18.75 mg imiquimod) for the animal multiples of human exposure presented in this label. Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1, 5, and 20 mg/kg/day imiquimod were administered during the period of organogenesis to pregnant female rats.
In the presence of maternal toxicity, fetal effects noted at 20 mg/kg/day (163 times the MRHD based on AUC comparison) included increased resorptions, decreased fetal body weights, delays in skeletal ossication, bent limb bones, and two fetuses in one litter (2 of 1567 fetuses) demonstrated exencephaly, protruding tongues, and low-set ears. No treatmentrelated effects on embryofetal toxicity or malformation were noted at 5 mg/kg/day (28 times the MRHD based on AUC comparison). Intravenous doses of 0.5, 1, and 2 mg/kg/day imiquimod were administered during the period of organogenesis to pregnant female rabbits.
No treatment-related effects on embryofetal toxicity or malformation were noted at 2 mg/kg/day (2.1 times the MRHD based on BSA comparison), the highest dose evaluated in this study, or 1 mg/kg/day (115 times the MRHD based on AUC comparison). A combined fertility and peri- and postnatal development study was conducted in rats. Oral doses of 1, 1.5, 3, and 6 mg/kg/day imiquimod were administered to male rats from 70 days prior to mating through the mating period and to female rats from 14 days prior to mating through parturition and lactation.
No effects on growth, fertility, reproduction, or postnatal development were noted at doses up to 6 mg/kg/day (25 times the MRHD based on AUC comparison), the highest dose evaluated in this study. In the absence of maternal toxicity, bent limb bones were noted in the F1 fetuses at a dose of 6 mg/kg/day (25 times the MRHD based on AUC comparison). This fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod.
No treatment-related malformations were noted at 3 mg/kg/day (12 times the MRHD based on AUC comparison).
8.2Lactation Risk Summary There is no information regarding the presence of topically administered imiquimod in human milk, the effects on the breastfed infant, or the effects on milk production. Systemic concentration following topical administration of imiquimod cream is low; therefore, transfer of imiquimod into breastmilk is likely to be low [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for imiquimod cream and any potential adverse effects on the breastfed infant from imiquimod cream or from the underlying maternal condition.
Clinical Considerations Avoid application of imiquimod cream to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding…
🤰 Pregnancy ▾
8.1Pregnancy 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. In animal reproduction studies, there were no adverse developmental effects observed after oral administration of imiquimod in pregnant rats and intravenous administration of imiquimod in pregnant rabbits during organogenesis at doses up to 28 times and 115 times, respectively, the maximum recommended human dose (MRHD) (see Data).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data The MRHD was set at two packets per treatment of imiquimod cream, 3.75%, (18.75 mg imiquimod) for the animal multiples of human exposure presented in this label. Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1, 5, and 20 mg/kg/day imiquimod were administered during the period of organogenesis to pregnant female rats.
In the presence of maternal toxicity, fetal effects noted at 20 mg/kg/day (163 times the MRHD based on AUC comparison) included increased resorptions, decreased fetal body weights, delays in skeletal ossication, bent limb bones, and two fetuses in one litter (2 of 1567 fetuses) demonstrated exencephaly, protruding tongues, and low-set ears. No treatmentrelated effects on embryofetal toxicity or malformation were noted at 5 mg/kg/day (28 times the MRHD based on AUC comparison). Intravenous doses of 0.5, 1, and 2 mg/kg/day imiquimod were administered during the period of organogenesis to pregnant female rabbits.
No treatment-related effects on embryofetal toxicity or malformation were noted at 2 mg/kg/day (2.1 times the MRHD based on BSA comparison), the highest dose evaluated in this study, or 1 mg/kg/day (115 times the MRHD based on AUC comparison). A combined fertility and peri- and postnatal development study was conducted in rats. Oral doses of 1, 1.5, 3, and 6 mg/kg/day imiquimod were administered to male rats from 70 days prior to mating through the mating period and to female rats from 14 days prior to mating through parturition and lactation.
