Drugs Details

Drugs Info of Veregen
Drugs Details
  • Drugs Type  : FDA
  • Date : 27th Jun 2015 05:56 am
  • Brand Name : Veregen
  • Generic Name : sinecatechins (topical) (Pronunciation: SYNE e KAT e kins TOP i kal)
Descriptions

Veregen® (sinecatechins) Ointment, 15% is a botanical drug product for topical use. The drug substance in Veregen® is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg), and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.

The structural formulae of catechins are shown below.

General Structure of Catechins

Veregen® (sinecatechins) Structural Formula Illustration

 

Each gram of the ointment contains 150 mg of sinecatechins in a water free ointment base consisting of isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.

 

What are the possible side effects of kunecatechins (Veregen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wash off the ointment with mild soap and water and call your doctor at once if you have any of these serious side effects:

  • severe redness, burning, or itching of treated skin;
  • swelling, blisters, sores, or skin changes where the medicine was applied;
  • hardening of the treated skin areas; or
  • bleeding of treated skin.

Less serious side effects may include mild stinging,...

Read All Potential Side Effects and See Pictures of Veregen »

What are the precautions when taking sinecatechins ointment (Veregen)?

Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you are allergic to green tea; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: open sores in the area being treated, recent/unhealed treatment or wound on the wart area (e.g., podophyllin, liquid nitrogen, surgery), immune system problem.

This product may stain clothing and bedding.

Do not expose the treated area to sunlight, tanning booths, or sunlamps.

Genital/anal warts are caused by a virus called human papillomavirus (HPV). This product...

Read All Potential Precautions of Veregen »

Indications

Indication

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

Limitations of Use

The safety and effectiveness of Veregen® have not been established for treatment beyond 16weeks or for multiple treatment courses.

The safety and effectiveness of Veregen® in immunosuppressed patients have not been established.

Dosage Administration

General Dosing Information

Veregen® is to be applied three times per day to all external genital and perianal warts.

Apply about an 0.5 cm strand of the Veregen® to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Patients should wash their hands before and after application of Veregen®.

It is not necessary to wash off the ointment from the treated area prior to the next application.

Veregen® is not for ophthalmic, oral, intravaginal, or intra-anal use.

Treatment Period

Treatment with Veregen® should be continued until complete clearance of all warts, however no longer than 16 weeks.

Local skin reactions (e.g. erythema) at the treatment site are frequent. Nevertheless, treatment should be continued when the severity of the local skin reaction is acceptable.

How Supplied

Dosage Forms And Strengths

Ointment, 15% w/w. Each gram of Veregen® Ointment, 15% contains 150 mg of sinecatechins in a brown ointment base.

Storage And Handling

Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube or 30 grams (NDC # 10337-450-03) of ointment per tube.

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

Keep out of reach of children.

Manufactured for: PharmaDerm, A division of fougers Pharmaceuticals Inc., Melville, New York 11747. Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham Germany. Revised: 11/2012

Side Effects

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 indurationwas 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.

Interactions

No information provided.

Warnings

Included as part of the PRECAUTIONS section.

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 perianalarea to sun/UV-light as Veregen® has not been tested under these circumstances.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION)

Patients using Veregen® should receive the following information and instructions:

