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Sinecatechins: Drug information

Sinecatechins: Drug information
(For additional information see "Sinecatechins: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Veregen
Brand Names: Canada
  • Veregen
Pharmacologic Category
  • Keratolytic Agent;
  • Topical Skin Product
Dosing: Adult
External genital and perianal warts

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)

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>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

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to the extract from green tea leaves or any component of the formulation.

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Veregen: 15% (30 g) [contains propylene glycol]

Generic Equivalent Available: US

No

Pricing: US

Ointment (Veregen External)

15% (per gram): $64.05

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Veregen: 10% (15 g, 30 g) [contains propylene glycol palmitostearate]

Administration: Adult

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.

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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Sinecatechins ointment may weaken condoms and diaphragms.

Pregnancy Considerations

Sinecatechins should not be used during pregnancy (CDC [Workowski 2021]).

Breastfeeding Considerations

It is not known if sinecatechins are present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Application site reactions

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 (Adult Data Unless Noted)

Absorption: Topical: Not sufficiently studied; based on limited data, minimal systemic absorption is expected.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Veregen;
  • (BE) Belgium: Veregen;
  • (CH) Switzerland: Veregen;
  • (CZ) Czech Republic: Veregen;
  • (DE) Germany: Veregen;
  • (ES) Spain: Veregen;
  • (FI) Finland: Veregen;
  • (GB) United Kingdom: Catephen;
  • (GR) Greece: Veregreen;
  • (HU) Hungary: Veregen;
  • (IE) Ireland: Catephen;
  • (IT) Italy: Veregen;
  • (LT) Lithuania: Veregen;
  • (LU) Luxembourg: Veregen;
  • (LV) Latvia: Veregen;
  • (MX) Mexico: Verephen;
  • (NL) Netherlands: Veregen;
  • (NO) Norway: Veregen;
  • (PL) Poland: Veregen;
  • (RO) Romania: Veregen;
  • (RU) Russian Federation: Veregen;
  • (SI) Slovenia: Veregen;
  • (SK) Slovakia: Veregen;
  • (TW) Taiwan: Veregen
  1. Veregen (sinecatechins) [prescribing information]. Baudette, MN: ANI Pharmaceuticals Inc; January 2022.
  2. Veregen (sinecatechins) [product monograph]. St-Laurent, Quebec, Canada: Paladin Labs Inc; March 2016.
  3. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
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