Varithena polidocanol Kit — NDC 60635-133-01 (Billing 60635-0133-01)
This is a package of Varithena polidocanol Kit from Boston Scientific Corporation, marketed since Nov 2013 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1485068
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Sclerosing Agent class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 60635-0133-01 You're viewing this Main listing | 1 CARTON in 1 PACKAGE / 1 POUCH in 1 CARTON / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER * 303 mL in 1 CANISTER | 2016-06-22 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Varithena 60635-0118-01 | Boston | 1 pouch | — | — | FDA listed | — |
| Varithenathis 60635-0133-01 | Boston | 1 pouch | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7814943 ↗ | Method of use | U-1461 | Nov 19, 2027 |
| US 9480652 ↗ | Drug product | — | May 12, 2032 |
Is there a generic version of this drug?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE VARITHENA (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. VARITHENA (polidocanol injectable foam) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee.
VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For intravenous use only. VARITHENA is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. Use up to 5 mL per injection and no more than 15 mL per session.
Physicians administering VARITHENA must be experienced with venous procedures and be trained in the administration of VARITHENA. Activate VARITHENA using the VARITHENA oxygen canister and polidocanol canister ( see Instructions for Use ). Once a VARITHENA transfer unit is in place, foam can be generated and transferred to a syringe.
Discard the syringe contents if there are any visible bubbles. Administer the injectable foam within 75 seconds of extraction from the canister to maintain injectable foam properties. Use a new sterile syringe after each injection.
Use a new VARITHENA transfer unit for each treatment session. Local anesthetic may be administered prior to cannula insertion but neither tumescent anesthesia nor patient sedation is required. Cannulate the vein to be treated using ultrasound guidance to confirm venous access.
Inject freshly generated VARITHENA injectable foam slowly (approximately 1 mL/second in the GSV and 0.5 mL/second in accessory veins or varicosities) while monitoring using ultrasound. Confirm venospasm of the treated vein using ultrasound. When treating the proximal GSV, stop the injection when VARITHENA is 3-5 cm distal to the saphenofemoral junction (SFJ).
Apply compression bandaging and stockings and have the patient walk for at least 10 minutes, while being monitored. Maintain compression for 2 weeks after treatment. Repeat treatment may be necessary if the size and extent of the veins to be treated require more than 15 mL of VARITHENA.
Separate treatment sessions by a minimum of 5 days. Retained coagulum may be removed by aspiration (microthrombectomy) to improve comfort and reduce skin staining. Incompetent great saphenous or accessory saphenous veins: Use Varithena 1% (CEAP Class 2-6 Disease).
( 2 ). For intravenous use which should be performed under ultrasound guidance when treating the GSV. Use up to 5 mL per injection and 15 mL per treatment session.
( 2 ) Separate treatment sessions by a minimum of 5 days. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS VARITHENA is available in the following presentations: 180 mg/18 mL (10 mg/mL) Once activated, VARITHENA is a white, injectable foam delivering a 1% polidocanol solution. Each mL of VARITHENA injectable foam contains 1.3 mg of polidocanol VARITHENA is supplied as polidocanol solution (10 mg/mL) in 18 mL; and must be activated before use. ( 3 ) Once activated, VARITHENA is a white, injectable foam delivering the polidocanol solution.
( 3 ) Each mL of VARITHENA injectable foam contains 1.3 mg of polidocanol.
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of VARITHENA is contraindicated in patients with: known allergy to polidocanol [see Warnings and Precautions ( 5.1 )] acute thromboembolic disease Known allergy to polidocanol ( 4 ) Acute thromboembolic disease ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Be prepared to treat anaphylaxis. ( 5.1 ) Tissue ischemia and necrosis: do not inject intra-arterially. ( 5.2 ) Venous Thrombosis. ( 5.3 )
5.1Anaphylaxis Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.
5.2Tissue Ischemia and Necrosis Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.
5.3Venous Thrombosis VARITHENA can cause venous thrombosis [see Adverse Reactions ( 6 )] . Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS In clinical trials, the most common related adverse events (occurring in ≥3% of patients treated with VARITHENA) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, and extravasation.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biocompatibles, Inc. at 1-855-971-VEIN (1-855-971-8346) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of VARITHENA cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice. A total of 1333 patients with GSVI in 12 clinical trials were evaluated for safety when treated with VARITHENA at dose concentrations of 0.125%, 0.5%, 1.0%, or 2.0%, including 437 patients treated with VARITHENA in placebo-controlled clinical trials.