  • This medication is only to be used as directed by a physician. It is for external use only. Eye contact should be avoided as well as application into the vagina or anus.
  • It is not necessary to wash off Veregen® prior to the next application. When the treatment area is washed or a bath is taken, the ointment should be applied afterwards.
  • It is common for patients to experience local skin reactions such aserythema, erosion, edema, itching, and burning at the site of application. Severe skin reactions can occur and should be promptly reported to the healthcare provider. Should severe local skin reaction occur, the ointment should be removed by washing the treatment area with mild soap and water, and further doses withheld.
  • Sexual (genital, anal or oral) contact should be avoided while the ointment is on the skin, or the ointment should be washed off prior to these activities. Veregen® may weaken condoms and vaginal diaphragms. Therefore, the use in combination with Veregen® is not recommended.
  • Female patients using tampons should insert the tampon before applying the ointment. If the tampon is changed while the ointment is on the skin, accidental application of the ointment into the vagina must be avoided.
  • Veregen® may stain clothing and bedding.
  • Veregen® is not a cure and new warts might develop during or after a course of therapy. If new warts develop during the 16-week treatment period, these should also be treated with Veregen®.
  • The effect of Veregen® on the transmission of genital/perianal warts is unknown.
  • 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.
  • The treatment area should not be bandaged or otherwise covered or wrapped as to be occlusive.
  • Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In an oral (gavage) carcinogenicity study, sinecatechins was administered daily for 26 weeks to p53 transgenic mice at doses up to 500 mg/kg/day (22-fold MRHD; [see Use In Specific Populations]). Treatment with sinecatechins was not associated with an increased incidence of either neoplastic or non-neoplastic lesions in the organs and tissues examined. Veregen® has not been evaluated in a dermal carcinogenicity study.

Sinecatechins was negative in the Ames test, in vivo rat micronucleus assay, UDS test, and transgenic mouse mutation assay, but positive in the mouselymphoma mutation assay.

Daily vaginal administration of Veregen® to rats from Day 4 before mating and throughout mating until Day 17 of gestation did not cause adverse effects on mating performance and fertility at doses up to 0.15 mL/rat/day. This dose corresponds to approximately 150 mg/rat/day (8-fold MRHD).

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well controlled studies in pregnant women. Veregen® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The Maximum Recommended Human Dose (MRHD) of Veregen® was set at three times daily topical administration of 250 mg, 750 mg total, containing 112.5 mg sinecatechins for the animal multiple of human exposure calculations presented in this labelling. Dose multiples were calculated based on the human equivalent dose (HED).

Embryo-fetal development studies were conducted in rats and rabbits using intravaginal and systemic routes of administration, respectively. Oral administration of sinecatechins during the period of organogenesis (gestational Days 6 to 15 in rats or 6 to 18 in rabbits) did not cause treatment related effects on embryo-fetal development or teratogenicity at doses of up to 1,000 mg/kg/day (86-fold MRHD in rats; 173-fold MRHD in rabbits).

In the presence of maternal toxicity (characterized by marked local irritation at the administration sites and decreased body weight and food consumption) in pregnant female rabbits, subcutaneous doses of 12 and 36 mg/kg/day of sinecatechins during the period of organogenesis (gestational Days 6 to 19) resulted in corresponding influences on fetal development including reduced fetal body weights and delays in skeletal ossification. No treatment related effects on embryo-fetal development were noted at 4 mg/kg/day (0.7-fold MRHD). There was no evidence of teratogenic effects at any of the doses evaluated in this study.

A combined fertility / embryo-fetal development study using daily vaginal administration of Veregen® to rats from Day 4 before mating and throughout mating until Day 17 of gestation did not show treatment-related effects on embryo-fetal development or teratogenicity at doses up to 0.15 mL/rat/day (8-fold MRHD).

A pre-and post-natal development study was conducted in rats using vaginal administration of Veregen® at doses of 0.05, 0.10 and 0.15 mL/rat/day from Day 6 of gestation through parturition and lactation. The high and intermediate dose levels of 0.15 (8-fold MRHD) and 0.10 mL/rat/day resulted in an increased mortality of the F0 dams, associated with indications of parturition complications. The high dose level of 0.15 mL/rat/day also resulted in an increased incidence of stillbirths. There were no other treatment-related effects on pre-and post-natal development, growth, reproduction and fertility at any dose tested.

Nursing Mothers

It is not known whether topically applied Veregen® is excreted in breast milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Seven patients (1.4%), older than 65 years of age were treated with Veregen® in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects.

OverDose

No information provided.

ContrainDications

None

Clinical Pharamacology

Mechanism of Action

The mode of action of Veregen® involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding is unknown.

Pharmacodynamics

The pharmacodynamics of Veregen® is unknown.

