Imiquimod 5% Cream Single Use Pkts
It is used to treat genital warts.It is used to treat perianal warts.It is used to treat skin harmed by the sun and some skin cancers.
Drug Class
Immune Response Modifier
Pharmacologic Class
Toll-like Receptor 7 (TLR7) Agonist
Pregnancy Category
Category C
FDA Approved
Feb 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Imiquimod is a cream applied to the skin to help your body's immune system fight certain skin conditions, like warts, sun-damaged skin (actinic keratosis), and a type of skin cancer (superficial basal cell carcinoma). It works by boosting your natural defenses.
How to Use This Medicine
Proper Use of This Medication
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines below.
General Instructions
Use this medication only as directed by your doctor. Do not exceed the recommended dose or duration of treatment, as this may increase the risk of severe skin reactions or other side effects.
Apply this medication topically, only to the affected skin areas. Avoid ingestion, and keep the medication away from your mouth, nose, and eyes, as it may cause irritation.
Do not apply this medication to the vagina or anus.
Use this medication at bedtime, and wash your hands before and after application.
Clean the affected area before applying the medication, and ensure it is completely dry (at least 10 minutes) before use.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying this medication to sunburned skin, cuts, scrapes, burns, rashes, or infected or damaged skin.
Unless directed by your doctor, do not apply this medication to healthy skin.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
After applying the medication, avoid bathing, showering, or swimming.
Leave the medication on the skin for the duration specified by your doctor, then wash it off.
Discard any unused portion of the medication packet after use.
Specific Instructions for Genital or Perianal Warts
If you are an uncircumcised male with warts under the foreskin, gently pull back the foreskin and clean the area daily.
Specific Instructions for Actinic Keratosis
You may notice an initial increase in the number of lesions before they start to improve. Continue using the medication as directed by your doctor, even if the skin appears to be healed.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures. Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, skip it and resume your regular application schedule. Do not apply extra doses or double doses to make up for the missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines below.
General Instructions
Use this medication only as directed by your doctor. Do not exceed the recommended dose or duration of treatment, as this may increase the risk of severe skin reactions or other side effects.
Apply this medication topically, only to the affected skin areas. Avoid ingestion, and keep the medication away from your mouth, nose, and eyes, as it may cause irritation.
Do not apply this medication to the vagina or anus.
Use this medication at bedtime, and wash your hands before and after application.
Clean the affected area before applying the medication, and ensure it is completely dry (at least 10 minutes) before use.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying this medication to sunburned skin, cuts, scrapes, burns, rashes, or infected or damaged skin.
Unless directed by your doctor, do not apply this medication to healthy skin.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
After applying the medication, avoid bathing, showering, or swimming.
Leave the medication on the skin for the duration specified by your doctor, then wash it off.
Discard any unused portion of the medication packet after use.
Specific Instructions for Genital or Perianal Warts
If you are an uncircumcised male with warts under the foreskin, gently pull back the foreskin and clean the area daily.
Specific Instructions for Actinic Keratosis
You may notice an initial increase in the number of lesions before they start to improve. Continue using the medication as directed by your doctor, even if the skin appears to be healed.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures. Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, skip it and resume your regular application schedule. Do not apply extra doses or double doses to make up for the missed dose.
Lifestyle & Tips
- Apply the cream exactly as directed by your doctor, usually at bedtime.
- Wash your hands thoroughly before and after applying the cream.
- Use one single-use packet for each application; do not reuse opened packets.
- Apply a thin layer to the affected area and rub it in until it disappears.
- Leave the cream on for the prescribed time (usually 6-10 hours) and then wash it off with mild soap and water.
- Avoid contact with eyes, lips, nostrils, and internal mucous membranes.
- Do not apply to open wounds or broken skin.
- Avoid sexual contact when the cream is on the skin, especially for genital warts, as it can weaken condoms/diaphragms and may irritate a partner's skin.
- Protect treated areas from sun exposure, as the cream can increase sun sensitivity.
- Local skin reactions (redness, swelling, itching, burning, flaking) are common and expected; they indicate the medicine is working. Report severe reactions to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For external genital/perianal warts: Apply 3 times per week at bedtime. For actinic keratosis: Apply 2 times per week at bedtime. For superficial basal cell carcinoma: Apply 5 times per week at bedtime.
