Medical Editor: John P. Cunha, DO, FACOEP
Cathflo Activase (alteplase) is a tissue plasminogen activator (t-PA) indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. Common side effects of Cathflo Activase include:
- bleeding (may be serious),
- blood clots, and
Cathflo Activase is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL. The dose of Cathflo Activase for patients weighing 30kg or more is 2 mg in 2mL. The dose of Cathflo Activase for patients weighing less than 30 kg is 110% of the internal lumen volume of the catheter, not to exceed 2mg in 2 mL. Cathflo Activase may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Cathflo Activase; it is unknown how it may affect a fetus. It is unknown if Cathflo Activase passes into breast milk. Consult your doctor before breastfeeding.
Our Cathflo Activase (alteplase) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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. Nonserious 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. Spontaneously reported deaths and serious adverse events that were not thought to be related to the patient's underlying disease were also recorded during the 30 days following treatment.
Four catheter-related sepsis events occurred from 15 minutes to 1 day after treatment with Alteplase, and a fifth sepsis event occurred on Day 3 after Alteplase treatment. All 5 patients had positive catheter or peripheral blood cultures within 24 hours after symptom onset.
Three patients had a major hemorrhage from a gastrointestinal source from 2 to 3 days after Alteplase treatment. One case of injection site hemorrhage was observed at 4 hours after treatment in a patient with pre-existing thrombocytopenia. These events may have been related to underlying disease and treatments for malignancy, but a contribution to occurrence of the events from Alteplase cannot be ruled out. There were no reports of intracranial hemorrhage.
Three cases of subclavian and upper extremity deep venous thrombosis were reported 3 to 7 days after treatment. These events may have been related to underlying disease or to the long-term presence of an indwelling catheter, but a contribution to occurrence of the events from Alteplase treatment cannot be ruled out. There were no reports of pulmonary emboli.
There were no gender-related differences observed in the rates of adverse reactions. Adverse reactions profiles were similar across all age subgroups.
In Trial 3 all serious adverse events were recorded with a specific interest in intracranial hemorrhage, major hemorrhage, thrombosis, embolic events, sepsis and catheter related complications. Major hemorrhage was defined as severe blood loss ( > 5 mL/kg), blood loss requiring transfusion, or blood loss causing hypotension. Non-serious adverse events were not recorded. Patients were observed until catheter function was deemed to be restored or for a maximum of 4 hours after the first dose. Additionally, serious adverse events were elicited from patients at 48 hours (up to 96 hours) following completion of treatment.
No pediatric patients in Trial 3 experienced an intracranial hemorrhage, major hemorrhage, thrombosis, or an embolic event.
Three cases of sepsis occurred 2 to 44 hours after treatment with Cathflo Activase. All of these patients had evidence of infection prior to administration of Cathflo Activase. An additional patient developed fever and lethargy within one day of Cathflo Activase administration, which required outpatient intravenous antibiotics. In one subject, the lumen of the catheter, placed 2 years previously, ruptured with infusion of the study drug.
There were no gender-related differences observed in the rates of adverse reactions. Adverse reactions profiles were similar across all age groups.
No allergic-type reactions were observed in the trials in patients treated with Alteplase. If an anaphylactic reaction occurs, appropriate therapy should be administered.
Read the entire FDA prescribing information for Cathflo Activase (Alteplase Powder for Reconstitution for Use in Central Venous Access Devices)