Dosing & Uses
Dosage Forms & Strengths
powder for injection (reconstitute before use)
- 2mg (Cathflo Activase)
- 50mg (Activase)
- 100mg (Activase)
Acute Myocardial Infarction
Administer as soon as possible after onset of symptoms
Recommended total dose for AMI is based on patient weight, not to exceed 100 mg, regardless of the selected administration regimen (accelerated or 3 hr)
Accelerated infusion (1-1/2 hr)
- ≤67 kg: 15 mg IVP bolus over 1-2 minutes, THEN 0.75 mg/kg IV infusion over 30 minutes (not to exceed 50 mg), and THEN 0.5 mg/kg IV over next 60 minutes (not to exceed 35 mg over 1 hr)
- >67 kg (100 mg total dose infused over 1.5 hr): 15 mg IVP bolus over 1-2 minutes, THEN 50 mg IV infusion over next 30 minutes, and THEN remaining 35 mg over next 60 minutes
3-hr infusion
- <65 kg: 0.075 mg/kg IVP bolus over 1-2 minutes, THEN 0.675 mg/kg infused over the rest of the first hr, THEN 0.25 mg/kg IV for the next 2 hr
- ≥65 kg: (100 mg total dose infused over 3 hr): 6-10 mg IVP bolus over 1-2 minutes, THEN 50-54 mg infused over the rest of the first hr (ie, 60 mg in 1st hr including 6-10 mg bolus), THEN 20 mg/hr for the next 2 hr
Pulmonary Embolism
100 mg IV infused over 2 hr; institute parenteral anticoagulation near the end of or immediately following alteplase infusion when the PTT or thrombin time returns to <2x normal
Acute Ischemic Stroke
0.9 mg/kg IV; not to exceed 90 mg total dose; administer 10% of the total dose as an initial IV bolus over 1 minute and the remainder infused over 60 minutes
Dosing considerations (acute ischemic stroke)
- Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment (see Contraindications)
- Administer as soon as possible but within 3 hr after onset of symptoms; AHA/ASA 2019 Acute Stroke Guidelines recommend use within 4.5 hr of stroke onset
- Monitor and control blood pressure during and following administration
- In patients without recent use of oral anticoagulants or heparin, treatment can be initiated prior to the availability of coagulation study results
- Discontinue if the pretreatment INR is >1.7 or the aPTT is elevated
Central Venous Catheter Occlusion
Cathflo Activase: 2 mg in 2 mL instilled into occluded catheter
Assess catheter function after 30 minutes of dwell time by attempting to aspirate blood; if unable to aspirate after 120 minutes dwell time, a 2nd dose may be administered and the process repeated
If catheter function restored, aspirate 4-5 mL blood to remove Cathflo Activase and residual clot
Gently irrigate with 0.9% NaCl
Arterial Thrombosis & Embolism (Off-label)
0.05-0.1 mg/kg/hr by transcatheter intra-arterial infusion for 1-8 hours or until lysis of thrombus
Intracerebral Hemorrhage (Orphan)
Treatment of intraventricular hemorrhage associated with intracerebral hemorrhage
Orphan indication sponsor
- Daniel F Hanley, MD; Johns Hopkins University, 600 N Wolfe St, Jefferson 1-109; Baltimore, MD 21287
Bronchitis (Orphan)
Orphan designation for treatment of plastic bronchitis
Sponsor
- Kathleen A Stringer, PharmD, FCCP - Professor; University of Michigan; 428 Church St; Ann Arbor, MI 48109-1065
Dosage Forms & Strengths
powder for injection (reconstitute before use)
- 2mg (Cathflo Activase)
Central Venous Catheter Occlusion
<30 kg
- Cathflo Activase: Instill 110% of the internal lumen volume of the catheter; not to exceed 2 mg in 2 mL
≥30 kg
- Cathflo Activase: 2 mg instilled into occluded catheter
- Assess catheter function after 30 minutes of dwell time by attempting to aspirate blood; if unable to aspirate after 120 minutes dwell time, a 2nd dose may be administered and the process repeated
- If catheter function restored, aspirate 4-5 mL blood in patients 10 kg or more (aspirate 3 mL if <10 kg) to remove Cathflo Activase and residual clot
- Gently irrigate with 0.9% NaCl
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- defibrotide
defibrotide increases effects of alteplase by pharmacodynamic synergism. Contraindicated. Coadministration of defibrotide is contraindicated with antithrombotic/fibrinolytic drugs. This does not include use for routine maintenance or reopening of central venous lines.
