MESSAGE
| DATE | 2020-05-05 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout - NYLXS] Pulmonary Embolisms and thombosis and Wuhan-19
|
I am looking over the indications of ACTIVASE which has been update in
2015.
I've alway hated this indication. The indications and the
contrainidcations are for the same condition...
It is like - use it for an AMI within 3 hours UNLESS... a.b.c.d and then
it is contraindicated because it will kill the patient. How do yuu have
a ischemic thomobolyc event without also having underlining bleeding? I
am missing something in the Anotomy and Physiciology lesson.. :(
Anyway, it is indicated alread for Pulononry embolism
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103172s5203lbl.pdf
1.3 Pulmonary Embolism Activase is indicated for the lysis of acute
massive pulmonary embolism, defined as: Acute pulmonary emboli
obstructing blood flow to a lobe or multiple lung segments. Acute
pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to
maintain blood pressure without supportive measures.
Contrindications:
4.2Acute Myocardial Infarction or Pulmonary Embolism Do not administer
Activase for treatment of AMI or PE in the following situations in which
the risk of bleeding is greater than the potential benefit [see Warnings
and Precautions (5.1)]: Active internal bleeding History of recent
stroke Recent (within 3 months) intracranial or intraspinal surgery or
ser ious head trauma Presence of intracranial conditions that may
increase the risk of bleeding (e.g. some neoplasms, arteriovenous
malformations, or aneurysms) Bleeding diathesis or current severe
bleeding
(5.1)
WARNINGS AND PRECAUTIONS
5.1
Bleeding Activase can cause internal bleeding (intracranial,
retroperitoneal, gastrointestinal, genitourinary, respiratory) or
external bleeding, especially at arterial and venous puncture sites .
Avoid intramuscular injections and trauma to the patient while on
Activase. Perform venipunctures carefully and only as required. To
minimize bleeding from noncompressible sites, avoid internal jugular and
subclavian venous punctures. If an arterial puncture is necessary during
Activase infusion, use an upper extremity vessel that is accessible to
manual compression, apply pressure for at least 30 minutes, and monitor
the puncture site closely. Because of the higher risk of intracranial
hemorrhage in patients treated for acute ischemic stroke, limit
treatment to facilities that can provide timely access to appropriate
evaluation and management of intracranial hemorrhage. Fatal cases of
hemorrhage associated with traumatic intubation in patients administered
Activase have been reported. Aspirin and heparin have been administered
concomitantly with and following infusions of Activase in the management
of acute myocardial infarction and pulmonary embolism, but the
concomitant administration of heparin and aspirin with and following
infusions of Activase for the treatment of acute ischemic stroke during
the first 24 hours after symptom onset has not been investigated.
Because heparin, aspirin, or Activase may cause bleeding complications,
carefully monitor for bleeding, especially at arterial puncture sites.
Hemorrhage can occur 1 or more days after administration of Activase,
while patients are still receiving anticoagulant therapy. If serious
bleeding occurs, terminate the Activase infusion. In the following
conditions, the risks of bleeding with Activase therapy for all approved
indications are increased and should be weighed against the anticipated
benefits: Recent major surgery or procedure, (e.g., coronary artery
bypass graft, obstetrical delivery, organ biopsy, previous puncture of
noncompressible vessels) Cerebrovascular disease Recent intracranial
hemorrhage Recent gastrointestinal or genitourinary bleeding Recent
trauma Hypertension: systolic BP above 175 mm Hg or diastolic BP above
110 mm Hg High likelihood of left heart thrombus, e.g., mitral
stenosis with atrial fibrillation Acute pericarditis Subacute bacterial
endocarditis Hemostatic defects including those secondary to severe
hepatic or renal disease Significant hepatic dysfunction Pregnancy
Diabetic hemorrhagic retinopathy, or other hemorrhagic ophthalmic
conditions Reference ID: 3702389
Septic thrombophlebitis or occluded AV cannula at seriously infected
site Advanced age [s ee Use in Specific Populations (8.5)] Patients
currently receiving anticoagulants (e.g., warfarin sodium) Any
other condition in which bleeding constitutes a significant hazard or
would be particularly difficult to manage because of its location.
-----
So many immigrant groups have swept through our town
that Brooklyn, like Atlantis, reaches mythological
proportions in the mind of the world - RI Safir 1998
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but incompatible with living as a free human being. -RI Safir 2013
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