Pharmacokinetics

Systemic exposure to EGCg, EGC, ECg, and EC were evaluated following either topical application of Veregen® to subjects with external genital and perianal warts (250 mg applied 3 times a day for 7 days) or following oral ingestion of green tea beverage (500 mL ingested 3 times a day for 7 days). Following topical application of Veregen®, plasma concentration of all 4 catechins were below the limit of quantification ( < 5 ng/mL) on Day 1. After application of Veregen® for 7 days, plasma EGC, ECg, and EC concentrations were below the limit of quantification while plasma concentration of EGCg were measurable in 2 out of 20 subjects. The mean maximal plasma concentration (Cmax) of EGCg was 10.1 ng/mL and the mean area under the concentration versus time curve (AUC) of EGCg was 52.2 ng•h/mL in these 2 subjects. Oral ingestion of green tea beverage resulted in measurable concentration of EGCg in all subjects on both Day 1 and Day 7, with mean (SD) Cmax of 23.0 (12.0) ng/mL and AUC of 104.6 (39.0) ng•h/mL on Day 7.

Clinical Studies

Two randomized, double-blind, vehicle-controlled trials were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent subjects 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).

Over both trials the median baseline wart area was 51 mm² (range 12 to 585 mm² ), and the median baseline number of warts was 6 (range 2 to 30).

The primary efficacy outcome measure was the response rate defined as the proportion of subjects with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 2 and 3 for all randomized subjects dispensed medication.

Table 2: Efficacy by Region

  COMPLETE CLEARANCE
All Countries (includes the United States)
  Veregen® 15% (N = 397) 213 (53.6%)
  Vehicle (N = 207) 73 (35.3%)
United States
  Veregen® 15% (N = 21) 5 (23.8%)
  Vehicle (N = 9) 0 (0.0%)

 

Table 3: Efficacy by Gender

  COMPLETE CLEARANCE
Males
  Veregen® 15% (N = 205) 97 (47.3%)
  Vehicle (N = 118) 34 (28.8%)
Females
  Veregen® 15% (N = 192) 116 (60.4%)
  Vehicle (N = 89) 39 (43.8%)

 

Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.

The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.

Patient Information

Veregen® 
(sinecatechins) Ointment, 15%

Read this leaflet carefully before you start using Veregen® Ointment and each time you refill your prescription. There may be new information. This information does not take the place of your doctor's advice. If you have any questions about Veregen® Ointment or your condition ask your doctor or pharmacist. Only your doctor can prescribe Veregen® and determine if it is right for you.

What is Veregen® Ointment?

Veregen® Ointment is a medicine for skin use only (topical) for the treatment of warts on the outside of the genitals and around the outside of the anus. It is not a treatment for warts in the vagina, cervix, or inside the anus. Your doctor may recommend examination and screening tests (such as a Pap smear) to evaluate these areas.

Who should not use Veregen® Ointment?

Do not use Veregen® Ointment if you are allergic to an ingredient in Veregen® Ointment. The list of ingredients is at the end of this leaflet.

What should I tell my doctor before using Veregen® Ointment?

Tell your doctor about all your health conditions and all the medicines you take including prescription, over-the-counter medicine, vitamins, supplements, and herbals. Be sure to tell your doctor if you are:

  • pregnant or planning to become pregnant, as it is not known if Veregen® Ointment can harm your unborn baby. Your doctor will determine whether the benefit outweighs the risk.
  • breastfeeding, as it is not known if Veregen® Ointment can pass into your milk and if it can harm your baby.
  • using any other type of skin product or have open wounds on the area to be treated. Veregen® Ointment should not be used until your skin has healed from other treatments applied to the same area.
  • immunocompromised. This means that your immune system cannot fight infections as well as it should.

How should I use Veregen® Ointment?

