pharmacopeia
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/api/v1/drug/alteplase

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Plasminogen Activators; Tissue Plasminogen Activators.

PlasminogenTissue Plasminogen

Indications

Sourced from openFDA
  • Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.

Contraindications

Sourced from openFDA
  • Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation (see DESCRIPTION ).contraindicated

Dosage & administration

Sourced from openFDA

Cathflo ® Activase ® (Alteplase) is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL. • Patients weighing ≥30 kg: 2 mg in 2 mL • Patients weighing <30 kg: 110% of the internal lumen volume of the catheter, not to exceed 2 mg in 2 mL If catheter function is not restored at 120 minutes after 1 dose of Cathflo Activase, a second dose may be instilled (see Instructions for Administration ). There is no efficacy or safety information on dosing in excess of 2 mg per dose for this indication. Studies have not been performed with administration of total doses greater than 4 mg (two 2‑mg doses). Instructions for Administration Preparation of Solution Reconstitute Cathflo Activase to a final concentration of 1 mg/mL: Aseptically withdraw 2.2 mL of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection. Inject the 2.2 mL of Sterile Water for Injection, USP, into the Cathflo Activase vial, directing the diluent stream into the powder. Slight foaming is not unusual; let the vial stand undisturbed to allow large bubbles to dissipate. Mix by gently swirling until the contents are completely dissolved. Complete dissolution should occur within 3 minutes. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution containing 1 mg/mL Cathflo Activase at a pH of approximately 7.3. Cathflo Activase contains no antibacterial preservatives and should be reconstituted immediately before use.

Warnings & precautions

Sourced from openFDA

None.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in greater detail in Section PRECAUTIONS of the label: Bleeding Hypersensitivity In the clinical trials, the most serious adverse events reported after treatment were sepsis (see PRECAUTIONS, Infections ), gastrointestinal bleeding, and venous thrombosis. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Trials 1 and 2 The data described for Trials 1 and 2 reflect exposure to Cathflo Activase in 1122 patients, of whom 880 received a single dose and 242 received two sequential doses of Cathflo Activase. In the Cathflo Activase Trials 1 and 2, only limited, focused types of serious adverse events were recorded, including death, major hemorrhage, intracranial hemorrhage, pulmonary or arterial emboli, and other serious adverse events not thought to be attributed to underlying disease or concurrent illness. Major hemorrhage was defined as severe blood loss ( > 5 mL/kg), blood loss requiring transfusion, or blood loss causing hypotension. Non‑serious adverse events and serious events thought to be due to underlying disease or concurrent illness were not recorded. Patients were observed for serious adverse events until catheter function was deemed to be restored or for a maximum of 4 or 6 hours depending on study. For most patients the observation period was 30 minutes to 2 hours.

Use in specific populations

Sourced from openFDA

Pregnancy Alteplase has been shown to have an embryocidal effect due to an increased postimplantation loss rate in rabbits when administered intravenously during organogenesis at a dose (3 mg/kg) approximately 50 times human exposure (based on AUC) at the dose for restoration of function to occluded CVADs. No maternal or fetal toxicity was evident at a dose (1 mg/kg) approximately 16 times human exposure at the dose for restoration of function to occluded CVADs. There are no adequate and well‑controlled studies in pregnant women. Cathflo Activase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Approval history

Sourced from openFDA
  • Nov 13, 1987BLABLA103172Genentech

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Activase, Injection, 1 KIT in 1 CARTON (50242-085-27) * 100 mL in 1 VIAL, SINGLE-USE * 100 mL in 1 VIAL, SINGLE USE (NDC 50242-085-27)To be discontinued
    Sponsor: Genentech, Inc
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
14,763 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1No Adverse Event2,48917%
  2. 2Off Label Use1,84613%
  3. 3Death1,1858.0%
  4. 4Gingival Bleeding1,0206.9%
  5. 5Cerebral Haemorrhage8035.4%
  6. 6Haemorrhage Intracranial7264.9%
  7. 7Drug Ineffective6264.2%
  8. 8Angioedema6204.2%
  9. 9Haemorrhage5703.9%
  10. 10Haemorrhagic Transformation Stroke4302.9%
  11. 11Product Storage Error3812.6%
  12. 12Nausea3632.5%
  13. 13Hypotension3432.3%
  14. 14Dyspnoea3392.3%
  15. 15Vomiting3352.3%

Literature

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Recent PubMed references pinned to Alteplase as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 507 ClinicalTrials.gov registrations naming Alteplase as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Alteplase work?
Mechanism-of-action classes: Plasminogen Activators; Tissue Plasminogen Activators.
What is Alteplase used for?
According to FDA labeling, Alteplase carries indications including: Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Alteplase?
Alteplase is classified as Enzymes, Other ophthalmologicals, Plasminogen Activators, Tissue Plasminogen Activators, Increased Thrombolysis.
What are the brand names for Alteplase?
Alteplase is marketed under brand names including Activase.
What are the contraindications for Alteplase?
Alteplase labeling lists contraindications including: Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation (see DESCRIPTION ).. Always consult the full prescribing information and a clinician.
Note. Data for alteplase is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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