- prothrombin complex concentrate, human
alteplase, prothrombin complex concentrate, human. pharmacodynamic synergism. Contraindicated.
Serious - Use Alternative (3)
- apixaban
alteplase and apixaban both increase anticoagulation. Avoid or Use Alternate Drug.
- caplacizumab
caplacizumab, alteplase. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- zanubrutinib
alteplase, zanubrutinib. Either decreases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Zanubrutinib-induced cytopenias increases risk of hemorrhage. Coadministration of zanubritinib with antiplatelets or anticoagulants may further increase this risk.
Monitor Closely (70)
- alfalfa
alteplase and alfalfa both increase anticoagulation. Modify Therapy/Monitor Closely.
- American ginseng
alteplase and American ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.
- antithrombin alfa
antithrombin alfa and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- antithrombin III
antithrombin III and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- argatroban
argatroban and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- aspirin
aspirin, alteplase. Either increases toxicity of the other by anticoagulation. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.
- aspirin rectal
aspirin rectal and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- aspirin/citric acid/sodium bicarbonate
aspirin/citric acid/sodium bicarbonate, alteplase. Either increases toxicity of the other by anticoagulation. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.
- azficel-T
azficel-T, alteplase. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- bivalirudin
bivalirudin and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- celecoxib
celecoxib and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- choline magnesium trisalicylate
choline magnesium trisalicylate and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- cinnamon
alteplase and cinnamon both increase anticoagulation. Use Caution/Monitor. In theory, cinnamon may interact with blood-thinning medications due to the presence of coumarin.
- cordyceps
alteplase and cordyceps both increase anticoagulation. Modify Therapy/Monitor Closely.
- dabigatran
dabigatran and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.
- dalteparin
dalteparin and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- danshen
alteplase and danshen both increase anticoagulation. Modify Therapy/Monitor Closely.
- devil's claw
alteplase and devil's claw both increase anticoagulation. Use Caution/Monitor. Devil's claw may have additive anticoagulant activity.
- diclofenac
diclofenac and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- diflunisal
diflunisal and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- dong quai
alteplase and dong quai both increase anticoagulation. Modify Therapy/Monitor Closely.
- enoxaparin
enoxaparin and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- epoprostenol
alteplase and epoprostenol both increase anticoagulation. Use Caution/Monitor. Coadministration can increase the risk of bleeding, although this did not occur in clinical trials.
- etodolac
etodolac and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- fenoprofen
fenoprofen and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- feverfew
alteplase and feverfew both increase anticoagulation. Modify Therapy/Monitor Closely.
- fish oil
fish oil, alteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking fish oil and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .
- fish oil triglycerides
fish oil triglycerides will increase the level or effect of alteplase by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.
- flurbiprofen
flurbiprofen and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- fondaparinux
fondaparinux and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- forskolin
alteplase and forskolin both increase anticoagulation. Modify Therapy/Monitor Closely. Forskolin may cause bleeding due to additive platelet inhibition.
- garlic
alteplase and garlic both increase anticoagulation. Modify Therapy/Monitor Closely.
- ginger
alteplase and ginger both increase anticoagulation. Use Caution/Monitor.
- ginkgo biloba
alteplase and ginkgo biloba both increase anticoagulation. Modify Therapy/Monitor Closely.
- green tea
green tea, alteplase. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of bleeding.
- heparin
heparin and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- horse chestnut seed
alteplase and horse chestnut seed both increase anticoagulation. Modify Therapy/Monitor Closely.
- ibrutinib
ibrutinib will increase the level or effect of alteplase by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding.
- ibuprofen
ibuprofen and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- ibuprofen IV
ibuprofen IV and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- imatinib
imatinib, alteplase. Either increases toxicity of the other by Other (see comment). Modify Therapy/Monitor Closely. Comment: Imatinib may cause thrombocytopenia; bleeding risk increased when imatinib is coadministered with anticoagulants, NSAIDs, platelet inhibitors, and thrombolytic agents.
