Кераворт

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Кераворт

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Кераворт

Quick Facts

Property Description
Active ingredient Imiquimod
Form Topical Cream (e.g., 5%, 3.75%)
Pharmacological class Immune Response Modifier (IRM)
General purpose Clearing specific abnormal or infected skin cells
Origin Synthetic (Imidazoquinoline derivative)

The Active Substance: Imiquimod and Its Core Identity

Кераворт is a targeted topical medicine defined by the single active ingredient, Imiquimod, delivered in a topical cream formulation. This compound is a synthetic small molecule belonging to the imidazoquinoline chemical class, a distinctive group recognized for its immune-modulating properties. The medicine is strictly a prescription-only product, and its essential composition features Imiquimod dispersed within a specialized cream base designed for effective local absorption into the affected skin layers. Imiquimod is classified as an immune response modifier intended for topical use.

Pharmacological Type: Immune Response Modifier (IRM)

The pharmacological classification of Imiquimod is clinically recognized as an Immune Response Modifier (IRM) and a highly specific Toll-like Receptor 7 (TLR7) agonist. This specialized action mechanism describes how the molecule selectively activates specific immune cells to trigger an anti-viral and anti-tumor response. The medicine's differentiation lies in its use for localized skin issues in adult patients as a self-administered topical agent. By targeting the TLR7 pathway, the medication indirectly induces the production of vital signaling proteins, including Interferon-alpha and various cytokines, which are crucial for cellular defense.

General Purpose and Benefit

The central purpose of Кераворт is to leverage and amplify the body’s localized immune response to promote the efficient clearance of abnormal or infected skin cells. By generating this controlled immune system activity increase, the treatment provides the general therapeutic benefit of establishing a sustained biological defense reaction, leading to the resolution of specific external skin conditions. Its application is typically reserved for instances where the condition requires the patient's own immune system to be locally mobilized against pathological tissue.

What side effects are possible with Кераворт?

Possible Side Effects and Safety Information

The safety profile of Кераворт (Imiquimod) is primarily defined by high-incidence local inflammatory reactions at the application site, consistent with its function as an Immune Response Modifier, along with documented systemic flu-like symptoms.


Adverse Reaction Classification

Official regulatory documents classify adverse events by frequency and physiological system. Very common (ge 1/10) reactions include local skin effects such as erythema (redness), flaking/scaling, scabbing, swelling, and pruritus (itching). Common (ge 1/100 to < 1/10) systemic effects may include headache, fatigue, fever, and influenza-like illness. These effects are generally grouped under Skin and Subcutaneous Tissue Disorders and General Disorders and Administration Site Conditions.


Serious Adverse Reactions and Constraints

The official labeling notes the potential for intense local inflammatory reactions (e.g., skin weeping and erosion) which may necessitate temporary interruption of use. A specific serious reaction documented for use in the female external genitalia is severe vulvar swelling, potentially leading to urinary retention. Safety constraints note that the medicine should not be applied to broken or non-intact skin. The safety and effectiveness have not been established in immunosuppressed patients or in children under 12 for certain indications. Local skin reactions are often observed after only a few applications, establishing an early-onset safety pattern.

Overdose and Emergency Response

Overdose and When to Seek Help

This section addresses the officially documented manifestations of overdose with Кераворт (Imiquimod cream) as described in government regulatory documents.

Overdose scenarios are primarily defined by two conditions: excessive topical application and accidental oral ingestion.

Documented Overdose Manifestations

Overdose Type Manifestations and Outcomes (as listed in regulatory sources)
Excessive Topical Use May result in severe local skin reactions, including skin weeping and erosion at the application site.
Accidental Oral Ingestion Systemic symptoms may include nausea, emesis (vomiting), headache, myalgia (muscle pain), and fever. The most serious documented outcome following large oral doses is hypotension (low blood pressure).

Emergency Actions and Required Care

Immediate actions are determined by the nature of the overdose:

  • For Excessive Topical Use: If a severe local skin reaction occurs, the cream should be removed by washing the affected area with mild soap and water.
  • For Oral Ingestion: Accidental ingestion requires symptomatic treatment. Hypotension following severe ingestion is documented as being managed with oral or intravenous fluid administration.
  • Secondary Complication: Severe local inflammatory reactions (e.g., severe vulvar swelling) may lead to urinary retention, requiring interruption of dosing and potentially emergency catheterisation.

