to intensify [2%),:<2%) Hypersensitivity: Hypersensitivity reaction (1%) Local: Injection site reaction (1%) Neuromuscular & skeletal: Osteoarthrosis (1%) Renal: Renal function abnormality (1%) Respiratory: Pneumonia (1%) Miscellaneous: Fever (4%), decreased therapeutic response (> <2%)> <1% (Limited to important or life-threatening): Anaphylactic shock, anaphylaxis, angina pectoris, angioedema, antibody development, arterial embolism (retinal), arterial thrombosis, arterial thrombosis (limb, retinal), bowel infarction, cerebral infarction, cerebral ischemia, cerebrovascular accident, deep vein thrombosis, hepatic artery thrombosis, hypersensitivity, immunogenicity, increased fibrin degradation products (including D-dimer elevation), intracardiac thrombus, local phlebitis, myocardial infarction, myocardial ischemia, nausea, occlusion of cerebral arteries, peripheral ischemia, portal vein thrombosis, pulmonary embolism, renal artery thrombosis, thrombophlebitis, venous thrombosis at injection site ALERT: U.S. Boxed Warning Thrombosis: Serious arterial and venous thrombotic events following administration of Factor VIIa (recombinant) have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive Factor VIIa (recombinant). Monitor patients for signs and symptoms of activation of the coagulation system and for thrombosis. Warnings/Precautions Concerns related to adverse effects: Antibody formation: In patients with factor VII deficiency, if factor VIIa activity does not reach the expected level, prothrombin time is not corrected, or bleeding is uncontrolled (with recommended doses), suspect antibody formation and perform antibody analysis. Prothrombin time and factor VII coagulant activity should be measured before and after administration in patients with factor VII deficiency. Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have been reported with use. Use with caution in patients with known hypersensitivity to mouse, hamster, or bovine proteins, or factor VIIa, or any components of the product. If hypersensitivity reaction occurs, discontinue use and administer appropriate treatment; carefully consider the benefits versus the risk of continued treatment with factor VIIa. Thromboembolic events: [US Boxed Warning]: Serious arterial and venous thrombotic events following administration of Factor VIIa (recombinant) have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive factor VIIa (recombinant). Monitor patients for signs and symptoms of activation of the coagulation system and for thrombosis. All patients receiving factor VIIa should be monitored for signs and symptoms of activation of the coagulation system or thrombosis; thrombotic events may be increased due to circulating tissue factor or predisposing coagulopathy in patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, septicemia, crush injury, concomitant treatment with activated or nonactivated prothrombin complex concentrates, or uncontrolled postpartum hemorrhage. Use with caution in patients with an increased risk of thromboembolic complications (eg, coronary heart disease, liver disease, DIC, postoperative immobilization, elderly patients, and neonates). Decreased dosage or discontinuation is warranted with confirmed intravascular coagulation or presence of clinical thrombosis. Dosage form specific issues: Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer s labeling. Other warnings/precautions: Reduced efficacy: A number of factors influence the efficacy of factor VIIa, including hypothermia, thrombocytopenia, acidosis, and the amount of blood products transfused prior to administration (Dunkley, 2008). Monitoring Parameters Monitor for evidence of hemostasis and thrombosis (including laboratory confirmation of intravascular coagulation, if appropriate). Although the prothrombin time (PT)/INR, aPTT, and factor VII clotting activity have shown no direct correlation with achieving hemostasis, these parameters may be useful as adjunct tests to evaluate efficacy and guide dose or interval adjustments. In factor VII deficient patients, monitor PT and factor VII clotting activity before and after administration; if the factor VIIa activity fails to reach the expected level, if PT is not corrected, or if bleeding is not controlled after treatment with recommended doses, monitor for factor VII antibodies. Pregnancy Considerations Adverse events have been observed in animal reproduction studies. Factor VII concentrations may vary significantly in pregnant women with coagulation disorders. Pregnant women with hemophilia should have clotting factors monitored, particularly at 28 and 34 weeks gestation and prior to invasive procedures. Recombinant factor VIIa is recommended for the management of bleeding disorders in pregnant women with factor VII deficiency. Prophylaxis at delivery may be needed if factor VII concentrations are> <10 to 20 units /dL or in women with a significant bleeding history and treatment should continue for 3 to 5 days postpartum depending on route of delivery. The neonate may also be at an increased risk of bleeding following delivery and should be tested for the coagulation disorder (Kadir 2009; Lee 2006). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of blood clots (numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; angina; shortness of breath; tachycardia; or coughing up blood), severe headache, vision changes, severe dizziness, passing out, abdominal pain, or abdominal edema (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about coagulation factor viia Side Effects During Pregnancy Dosage Information Drug Interactions Compare Alternatives Support Group En Español 0 Reviews Add your own review/rating Drug class: miscellaneous coagulation modifiers Consumer resources Coagulation factor VIIa injection Factor VIIa (Recombinant) Coagulation factor viia Intravenous (Advanced Reading) Professional resources Factor VIIa (Recombinant) (AHFS Monograph) Other brands: NovoSeven RT Related treatment guides Hemophilia A Factor VII Deficiency Glanzmann's Disease Hemophilia B> ] Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Coagulation factor viia Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Miscellaneous coagulation modifiers Related Drugs miscellaneous coagulation modifiers pentoxifylline , Trental , tranexamic acid , Amicar , Lysteda , BeneFix Factor VII Deficiency NovoSeven RT , Profilnine SD , coagulation factor viia , More... Hemophilia A desmopressin , tranexamic acid , DDAVP , Advate , Cyklokapron , Eloctate , More... Hemophilia B BeneFix , Alprolix , NovoSeven RT , Profilnine SD , Alphanine SD , Idelvion , More... 1 more conditions... recommendations
a greater diversity Factor VIIa (Recombinant) most efficient
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