cathflo activase
Pharmaranks rates Cathflo Activase 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cathflo Activase (Alteplase) is a medication used to treat Arterial Occlusive Diseases, Intracranial Embolism and Thrombosis, Myocardial Infarction, Pulmonary Embolism.
Alteplase · by Genentech Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Alteplase
- Form
- Injectable
- Strength
- Alteplase 2MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Genentech Inc
- FDA application
- BLA103172
What is Cathflo Activase?
From the FDA label:Cathflo ® Activase ® (Alteplase) is a tissue plasminogen activator (t‑PA) produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue‑type plasminogen activator (t‑PA) obtained from an established human cell line. The manufacturing process involves secretion of the enzyme Alteplase into the culture medium by an established mammalian cell line (Chinese hamster ovary cells) into which the cDNA for Alteplase has been genetically inserted. Cathflo Activase (Alteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intracatheter instillation for restoration of function to central venous access devices following reconstitution with Sterile Water for Injection, USP. Each vial of Cathflo Activase contains 2.2 mg of Alteplase (which includes a 10% overfill), 77 mg of L‑arginine, 0.2 mg of polysorbate 80, and phosphoric acid for pH adjustment. Each reconstituted vial will deliver 2 mg of Cathflo Activase, at a pH of approximately 7.3.
How to use
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…
Side effects
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…
Warnings
Important safety information
None.
Who should not take Cathflo Activase
Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation (see DESCRIPTION ).
Interactions
The interaction of Cathflo Activase with other drugs has not been formally studied. Concomitant use of drugs affecting coagulation and/or platelet function has not been studied.
Storing Cathflo Activase, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store lyophilized Cathflo Activase at refrigerated temperature (2–8°C/36–46°F).”
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Cathflo Activase treat?
- Cathflo Activase (Alteplase) may be used to treat arterial occlusive diseases, intracranial embolism and thrombosis, myocardial infarction, pulmonary embolism, stroke, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Cathflo Activase rated?
- pharmaranks gives Cathflo Activase a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Cathflo Activase?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cathflo Activase. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cathflo Activase?
- Cathflo Activase is marketed by Genentech Inc. You can see Genentech Inc's full profile, rating, and other products on pharmaranks.
- Is Cathflo Activase a brand-name or generic drug?
- Cathflo Activase is a brand-name product with the active ingredient Alteplase.
- Is Cathflo Activase available over the counter?
- No. Cathflo Activase is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cathflo Activase come in?
- Cathflo Activase is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Cathflo Activase FDA-registered?
- Cathflo Activase is on record with the U.S. FDA under application number BLA103172. You can verify this on its official FDA label.
- Has Cathflo Activase been recalled by the FDA?
- Yes. Cathflo Activase has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Cathflo Activase safe?
- There's no single safe-or-not verdict. pharmaranks gives Cathflo Activase a recall-safety score of 70/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cathflo Activase?
- Cathflo Activase's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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cathflo activase
70/100