Urgent medical attention is necessary for symptoms of systemic effects, such as hypotension, and for complications like urinary retention. No specific antidote for Imiquimod is documented in official labeling.

Therapeutic Uses of Кераворт

What Кераворт Treats: Main Uses and Benefits

Кераворт (Imiquimod) is a topical medication generally used to manage specific skin conditions characterized by abnormal or virally infected cell growth. It is primarily applied across domains where additional symptomatic support is needed and localized intervention is appropriate. This medication is relevant for easing certain distressing symptoms in contexts involving external genital and perianal warts, actinic keratosis, and certain superficial basal cell carcinomas.

This treatment is relevant in clinical settings that involve localized skin manifestations where symptoms may create noticeable functional strain. The therapeutic goal is that it may assist with managing these manifestations and contributes to easing the overall symptom load. For patients, this provides supportive relief during symptomatic periods.

“This medication is applied in scenarios where additional management of discomfort is required, supporting general well-being during symptomatic phases.”


Quick Fact: Applied in Addressing Localized Skin Growths

The core benefit is that it helps improve day-to-day comfort by offering a topical approach. It is relevant in situations involving recurrent or episodic manifestations.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Кераворт — Official Regulatory Information

This section outlines the officially documented patient eligibility and non-eligibility information for Кераворт (Imiquimod) cream, based strictly on government regulatory documents.


Eligibility Scope

Classification Population or Condition Regulatory Status
Contraindicated Hypersensitivity Prohibited due to known allergy to Imiquimod or excipients.
Allowed Use Immunocompetent Adults (Age ge 18) Approved for all labeled indications.
Allowed Use (Limited) Adolescents ge 12 years Approved only for External Genital Warts (EGW).
Not Recommended Children < 18 years Safety and efficacy not established for most uses (e.g., Actinic Keratosis).

Condition-Specific and Special Population Rules

  • Immunosuppression: Use is generally not recommended or not established as the drug's action is tied to the immune response. Repeat treatment is not established.
  • Autoimmune Conditions: Use requires caution due to the potential for the pre-existing condition to worsen.
  • Pregnancy Status: Classified as Pregnancy Category C; use is only permitted if the potential benefit justifies the potential risk to the fetus.
  • Lactation: It is not known if the drug is excreted in human milk; the decision involves considering discontinuing nursing or discontinuing the drug.
  • Skin Integrity: Application must be avoided on skin that is not intact (e.g., cuts, abrasions, or unhealed surgical sites).

Connection to the Overall Eligibility Profile

Regulatory documents define that full eligibility for all indicated uses is limited to immunocompetent adults, with hypersensitivity serving as an absolute prohibition. Eligibility for other groups is restricted based on age or physiological status, such as during pregnancy, where caution is advised, or in children, where use for most indications is not established.

What should I know about interactions with other medicines?

Кераворт (Imiquimod) interaction information is primarily focused on co-administration restrictions, specific substance cautions, and pharmacodynamic effects, reflecting its topical application and immune-modifying class. No formal systemic drug-drug interactions via metabolic (CYP) or transporter pathways are documented in official regulatory labeling.

Pharmacodynamic and Population Cautions

A documented pharmacodynamic interaction exists with immunosuppressive medication, as co-administration may increase the risk of systemic immunosuppression. Caution is specifically noted for use in organ transplant patients due to the potential risk of graft rejection and in patients with pre-existing autoimmune conditions due to the risk of exacerbation.

Restrictions and Substance Interactions

Interaction-related restrictions govern co-administration and physical contact. The cream may weaken the integrity of latex contraceptives such as condoms and diaphragms; concurrent use is not recommended. For this reason, the cream must be washed from the skin before sexual activity. There is also a formal restriction on the simultaneous use of other Imiquimod products in the same treatment area due to the potential for increased local and systemic exposure. Furthermore, Imiquimod treatment may cause heightened sunburn susceptibility (photosensitivity), requiring the avoidance or minimization of exposure to UV light and sunlight. The label also specifies a timing rule: treatment is not recommended until the skin has fully healed after any previous drug or surgical cutaneous treatment.

