|
|
| (33 intermediate revisions by 3 users not shown) |
| Line 1: |
Line 1: |
| {{DrugProjectFormSinglePage
| | #REDIRECT [[Factor VIIa complex]] |
| |authorTag={{SS}}
| |
| |genericName=prothrombin, coagulation factor vii, coagulation factor ix, coagulation factor x, protein c, protein s
| |
| |aOrAn=an
| |
| |drugClass=Anti-coagulant
| |
| |indication=acute major bleeding, need for an urgent surgery/invasive procedure
| |
| |hasBlackBoxWarning=Yes
| |
| |adverseReactions=a list of adverse reactions, separated by commas.
| |
| |blackBoxWarningTitle=<span style="color:#FF0000;">WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS</span>
| |
| |blackBoxWarningBody=Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.
| |
| | |
| * Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Kcentra in clinical trials and post marketing surveillance. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events.
| |
| * Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2)
| |
| |fdaLIADAdult======Urgent Reversal of Acquired Coagulation Factor Deficiency=====
| |
| | |
| * Dosing Information
| |
| | |
| :* Individualize Kcentra dosing based on the patient's current pre-dose International Normalized Ratio (INR) value, and body weight (see [[Kcentra#Administration and Monitoring|Administration and Monitoring]]).
| |
| | |
| | |
| |contraindications=Kcentra is contraindicated in:
| |
| | |
| * Patients with known [[anaphylactic]] or severe systemic reactions to Kcentra or any components in Kcentra including [[heparin]], Factors II, VII, IX, X, [[Proteins C]] and S, [[Antithrombin]] III and human [[albumin]].
| |
| * Patients with [[disseminated intravascular coagulation]] ([[DIC]]).
| |
| * Patients with known [[heparin-induced thrombocytopenia]] ([[HIT]]). Kcentra contains [[heparin]] [see Description (11)].
| |
| |warnings======Hypersensitivity Reactions=====
| |
| | |
| [[Hypersensitivity]] reactions including [[flushing]], [[urticaria]], [[tachycardia]], [[anxiety]], [[angioedema]], [[wheezing]], [[nausea]], [[vomiting]], [[hypotension]], [[tachypnea]], [[dyspnea]], [[pulmonary edema]], and [[bronchospasm]] have been observed with Kcentra.
| |
| If severe allergic reaction or anaphylactic type reactions occur, immediately discontinue administration, and institute appropriate treatment.
| |
| | |
| =====Thromboembolic Risk/Complications=====
| |
| | |
| Both fatal and non-fatal arterial thromboembolic events (including [[acute myocardial infarction]] and [[arterial thrombosis]]), and venous thromboembolic events (including [[pulmonary embolism]] and [[venous thrombosis]]) and disseminated [[intravascular coagulation]] have been reported with Kcentra in clinical trials and post marketing surveillance [see Adverse Reactions (6) and Clinical Studies (14)]. Patients being treated with VKA therapy have underlying disease states that predispose them to thromboembolic events. Reversing VKA therapy exposes patients to the thromboembolic risk of their underlying disease. Resumption of [[anticoagulation]] should be carefully considered following administration of Kcentra and Vitamin K once the risk of thromboembolic events outweighs the risk of bleeding.
| |
| Thromboembolic events occurred more frequently following Kcentra compared to plasma in a randomized, plasma controlled trial in subjects requiring urgent reversal of VKA [[anticoagulation]] due to acute major bleeding, and the excess in thromboembolic events was more pronounced among subjects who had a history of prior thromboembolic event, although these differences were not statistically significant [see Adverse Reactions (6.1), Clinical Studies (14)]. Potential benefits of treatment with Kcentra should be weighed against the potential risks of thromboembolic events [see Adverse Reactions (6)]. Patients with a history of thrombotic events, [[myocardial infarction]], cerebral vascular accident, [[transient ischemic attack]], [[unstable angina pectoris]], severe peripheral vascular disease, or [[disseminated intravascular coagulation]], within the previous 3 months were excluded from participating in the plasma-controlled RCT. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months. Because of the risk of thromboembolism associated with reversal of [[VKA]], closely monitor patients for signs and symptoms of [[thromboembolism]] during and after administration of Kcentra. [see 17 Patient Counseling Information]
| |
| | |
| =====Transmissible Infectious Agents=====
| |
| | |
| Because Kcentra is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease agent. There is also the possibility that unknown infectious agents may be present in such products. Despite the use of two dedicated virus reduction steps in manufacturing to reduce risks, such products may still potentially transmit disease.
| |
| Reports of suspected virus transmission of [[hepatitis]] A, B, C, and [[HIV]] were generally confounded by concomitant administration of blood/blood components and/or other plasma-derived products. No causal relationship to Kcentra administration was established for any of these reports since introduction of a virus filtration step in 1996.
