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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 ) 5.1 Anaphylaxis 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. 5.2 Tissue 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. 5.3 Venous 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.
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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 . 6.1 Clinical 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
adverse reactions table
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 ReactionPlacebo (N=151)VARITHENA 1.0% (N=149)Pain in extremity14 (9.3)25 (16.8)Infusion site thrombosisb024 (16.1)Contusion/injection site hematoma9 (6.0)23 (15.4)Limb discomfort5 (3.3)18 (12.1)Tenderness/injection site pain5 (3.3)16 (10.7)Venous thrombosis limbc012 (8.1)Thrombophlebitis superficial2 (1.3)8 (5.4)Deep vein thrombosis07 (4.7)