Condition-Specific Dosing:
externalGenitalPerianalWarts:
Apply a thin layer to the affected area and rub in until the cream is no longer visible. Apply 3 times per week (e.g., Monday, Wednesday, Friday) prior to normal sleeping hours and leave on the skin for 6 to 10 hours. Remove cream by washing the treated area with mild soap and water. Treatment should continue until clearance of the warts or for a maximum of 16 weeks per episode of warts.
actinicKeratosis:
Apply a thin layer to the affected area and rub in until the cream is no longer visible. Apply 2 times per week (e.g., Monday and Thursday) prior to normal sleeping hours and leave on the skin for approximately 8 hours. Remove cream by washing the treated area with mild soap and water. Treatment should continue for 16 weeks.
superficialBasalCellCarcinoma:
Apply a thin layer to the tumor and 1 cm of skin surrounding the tumor and rub in until the cream is no longer visible. Apply 5 times per week (e.g., Monday through Friday) prior to normal sleeping hours and leave on the skin for approximately 8 hours. Remove cream by washing the treated area with mild soap and water. Treatment should continue for 6 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Safety and efficacy not established for external genital/perianal warts in patients <12 years of age, and for actinic keratosis or superficial basal cell carcinoma in patients <18 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No adjustment needed (minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
Mechanism of Action
Imiquimod is an immune response modifier. It acts as a Toll-like receptor 7 (TLR7) agonist, stimulating immune cells (e.g., monocytes, macrophages, dendritic cells) to release pro-inflammatory cytokines, including interferon-alpha (IFN-Ξ±), tumor necrosis factor-alpha (TNF-Ξ±), and interleukins (IL-1, IL-6, IL-8, IL-10, IL-12). These cytokines mediate an antiviral and antitumor immune response.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<0.9%) after topical application.
Tmax:
Approximately 15 hours (after single topical dose).
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not available (minimal systemic absorption).
ProteinBinding:
Not available (minimal systemic absorption).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Approximately 2-30 hours (systemic, highly variable due to low absorption).
Clearance:
Not available (minimal systemic absorption).
ExcretionRoute:
Renal and fecal excretion of metabolites.
Unchanged:
<0.1% (systemic, in urine).
Pharmacodynamics
OnsetOfAction:
Immune response develops over weeks of treatment.
PeakEffect:
Clinical response observed over several weeks to months of treatment.
DurationOfAction:
Not applicable in terms of single dose effect; sustained immune modulation with continued use.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Flu-like symptoms, including:
+ Headache
+ Weakness
+ Fever
+ Chills
+ Aches
+ Pains
+ Sweating
Bleeding
Swollen glands
Skin reactions at the application site or surrounding area, such as:
+ Burning
+ Crusting
+ Dryness
+ Flaking
+ Itching
+ Oozing
+ Pain
+ Redness
+ Scabbing
+ Scaling
+ Sores or ulcers
+ Swelling
If these skin reactions become severe, your doctor may advise you to take a break from using the medication. Gently wash the affected area with mild soap and water, and consult your doctor.
Contact your doctor immediately if you experience a skin reaction that:
Bothers you
Interferes with daily activities
Causes problems with applying the medication
For genital or perianal warts:
Vaginal pain or swelling
Difficulty urinating
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Skin color changes (may be permanent)
Headache
Upset stomach
Fatigue or weakness
Common cold symptoms
Sinus pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Flu-like symptoms, including:
+ Headache
+ Weakness
+ Fever
+ Chills
+ Aches
+ Pains
+ Sweating
Bleeding
Swollen glands
Skin reactions at the application site or surrounding area, such as:
+ Burning
+ Crusting
+ Dryness
+ Flaking
+ Itching
+ Oozing
+ Pain
+ Redness
+ Scabbing
+ Scaling
+ Sores or ulcers
+ Swelling
If these skin reactions become severe, your doctor may advise you to take a break from using the medication. Gently wash the affected area with mild soap and water, and consult your doctor.
Contact your doctor immediately if you experience a skin reaction that:
Bothers you
Interferes with daily activities
Causes problems with applying the medication
For genital or perianal warts:
Vaginal pain or swelling
Difficulty urinating
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Skin color changes (may be permanent)
Headache
Upset stomach
Fatigue or weakness
Common cold symptoms
Sinus pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe skin reactions (e.g., blistering, severe swelling, open sores)
- Signs of infection (e.g., pus, increasing pain, fever)
- Severe flu-like symptoms (rare)
- Allergic reaction (rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If your skin has not fully healed from previous treatments or surgeries.
* If you are currently taking any other medications that contain the same active ingredient as this drug.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If your skin has not fully healed from previous treatments or surgeries.
* If you are currently taking any other medications that contain the same active ingredient as this drug.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
Important Warnings and Cautions for This Medication
General Precautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Regularly check your skin as advised by your doctor to monitor for any changes.
Be aware that you may be more susceptible to sunburn while using this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when going outside.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Specific Considerations for Genital or Perianal Warts
This medication will not cure your genital or perianal warts, and it is possible that new warts may develop during treatment. Notify your doctor if you notice any new warts.
When using this medication for genital or perianal warts, be aware that condoms or diaphragms may not be effective in preventing pregnancy. Consider using an alternative method of birth control.