| |
| All infections thought by a physician to have been possibly transmitted by Kcentra should be reported by the physician or other healthcare provider to the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| |
| |clinicalTrials=======Central Nervous System======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Cardiovascular======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Respiratory======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Gastrointestinal======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Hypersensitive Reactions======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Miscellaneous======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| =====Condition 2=====
| |
| | |
| ======Central Nervous System======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Cardiovascular======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Respiratory======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Gastrointestinal======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Hypersensitive Reactions======
| |
| | |
| : (list/description of adverse reactions)
| |
| | |
| ======Miscellaneous======
| |
| | |
| : (list/description of adverse reactions)
| |
| |postmarketing=(Description)
| |
| |drugInteractions=* Drug 1
| |
| * Drug 2
| |
| * Drug 3
| |
| * Drug 4
| |
| * Drug 5
| |
| | |
| =====Drug 1=====
| |
| | |
| (Description)
| |
| | |
| =====Drug 2=====
| |
| | |
| (Description)
| |
| | |
| =====Drug 3=====
| |
| | |
| (Description)
| |
| | |
| =====Drug 4=====
| |
| | |
| (Description)
| |
| | |
| =====Drug 5=====
| |
| | |
| (Description)
| |
| |useInPregnancyFDA=(Description)
| |
| |useInPregnancyAUS=(Description)
| |
| |useInLaborDelivery=(Description)
| |
| |useInNursing=(Description)
| |
| |useInPed=(Description)
| |
| |useInGeri=(Description)
| |
| |useInGender=(Description)
| |
| |useInRace=(Description)
| |
| |useInRenalImpair=(Description)
| |
| |useInHepaticImpair=(Description)
| |
| |useInReproPotential=(Description)
| |
| |useInImmunocomp=(Description)
| |
| |othersTitle=Others
| |
| |useInOthers=(Description)
| |
| |administration=(Oral/Intravenous/etc)
| |
| |monitoring======Condition 1=====
| |
| | |
| (Description regarding monitoring, from ''Warnings'' section)
| |
| | |
| =====Condition 2=====
| |
| | |
| (Description regarding monitoring, from ''Warnings'' section)
| |
| | |
| =====Condition 3=====
| |
| | |
| (Description regarding monitoring, from ''Warnings'' section)
| |
| |IVCompat====Solution===
| |
| | |
| ====Compatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Not Tested====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Variable====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Incompatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ===Y-Site===
| |
| | |
| ====Compatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Not Tested====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Variable====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Incompatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ===Admixture===
| |
| | |
| ====Compatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Not Tested====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Variable====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Incompatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ===Syringe===
| |
| | |
| ====Compatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Not Tested====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Variable====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Incompatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ===TPN/TNA===
| |
| | |
| ====Compatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Not Tested====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Variable====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| | |
| ====Incompatible====
| |
| | |
| * Solution 1
| |
| * Solution 2
| |
| * Solution 3
| |
| |overdose====Acute Overdose===
| |
| | |
| ====Signs and Symptoms====
| |
| | |
| (Description)
| |
| | |
| ====Management====
| |
| | |
| (Description)
| |
| | |
| ===Chronic Overdose===
| |
| | |
| ====Signs and Symptoms====
| |
| | |
| (Description)
| |
| | |
| ====Management====
| |
| | |
| (Description)
| |
| |drugBox={{Drugbox2
| |
| | verifiedrevid =
| |
| | IUPAC_name =
| |
| | image =
| |
| | drug_name =
| |
| | |
| <!--Clinical data-->
| |
| | tradename =
| |
| | MedlinePlus =
| |
| | licence_US =
| |
| | pregnancy_AU =
| |
| | pregnancy_US =
| |
| | legal_status =
| |
| | routes_of_administration =
| |
| | |
| <!--Pharmacokinetic data-->
| |
| | bioavailability =
| |
| | metabolism =
| |
| | elimination_half-life =
| |
| | excretion =
| |
| | |
| <!--Identifiers-->
| |
| | CAS_number_Ref =
| |
| | CAS_number =
| |
| | ATC_prefix =
| |
| | ATC_suffix =
| |
| | PubChem =
| |
| | IUPHAR_ligand =
| |
| | DrugBank_Ref =
| |
| | DrugBank =
| |
| | ChemSpiderID_Ref =
| |
| | ChemSpiderID =
| |
| | UNII_Ref =
| |
| | UNII =
| |
| | KEGG_Ref =
| |
| | KEGG =
| |
| | ChEBI_Ref =
| |
| | ChEBI =
| |
| | ChEMBL_Ref =
| |
| | ChEMBL =
| |
| | |
| <!--Chemical data-->
| |
| | C= | H= | N= | O=
| |
| | molecular_weight =
| |
| | smiles =
| |
| | InChI =
| |
| | InChIKey =
| |
| | StdInChI_Ref =
| |
| | StdInChI =
| |
| | StdInChIKey_Ref =
| |
| | StdInChIKey =
| |
| | melting_point =
| |
| }}
| |
| |mechAction=(Description)
| |
| |structure=(Description with picture)
| |
| |PD=(Description)
| |
| |PK=(Description)
| |
| |nonClinToxic=(Description)
| |
| |clinicalStudies======Condition 1=====
| |
| | |
| (Description)
| |
| | |
| =====Condition 2=====
| |
| | |
| (Description)
| |
| | |
| =====Condition 3=====
| |
| | |
| (Description)
| |
| |howSupplied=(Description)
| |
| |fdaPatientInfo=(Patient Counseling Information)
| |
| |nlmPatientInfo=(Link to patient information page)
| |
| |lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
| |
| * (Paired Confused Name 2a) — (Paired Confused Name 2b)
| |
| * (Paired Confused Name 3a) — (Paired Confused Name 3b)
| |
| |drugShortage=Drug Shortage
| |
| }}
| |