  • Use Veregen® Ointment only on the area affected exactly as prescribed by your doctor.
  • Wash your hands before and after application of Veregen® Ointment. A small amount of the ointment should be applied to all warts using your finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts as directed by your doctor.
  • Apply Veregen® Ointment three times per day ---in the morning, at noontime and in the evening.
  • Do not wash off the ointment from the treated area before the next application. When you wash the treatment area or bathe, apply the ointment afterwards.
  • Treatment with Veregen® Ointment should be continued until complete clearance of all warts, however no longer than 16 weeks. If your warts do not go away, or if they come back after treatment call your doctor.
  • Veregen® Ointment is not a cure for warts on your genitals or around your anus with certainty. New warts may develop during or after treatment, and may need treatment.

What should I avoid while using Veregen® Ointment?

  • Do not apply Veregen® Ointment on open wounds or into the vagina or into the anus.
  • Genital warts are a sexually transmitted disease, and you may infect your partner.
  • Avoid sexual contact (genital, anal or oral) when Veregen® Ointment is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms. Talk to your doctor about safe sex practices.
  • Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).
  • Women using tampons: insert the tampon before applying the ointment. If you need to change your tampon while the ointment is on your skin, avoid getting the ointment into the vagina.
  • Uncircumcised men treating warts under the foreskin should retract the foreskin and clean the area daily.
  • Do not expose the genital area treated with Veregen® Ointment to sunlight, sunlamps or tanning beds.
  • Do not cover the treated area. Loose-fitting undergarments can be worn after applying Veregen® Ointment.
  • Veregen® Ointment may stain your light colored clothes and bedding.

What are the possible side effects of Veregen® Ointment?

The most common side effects with Veregen® Ointment are local skin and application site reactions including:

  • redness
  • swelling
  • sores or blisters
  • burning
  • itching
  • pain

Many patients experience itching, reddening or swelling on or around the application site during the course of treatment. Some of these side effects could be a sign of an allergic reaction. If you experience open sores or other severe reactions at the locations you applied Veregen® Ointment, stop treatment and call your doctor right away.

You may experience other side effects of Veregen® Ointment, which are not mentioned here. Ask your doctor or pharmacist for more information.

Patients should be aware that new warts may develop during treatment as Veregen® Ointment is not a cure.

How should I store Veregen® Ointment?

  • Store Veregen® Ointment refrigerated or up to 77°F (25 °C).
  • Do not freeze.
  • Make sure the cap on the tube is tightly closed.
  • Safely throw away Veregen® Ointment tubes that are out of date or are empty.

Keep Veregen® Ointment and all medicines out of the reach of children.

General advice about prescription medicines

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Veregen® Ointment for a condition for which it was not prescribed. Do not give Veregen® Ointment to other people, even if they have the same symptoms you have. It may harm them. Do not use Veregen® Ointment after the expiration date on the tube.

This leaflet summarizes the most important information about Veregen® Ointment. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Veregen® Ointment that is written for the doctor.

For more information, go to www.pharmaderm.com or call 1-800-645-9833.

What are the ingredients in Veregen® Ointment?

Active ingredient:

A defined green tea extract named sinecatechins.

Inactive ingredients:

Isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

SINECATECHINS (CAMELLIA SINENSIS) OINTMENT - TOPICAL

 

(sin-e-KAT-e-kins)

 

COMMON BRAND NAME(S): Veregen

 

USES: Sinecatechins are used to treat warts on and around the genitals and anus. These warts are caused by the human papillomavirus (HPV). Sinecatechins are natural substances found in certain green tea leaves. It is not known how this medication works.

This medication does not cure warts, but it may help the infection clear faster. New warts may occur during or after treatment. This medication does not prevent the spread of warts through sexual contact, and it may weaken condoms and diaphragms. Talk to your doctor about safer sex practices.

 

HOW TO USE: This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.

Use this medication on the skin only. Wash your hands before and after applying. Apply the ointment to all warts as prescribed, usually 3 times a day or as directed by your doctor. Use your finger to apply a small amount, about 0.2 inches (0.5 centimeters), to completely cover each wart with a thin layer. Do not wash off the ointment from the previous treatment before re-applying. Always re-apply the ointment after taking your usual baths/showers. Do not cover the treated area with bandages or other waterproof dressings. You may cover the area with cotton gauze or cotton underwear. Do not use more often or for longer than prescribed.