- indomethacin
indomethacin and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- ketoprofen
ketoprofen and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- ketorolac
ketorolac and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- ketorolac intranasal
ketorolac intranasal and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- meclofenamate
meclofenamate and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- mefenamic acid
mefenamic acid and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- melatonin
melatonin increases effects of alteplase by anticoagulation. Use Caution/Monitor. Melatonin may decrease prothrombin time.
- meloxicam
meloxicam and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- nabumetone
nabumetone and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- naproxen
naproxen and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- nitroglycerin rectal
nitroglycerin rectal decreases effects of alteplase by Other (see comment). Use Caution/Monitor. Comment: Caution should be observed in patients receiving nitroglycerin during t-PA therapy. IV administration of nitroglycerin decreases the thrombolytic effect of tissue-type plasminogen activator (t-PA). Plasma levels of t-PA are reduced when coadministered with nitroglycerin. .
- omega 3 carboxylic acids
omega 3 carboxylic acids, alteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- omega 3 fatty acids
omega 3 fatty acids, alteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3-fatty acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .
- oxaprozin
oxaprozin and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- panax ginseng
alteplase and panax ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.
- piroxicam
piroxicam and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- reishi
alteplase and reishi both increase anticoagulation. Modify Therapy/Monitor Closely.
- reteplase
alteplase and reteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- rivaroxaban
rivaroxaban, alteplase. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.
- salicylates (non-asa)
salicylates (non-asa) and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- salsalate
salsalate and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- Siberian ginseng
alteplase and Siberian ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.
- sulindac
sulindac and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- tenecteplase
alteplase and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- ticagrelor
ticagrelor, alteplase. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Increased risk of bleeding during concomitant use of medications that increase potential for bleeding.
- tolmetin
tolmetin and alteplase both increase anticoagulation. Use Caution/Monitor. Potential for increased risk of bleeding, caution is advised.
- tranexamic acid oral
tranexamic acid oral, alteplase. Either decreases effects of the other by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- vorapaxar
alteplase, vorapaxar. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Coadministration of anticoagulants, antiplatelets, or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- vortioxetine
alteplase, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.
Minor (1)
- ceftaroline
ceftaroline increases effects of alteplase by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
Adverse Effects
1-10%
Stroke (1.6%)
Frequency Not Defined
Accelerated idioventricular rhythm
Pulmonary edema
Arterial embolism
Bruising
Bleeding
DVT
Hypotension
Intracranial hemorrhage
GI/GU hemorrhage
Pulmonary embolism
Fever/chills
Nausea/vomiting
Sensitivity reaction
Sepsis
Shock
Hypersensitivity
Cerebral edema
Cerebral herniation
Seizure
Ischemic stroke
Thromboembolism
Warnings
Contraindications
Acute Ischemic Stroke
-
Do not administer to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit
- Current or prior intracranial hemorrhage
- Subarachnoid hemorrhage suspected
- Active internal bleeding
- Stroke within 3 months
- Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma
- Presence of intracranial conditions that may increase the risk of bleeding (eg, some neoplasms, arteriovenous malformations, aneurysms)
- Bleeding diathesis
- Current severe uncontrolled hypertension
Acute myocardial infarction or pulmonary embolism
-
Do not administer for treatment of AMI or PE in the following situations in which the risk of bleeding is greater than the potential benefit
- Active internal bleeding
- History of recent stroke
- Ischemic stroke within 3 months except when within 4.5 hr
- Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma
- Presence of intracranial conditions that may increase the risk of bleeding (eg, some neoplasms, arteriovenous malformations, aneurysms)
- Significant closed head or facial trauma with radiographic evidence of brain injury or facial trauma within 3 months
- Bleeding diathesis
- Aortic dissection
- Current severe uncontrolled hypertension
- Prior intracranial hemorrhage
Cautions
Catheter dysfunction may be caused by a variety of conditions other than thrombus formation, such as catheter malposition, mechanical failure, constriction by a suture, and lipid deposits or drug precipitates within the catheter lumen; considers these types of conditions before administering treatment