Mechanism of Action

Кераворт (Imiquimod) functions as an Immune Response Modifier (IRM) defined by the specific activation of the innate immune system, resulting in the induction of programmed cell death pathways. The molecule acts as an agonist by binding directly to the Toll-like Receptor 7 (TLR7), a pattern recognition receptor expressed inside specialized immune cells, primarily plasmacytoid dendritic cells (pDCs). This initial molecular recognition initiates the signaling cascade of the innate immune system. Activation of TLR7 triggers internal signaling pathways, including IRF-7 and NF-κB, which induce the host cells to synthesize and release key signaling proteins. This mediator release is characterized by robust production of Interferon-alpha (IFN-α) and various cytokines (e.g., IL-6, TNF-α), establishing a localized inflammatory and signaling environment. The resulting cascade of immune mediators attracts and activates effector cells like Natural Killer (NK) cells and T-lymphocytes to the site of action. This activity induces programmed cell death (apoptosis) and exerts anti-proliferative effects on the cells, resulting in their immune-mediated clearance.

Dosage and Administration Information

How to Use Кераворт: Official Administration Guidelines

Кераворт (Imiquimod) cream is a medicine restricted to topical use only and is not approved for internal application, such as oral, ophthalmic, or intra-anal use. The administration protocol is structured and varies based on the cream strength and the specific condition being addressed.

Administration Schedule and Duration

Indication Strength Frequency Max Duration/Cycle
Superficial Basal Cell Carcinoma (sBCC) 5% Cream 5 times per week 6 weeks continuous
External Genital Warts (EGW) 5% Cream 3 times per week Max 16 weeks
Actinic Keratosis (AK) 3.75% Cream Once daily Two 2-week cycles (total 6 weeks)

Procedural Steps and Timing

Application must always occur once daily on scheduled treatment days, ideally before bedtime. The protocol mandates that the cream must be applied to the specified treatment area in a thin layer and rubbed in until it vanishes. Following this, the cream is required to remain on the skin for a defined dwell period of approximately 8 hours. It is essential that the cream be removed with mild soap and water after this period. Single-use packets must not be re-used, and the area must not be covered with bandages.

Population Use and Missed Doses

Кераворт is approved for use in External Genital Warts for patients 12 years of age and older, with use in younger children not being established. If a dose is missed, the standard procedure involves applying the cream as soon as remembered and resuming the regular schedule, with the instruction not to apply the cream more than once per day.

Recent Clinical Evidence

Research evidence / Overview of studies for Кераворт

The research on Кераворт (Imiquimod) primarily consists of randomized controlled trials (RCTs). These studies randomly assign participants to receive either the active cream or an inactive vehicle (placebo) cream to allow researchers to observe and measure any differences in outcomes. The findings from these studies help contextualize how patients reported their experience in defined patient groups under specific, controlled conditions.


Evidence for use in External Genital and Perianal Warts

Research examined adult patients with external genital and perianal warts, which are conditions characterized by fluctuating or episodic manifestations. Studies compared the topical application of Imiquimod cream to a non-active vehicle cream, and some research also examined other treatment modalities as comparators. The main outcomes that research monitored were the proportion of patients who achieved the defined criteria for complete clearance of visible warts and the subsequent recurrence frequency during a treatment-free follow-up period.

Studies monitored outcomes where a specific proportion of patients met the defined criteria for complete clearance during the treatment period, with lower corresponding proportions reported in the vehicle cream group. Some research described how outcomes evolved when comparing male and female study participants. Long-term outcomes are not well characterized beyond the observation periods reported in key studies, and data for certain groups remain insufficient, particularly for immunocompromised patients.


Evidence for use in Small Superficial Basal Cell Carcinomas

For small superficial basal cell carcinomas (sBCCs), the research was evaluated in adult patients, typically excluding tumors in anatomically complex or high-risk areas. Key measures studies monitored were the histologic clearance rate (which requires a tissue biopsy to confirm tumor status) and the long-term recurrence rate over multiple years (up to five years).

