Veregen

kunecatechins

(koo-ne-kat-chinz) ,

Veregen

(trade name)

Classification

Therapeutic: none assigned
Pharmacologic: catechins
Pregnancy Category: C

Indications

Treatment of external genital and perianal warts in immunocompetent patients.Contains catechins and other components extracted from green tea leaves.

Action

Action in the treatment of warts may be due to anti-oxidative properties.

Therapeutic effects

Clearance of warts.

Pharmacokinetics

Absorption: Assumed to be minimal.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile

ROUTEONSETPEAKDURATION
topwithin daysunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Use on open wounds.
Use Cautiously in: Obstetric: Use during pregnancy only if maternal benefit outweighs fetal risk; Pediatric: Safe use in children <18 yr not established.

Adverse Reactions/Side Effects

Genitourinary

  • phimosis

Local

  • burning (most frequent)
  • edema (most frequent)
  • erosion (most frequent)
  • erythema (most frequent)
  • itching (most frequent)

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Topical (Adults) Apply three times daily to warts; treatment should not exceed 16 weeks.

Availability

Ointment: 15% in 15 g tubes

Nursing implications

Nursing assessment

  • Assess genital and perianal area prior to and periodically during therapy.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • Apply 0.5 cm strand to each wart using fingers, dabbing it on to ensure complete coverage and leaving a thin layer of ointment on warts. It is not necessary to wash ointment from treated area prior to next application. Do not bandage or cover with occlusive dressing Loose-fitting undergarments should be warn during treatment.
    • Do not apply to open wounds.
    • Do not apply into vagina or anus.

Patient/Family Teaching

  • Instruct patient on proper application technique. Inform patient that ointment may stain clothing and bedding. Darker colored undergarments are recommended. Advise patient to read Patient Information sheet before starting treatment and with each prescription refill.
  • Emphasize the importance of washing hands before and after application and avoiding contact with eyes. Advise patient not to use more cream than was prescribed. Missed doses should be applied as soon as possible; then return to regular schedule.
  • Inform patient that ointment is not a cure and new warts might develop during or after course of therapy. If new warts develop during treatment, treat with kunecatechins.
  • Uncircumcised males treating warts under the foreskin should retract foreskin and clean area daily.
  • Instruct patient to avoid genital, oral, or anal sexual contact while the ointment is on the skin. Wash ointment off before engaging in sexual activities. Inform patient that oils in the ointment weaken latex contraceptive devices, such as cervical caps, condoms, and diaphragms.
  • Advise female patients using tampons to insert tampon before applying ointment. If tampon is changed while ointment is on skin, accidental application of ointment into vagina should be avoided.
  • Inform patient that local skin reactions (erythema, erosion, edema, itching, burning) are common and treatment should be continued. If severe reactions occur, remove ointment by washing with mild soap and water and notify health care professional promptly.
  • Advise patient to avoid exposure of genital and perineal area to sun or UV light.
  • Advise patient to notify health care professional before taking any Rx, OTC, or herbal products.
  • Advise patient to avoid use of other topical medications on same treatment area unless recommended by health care professional.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Healing of genital or perianal warts. Treatment is continued until wart is healed or up to 16 wk.

sinecatechins

(sin-e-ka-tech-ins) ,

Veregen

(trade name)

Classification

Therapeutic: antivirals
Pharmacologic: botanical agents
Pregnancy Category: C

Indications

Treatment of external genital and perianal warts (Condylomata acuminata caused by human papillomavirus[HPV]) in immunocompetent patients 18 years and older.

Action

Beneficial effects may be due to antioxidant properties; made from extract of green tea.

Therapeutic effects

Regression of warts.

Pharmacokinetics

Absorption: Minimal systemic absorption (less than that of a cup of green tea).
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile

ROUTEONSETPEAKDURATION
TOPunknownunknownunknown

Contraindications/Precautions

Contraindicated in: Not to be used for urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease or on open wounds.
Use Cautiously in: Safe and effective use in immunosuppressed patients has not been established; Obstetric: Use during pregnancy only if potential maternal benefit justifies potential risk to the fetus.; Pediatric: Safe and effective use in patients <18 yr has not been established.

Adverse Reactions/Side Effects

Local

  • burning (most frequent)
  • edema (most frequent)
  • erythema (most frequent)
  • induration (most frequent)
  • pain/discomfort (most frequent)
  • pruritis (most frequent)
  • erosion/ulceration (most frequent)
  • vescicular rash (most frequent)
  • bleeding
  • desquamation
  • discharge
  • irritation
  • phimosis
  • rash
  • regional lymphadenitis
  • scar

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Oral (Adults >18 yr) apply to warts three times daily for up to 16 wk.