No effects on growth, fertility, reproduction, or postnatal development were noted at doses up to 6 mg/kg/day (25 times the MRHD based on AUC comparison), the highest dose evaluated in this study. In the absence of maternal toxicity, bent limb bones were noted in the F1 fetuses at a dose of 6 mg/kg/day (25 times the MRHD based on AUC comparison). This fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod.
No treatment-related malformations were noted at 3 mg/kg/day (12 times the MRHD based on AUC comparison).
🧒 Pediatric Use ▾
8.4Pediatric Use Actinic Keratosis The safety and effectiveness of imiquimod cream for the treatment of AK in pediatric patients have not been established. External Genital Warts The safety and effectiveness of imiquimod cream for the treatment of EGW in pediatric patients 12 years of age and older have been established. Use of imiquimod cream for this indication is supported by evidence from adequate and well controlled trials in adults and pediatric subjects [see Clinical Studies (14.2)].
The safety and effectiveness of imiquimod cream for the treatment of EGW in pediatric patients less than 12 years of age have not been established. Molluscum Contagiosum The safety and effectiveness of imiquimod cream for the treatment of molluscum contagiosum (MC) in pediatric patients have not been established. Safety and effectiveness of imiquimod cream, 5% was not demonstrated in two randomized, vehicle-controlled, double-blind trials involving 702 pediatric subjects with MC (470 exposed to imiquimod cream; median age 5 years, range 2 to12 years).
Adverse reactions reported in pediatric subjects with MC (and not previously reported) included otitis media (5% imiquimod cream vs. 3% vehicle) and conjunctivitis (3% imiquimod cream vs. 2% vehicle).
In a pharmacokinetics trial in subjects aged 2 to 12 years with extensive MC involving a least 10% of total body surface area; among the 20 subjects with evaluable laboratory assessments, the median white blood cell (WBC) count decreased by 1.4 x 10 9 /L and the median absolute neutrophil count decreased by 1.42 x 10 9 /L.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 320 subjects treated with imiquimod cream in the AK clinical trials, 150 subjects (47%) were 65 years of age or older. No overall differences in safety or effectiveness of imiquimod cream have been observed between subjects 65 years of age and older and younger adult subjects. Of the 400 subjects treated with imiquimod cream in the EGW clinical studies, 5 subjects (1%) were 65 years or older.
Clinical studies of imiquimod cream for EGW did not include sufficient numbers of subjects aged 65 years of age and older to determine whether they respond differently from younger adult subjects.
🆘 Overdosage ▾
10 OVERDOSAGE Topical overdosing of imiquimod cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions. Hypotension was reported in a clinical trial following multiple oral imiquimod doses of >200 mg (equivalent to ingestion of the imiquimod content of more than 21 packets or pump actuations of imiquimod cream, 3.75% or more than 32 pump actuations of imiquimod cream, 2.5%). The hypotension resolved following oral or intravenous fluid administration.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of imiquimod cream in treating AK and EGW lesions is unknown.
12.2Pharmacodynamics The pharmacodynamics of imiquimod cream are unknown. Imiquimod is a Toll-like receptor 7 agonist that activates immune cells. Topical application to skin is associated with increases in markers for cytokines and immune cells.
Actinic Keratosis In a study of 18 subjects with AK comparing imiquimod cream, 5% to vehicle, increases from baseline in Week 2 biomarker levels were reported for CD3, CD4, CD8, CD11c, and CD68 for imiquimod cream, 5% treated subjects; however, the clinical relevance of these findings is unknown. External Genital Warts Imiquimod has no direct antiviral activity in cell culture.
12.3Pharmacokinetics Absorption Following dosing with two packets of imiquimod cream, 3.75% once daily (18.75 mg imiquimod/day) for up to 3 weeks, systemic absorption of imiquimod was observed in all subjects when imiquimod cream was applied to the face and/or scalp in 17 subjects with at least 10 AK lesions. The mean peak serum imiquimod concentration at the end of the trial was approximately 0.323 ng/mL. The median time to maximal concentrations (Tmax) occurred at 9 hours after dosing.
