Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, External:
Veregen: 15% (30 g) [contains propylene glycol]
Pharmacology
Mechanism of Action
The mechanism by which sinecatechins ointment aids in the clearance of genital and perianal warts is unknown. Antioxidant properties have been demonstrated in vitro; however, the significance of this finding is not known.
Pharmacokinetics/Pharmacodynamics
Absorption
Topical: Not sufficiently studied; based on limited data, minimal systemic absorption is expected.
Use: Labeled Indications
External genital and perianal warts (Condyloma acuminatum): Treatment of external genital and perianal warts (Condyloma acuminatum) in immunocompetent patients ≥18 years of age.
Contraindications
There are no contraindications listed in the prescribing information.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to the extract from green tea leaves or any component of the formulation.
Dosage and Administration
Dosing: Adult
External genital and perianal warts (Condylomata acuminata): Topical: Apply a thin layer (~0.5 cm strand) 3 times daily to all external genital and perianal warts until all warts have been cleared (maximum duration: 16 weeks)
Administration
Wash hands before and after application; apply with fingers, leaving a thin layer of ointment; do not wash ointment off affected area after application. Discontinue treatment if the severity of local skin reactions becomes unacceptable. Do not apply internally; do not apply to open wounds; do not apply occlusive dressing. Sexual contact should be avoided while ointment is on skin. For females requiring tampon use during treatment, tampon should be inserted prior to application of ointment to prevent accidental application of ointment into the vagina. May stain clothing or bedding.
Storage
Store at 2°C to 8°C (36°F to 46°F) until dispensed; after dispensing, patient may store under refrigeration or up to 25°C (77°F). Do not freeze.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
>10%:
Central nervous system: Localized burning (67%), local discomfort (≤56%)
Dermatologic: Erythema (70%), pruritus (69%), skin erosion (≤49%), skin sclerosis (35%), vesicular eruption (20%)
Local: Local pain (≤56%), dermal ulcer (≤49%), localized edema (45%)
1% to 10%:
Dermatologic: Desquamation (5%), dermatological reaction (2%), scarring (1%), skin rash (1%)
Genitourinary: Foreskin irretraction (3%; uncircumcised males)
Hematologic & oncologic: Lymphadenitis (3%; local), local hemorrhage (2%)
Hypersensitivity: Hypersensitivity reaction (2%)
Local: Application site discharge (3%), local irritation (1%)
<1%, postmarketing, and/or case reports: Dyschromia, eczema, facial rash, hyperesthesia, infection (perianal), local discoloration, local dryness, local tissue necrosis, papule, pelvic pain, staphylococcal bacteremia, urethritis, vulvitis
Warnings/Precautions
Concerns related to adverse effects:
- Skin irritation: Local skin reactions are common (eg, erythema, erosion, edema, itching, and burning); women may be at increased risk. If possible, continue treatment; severe reactions may require treatment interruption or discontinuation.
Disease-related concerns:
- HPV infection: Not intended for the treatment of urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease.
Special populations:
- Immunosuppressed patients: Safety and efficacy have not been established in immunosuppressed patients.
Other warnings/precautions:
- Appropriate use: For topical use only; ointment is not intended for internal use; avoid contact with eyes, nostrils, lips and mouth; avoid topical application to open wounds; has been shown to increase the risk of adverse reactions. The use of occlusive dressings should be avoided; do not bandage, cover or wrap. Avoid exposure of treated area to sun and/or UV-light.
- Duration of therapy: Continue treatment until all warts have been cleared (maximum duration: 16 weeks); the safety and efficacy of treatment lasting >16 weeks have not been established.
Monitoring Parameters
Application site reactions
Pregnancy
Pregnancy Considerations
Sinecatechins ointment may weaken condoms and diaphragms. Sinecatechins should not be used during pregnancy (CDC [Workowski 2015])
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience redness, burning, stinging, itching, or pain. Have patient report immediately to prescriber severe skin irritation, blisters, skin sores, oozing, bleeding, painful urination, difficult urination, or groin or pelvic pain or edema (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