Research describes the histologic clearance rates at the primary assessment point. Comparative trials studies explored whether the reported long-term clearance rates data show patterns related to surgical methods. Data for certain groups remain insufficient, particularly for lesions located in high-risk areas or for types of basal cell carcinoma that are not classified as superficial.


What is Still Uncertain About Кераворт's Evidence

The evidence base contributes to the broader evidence landscape. Key areas that require further research include more head-to-head comparative evidence against all established treatments, especially regarding long-term durability of response beyond a few years. Results apply only to the populations studied in the major trials, meaning the activity of the cream in patients with complex health issues is less well-characterized.

Frequently Asked Questions (FAQ)

Common questions about Кераворт (FAQ)


Q: How long does it typically take to start feeling the effects of Кераворт?

The onset of the medicine’s activity is commonly indicated by the appearance of expected local skin reactions, which often begin after only a few applications. These reactions signal that the immune system is responding to the cream. The full assessment of the treatment's effectiveness, however, is officially conducted after the entire prescribed course is completed and local skin reactions have fully resolved.


Q: Do I need to avoid any specific foods or drinks while using Кераворт?

Official regulatory information, such as the prescribing label, does not document any specific foods or beverages that must be avoided while using this topical medicine. As systemic absorption is low, dietary restrictions are generally not specified in the product labeling.


Q: Can Кераворт be taken with common pain relievers like ibuprofen or paracetamol?

Official labeling does not document known systemic drug-drug interactions for this topical cream because it acts primarily locally. In fact, regulatory documents acknowledge that common pain relievers like paracetamol have been used in clinical settings to manage expected systemic side effects, such as fever or flu-like symptoms.


Q: Are there any known long-term effects of taking Кераворт for many years?

The official product information states that long-term outcomes for the medicine are not well characterized beyond the observation periods reported in the key studies that led to regulatory approval. Patients are generally monitored for recurrence of the treated condition during follow-up.


Q: Can I use Кераворт if I have a history of liver or kidney problems?

Regulatory documents do not specifically list liver or kidney impairment as a contraindication for using the cream. The active ingredient is a topical treatment with a primarily local effect and minimal systemic absorption into the bloodstream.


Q: Is Кераворт used for the same things in all countries?

The official indications for this medicine include the topical treatment of specific conditions, such as Actinic Keratosis, Superficial Basal Cell Carcinoma, and External Genital Warts. These approved uses are generally recognized by major international regulatory bodies, though local approvals may vary.


Q: What kind of specialist usually recommends Кераворт?

As a topical medicine indicated for specific skin conditions, including certain types of skin cancer and warts, it is typically prescribed by a healthcare professional specializing in skin care. This usually includes a dermatologist or a specialist familiar with dermatological oncology.


Q: Is it normal to feel a bit nauseous when first starting Кераворт?

Yes, according to the official prescribing information, nausea is documented as one of the systemic flu-like signs and symptoms that may occur while the body's immune system is reacting to the cream. This is grouped among other common effects like headache and fatigue.


Q: How does Кераворт affect my ability to drive or operate machinery?

Official documents do not contain a specific warning against driving or operating machinery. However, systemic side effects such as fatigue, headache, and dizziness have been reported in clinical trials. These reported effects could potentially impact a patient's ability to perform complex tasks.


Q: Is Кераворт related to any older, discontinued medications?

The active ingredient in the cream, Imiquimod, is defined as a synthetic small molecule. It belongs to the imidazoquinoline chemical class, which is recognized for its immune-modulating properties.


Q: What should I do if I suspect an interaction between Кераворт and another medicine?

Official regulatory guidance emphasizes the importance of transparent communication with a healthcare team regarding all prescription and nonprescription medicines or supplements. This communication helps manage potential interactions.


Q: Are there any specific safety rules to follow when traveling with Кераворт?

The key safety rules for handling the medicine apply during travel. Official requirements specify that the cream should be stored at controlled room temperature, kept tightly closed, and protected from excessive heat, moisture, and especially freezing.