Adverse reactions occurring in 3% more patients receiving VARITHENA 1% than receiving placebo are shown in Table 1 . a Retained coagulum. b Common femoral vein thrombus extension (non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein). Table 1: Treatment-emergent adverse reactions (3% more on VARITHENA 1% than on placebo) through Week 8 (n=588) Adverse Reaction Placebo (N=151) VARITHENA 1.0% (N=149) Pain in extremity 14 (9.3) 25 (16.8) Infusion site thrombosis b 0 24 (16.1) Contusion/injection site hematoma 9 (6.0) 23 (15.4) Limb discomfort 5 (3.3) 18 (12.1) Tenderness/injection site pain 5 (3.3) 16 (10.7) Venous thrombosis limb c 0 12 (8.1) Thrombophlebitis superficial 2 (1.3) 8 (5.4) Deep vein thrombosis 0 7 (4.7) In VARITHENA-treated patients, 80% of pain events in the treated extremity resolved within 1 week.
Proximal symptomatic venous thrombi occurred in <1% of patients treated with VARITHENA. Approximately half of patients with thrombi received treatment with anticoagulants. Since VARITHENA induces thrombosis in the treated superficial veins, D-dimer is commonly elevated post-treatment and is not useful diagnostically to assess patients for venous thrombus following treatment with VARITHENA.
Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician compounded foam sclerosants. None of the 1333 patients in the VARITHENA trials experienced clinically important neurological or visual adverse events suggestive of cerebral gas embolism. The incidence of neurologic and visual adverse events within 1 day of treatment in the placebo-controlled studies was 2.7% in the pooled VARITHENA group and 4.0% in the placebo groups.
Skin discoloration adverse events were reported in 1.1% of the pooled VARITHENA group and 0.7% of the placebo group in the placebo-controlled studies.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No specific drug interaction studies have been performed. There are no known drug interactions with VARITHENA. There are no known drug interactions with VARITHENA. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Few published case reports with use of polidocanol-containing products, including VARITHENA, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although no risks have been identified, there is minimal benefit in treating lower extremity varicosities during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum. In animal reproduction studies, no adverse developmental effects were observed with intravenous administration of polidocanol to pregnant rats and rabbits during organogenesis at dose levels up to approximately 13.5 and 12 times, respectively, the proposed maximum human dose of 15 mL of 1% VARITHENA based on body surface area (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Developmental reproductive toxicity testing was performed in rats and rabbits using intravenous administration of polidocanol solution. In rabbits, dose levels up to and including 10 mg/kg/day (approximately 12 times the proposed maximum human dose of 15 mL of 1% VARITHENA based on body surface area) did not produce any indication of adverse effects on embryo-fetal mortality, fetal weight, or the incidences of fetal abnormalities and variants. In rats administered 27 mg/kg/day of polidocanol solution (approximately 13.5 times the human dose based on body surface area), there were no adverse effects on pregnancy performance or fetal development.
In a peri-natal and post-natal study in rats, dose levels of polidocanol up to 9 mg/kg/day (approximately 4.5 times the human dose based on body surface area) were without effects on the development of the conceptus and offspring, and at a dose level of 27 mg/kg/day of polidocanol solution (approximately 13.5 times the human dose based on body surface area), effects were confined to an equivocal reduction in body weights of first-generation males, and an associated equivocal delay in the age of preputial separation.
8.2Lactation Risk Summary There are no data on the presence of polidocanol in human milk, the effects on the breastfed infant, or the effects on milk production. A lactating woman may consider interrupting breastfeeding and pumping anddiscarding breast milk up to 8 hours after VARITHENA administration in order to minimize exposure to a breastfed infant.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Of the 1333 subjects in clinical studies treated with VARITHENA, 9.1% (n=121) were ≥65 years of age. No clinically important differences in safety or efficacy were observed between older and younger patients in all studies.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Few published case reports with use of polidocanol-containing products, including VARITHENA, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although no risks have been identified, there is minimal benefit in treating lower extremity varicosities during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum. In animal reproduction studies, no adverse developmental effects were observed with intravenous administration of polidocanol to pregnant rats and rabbits during organogenesis at dose levels up to approximately 13.5 and 12 times, respectively, the proposed maximum human dose of 15 mL of 1% VARITHENA based on body surface area (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Developmental reproductive toxicity testing was performed in rats and rabbits using intravenous administration of polidocanol solution. In rabbits, dose levels up to and including 10 mg/kg/day (approximately 12 times the proposed maximum human dose of 15 mL of 1% VARITHENA based on body surface area) did not produce any indication of adverse effects on embryo-fetal mortality, fetal weight, or the incidences of fetal abnormalities and variants. In rats administered 27 mg/kg/day of polidocanol solution (approximately 13.5 times the human dose based on body surface area), there were no adverse effects on pregnancy performance or fetal development.
