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Alteplase

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

Prescription medicine Intravenous Safety alerts on record

How to use Alteplase

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

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

How to take it and how often

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

Children
  • A total of 432 subjects under age 17 have received Cathflo Activase in the three trials
  • Rates of serious adverse events were similar in the pediatric and adult patients, as were the rates of catheter function restoration
Older adults

In 312 patients enrolled who were age 65 years and over, no incidents of intracranial hemorrhage (ICH), embolic events, or major bleeding events were observed. One hundred three of these patients were age 75 years and over, and 12 were age 85 years and over. The effect of Alteplase on common age-related comorbidities has not been studied. …

Talk to a doctor first if

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

Medicines it may not mix with

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.

Warnings

None.

Possible 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. …

Pregnancy and breastfeeding

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. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-01-20.

Brands around the world

Products with Alteplase as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

AlteplaseALTEPLASE 2.5 mg/2.5mg · Solution · Boehringer Ingelheim Pharma GmbH and Co. KG
NDC 12714-081Label
AlteplaseALTEPLASE 50 mg/50mg · Powder · Boehringer Ingelheim Pharma GmbH and Co. KG
NDC 12714-082Label
AlteplaseALTEPLASE 100 mg/100mg · Powder · Boehringer Ingelheim Pharma GmbH and Co. KG
NDC 12714-083Label
Cathflo ActivaseALTEPLASE 2.2 mg/2mL · Injection, Powder, Lyophilized, For Solution · Genentech, Inc.
NDC 50242-041Label
ActivaseKit · Genentech, Inc.
NDC 50242-044Label

Nigeria (NAFDAC)

NAFDACActilyse Powder A6-0592

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64U.S. FDA Class II
20 May 2024 · Genentech, Inc. · TerminatedLack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 GenentechU.S. FDA Class II
15 Mar 2021 · Cardinal Health Inc. · TerminatedCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.U.S. FDA Class II
12 Apr 2019 · CMC Enterprise Pharmacy · TerminatedLack of sterility assurance.
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by:U.S. FDA Class I
5 Sep 2017 · Genentech, Inc. · TerminatedNon-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Alteplase

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

Questions about Alteplase

What is Alteplase used for?

Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. (From the official U.S. FDA label.)

How do I take Alteplase?

Follow your prescription or the leaflet in your pack. The official label says: 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…

Do I need a prescription for Alteplase?

Usually yes. Alteplase is a prescription medicine in most countries. Rules differ by country.

What brands contain Alteplase?

Alteplase is sold under names such as Activase, Cathflo Activase. Brand names differ between countries.

How can I check that my Alteplase is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.