Because of risk of damage to vascular wall or collapse of soft-walled catheters, vigorous suction should not be applied during attempts to determine catheter occlusion
Avoid applying excessive pressure when agent is instilled into catheter; such force could cause rupture of catheter or expulsion of clot into circulation
Use caution in recent major surgery, cerebrovascular disease, HTN, acute pericarditis, hemostatic defects, severe thrombophlebitis, severe hepatic/renal dysfunction
Hypersensitivity, including urticaria, angioedema and anaphylaxis, reported in association with therapy; monitor patients during and for several hours after infusion for hypersensitivity; if signs of hypersensitivity occur, e.g. anaphylactoid reaction or angioedema develops, discontinue therapy and promptly institute appropriate therapy
Monitor patients during and for several hours after infusion for orolingual angioedema; discontinue therapy if angioedema develops
Cholesterol embolism reported rarely in patients treated with thrombolytic agents; may present with pancreatitis, cerebral infarction, acute renal failure, gangrenous digits, hypertension, rhabdomyolysis, or retinal artery oclusion
Consider risk of reembolization from lysis of underlying deep venous thrombi in patients with pulmonary embolism
Internal bleeding (intracranial, retroperitoneal, gastrointestinal, genitourinary, respiratory) or external bleeding, especially at arterial and venous puncture sites may occur
Avoid intramuscular injections and trauma to patient while on therapy
Perform venipunctures carefully and only as required
Minimize bleeding from noncompressible sites by avoiding internal jugular and subclavian venous punctures
If arterial puncture necessary during therapy infusion, use upper extremity vessel that is accessible to manual compression, apply pressure for at least 30 min, and monitor puncture site closely
Patients treated for acute ischemic stroke, with high risk of intracranial hemorrhage, should be treated at facilities that can provide timely access to appropriate evaluation and management of intracranial hemorrhage
Coronary thrombolysis may result in reperfusion arrhythmias
Patients who present within 3 hr of stroke symptom onset, should be treated with alteplase unless contraindications exist; longer time window (3-4.5 hr after symptom onset) shown to be safe and efficacious for select individuals; treatment of patients with minor neurological symptoms not recommended
Alteplase does not treat adequately underlying deep vein thrombosis in patients with pulmonary embolism; consider possible risk of re-embolization due to lysis of underlying deep venous thrombi in this setting
Use with caution in presence of known or suspected infection in catheter; using agent in patients with infected catheters may release a localized infection into the systemic circulation; as with all catheterization procedures, use care to maintain aseptic technique
Bleeding
Agent has not been studied in patients known to be at risk for bleeding events that may be associated with use of thrombolytics; exercise caution with patients who have active internal bleeding or who have had any of the following within 48 hours: surgery, obstetrical delivery, percutaneous biopsy of viscera or deep tissues, or puncture of non-compressible vessels
Exercise caution with patients who have thrombocytopenia, other hemostatic defects (including those secondary to severe hepatic or renal disease), or any condition for which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location, or who are at high risk for embolic complications (e.g., venous thrombosis in the region of the catheter)
Death and permanent disability reported in patients who have experienced stroke and other serious bleeding episodes when receiving pharmacologic doses of a thrombolytic
Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur, therapy should be stopped and the drug should be withdrawn from the catheter
Clinical conditions that increase risk of bleeding for all indications
- Recent major surgery or procedure, (e.g., coronary artery bypass graft, obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels)
- Cerebrovascular disease or 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 or patients currently receiving anticoagulants (e.g., warfarin sodium)
- Septic thrombophlebitis or occluded AV cannula at seriously infected site ⋅
- Advanced age
- Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location
Pregnancy & Lactation
Pregnancy
Published studies and case reports on alteplase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes; alteplase is embryocidal in rabbits when intravenously administered during organogenesis at clinical exposure for AMI, but no maternal or fetal toxicity was evident at lower exposure in pregnant rats or rabbits; the most common complication of thrombolytic therapy is bleeding; pregnancy may increase this risk; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus
Lactation