In a peri-natal and post-natal study in rats, dose levels of polidocanol up to 9 mg/kg/day (approximately 4.5 times the human dose based on body surface area) were without effects on the development of the conceptus and offspring, and at a dose level of 27 mg/kg/day of polidocanol solution (approximately 13.5 times the human dose based on body surface area), effects were confined to an equivocal reduction in body weights of first-generation males, and an associated equivocal delay in the age of preputial separation.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1333 subjects in clinical studies treated with VARITHENA, 9.1% (n=121) were ≥65 years of age. No clinically important differences in safety or efficacy were observed between older and younger patients in all studies.
🆘 Overdosage ▾
10 OVERDOSAGE There are no known cases of overdosage with VARITHENA. In clinical studies, total volumes of up to 60 mL of VARITHENA per treatment session have been administered.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action VARITHENA is a drug/device combination product that generates injectable foam. The injectable foam is composed of a liquid and gas phase, both of which are necessary to have its therapeutic effect. VARITHENA is intended to act as follows: (1) the foam displaces blood from the vein to be treated, and (2) the polidocanol then scleroses the endothelium.
The active pharmaceutical ingredient of VARITHENA is polidocanol, a non-ionic surfactant sclerosing agent. The hydrophobic pole of the polidocanol molecule attaches to the lipid cell membrane of the venous endothelium, resulting in disruption of the osmotic barrier, destruction of the venous endothelium, and vasospasm. Following exposure to polidocanol, the interior surface of the vein becomes thrombogenic, which leads to thrombus formation and venous occlusion.
The occluded vein is eventually replaced by fibrous connective tissue. Polidocanol is deactivated upon contact with blood, thus limiting the sclerosant action to the endothelium near the site of injection.
12.2Pharmacodynamics The active pharmaceutical ingredient in VARITHENA is polidocanol. Polidocanol damages the endothelium of blood vessels.
12.3Pharmacokinetics The pharmacokinetics of VARITHENA (as a weighted sum of 4 oligomers: E5, E9, E12 and E14) were evaluated at two concentrations (1% and 2%) randomly assigned within gender in 20 patients with GSV incompetence. When administered as an intravenous injectable foam as two fixed 5 mL doses separated by 10 minutes, polidocanol was rapidly detected in plasma, reaching maximum concentration of drug in the body after dosing (C max ) within 15 minutes of the first injection and within 5 minutes of receiving the second injection of VARITHENA 1% or VARITHENA 2%.
The mean volume of distribution (Vd) of polidocanol ranged from 35 to 82 L. Mean systemic clearance (CL) of polidocanol ranged from 0.2 to
0.4L/min. The clearance of E5 was significantly greater than that of longer oligomers. Mean terminal elimination half-life (t 1/2 ) ranged from 102 to 153 minutes, with most plasma samples below the limit of quantitation (BLQ) at the end of the 8-hour collection period.
The increase in plasma polidocanol concentrations was less than proportional with increasing VARITHENA concentration. Weight-normalized data demonstrated no consistent differences in C max or AUC between males and females.
🧬 Mechanism of Action ▾
12.1Mechanism of Action VARITHENA is a drug/device combination product that generates injectable foam. The injectable foam is composed of a liquid and gas phase, both of which are necessary to have its therapeutic effect. VARITHENA is intended to act as follows: (1) the foam displaces blood from the vein to be treated, and (2) the polidocanol then scleroses the endothelium.
The active pharmaceutical ingredient of VARITHENA is polidocanol, a non-ionic surfactant sclerosing agent. The hydrophobic pole of the polidocanol molecule attaches to the lipid cell membrane of the venous endothelium, resulting in disruption of the osmotic barrier, destruction of the venous endothelium, and vasospasm. Following exposure to polidocanol, the interior surface of the vein becomes thrombogenic, which leads to thrombus formation and venous occlusion.
