Polidocanol

Varithena

180MG/18ML, 77.5MG/7.75ML solutionÉtats-UnisCommercialiséAutorisé le 25 nov. 2013

Contenu en anglais

Indications

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 ).

Contre-indications

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 )

Mises en garde et précautions d’emploi

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.

Indications

VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. ( 1 ).

Mises en garde et précautions d’emploi

Be prepared to treat anaphylaxis. ( 5.1 ) Tissue ischemia and necrosis: do not inject intra-arterially. ( 5.2 ) Venous Thrombosis. ( 5.3 )

5.1Anaphylaxis

5.2Tissue Ischemia and Necrosis

Grossesse et allaitement

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.

Effets indésirables

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.

Conditionnement	Code	Statut
POLIDOCANOL 180MG/18ML (10MG/ML)	NDA205098-001	Prescription
POLIDOCANOL 77.5MG/7.75ML (10MG/ML)	NDA205098-002	Discontinued

Varithena

Indications

Contre-indications

Mises en garde et précautions d’emploi

5.1Anaphylaxis

5.2Tissue Ischemia and Necrosis

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Varithena

Indications

Contre-indications

Mises en garde et précautions d’emploi

5.1Anaphylaxis

5.2Tissue Ischemia and Necrosis

Deux médicaments dans une même question ?

5.3Venous Thrombosis

Interactions

Grossesse et allaitement

8.1Pregnancy Risk Summary

Effets indésirables

6.1Clinical Trials Experience

Dans d’autres pays

Conditionnements

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