Male patients who are not circumcised and who are treating warts under the foreskin should pull the foreskin back and clean the area daily, then apply this medication.

Women using tampons should insert the tampon before applying the ointment. If you need to change the tampon while the ointment is on the skin, avoid getting the ointment inside the vagina.

Do not use this medication inside the vagina or anus or on an open sore. Avoid touching your eyes, nose, or mouth while the ointment is on your finger. If you get this medication in those areas, flush with plenty of water. If irritation occurs, contact your doctor immediately.

Avoid sexual contact while using this product. This product may weaken condoms and vaginal diaphragms. This effect increases the risk of pregnancy and passing sexually transmitted disease (including genital warts) to others. Wash the product off before sexual activity. Ask your doctor about safer sex practices.

Use this medication regularly to get the most benefit from it. Continue treatment until the warts are gone. Do not use for longer than 16 weeks unless directed by your doctor. Tell your doctor if your condition does not improve or if new warts appear.

Consumer Overview Side Effect

SIDE EFFECTS: Mild skin reactions such as itching/burning/pain/swelling/reddening of the treated area frequently occur. If any of these effects persist or worsen, wash off the ointment with soap and water, stop using this product, and call your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/oozing/peeling skin in treated area, open sore in treated area (skin ulcer).

If you are an uncircumcised male who is using this drug to treat warts on the penis, narrowing of the foreskin (phimosis) may infrequently occur. If you notice tightening/pain in your foreskin, tell your doctor immediately.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Veregen (sinecatechins ointment) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you are allergic to green tea; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: open sores in the area being treated, recent/unhealed treatment or wound on the wart area (e.g., podophyllin, liquid nitrogen, surgery), immune system problem.

This product may stain clothing and bedding.

Do not expose the treated area to sunlight, tanning booths, or sunlamps.

Genital/anal warts are caused by a virus called human papillomavirus (HPV). This product does not destroy the virus but only helps to get rid of the wart. Therefore, new warts may form even while you are being treated.

You may also be able to infect any sexual partner who comes into contact with the areas of skin infected with HPV. To reduce the risk of spreading HPV to others, always use effective barrier protections (e.g., latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During treatment of genital/anal warts, avoid all sexual contact while the ointment is on the skin. Condoms, dental dams, and diaphragms may be weakened by the ointment. Therefore, they may not work as well to prevent pregnancy or the spread of HPV or other sexually transmitted diseases (e.g., HIV).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may affect the immune system (e.g., chemotherapy, cyclosporine, corticosteroids such as hydrocortisone/prednisone).

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.

Be sure to keep all medical appointments. HPV can increase the risk of cancer of the cervix. It is very important that women exposed to HPV have regular PAP tests to check for cancer.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store this product in the refrigerator or at room temperature at or below 77 degrees F (25 degrees C) away from moisture. Different brands of this medication may have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Close the container tightly after each use. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised August 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Veregen

Generic Name: sinecatechins (topical) (Pronunciation: SYNE e KAT e kins TOP i kal)

  • What is kunecatechins (Veregen)?
  • What are the possible side effects of kunecatechins (Veregen)?
  • What is the most important information I should know about kunecatechins (Veregen)?
  • What should I discuss with my health care provider before taking kunecatechins (Veregen)?
  • How should I take kunecatechins (Veregen)?
  • What happens if I miss a dose (Veregen)?
  • What happens if I overdose (Veregen)?
  • What should I avoid while taking kunecatechins (Veregen)?
  • What other drugs will affect kunecatechins (Veregen)?
  • Where can I get more information?

What is kunecatechins (Veregen)?

 

Kunecatechins is an herbal product made from green tea leaves.

Kunecatechins is used to treat external (on the outside of the body) genital and anal warts in adult patients.

Kunecatechins will not cure genital or anal warts, and will not keep you from spreading the warts to other people through sexual intercourse or skin-to-skin contact. Kunecatechins will not treat genital warts that are caused by the human papilloma virus (HPV).