The occluded vein is eventually replaced by fibrous connective tissue. Polidocanol is deactivated upon contact with blood, thus limiting the sclerosant action to the endothelium near the site of injection.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied VARITHENA (polidocanol injectable foam) product is available in four configurations, each containing two sterile, connected, 303-mL aluminum alloy cylinders, one containing polidocanol solution (10 mg/mL) under carbon dioxide, and the other containing pressurized oxygen. Polidocanol mg Usable foam mL NDC 180 45 60635-118-01 PD Canister - 60635-018-01
16.2Storage and Handling Do not shake VARITHENA canisters. Avoid contact with eyes. Store the VARITHENA Bi-Canister at or below 86°F (30°C); Do not refrigerate or freeze.
Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place.
Store the canisters away from sources of heat including strong light conditions. Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.
Once activated, the canister of 180 mg/18 mL (10 mg/mL) VARITHENA must be used within thirty (30) days. Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA Bi-Canister. Use a new VARITHENA transfer unit for each treatment session.
Discard aerosol canisters after use in accordance with state and local requirements. For more information, please refer to the IFU.
📦 Storage and Handling ▾
16.2Storage and Handling Do not shake VARITHENA canisters. Avoid contact with eyes. Store the VARITHENA Bi-Canister at or below 86°F (30°C); Do not refrigerate or freeze.
Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place.
Store the canisters away from sources of heat including strong light conditions. Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.
Once activated, the canister of 180 mg/18 mL (10 mg/mL) VARITHENA must be used within thirty (30) days. Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA Bi-Canister. Use a new VARITHENA transfer unit for each treatment session.
Discard aerosol canisters after use in accordance with state and local requirements. For more information, please refer to the IFU.
📋 Description ▾
11 DESCRIPTION VARITHENA injectable foam contains the sclerosant, polidocanol. It is intended for intravenous use only. Chemically, polidocanol is polyoxyl lauryl ether.
The structural formula is represented below: Polidocanol has the molecular formula CH 3 (CH 2 ) 11 (OCH 2 CH 2 ) n OH and a molecular weight of 582.9 when the average ethylene glycol moieties is nine (n=9). Polidocanol is a white to almost white, waxy, hygroscopic solid that is soluble in water and alcohol and melts at temperatures above 20°C. VARITHENA is a sterile, injectable foam of an aqueous polidocanol solution (1%) containing the following inactive ingredients: alcohol (4.2% w/w, purity 96% v/v) disodium hydrogen phosphate dihydrate (0.24% w/w), and potassium dihydrogen phosphate (0.085% w/w) with a pH of 6.0-7.5.
The injectable foam is generated after activation of the polidocanol canister with oxygen from a second aluminum canister, resulting in a final gas mixture of oxygen:carbon dioxide in a ratio of 65:35 with low (<0.8%) nitrogen content. At the time of use, VARITHENA is generated as an injectable foam of controlled density and bubble size. The foam is then transferred to a syringe through the VARITHENA transfer unit.
The injectable foam has a liquid to gas ratio of approximately 1:7 by volume. The median bubble diameter is less than 100 µm and no bubbles are greater than 500 µm. polidocanol Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to keep post-treatment bandages dry and in place for 48 hours and to wear compression stockings on the treated legs continuously for 2 weeks. Compression stockings should be thigh high or knee high, depending upon the area treated, in order to provide adequate coverage. Advise the patient to walk for at least 10 minutes immediately after the procedure and daily for the next month.
Following treatment, advise the patient to avoid heavy exercise for 1 week and extended periods of inactivity for 1 month. If you would like more information, please talk with your doctor. For more information about VARITHENA, you can also call us at 1-855-971-VEIN (1-855-971-8346) or go to www.VARITHENA.com.
Manufactured by: Biocompatibles UK Ltd Chapman House, Weydon Lane Farnham, UK, GU9 8QL Boston Scientific Limited Business and Technology Park Model Farm Road Cork Ireland Distributed by: Boston Scientific Corporation, USA, and its subsidiaries VARITHENA and VVSymQ are registered trademarks of a subsidiary of Boston Scientific Corporation, USA.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetics of VARITHENA (as a weighted sum of 4 oligomers: E5, E9, E12 and E14) were evaluated at two concentrations (1% and 2%) randomly assigned within gender in 20 patients with GSV incompetence. When administered as an intravenous injectable foam as two fixed 5 mL doses separated by 10 minutes, polidocanol was rapidly detected in plasma, reaching maximum concentration of drug in the body after dosing (C max ) within 15 minutes of the first injection and within 5 minutes of receiving the second injection of VARITHENA 1% or VARITHENA 2%.
