Sinecatechins (Monograph)

Brand name: Veregen
Drug class: Skin and Mucous Membrane Agents, Miscellaneous
CAS number: 188265-33-0

Introduction

Antioxidant; a green tea extract consisting predominantly of catechins.

Uses for Sinecatechins

External Genital and Perianal Human Papillomavirus Warts

Treatment of external genital and perianal warts (condylomata acuminata) caused by human papillomavirus (HPV) in immunocompetent patients.

CDC recommends that external HPV genital warts be treated with a self-administered topical therapy (imiquimod, podofilox, sinecatechins), a topical therapy administered by a health-care provider (podophyllum resin, trichloroacetic acid [TCA], bichloroacetic acid [BCA]), or a surgical technique (cryotherapy, electrosurgery, surgical excision).

Should not be used for treatment of urethral, intravaginal, cervical, rectal, or intra-anal HPV disease; safety and efficacy not established.

Sinecatechins Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 15% ointment. For external use only.

Avoid contact with the eyes; do not administer orally, intravaginally, or intra-anally. Do not apply to open wounds.

Wash hands before and after application. Apply a thin layer to each wart with the finger(s), dabbing to ensure complete coverage. Do not use bandages, occlusive dressings, or wrappings.

Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.

Washing ointment from the treated area prior to the next application is not necessary. If bathing or washing the treatment area, apply ointment afterwards. (See Advice to Patients.)

Dosage

Adults

HPV Infections

External Genital and Perianal HPV Warts

Topical

Apply a 0.5-cm strand of ointment to each wart 3 times daily, dabbing with fingers to ensure complete coverage and leaving a thin film on warts.

Continue therapy until all warts have completely cleared or for a maximum of 16 weeks.

Safety and efficacy of multiple treatment courses not established.

Prescribing Limits

Adults

HPV Infections

External Genital and Perianal HPV Warts

Topical

Maximum of 16 weeks.

Special Populations

No special population dosage recommendations.

Cautions for Sinecatechins

Contraindications

• No known contraindications.

Warnings/Precautions

Other Forms of HPV Disease

Safety and efficacy not established for treatment of urethral, intravaginal, cervical, rectal, or intra-anal HPV disease.

Dermatologic Effects

Do not apply to open wounds. Local skin reactions occur frequently. (See Common Adverse Effects under Cautions.) Continue therapy when severity of the local skin reaction is acceptable. In case of severe local reactions (i.e., pruritus), wash area with mild soap and water to remove the ointment; withhold further doses and notify clinician.

Avoid exposure of the genital and perianal area to sunlight or ultraviolet light; effects of such light not studied.

Immunologic Effects

Safety and efficacy in immunosuppressed patients not established.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether topical sinecatechins is distributed into human milk.

Pediatric Use

Safety and efficacy not established in pediatric patients. Consult a clinician before using in children <12 years of age.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.

Common Adverse Effects

Erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, vesicular rash.

Drug Interactions

No formal drug interaction studies to date.

Sinecatechins Pharmacokinetics

Absorption

Bioavailability

Pharmacokinetics after topical application not fully characterized. Data suggest that systemic exposure to catechins following repeated topical application of sinecatechins ointment probably is less than that observed after single ingestion of 400 mL of green tea.

Distribution

Extent

Not known whether distributed into milk following topical application.

Stability

Storage

Topical

Ointment

Before dispensing to patient: 2–8°C. After dispensing, store refrigerated or at temperatures <25°C. Do not freeze.

Actions

• A botanical drug product; a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze.

• Mechanism of action in treatment of external genital and perianal HPV warts is unknown. Antioxidant activity demonstrated in vitro; the clinical importance of this finding is unknown. Green tea catechins may have immunostimulant, antitumor, and potent antiviral properties that may contribute to the therapeutic effect of sinecatechins ointment.

• Consists principally of catechins (85–95% by weight), including more than 55% epigallocatechin gallate (EGCg); other catechin derivatives present include epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECg), gallocatechin gallate (GCg), gallocatechin (GC), catechin gallate (Cg), and catechin (C). Also contains gallic acid, caffeine, and theobromine (together account for 2.5% of total drug substance) plus undefined botanical constituents.

Advice to Patients

• Importance of reading manufacturer’s patient information.

• Importance of using only as directed by clinician.

  Importance of applying externally only; importance of avoiding contact with the eyes or application into the vagina or anus.

• Importance of advising patients that sinecatechins ointment is not a cure for external genital and perianal warts. New warts may appear during therapy and also should be treated.

• Local skin reactions are common. (See Dermatologic Effects under Cautions.) If severe skin reactions occur, contact clinician, wash treatment area with mild soap and water, and withhold further application.

• Importance of advising patients to avoid sexual (genital, anal, or oral) contact while the ointment is on the skin. The ointment must be washed off carefully before having protected sexual contact, since the ointment may weaken condoms and vaginal diaphragms. Importance of advising patients that the effect of sinecatechins on the transmission of genital and perianal warts is unknown.

• Importance of advising female patients using tampons that a tampon should be inserted before applying the ointment; avoid accidental application of the ointment into the vagina if the tampon is changed while the ointment is on the skin.

• Importance of advising uncircumcised males to retract the foreskin and clean the area daily.

• Importance of advising patients to avoid exposure of the genital and perianal area to sunlight or ultraviolet light.

• Importance of advising patients not to bandage, cover, or wrap the treatment area. (See Topical Administration under Dosage and Administration.)

• Importance of advising patients that the ointment may stain clothing or bedding.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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