Cathflo

Generic name: Alteplase
Brand name: Activase, Cathflo Activase
Drug class: Thrombolytics

Cathflo (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.

cathfloThe 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 for injection is a sterile, white to pale yellow, lyophilized powder for intracatheter installation 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.

What is Cathflo pharmacology?

Alteplase is an enzyme (serine protease) that has the property of fibrin-enhanced conversion of plasminogen to plasmin. It produces limited conversion of plasminogen in the absence of fibrin. Alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin, thereby initiating local fibrinolysis

cathfloIn patients with acute myocardial infarction administered 100 mg of Activase as an accelerated intravenous infusion over 90 minutes, plasma clearance occurred with an initial half‑life of less than 5 minutes and a terminal half‑life of 72 minutes. Clearance is mediated primarily by the liver.

When Cathflo Activase is administered for restoration of function to central venous access devices, circulating plasma levels of Alteplase is not expected to reach pharmacologic concentrations. If a 2 mg dose of Alteplase were administered by bolus injection directly into the systemic circulation (rather than instilled into the catheter), the concentration of circulating Alteplase would be expected to return to endogenous circulating levels of 5–10 ng/mL within 30 minutes

Indications and Usage

Cathflo is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.

Contraindication

Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation

Precautions and warnings

General

Bleeding

Infections

Hypersensitivity

Re-Administration

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Nursing Mothers

Pediatric Use

Geriatric Use

Cathflo side effects

 Allergy such as Hives and breathing problems and swelling of your lips, face, and tongue.

Consult your physician or seek medical attention in an emergency situation If you are experiencing indications of bleeding, for example:

Make sure to contact your doctor at the earliest opportunity if you are suffering from:

Dosage and Administration

Cathflo 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:

  1. Aseptically withdraw 2.2 mL of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection.

No other medication should be added to solutions containing Cathflo Activase.

Instillation of Solution into the Catheter

  1. Inspect the product prior to administration for foreign matter and discoloration.

Any unused solution should be discarded.

Stability and Storage

Store lyophilized Cathflo Activase at refrigerated temperature (2–8°C/36–46°F). Do not use beyond the expiration date on the vial. Protect the lyophilized material during extended storage from excessive exposure to light.

How Supplied

 

cathflo

 

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