The mean volume of distribution (Vd) of polidocanol ranged from 35 to 82 L. Mean systemic clearance (CL) of polidocanol ranged from 0.2 to
0.4L/min. The clearance of E5 was significantly greater than that of longer oligomers. Mean terminal elimination half-life (t 1/2 ) ranged from 102 to 153 minutes, with most plasma samples below the limit of quantitation (BLQ) at the end of the 8-hour collection period.
The increase in plasma polidocanol concentrations was less than proportional with increasing VARITHENA concentration. Weight-normalized data demonstrated no consistent differences in C max or AUC between males and females.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The active pharmaceutical ingredient in VARITHENA is polidocanol. Polidocanol damages the endothelium of blood vessels.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES VARITHENA was evaluated in two randomized, blinded, multicenter clinical trials designed to assess the efficacy and safety of VARITHENA 0.5%, 1.0%, and 2.0% (VANISH-1) and VARITHENA 0.5% and 1.0% (VANISH-2) compared with placebo in the treatment of both symptoms and appearance in patients with SFJ incompetence as evidenced by reflux of the GSV or major accessory veins. In both studies, a VARITHENA 0.125% treatment group was included as a control for blinding of the duplex ultrasound assessment. Patients with history of deep vein thrombosis or pulmonary embolism; inability to comply with post-treatment compression due to severe peripheral arterial disease or leg obesity; incompetence of the small saphenous vein or deep venous reflux as a major source of reflux; or reduced mobility, major surgery, pregnancy, or prolonged hospitalization within 3 months were excluded.
Patients were randomized in an equal distribution to each treatment group; the primary time point for analyses of the primary, secondary, and tertiary efficacy endpoints was Week 8. In these clinical trials, the maximum volume of injectable foam or placebo to be administered per treatment session was 15 mL. In VANISH-1, patients received one blinded treatment and in VANISH-2, patients received one blinded treatment with an option for a second blinded treatment 1 week later.
In VANISH-2, patients in the VARITHENA 1.0% treatment group received an average of 1.4 blinded treatments. All patients received post-procedure compression therapy for 14 days following treatment. Of the 519 patients randomized into VANISH-1 and VANISH-2, a total of 511 were treated with either VARITHENA 0.5% (n=111), 1.0% (n=110), or 2.0% (n=63), VARITHENA 0.125% as control (n=114), or placebo (n=113).
Ninety-nine percent of the patients in VANISH-1 and VANISH-2 completed the blinded treatment period. In the VARITHENA 1% group in VANISH-2, 23 of 58 patients received an additional blinded treatment. Two of these patients had retreatment of veins treated in the initial treatment session.
The remaining 21 patients received treatment for additional veins not treated in the initial treatment session. The mean age was approximately 50 years and approximately three-fourths of the patients were women. The mean BMI was similar in VANISH-1 and VANISH-2, at 28 kg/m 2 (range 16 to 44 kg/m 2 ) and 30 kg/m 2 (range 17 to 48 kg/m 2 ), respectively.
The mean baseline GSV diameter was also similar in VANISH-1 and VANISH-2, at 7.6 mm (range 1.5 to 25.9 mm) and 8.7 mm (range 3.1 to 19.4 mm), respectively. Overall, 22% of patients in VANISH-1 and 25% of patients in VANISH-2 reported one or more prior varicose vein procedures in the leg to be treated. For both clinical trials, the primary efficacy endpoint was improvement in patient symptoms, as measured by the change from baseline to Week 8 in the 7-day average electronic daily diary VVSymQ ® score.
The VVSymQ ® score is a patient-reported outcome measure based on daily patient assessment of the varicose vein symptoms determined to be most important to patients: heaviness, achiness, swelling, throbbing, and itching. VVSymQ ® scores range from 0 to 25, where 0 represents no symptoms and 25 represents all 5 symptoms experienced all of the time. Results are shown in Table 2 .