Based on the plasma half-life of imiquimod observed at the end of the trial, 29.3±17 hours, steadystate concentrations can be anticipated to occur by Day 7 with once-daily dosing. Systemic absorption of imiquimod (up to 9.4 mg [one packet]) across the affected skin of 18 subjects with EGW was observed with once daily dosing for 3 weeks in all subjects. The subjects had either a minimum of 8 warts (range 8 to 93) or a surface area involvement of greater than 100 mm 2 (range 15 to 620 mm 2 ) at trial entry.
The mean peak serum imiquimod concentration at Day 21 was 0.488 +/- 0.368 ng/mL. The median time to maximal concentrations (Tmax) occurred 12 hours after dosing. Based on the plasma half-life of imiquimod observed at the end of the trial, 24.1+/-12.4 hours, steady-state concentrations can be anticipated to occur by Day 7 with once daily dosing.
Because of the small number of subjects present (13 males, 5 females) it was not possible to select out or do an analysis of absorption based on sex/site of application.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of imiquimod cream in treating AK and EGW lesions is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Imiquimod cream is white to slightly yellow in color. Imiquimod cream USP, 3.75%, is supplied as white plastic 30 mL pump bottle, equipped with a white cap. The 7.5 g pump delivers no fewer than 28 full actuations.
3.75% cream, NDC 51672-4174-9 Imiquimod cream USP, 3.75%, is also supplied in unit-dose foil packets which contain 0.25 g of cream: 3.75% cream, box of 28 packets, NDC 51672-4174-6 Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Avoid freezing Store imiquimod cream pump bottles upright.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Avoid freezing Store imiquimod cream pump bottles upright.
📋 Description ▾
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.
Imiquimod has a molecular formula of C 14 H 16 N 4 and a molecular weight of 240.3. Its structural formula is: Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Important Administration Instructions Inform all patients of the following [see Dosage and Administration (2.1)]: • Imiquimod cream is for topical use only and avoid contact with the eyes, lips, nostrils, or inside the anus and vagina. Instruct patients to rinse their mouth or eyes with water right away if contact with these areas occur. • Wash their hands before and after applying imiquimod cream. • If a imiquimod cream dose is missed, apply the next dose at the regularly scheduled time. • Discard and do not reuse partially used packets. • Discard pump bottles after completion of a full treatment course.
Inform patients with EGW of the following [see Dosage and Administration 2.3 and Warnings and Precautions (5.1)]: • Uncircumcised patients treating warts under the foreskin should retract the foreskin and clean the area daily. • Imiquimod cream may weaken condoms and vaginal diaphragms; therefore, concurrent use is not recommended. • Avoid sexual (genital, anal, oral) contact while imiquimod cream is on the skin. • Do not bandage or otherwise occlude the treatment area. Lactation Advise breastfeeding women to avoid application of imiquimod cream to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child [see Use in Specic Populations (8.2)].
Local Skin Reactions Inform patients of the following [see Dosage and Administration (2.2, 2.3) and Warnings and Precautions (5.1)]: • Local skin reactions may occur during treatment with imiquimod cream, ranging from mild to severe in intensity and extending beyond the application site onto the surrounding skin, and may require an interruption of dosing. • For female patients being treated for EGW, apply imiquimod cream at the opening of the vagina, avoiding intravaginal application because local skin reactions may cause difficulty in passing urine. • If severe local skin reactions occur, remove imiquimod cream by washing the treatment area with mild soap and water. • Contact their healthcare provider promptly if they experience any sign or symptom at the application site that restricts or prohibits their daily activity or makes continued application of imiquimod cream difficult. • Because of local skin reactions, during treatment and until healed, the treatment area is likely to appear noticeably different from normal skin.
Local Hypopigmentation and Hyperpigmentation Inform patients that localized hypopigmentation and hyperpigmentation have been reported following use of imiquimod cream and these skin color changes may be permanent in some patients [see Adverse Reactions (6.2)]. Systemic Reactions Inform patients that they may experience flu-like systemic signs and symptoms during treatment with imiquimod cream and these symptoms may require an interruption of dosing [see Warnings and Precautions (5.2)]. Ultraviolet Light Exposure Risks Instruct patients to avoid or minimize exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using imiquimod cream.
Instruct patients to use protective clothing and to not use imiquimod cream if sunburned [see Warnings and Precautions (5.3)].