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Brand Name
Zyclara
Generic Name
Imiquimod
View Brand Information FDA approval date: November 09, 2010
Form: Cream
What is Zyclara (Imiquimod)?
ZYCLARA Cream, 2.5% and.
Approved To Treat
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Brand Information
Zyclara (imiquimod)
1DOSAGE FORMS AND STRENGTHS
ZYCLARA is a white to faintly yellow cream available as:
- Cream: 2.5%, in pump bottles. Each pump bottle, when actuated after priming, delivers 0.235 grams of cream.
- 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.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Local Skin Reactions
- Systemic Reactions
3.1Clinical 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 ZYCLARA or vehicle in 479 subjects with AK enrolled in two double-blind, vehicle-controlled trials (Studies AK1 and AK2) [
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.
In the AK trials, 11% (17/160) of subjects in the ZYCLARA, 3.75% arm, 7% (11/160) of subjects in the ZYCLARA, 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 ZYCLARA 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 ZYCLARA, 3.75% or vehicle to all warts once daily for up to 8 weeks (Studies EGW1 and EGW2)
The most frequently reported adverse reactions were application site reactions and local skin reactions. Selected adverse reactions are listed in Table 3.
*Percentage based on female population of 6/216 for ZYCLARA, 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 in patient discontinuation from the trial. The incidence and severity of selected local skin reactions are shown in Table 4.
The frequency and severity of local skin reactions were similar in both sexes, with the following exceptions: a) flaking/scaling occurred in 40% of males and in 26% of females and b) scabbing/crusting occurred in 34% of males and in 18% of females.
In Studies EGW1 and EGW2, 32% (126/400) of subjects who used ZYCLARA, 3.75% and 2% (4/202) of subjects who used vehicle discontinued treatment temporarily (required rest periods) due to adverse local skin reactions, and 1% (3/400) of subjects who used ZYCLARA, 3.75% discontinued treatment permanently due to local skin/application site reactions.
Other adverse reactions reported in subjects treated with ZYCLARA, 3.75% included: rash, back pain, application site rash, application site cellulitis, application site excoriation, application site bleeding, scrotal pain, scrotal erythema, scrotal ulcer, scrotal edema, sinusitis, nausea, pyrexia, and influenza-like symptoms.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of imiquimod. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Application Site Disorders: tingling at the application site
Body as a Whole: angioedema
Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, supraventricular tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope
Endocrine: thyroiditis
Gastrointestinal System Disorders: abdominal pain
Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma
Hepatic: abnormal liver function
Infections and Infestations: herpes simplex
Musculoskeletal System Disorders: arthralgia
Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, paresis, suicide
Respiratory: dyspnea
Urinary System Disorders: proteinuria, urinary retention, dysuria
Skin and Appendages: exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypertrophic scar, hypopigmentation
Vascular: Henoch-Schönlein purpura syndrome
4OVERDOSAGE
Topical overdosing of ZYCLARA 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 ZYCLARA, 3.75% or more than 32 pump actuations of ZYCLARA, 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.
5DESCRIPTION
ZYCLARA (imiquimod) cream, 2.5% or 3.75% is for topical administration. Each gram contains 25 mg or 37.5 mg of imiquimod, respectively, in a white to faintly yellow oil-in-water 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
6HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
ZYCLARA (imiquimod) cream is white to faintly yellow in color.
ZYCLARA, 2.5% and 3.75% is supplied as white plastic 30 mL pump bottles, equipped with a white cap. The 7.5 g pump bottle delivers no fewer than 28 full actuations:
- 2.5% cream, NDC 99207-276-75
- 3.75% cream, NDC 99207-271-75
ZYCLARA, 3.75% is also supplied in unit-dose plastic laminate packets which contain 0.25 g of cream:
- 3.75% cream, box of 28 packets, NDC 99207-270-28
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Important Administration Instructions
Inform all patients of the following
- ZYCLARA 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.
Inform patients with EGW of the following
- Uncircumcised patients treating warts under the foreskin should retract the foreskin and clean the area daily.
Lactation
Advise breastfeeding women to avoid application of ZYCLARA to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child
Local Skin Reactions
Inform patients of the following
- Local skin reactions may occur during treatment with ZYCLARA, ranging from mild to severe in intensity and extending beyond the application site onto the surrounding skin, and may require an interruption of dosing.
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
Systemic Reactions
Inform patients that they may experience flu-like systemic signs and symptoms during treatment with ZYCLARA and these symptoms may require an interruption of dosing
Ultraviolet Light Exposure Risks
Instruct patients to avoid or minimize exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using ZYCLARA. Instruct patients to use protective clothing and to not use ZYCLARA if sunburned
Distributed by:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Manufactured by:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada
Patented. See https://patents.ortho-dermatologics.com for US patent information.
ZYCLARA is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2024 Bausch Health Companies Inc. or its affiliates
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8Patient Information
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 09/2024
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