For both VANISH-1 and VANISH-2, treatment with 1.0% was superior to placebo in improving symptoms as measured by VVSymQ ® , when either a duration or an intensity scale was used to measure patients’ symptoms. *Percent of patients who reported their symptoms had "moderately improved" or "much improved" compared with baseline. Table 2: Improvement in Symptoms of Varicose Veins as Measured by VVSymQ ® at Week 8, VANISH-1 and VANISH-2 VVSymQ ® VANISH-1 VANISH-2 Placebo VARITHENA 1.0% Placebo VARITHENA 1.0% N 55 50 54 57 Baseline score, mean 8.60 8.82 9.26
7.82Adjusted mean change from baseline at week 8 -2.13 -4.87 -2.00 -5.06 Clinically meaningful improvement in symptoms at week… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential of VARITHENA. No mutagenic activity was observed in the in vitro bacterial reverse mutation assay at non-toxic concentrations. No mutagenic activity was observed in the in vitro mouse lymphoma assay in the absence of S9 mix and was weakly mutagenic in the presence of S9 close to the limit of acceptance for the accompanying level of toxicity.
No micronucleus induction was detected in the in vivo assay on mouse bone marrow cells up to the maximum tolerated dose of 80 mg/kg. There was no adverse effect on fertility in both male and female rats at 27 mg/kg/day. This dose level is approximately 13.5 times the proposed maximum human dose based on body surface area.
13.2Animal Toxicology and/or Pharmacology The pharmacological effects of polidocanol solution on the renal function of the rat were evaluated and at the highest dose tested (10 mg/kg) hematuria occurred in 67% of animals. This dose is 5 times higher than the proposed maximum human dose based on body surface area. Blood was no longer detectable in urine 24 hours after dosing.
In the 28-day repeated dose toxicity study in rat blood, pigments were noted in the urine for animals in all treatment groups, including male controls, at the end of the 4-week treatment period with up to 27 mg polidocanol/kg/day. Following the 2-week recovery period, there was still evidence that blood pigments were present in the urine but the incidence and severity was decreased when compared to the main study animals. There were no histopathological findings in the urinary bladder in any study animals.
In a cardiovascular pharmacology study in the anesthetized dog at 20 mg/kg (approximately 33 times the human dose based on body surface area), statistically significantly higher values for P-Q interval were measured before and during dosing and at all time points up to 30 minutes after dosing. An increase in QRS interval was also measured after dosing of 20 mg/kg and at 5 and 10 minutes after dosing. This effect was short lived and was no longer seen at 15 minutes after dosing.
In addition, there was an increase in diastolic pressure with increasing dose of polidocanol. This increase became significantly greater (p<0.05) than baseline before injection of the final and highest dose (20 mg/kg). In a further cardiovascular pharmacology study conducted with a once weekly, for four weeks, intravenous bolus injection of VARITHENA in the conscious dog, dose levels of up to 8.0 mL/kg (approximately 17 times the human dose based on body surface area) to beagle dogs caused only a transient, but consistent, effect on respiration, evidenced by a decrease in tidal volume and RMV at 15 minutes post-dose, resolving by one hour post-dose.
Histopathology of the lung at the end of the 3-month follow-up period showed no abnormalities.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential of VARITHENA. No mutagenic activity was observed in the in vitro bacterial reverse mutation assay at non-toxic concentrations. No mutagenic activity was observed in the in vitro mouse lymphoma assay in the absence of S9 mix and was weakly mutagenic in the presence of S9 close to the limit of acceptance for the accompanying level of toxicity.
No micronucleus induction was detected in the in vivo assay on mouse bone marrow cells up to the maximum tolerated dose of 80 mg/kg. There was no adverse effect on fertility in both male and female rats at 27 mg/kg/day. This dose level is approximately 13.5 times the proposed maximum human dose based on body surface area.
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE VARITHENA Delivery System Instructions for Use Please read all prescribing information before using the product. Rx Only The Instructions for Use are for the entire VARITHENA system. 180 mg/18 mL Configuration: Bi-Canister box and Administration Pack 180 mg/18 mL Configuration: Always write the activation date and time on the canister and verify the product has not expired prior to use.
Once the VARITHENA canister has been activated, the shelf life for the product is thirty (30) days. A canister of VARITHENA generates 90 mL of foam which, following purging instructions contained in this IFU, is sufficient to yield 45 mL of usable foam for injection. The gas mix of the foam is 65:35 O 2 : CO 2 .
WARNINGS: As the foam fills the syringe and before injecting, inspect the syringe full of foam for any visible bubbles. If there are any present, the foam should be emptied into the VARITHENA transfer unit waste chamber and the syringe refilled. Do not shake VARITHENA canisters.