There are no data on presence of alteplase in human milk, effects on breastfed infant, or on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant human tissue-type plasminogen activator (t-PA); produces local fibrinolysis
Promotes thrombolysis by converting plasminogen to plasmin; plasmin degrades fibrin and fibrinogen
Absorption
Onset: Coronary thrombolysis occurs in 30 min; reaches peak response at 60 min
Peak plasma time: 20-40 min
Distribution
Vd: 27-53 L
Metabolism
Rapidly cleared from circulation by liver
Metabolites: Degradation products (constituent amino acids of alteplase)
Elimination
Initial half-life: 5 minutes (free, unbound form)
Terminal half-life: 72 minutes
Total body clearance: 34.3-38.4 mL/hr
Excretion: Urine
Administration
Vial Reconstitution
Use only the accompanying sterile water for injection (without preservatives); do not use bacteriostatic water for injection
Reconstitute using aseptic technique
Do not add other medication to resulting solution
Reconstitute no more than 8 hr before use (does not contains antibacterial preservatives)
Slight foaming is not unusual; let stand undisturbed for several minutes to allow large bubbles to dissipate
Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit
Activase may be administered as reconstituted at 1 mg/mL or further diluted immediately before administration in an equal volume of 0.9% NaCl or D5W, to yield a concentration of 0.5 mg/mL, using either PVC bags or glass vials
Avoid excessive agitation during dilution; mix by gently swirling and/or slow inversion
50-mg vials
- Do not use if vacuum is not present
- Using a large bore needle (eg, 18 gauge) and a syringe, reconstitute by adding the contents of the accompanying 50 mL vial of sterile water for injection (SWFI) to the 50 mg vial, directing the SWFI stream into the lyophilized cake
100-mg vials
- The 100 mg vials do not contain vacuum
- Using the transfer device provided, reconstitute by adding the contents of the accompanying 100 mL vial of SWFI to the 100 mg vial
- 1. Use aseptic technique
- 2. Remove the protective flip-caps from 1 vial of Activase and 1 vial of SWFI
- 3. Open the package containing the transfer device by peeling the paper label off the package
- 4. Remove the protective cap from 1 end of the transfer device and keeping the vial of SWFI upright, insert the piercing pin vertically into the center of the stopper of the vial of SWFI
- 5. Remove the protective cap from the other end of the transfer device; do NOT invert the vial of SWFI
- 6. Hold the vial of Activase upside down, position it so that the center of the stopper is directly over the exposed piercing pin of the transfer device, and push the vial of Activase down so that the piercing pin is inserted through the center of the Activase vial stopper
- 7. Invert the 2 vials so that the vial of Activase is on the bottom (upright) and the vial of SWFI is upside-down, allowing the SWFI to flow down through the transfer device; allow the entire contents of the vial of SWFI to flow into the Activase vial (approximately 0.5 mL of SWFI will remain in the diluent vial)
- 8. Remove the transfer device and the empty SWFI vial from the Activase vial and discard
- 9. Swirl gently to dissolve the Activase powder; do NOT shake
Bolus Dose Preparation
Prepare the bolus dose in 1 of the following ways
50-mg vials
- Remove the appropriate volume from the reconstituted vial (1 mg/mL) using a syringe and needle
- If this method is used with the 50 mg vials (contains vacuum), the syringe should not be primed with air and the needle should be inserted into the vial stopper
100-mg vials
- If the 100 mg vial (no vacuum) is used, the needle should be inserted away from the puncture mark made by the transfer device
- Remove the appropriate volume from a port (second injection site) on the infusion line after the infusion set is primed
- Program an infusion pump to deliver the appropriate volume as a bolus at the initiation of the infusion
Cathflo Activase preparation
Reconstitute 2 mg vial by adding 2.2 mL SWI (do not use bacteriostatic water for injection); yields final concentration of 1 mg/mL
Mix by gently swirling until completely dissolved; complete dissolution occurs within 3 minutes; do NOT shake
Use within 8 hr if stored at room temperature
Storage
Activase
- Protect from light
- Unopened vials: Store at room temperature, not to exceed 30ºC (86ºF), or refrigerate (2-8ºC [36-46ºF])
- Reconstituted vials: Stored at 2-30ºC (36-86ºF) for up to 8 hr following reconstitution
- Discard any unused solution after administration is complete
- Do not use beyond the expiration date stamped on the vial
Cathflo
- Contains no preservatives
- Unopened vials: Refrigerate at 2–8ºC [36–46ºF]; do not use beyond the expiration date on vial
- Protect from light
- Reconstituted vials: Stored at 2-30ºC (36-86ºF) for up to 8 hr following reconstitution
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Cathflo Activase intra-catheter - | 2 mg vial |  | |
| Activase intravenous - | 100 mg vial |  | |
| Activase intravenous - | 100 mg vial |  | |
| Activase intravenous - | 50 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
alteplase intravenous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
