NOVOSEVEN RT Rx
Generic Name and Formulations:
Recombinant Coagulation Factor VIIa (rFVIIa) Room Temperature Stable 1mg, 2mg, 5mg, 8mg; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Indications for NOVOSEVEN RT:
Treatment of bleeding and peri-operative management in adults and children with Hemophilia A and B with inhibitors, congenital Factor VII deficiency, and Glanzmann’s thrombasthenia refractory to platelet transfusions, with or without antibodies to platelets. Treatment of bleeding and peri-operative management in adults with acquired hemophilia.
Adults and Children:
See full labeling. Give by IV bolus only. Individualize; base treatment schedule modification on hemostasis evaluation. Hemophilia A or B with inhibitors: Bleeding: 90mcg/kg every 2hrs, adjust until hemostasis is achieved; post-hemostatic dosing: continue at 3–6hrs intervals for severe bleeds. Peri-operative: initially 90mcg/kg prior to surgery, repeat at 2hr intervals during surgery; minor (post-surgical dosing): every 2hrs for 48hrs, then every 2–6hrs until healed; major (post-surgical dosing): every 2hrs for 5 days, then every 4hrs until healed. Congenital Factor VII deficiency: Bleeding: 15–30mcg/kg every 4–6hrs until hemostasis is achieved; Peri-operative: 15–30mcg/kg prior to surgery, repeat every 4–6hrs during surgery and until hemostasis is achieved. Glanzmann’s thrombasthenia: Bleeding: 90mcg/kg every 2–6hrs until hemostasis is achieved; Peri-operative: initially 90mcg/kg prior to surgery, repeat every 2hrs during surgery, then every 2–6hrs post-surgical. Acquired hemophilia: Bleeding: 70–90mcg/kg every 2–3hrs until hemostasis is achieved; Peri-operative: 70–90mcg/kg prior to surgery, repeat every 2–3hrs during surgery and until hemostasis is achieved.
Risk of serious arterial and venous thromboembolic events. Disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, uncontrolled post-partum hemorrhage, history of coronary heart disease, hepatic disease, post-op immobilization, elderly, neonates; increased risk of developing thrombotic events. Monitor for signs/symptoms of coagulation activation or thrombosis; discontinue or reduce dose if occur. Monitor prothrombin time and FVII coagulant activity before and after dosing in FVII deficiency. Perform analysis for antibodies if factor VIIa activity fails to reach expected level. Mouse, hamster, or bovine protein hypersensitivity. Pregnancy (Cat.C). Nursing mothers: not recommended.
Avoid concomitant activated or non-activated prothrombin complex concentrates; may increase risk of thrombotic events. Do not mix with infusion solutions. Concomitant Coagulation Factor XIII may cause thrombosis.
Thrombotic events, fever, fibrinogen plasma decreased, hypertension, headache, nausea, dyspnea; pain, thrombophlebitis, pulmonary embolism, decreased therapeutic response, cerebrovascular disorder, angina pectoris, abnormal hepatic function, DIC, hypersensitivity reactions (discontinue and treat if occur).
Single-use vial—1 (w. diluent); MixPro—1 (single-use vial + pre-filled diluent syringe + vial adapter)
Endocrinology Advisor Articles
- Cushing Syndrome Results in Poor Quality of Life Even After Remission
- DPP-4 Inhibitors and Incidence of Rheumatoid Arthritis in Type 2 Diabetes
- Cost-Benefit Analysis of Insulin Analogs in Type 2 Diabetes
- Nonfunctioning Adrenal Incidentaloma Associated With Metabolic Syndrome
- Low Predictive Power of Biomarkers for Estimated Glomerular Filtration Rate Decline
- Nutraceuticals May Benefit Patients Who Are Statin Intolerant
- Link Between Gestational Diabetes and Risk for CVD and Diabetes in Hispanic/Latina Population
- Clinical Characteristics Altering Risks and Benefits of Sulfonylureas and Thiazolidinedione Therapy in T2D
- 6 Factors Related to Inclusion in Health Care Workplace Identified
- Weight Gain After Quitting Smoking May Increase Risk for T2D