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warnings and cautions
5 WARNINGS AND PRECAUTIONS Pulmonary edema: Discontinue therapy if pulmonary edema occurs. ( 5.1 ) Rebound pulmonary hypertension: Do not abruptly discontinue or decrease the dose. ( 5.2 ) Vasodilation reactions: Monitor blood pressure and symptoms regularly during initiation and after dose change. ( 5.3 ) Increased risk for bleeding: Increased risk for hemorrhagic complications, particularly for patients with other risk factors for bleeding. ( 5.4 ) 5.1 Pulmonary Edema If the patient develops pulmonary edema during initiation with epoprostenol, discontinue therapy and do not readminister. Consider the possibility of associated pulmonary veno-occlusive disease in such patients. 5.2 Rebound Pulmonary Hypertension following Abrupt Withdrawal Avoid abrupt withdrawal (including interruptions in drug delivery) or sudden large reductions in dosage of epoprostenol because symptoms associated with rebound pulmonary hypertension (e.g., dyspnea, dizziness, and asthenia) may occur. In clinical trials, one Class III patient's death was judged attributable to the interruption of epoprostenol. 5.3 Vasodilation Epoprostenol is a potent pulmonary and systemic vasodilator and can cause hypotension and other reactions such as flushing, nausea, vomiting, dizziness, and headache. Monitor blood pressure and symptoms regularly during initiation and after dose change [see Dosage and Administration ( 2.2 )]. 5.4 Increased Risk for Bleeding Epoprostenol is a potent inhibitor of platelet aggregation. Therefore, expect an increased risk for hemorrhagic complications, particularly for patients with other risk factors for bleeding [see Clinical Pharmacology ( 12.3 )] .
6 ADVERSE REACTIONS The most common adverse reactions are dizziness, jaw pain, headache, musculoskeletal pain, and nausea/vomiting, and are generally associated with vasodilation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions are shown in Table 3 and are generally related to vasodilatory effects. Table 3. Adverse Reactions Occurring in Patients with Idiopathic or Heritable PAH and with PAH Associated with Scleroderma Spectrum of Diseases (PAH/SSD) Occurring ≥10% More Frequently on Epoprostenol than Conventional Therapy Adverse Reaction Idiopathic or Heritable PAH PAH/SSD Epoprostenol (n = 52) Conventional Therapy (n = 54) Epoprostenol (n = 56) Conventional Therapy (n = 55) Body as a whole Jaw pain 54% 0% 75% 0% Nonspecific musculoskeletal pain 35% 15% 84% 65% Headache 83% 33% 46% 5% Chills/fever/sepsis/flu-like symptoms 25% 11% 13% 11% Cardiovascular system Flushing 42% 2% 23% 0% Hypotension 27% 31% 13% 0% Tachycardia 35% 24% 43% 42% Digestive system Anorexia 25% 30% 66% 47% Nausea/Vomiting 67% 48% 41% 16% Diarrhea 37% 6% 50% 5% Skin and Appendages Skin ulcer - - 39% 24% Eczema/rash/urticaria 10% 13% 25% 4% Musculoskeletal system Myalgia 44% 31% - - Nervous system Anxiety/hyperkinesias/nervousness /tremor 21% 9% 7% 5% Hyperesthesia/hypesthesia/paresthesia 12% 2% 5% 0% Dizziness 83% 70% 59% 76% Adverse Events Attributable to the Drug Delivery System Chronic infusions of epoprostenol are delivered using a small, portable infusion pump through an indwelling central venous catheter. During controlled PAH trials of up to 12 weeks’ duration, the local infection rate was about 18% and the rate for pain was about 11%. During long-term follow-up, sepsis was reported at a rate of 0.3 infections/patient per year in patients treated with epoprostenol. 6.2 Postmarketing Experience The following events have been identified during postapproval use of epoprostenol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic Anemia, hypersplenism, pancytopenia, splenomegaly, thrombocytopenia. Cardiac High output cardiac failure. Endocrine and Metabolic Hyperthyroidism. Gastrointestinal Hepatic failure. Respiratory, Thoracic, and Mediastinal Pulmonary embolism.