FDA

Veregen

Approved 31 Oct 2006TopicalOintment

Indications

Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older (1.1) . Limitations of Use Safety and effectiveness of Veregen have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses (1.2) .

1.1Indication

Veregen is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

1.2Limitations of Use

The safety and effectiveness of Veregen have not been established for treatment beyond 16-weeks or for multiple treatment courses. The safety and effectiveness of Veregen in immunosuppressed patients have not been established.

Contraindications

None None (4)

Warnings and precautions

Veregen has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions. Use of Veregen on open wounds should be avoided. Patients should be advised to avoid exposure of the genital and perianal area to sun/UV-light as Veregen has not been tested under these circumstances.

Veregen should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease (5) .
Use of Veregen on open wounds should be avoided (5) .
Avoid exposure of Veregen treated areas to sun/UV-light as Veregen has not been tested under these circumstances (5) .

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on Veregen use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, sinecatechins did not cause malformations, but did affect the developing fetus in the presence of maternal toxicity when given to pregnant rabbits and rats by intravaginal or systemic routes of administration during the period of organogenesis ( see Data ).

At a glance

Brand name: Veregen
Active substance: sinecatechins
Route: Topical
Dosage form: Ointment
Applicant: Ani Pharms
Status: Prescription
FDA approval: 31 Oct 2006
Application: NDA021902-001

Indications

1.1Indication

Veregen is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

1.2Limitations of Use

Warnings and precautions

Veregen should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease (5) .
Use of Veregen on open wounds should be avoided (5) .
Avoid exposure of Veregen treated areas to sun/UV-light as Veregen has not been tested under these circumstances (5) .

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

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. In Phase 3 clinical trials, a total of 397 subjects received Veregen three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.

Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women. In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.

Local and regional reactions (including adenopathy) occurring at >1% in the treated groups are presented in Table 1. Table 1: Local and Regional Adverse Reactions During Treatment (% Subjects) Veregen ® (N = 397) Vehicle (N = 207) Erythema 70 32 Pruritus 69 45 Burning 67 31 Pain/discomfort 56 14 Erosion/Ulceration 49 10 Edema 45 11 Induration 35 11 Rash vesicular 20 6 Regional Lymphadenitis 3 1 Desquamation 5 <1 Discharge 3 <1 Bleeding 2 <1 Reaction 2 0 Scar 1 0 Irritation 1 0 Rash 1 0 A total of 266/397 (67%) of subjects in the Veregen group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction.

Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only. Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen and in 1% (1/99) in vehicle.

The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment. Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia. In a dermal sensitization study of Veregen in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

Most common adverse reactions are local skin and application site reactions including (incidence ≥ 20%) erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, and rash vesicular (6) . To report SUSPECTED ADVERSE REACTIONS, ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Veregen

Indications

1.1Indication

1.2Limitations of Use

Contraindications

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Veregen

Indications

1.1Indication

1.2Limitations of Use

Contraindications

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Adverse reactions

Composition

Official product information