Availability

15% Ointment: 15–g tubes

Nursing implications

Nursing assessment

  • Assess affected area(s) prior to and periodically during therapy.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • Topical: Apply about 0.5 cm strand of brown ointment to each wart using finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of ointment on warts. Uncircumcised males treating warts under the foreskin should retract foreskin and clean area daily. Avoid application to open wounds, eyes, vagina, or anus. Ointment does not need to be washed off prior to next application. When area is washed or a bath is taken, re-apply ointment.

Patient/Family Teaching

  • Instruct patient to wash hands before and after application and on how to apply ointment. Avoid bandages or occlusive dressings; loose fitting clothing may be worn. Instruct patient to read Patient Information prior to application. Continue therapy up to 16 wks or until complete clearance of all warts. Inform patient that sinecatechins is not a cure. New warts may develop during 16–wk treatment period and may be treated with ointment. If warts do not go away or return after 16 wks, contact health care professional.
  • Inform patient that genital warts are sexually transmitted and may infect partners. Advise patient to avoid sharing this medication with others, even with same symptoms.
  • Inform patient that local skin reactions (erythema, erosion, edema, itching, burning) frequently occur. Continue treatment when severity is acceptable. If severe reactions occur, wash ointment off with mild soap and water, withhold further doses and notify health care professional.
  • Advise patient to avoid exposure of treated areas to sun and UV light.
  • Advise patient to avoid sexual contact while ointment is on skin. Ointment may weaken condoms and vaginal diaphragms. Wash prior to sexual contact.
  • Advise female patients to insert tampon prior to applying ointment. If tampon is changed while ointment is on skin, avoid accidental application of ointment to the vagina.
  • Inform patient that ointment may stain clothing and bedding.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Healing of external genital and perianal warts. Treatment is continued until warts are healed or up to 16 wks.
References in periodicals archive ?
In April, Medigene sold the remaining rights and stock of Veregen to Aresus Pharma and thereby completed its transformation into a pure-play immunotherapy company.
The new drug Veregen (Polyphenon E) Ointment is the first prescription botanical (herbal) drug approved by the U.S.
sinensis constituents in a topical 15% ointment (Veregen).
Jiang used a case study of Veregen (a FDA approved Botanical Medicine derived from green tea leaves) to demonstrate that FDA can be flexible in the review process if a product addresses an unmet medical need.
Brodell serves on speakers' bureaus for 3M/Graceway Pharmaceuticals, GlaxoSmithKIine/Stiefel, Dermik/BenzaClin, Galderma Laboratories LP, Medicis, Novartis Pharmaceuticals Corporation, PharmaDerm, Sanofi-Aventis, Veregen, and AbbVie.
* In November 2012, German Medigene AG and pan-European group Nordic Pharma entered into an exclusive agreement for the supply and marketing of Veregen (sinecatechins 15% ointment; formerly known as Polyphenon E) for the treatment of genital warts in the Czech Republic, Slovakia, Poland, Hungary, the Baltic countries, Georgia and the Commonwealth of Independent States (CIS).
(SeeNews) - Nov 8, 2012 - German biotechnology firm Medigene AG (ETR:MDG) today announced it launched its Veregen ointment for treatment of genital warts on the Swiss market and received approval for the product in eight other countries.
M2 PHARMA-January 23, 2012-MediGene signs licensing agreement for Veregen with EIP Eczacibasi(C)2012 M2 COMMUNICATIONS
Improper use may cause a hematologic remission while neurologic manifestations continue to progress' Explicit lack of evidence * Veregen (sinecatechins) ointment: ('not established'; 'The safety and effectiveness of 'not evaluated'; Veregen have not been established for 'not studied'; treatment beyond I6 weeks or for 'not determined') multiple treatment courses.
Biotech company MediGene AG (Frankfurt:MDG) (Xetra:MDG) has signed two additional license and supply agreements for the commercialisation and marketing of Veregen.
Langley, Ph.D., of the University of Minnesota, Minneapolis, used pharmacoeconomic modeling based on data from the two phase III, double-blind, vehicle-controlled, randomized trials of sinecatechins ointment 15% (Veregen) that included more than 1,000 patients, along with a systematic review of the published imiquimod (Aldara) literature, Dr.