Imiquimod (Page 5 of 6)

14.3 External Genital Warts

In a double-blind, placebo-controlled clinical study, 209 otherwise healthy subjects 18 years of age and older with genital/perianal warts were treated with Imiquimod Cream or vehicle control 3 times per week for a maximum of 16 weeks. The median baseline wart area was 69 mm2 (range 8 to 5525 mm2). Subject accountability is shown in the figure below.

Figure 1: Subject Accountability (External Genital Warts)
Figure 1
(click image for full-size original)

Data on complete clearance are listed in the table below. The median time to complete wart clearance was 10 weeks.

Table 14: Complete Clearance Rates (External Genital Warts) — Study EGW1
TreatmentSubjects with Complete Clearance of WartsSubjects Without Follow-upSubjects with Warts Remaining at Week 16
Overall
Imiquimod Cream
(n =109)
54 (50%)19 (17%)36 (33%)
Vehicle (n =100)11 (11%)27 (27%)62 (62%)
Females
Imiquimod Cream
(n =46)
33 (72%)5 (11%)8 (17%)
Vehicle (n =40)8 (20%)13 (33%)19 (48%)
Males
Imiquimod Cream
(n =63)
21 (33%)14 (22%)28 (44%)
Vehicle (n =60)3 (5%)14 (23%)43 (72%)

16 HOW SUPPLIED/STORAGE AND HANDLING

Imiquimod Cream, 5%, is supplied in single-use packets which contain 250 mg of the cream:

Box of 24 single-use packets – NDC 51672-4145-6 Discard unused packet.

Store at 4° — 25°C (39° — 77°F)

Avoid freezing.

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling

17.1 General Information: All Indications

Imiquimod Cream should be used as directed by a physician [see Dosage and Administration (2)].

Imiquimod Cream is for external use only. Contact with the eyes, lips and nostrils should be avoided. [see Indications and Usage (1) and Dosage and Administration (2)] The treatment area should not be bandaged or otherwise occluded. Partially-used packets should be discarded and not reused. The prescriber should demonstrate the proper application technique to maximize the benefit of Imiquimod Cream therapy.

It is recommended that patients wash their hands before and after applying Imiquimod cream.

17.2 Local Skin Reactions: All Indications

Patients may experience local skin reactions during treatment with Imiquimod Cream (even with normal dosing). Potential local skin reactions include erythema, edema, vesicles, erosions/ulcerations, weeping/exudate, flaking/scaling/dryness, and scabbing/crusting. These reactions can range from mild to severe in intensity and may extend beyond the application site onto the surrounding skin. Patients may also experience application site reactions such as itching and/or burning [see Adverse Reactions (6)]. Local skin reactions may be of such an intensity that patients may require rest periods from treatment. Treatment with Imiquimod Cream can be resumed after the skin reaction has subsided, as determined by the physician. Patients should contact their physician promptly if they experience any sign or symptom at the application site that restricts or prohibits their daily activity or makes continued application of the cream difficult. Because of local skin reactions, during treatment and until healed, the treatment area is likely to appear noticeably different from normal skin. Localized hypopigmentation and hyperpigmentation have been reported following use of Imiquimod Cream. These skin color changes may be permanent in some patients.

17.3 Systemic Reactions: All Indications

Patients may experience flu-like systemic signs and symptoms during treatment with Imiquimod Cream (even with normal dosing). Systemic signs and symptoms may include malaise, fever, nausea, myalgias and rigors [see Adverse Reactions (6)]. An interruption of dosing should be considered.

17.4 Patients Being Treated for Actinic Keratosis (AK)

Dosing is 2 times per week for a full 16 weeks, unless otherwise directed by the physician. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods [see Dosage and Administration (2.1)].

It is recommended that the treatment area be washed with mild soap and water 8 hours following Imiquimod Cream application.

Most patients using Imiquimod Cream for the treatment of AK experience erythema, flaking/scaling/dryness and scabbing/crusting at the application site with normal dosing [see Adverse Reactions (6.1)].

Use of sunscreen is encouraged, and patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Imiquimod Cream [see Warnings and Precautions (5.3)].

Sub-clinical AK lesions may become apparent in the treatment area during treatment and may subsequently resolve [see Clinical Studies (14.1)].

17.6 Patients Being Treated for External Genital Warts

Dosing is 3 times per week to external genital/perianal warts. Imiquimod Cream treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks.

It is recommended that the treatment area be washed with mild soap and water 6-10 hours following Imiquimod Cream application.

It is common for patients to experience local skin reactions such as erythema, erosion, excoriation/flaking, and edema at the site of application or surrounding areas. Most skin reactions are mild to moderate.

Sexual (genital, anal, oral) contact should be avoided while Imiquimod Cream is on the skin.

Application of Imiquimod Cream in the vagina is considered internal and should be avoided. Female patients should take special care if applying the cream at the opening of the vagina because local skin reactions on the delicate moist surfaces can result in pain or severe swelling, and may cause difficulty in passing urine or inability to urinate. Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.

New warts may develop during therapy, as Imiquimod Cream is not a cure.

The effect of Imiquimod Cream on the transmission of genital/perianal warts is unknown. Imiquimod Cream may weaken condoms and vaginal diaphragms; therefore, concurrent use is not recommended.

Should severe local skin reaction occur, the cream should be removed by washing the treatment area with mild soap and water.

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