Avoid engaging in sexual activity when the medication is applied to your genital or anal skin.
Special Instructions for Actinic Keratosis
If you are breastfeeding, take precautions to prevent the medication from coming into contact with your baby's mouth or eyes.
* Avoid applying the medication to areas of skin that may come into contact with your baby's face, as this could cause unintended exposure.
General Precautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Regularly check your skin as advised by your doctor to monitor for any changes.
Be aware that you may be more susceptible to sunburn while using this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when going outside.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Specific Considerations for Genital or Perianal Warts
This medication will not cure your genital or perianal warts, and it is possible that new warts may develop during treatment. Notify your doctor if you notice any new warts.
When using this medication for genital or perianal warts, be aware that condoms or diaphragms may not be effective in preventing pregnancy. Consider using an alternative method of birth control.
Avoid engaging in sexual activity when the medication is applied to your genital or anal skin.
Special Instructions for Actinic Keratosis
If you are breastfeeding, take precautions to prevent the medication from coming into contact with your baby's mouth or eyes.
* Avoid applying the medication to areas of skin that may come into contact with your baby's face, as this could cause unintended exposure.
Overdose Information
Overdose Symptoms:
- Excessive local skin reactions (severe erythema, edema, erosion, crusting)
- Systemic flu-like symptoms (fever, fatigue, headache, myalgia) - rare with topical use
What to Do:
Topical overdose is unlikely to cause systemic symptoms due to minimal absorption. Treatment should consist of washing the area with mild soap and water. Management of severe local skin reactions may include temporary cessation of treatment. For accidental ingestion, call a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Routine Monitoring
Local skin reactions (erythema, erosion, excoriation, flaking, edema, induration, vesiculation, ulceration, crusting)
Frequency: At each follow-up visit
Target: Expected and generally manageable
Action Threshold: Severe reactions may require temporary cessation of treatment or dose reduction. Advise patients that intense local inflammatory reactions are common and expected.
Flu-like symptoms (fever, fatigue, headache, myalgia)
Frequency: As reported by patient
Target: Mild to moderate, if present
Action Threshold: Rare due to minimal systemic absorption; if severe, consider temporary cessation.
Symptom Monitoring
- Local skin irritation (redness, swelling, itching, burning, pain, tenderness)
- Skin peeling or flaking
- Crusting or scabbing
- Open sores or blisters
- Changes in skin color at the application site
- Flu-like symptoms (fever, chills, body aches, fatigue)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high systemic doses, but human data are limited. Minimal systemic absorption is expected with topical use.
Trimester-Specific Risks:
First Trimester:
Limited data; theoretical risk based on animal studies at high systemic doses.
Second Trimester:
Limited data; theoretical risk based on animal studies at high systemic doses.
Third Trimester:
Limited data; theoretical risk based on animal studies at high systemic doses.
Lactation
It is not known whether imiquimod is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be low. Exercise caution when administering to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the motherβs clinical need for imiquimod and any potential adverse effects on the breastfed infant from imiquimod or from the underlying maternal condition.
Infant Risk:
Low risk due to minimal systemic absorption; monitor for local irritation if infant comes into contact with treated skin.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not recommended for use in children under 12 years for genital warts, or under 18 years for actinic keratosis or sBCC.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. No specific dose adjustment is required.
Clinical Information
Clinical Pearls
- Imiquimod is an immune response modifier, not a direct antiviral or cytotoxic agent. Its effects are mediated through the patient's own immune system.
- Local skin reactions (erythema, erosion, flaking, crusting) are common and expected. They are a sign that the medication is working and should be managed, not necessarily stopped, unless severe.
- Patients should be instructed on proper application technique, including applying a thin layer, rubbing it in, leaving it on for the specified duration, and washing it off.
- Treatment duration varies significantly by indication (e.g., 16 weeks for warts/AK, 6 weeks for sBCC). Adherence to the full course is crucial for efficacy.
- Avoid applying imiquimod to internal mucous membranes (vagina, anus, urethra) or open wounds.
- Sun protection is important during treatment as imiquimod can increase photosensitivity.
- For genital warts, advise patients that imiquimod may weaken condoms and diaphragms, and sexual contact should be avoided while the cream is on the skin.
Alternative Therapies
- For external genital/perianal warts: Podofilox, Sinecatechins, Cryotherapy, Surgical excision, Laser therapy.
- For actinic keratosis: 5-Fluorouracil, Diclofenac, Ingenol mebutate, Photodynamic therapy, Cryosurgery, Surgical excision.
- For superficial basal cell carcinoma: 5-Fluorouracil, Photodynamic therapy, Surgical excision (Mohs surgery), Cryosurgery, Radiation therapy.
Cost & Coverage
Average Cost:
Varies widely per single-use packet
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic may be Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.