Kunecatechins may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of kunecatechins (Veregen)?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wash off the ointment with mild soap and water and call your doctor at once if you have any of these serious side effects:

  • severe redness, burning, or itching of treated skin;
  • swelling, blisters, sores, or skin changes where the medicine was applied;
  • hardening of the treated skin areas; or
  • bleeding of treated skin.

Less serious side effects may include mild stinging, itching, or irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Veregen (sinecatechins ointment) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about kunecatechins (Veregen)?

 

Before using kunecatechins, tell your doctor if you have human papilloma virus (HPV), HIV or AIDS, or a weak immune system (from disease or medications such as steroids, chemotherapy, or radiation treatments).

Kunecatechins will not cure genital or anal warts, and will not keep you from spreading the warts to other people through sexual intercourse or skin-to-skin contact. Kunecatechins will not treat genital warts that are caused by the human papilloma virus (HPV).

Keep using kunecatechins until your warts have completely cleared. Do not use this medication for longer than 16 weeks without your doctor's advice.

Call your doctor if your warts do not clear up, or if they go away and then come back after treatment.

Talk with your doctor about safe methods of preventing transmission of genital warts during sex.

Patient Detailed How Take

What should I discuss with my health care provider before taking kunecatechins (Veregen)?

 

Using this medication will not prevent you from passing genital warts to another person during skin-to-skin contact or sexual intercourse. Talk with your doctor about safe methods of preventing transmission of genital warts during sex.

Do not use this medication if you are allergic to green tea.

Before using kunecatechins, tell your doctor if you are allergic to any drugs, or if you have:

  • human papilloma virus (HPV);
  • HIV or AIDS; or
  • a weak immune system (from disease or medications such as steroids, chemotherapy, or radiation treatments).

If you have any of these conditions, you may not be able to use kunecatechins, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether kunecatechins passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take kunecatechins (Veregen)?

 

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after applying this medicine.

Kunecatechins is usually applied 3 times daily. Apply enough ointment to cover each wart, leaving a thin layer of ointment on the skin surface.

Do not wash the treated skin area just after applying this medication. Reapply the ointment after you swim, bathe, or shower.

Women using this medication should wash the ointment off before inserting a tampon into the vagina. You may accidentally get some of the medicine into your vagina if you insert a tampon while the ointment is on the outside of your vagina.

Men using this medication on an uncircumcised penis should wash underneath the foreskin each day.

Keep using kunecatechins until your warts have completely cleared. Do not use this medication for longer than 16 weeks without your doctor's advice.

Call your doctor if your warts do not clear up, or if they go away and then come back after treatment.

Kunecatechins ointment can stain clothing or bed sheets. Avoid getting the medicine on these surfaces. You may want to wear dark-colored clothing to prevent unwanted staining. Do not use a sanitary napkin or other protective barrier without your doctor's advice.

Store this medication in the refrigerator and do not allow it to freeze.

Patient Detailed Avoid Taking

What happens if I miss a dose (Veregen)?

 

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Veregen)?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of applied kunecatechins applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while taking kunecatechins (Veregen)?

 

Avoid sexual intercourse while you have this medication on your skin. Wash the ointment off before having intercourse, even if you are using a condom. Kunecatechins can weaken the latex in a rubber condom, and an unintended pregnancy could occur.

Avoid touching the treated skin areas, or allowing another person to touch your treated skin after you have applied the ointment.

Kunecatechins is for use only on the outside of the body. Avoid getting this medication in your eyes, nose, or mouth or into your rectum, vagina, or the opening to your bladder.

Do not apply this medication to an open wound or broken skin.

Avoid exposing treated skin to sunlight or artificial UV rays (sunlamps or tanning beds).

What other drugs will affect kunecatechins (Veregen)?

 

Before using kunecatechins, tell your doctor about all other genital wart treatments you have used or are still using.

There may be other drugs that can affect kunecatechins. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist has information about kunecatechins written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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