Q: Does the effectiveness of Кераворт change over time?

Research suggests that long-term durability of response beyond a few years is an area that requires further study. The risk of the treated condition recurring is a known factor that is monitored in clinical trials, but initial effectiveness is based on the full course of treatment.


Q: Is Кераворт used for any conditions other than its primary approved use?

The use of the medicine is restricted by regulatory bodies to the specific conditions for which it has received approval. These conditions include Actinic Keratosis, Superficial Basal Cell Carcinoma, and External Genital Warts.


Q: Can elderly patients use Кераворт safely?

According to official regulatory documents, studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of the cream in the elderly population. Eligibility is primarily based on the specific indication and general health status.


Q: Why is it important for doctors to monitor certain things while a patient is on Кераворт?

Monitoring is important due to the risk of intense local inflammatory reactions and systemic flu-like signs that may occur as the immune system responds to the cream. Additionally, for certain uses like Superficial Basal Cell Carcinoma, follow-up monitoring is required to confirm that the condition has cleared.


Q: Is there a generic version of Кераворт available?

Yes, the active ingredient in Кераворт is Imiquimod. Generic formulations containing this active substance are available and are listed in general drug listings provided by authoritative sources like DailyMed.


Q: How soon after starting treatment can doctors evaluate if Кераворт is working?

Official guidelines note that the complete response to treatment generally cannot be adequately assessed until after the full treatment course is completed and local skin reactions have resolved. Follow-up evaluations may be scheduled several weeks after the treatment initiation to check progress.


Q: Why is Кераворт sometimes not recommended for people with certain heart conditions?

The product labeling does not include a general contraindication for 'certain heart conditions.' However, the official label notes that atrial fibrillation has been reported as an adverse event. Any prescribing decision considers the patient's full medical history.


Q: Are there patient support groups or official resources for people using Кераворт?

Yes, government-supported health information resources, such as the NIH's MedlinePlus, provide patient-friendly, factual information about this active ingredient and its authorized uses. These resources are designed to supplement discussions with a healthcare team.


Q: Does research suggest Кераворт has any unexpected benefits?

The research evidence provided by regulatory bodies primarily focuses on the medicine's effectiveness concerning its defined outcomes, such as cell clearance and recurrence rates. Official reviews of the studies do not focus on or emphasize unexpected benefits.


Q: Is it mandatory to have regular blood tests while taking Кераворт?

The standard application instructions provided in the official labeling do not require routine regular blood tests for all patients. However, white blood cell and platelet counts have been reported as decreasing in clinical trials, indicating that monitoring may be considered necessary by a healthcare professional.


Q: What kind of lifestyle changes are often suggested alongside using Кераворт?

The official label requires certain precautions during use. These include avoiding or minimizing exposure to UV light and sunlight due to the risk of photosensitivity, and washing the cream from the skin before sexual activity, as it can weaken latex contraceptives.


Q: Is Кераворт considered a safe drug according to regulatory bodies?

The medicine is a prescription-only product that has been approved by regulatory bodies, such as the FDA and EMA, for the topical treatment of specific skin conditions. All approved medicines have documented safety profiles, and eligibility is determined by the patient's contraindications and medical history.


Q: If I have a mild reaction to Кераворт, should I stop using it?

The official instructions note that a temporary interruption of dosing may be required only if a patient experiences intense local inflammatory reactions, such as weeping or erosion. Since mild skin reactions are common, official guidance recommends communication with a healthcare professional to determine if a rest period is necessary.

How should Кераворт be stored and disposed of?

Кераворт (Imiquimod cream) must be stored and handled according to the following official regulatory requirements:

Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F).
Protection Keep the container tightly closed and protect the cream from excessive heat, moisture, and freezing (Do not freeze).
Container The medication must be kept in its original container.
Stability Discard any opened or partially used unit-dose packets immediately; they are not intended for reuse.
Child Safety The medicine must be stored out of the reach of children and out of their sight.

Disposal

All unused or expired Кераворт must be discarded safely. Patients should consult a healthcare professional or pharmacist for specific instructions on how to dispose of the medication in accordance with local, regional, and national regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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