Always use a fresh pair of sterile gloves when handling the Bi-Canister and VARITHENA transfer unit. Notes: Use a new sterile syringe after each injection. Never fill a syringe until just before the foam is required.
Use foam within 75 seconds of generation or discard and generate new foam. The activated VARITHENA canister should always be stored with a VARITHENA transfer unit in place in the upright position at or below 86°F (30°C), in an appropriately controlled clean area to limit contamination. A new VARITHENA transfer unit must be used for each treatment session.
Unpacking VARITHENA: 180 mg/18 mL: Bi-Canister Box and Administration Pack Gather all the items needed for the generation of foam: the VARITHENA Bi-Canister box ( Figure 1 ) , Administration Pack (including: VARITHENA transfer unit, manometer tube, compression pad and silicone-free syringes) ( Figure 2 ) , and the following items that are not supplied: scissors, pen, sterile alcoholic wipes, timer and gloves ( Figure 3 ) . Open the VARITHENA Bi-Canister box and remove the VARITHENA Bi-Canister pouch. Open the Administration Pack and remove the components.
Inspect the pouch and components for damage (do not use product if there are any visible signs of damage to pouch or components). Preparing the Patient Preparations for treating the patient with VARITHENA should include the following steps: Position the patient comfortably on the treatment table in a supine position with their hip externally rotated to facilitate access to the GSV. Use ultrasound to find the best site for venous access.
Using an aseptic technique, infiltrate the skin over the venous access point with local anesthetic. Obtain venous access under ultrasound guidance. IV catheters that are 16 to 22 gauge and 40 - to 50 - mm long or micropuncture sets are recommended for venous access.
Prefill the manometer tube with sterile heparinized normal saline solution and connect to the IV catheter. Confirm venous access by aspirating with a syringe, blood should be dark and under low pressure. Flush the IV catheter and manometer tube with heparinized normal saline and secure it to the skin with adhesive tape, leave the saline syringe connected.
With the IV catheter in place and secure, place the patient supine and elevate the leg to approximately 45 degrees. Complete all preparation of the patient and preparations for VARITHENA injectable foam injection before generation of the foam. VARITHENA Preparation 1 Wearing appropriate sterile gloves, open Bi-Canister pouch using a pair of scissors.
Place canisters upright on a cleaned (sterile wipes) stable surface with the white oxygen canister on top ( Figure 4 ) . Discard empty pouch. 2 Remove the safety clip by lifting one corner of the clip out ( Figure 5 ) .
Discard the safety clip. Gas Activation of the VARITHENA Canistern 3 To begin the gas transfer, twist the canisters together clockwise ( Figure 6 ) until they come to a stop and the small indicators/marks on the collars… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
Principal Display Panel - Varithena Canister Label - NDC 60635-018-01 Principal Display Panel - Varithena Canister Label - NDC 60635-018-01
Principal Display Panel - Varithena Pouch Label - NDC 60635-118-01 Principal Display Panel - Varithena Pouch Label - NDC 60635-118-01
Principal Display Panel - Varithena Bi-Canister Box - NDC 60635-118-01 Principal Display Panel - Varithena Bi-Canister Box - NDC 60635-118-01
Principal Display Panel - Varithena Universal Administration Pack Principal Display Panel - Varithena Universal Administration Pack
Principal Display Panel - Varithena - 1 Count Transfer Unit Principal Display Panel - Transfer Unit
Principal Display Panel - 303 mL Oxygen Canister Principal Display Panel - 303 mL Oxygen Canister
Principal Display Panel - Varithena - 18 mL PD Canister label - NDC 60635-018-01 - Lot no. CN01304COR.01 Principal Display Panel - Varithena - 18 mL PD Canister label - NDC 60635-018-01 - Lot no. CN01304COR.01
Principal Display Panel - Varithena - 18 mL O2 Canister label Principal Display Panel - Varithena - 18 mL O2 Canister label
Principal Display Panel - Varithena - 18 mL Bi-Canister carton - NDC 60635-118-01 - Lot no. CN01313COR.01 Principal Display Panel - Varithena - 18 mL Bi-Canister carton - NDC 60635-118-01 - Lot no. CN01313COR.01
Principal Display Panel - Varithena - 18 mL Bi-Canister pouch label - NDC 60635-118-01 - Lot no. CN01301COR.01 18 mL Bi-Canister pouch label - NDC 60635-118-01 - Lot no. CN01301COR.01
About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| Product & package description | ✓ Available |
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| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
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| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
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