Cathflo (alteplase) - Particulate matter observed in some vials: additional instructions for use - Notice to Hospitals

Starting date:

May 8, 2013

Posting date:

May 10, 2013

Type of communication:

Notice to Hospitals

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Issue:

Contamination

Audience:

Healthcare Professionals

Identification number:

RA-29103

This is duplicated text of a letter from Hoffmann-La Roche Limited. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Information on CATHFLO (alteplase)

May 8, 2013

Dear Pharmacist/Chief of Medical Staff:

Please distribute to relevant Departments (that may be involved in the reconstitution and administration of CATHFLO, including Pharmacy, Intensive Care Unit, Oncology, Nephrology, Surgery, Internal Medicine, Anaesthesiology, Emergency Medicine, Cardiology), and other involved professional staff and post this NOTICE in your institution.

Subject: Particulate Matter Observed in Some Vials of CATHFLO^® (alteplase): Additional Instructions for Use

Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you that visible rubber stopper particulates have been observed in some vials of CATHFLO (alteplase) after reconstitution.

CATHFLO is a serine protease indicated for the restoration of function to central venous access devices.

Due to the medical necessity and to have continued availability of CATHFLO Roche is advising to:

• Follow all recommended steps for reconstitution of CATHFLO.
• Carefully inspect the reconstituted product. If you discover particulate matter upon reconstitution, do not administer CATHFLO.
• To minimize risk, a 5 micron filter needle should be used to withdraw the reconstituted product from the vial prior to patient administration.
• Carefully follow the attached "Instructions for Administration"

Further Information

Hoffmann-La Roche has observed visible rubber stopper particulates in some vials of CATHFLO^® (alteplase) following reconstitution. These particulates were observed in some vials but not all, and when present in a vial the number of particulates is low. An investigation into the source of the particulates is ongoing to determine the extent of the problem.

In the event you discover particulate matter upon reconstitution, do not administer CATHFLO to the patient. These visible particulates may pose a safety risk if administered to patients. Hoffmann-La Roche assesses the risk to patients as low when CATHFLO is administered for restoration of function to central venous access devices according to the "Preparation and Administration" section in the Product Monograph and package insert, which instructs health care providers to "inspect the product prior to administration for foreign matter and discolouration." When used according to the Product Monograph it is likely CATHFLO has minimal systemic exposure to the patient because the solution is withdrawn from the catheter after administration.

Based on a recent review of the company's adverse event surveillance systems, there have been no reports of adverse events that could be definitively attributed to the presence of particulate material in CATHFLO vials. However, to further minimize risk to patients, a filter needle should be used to withdraw the reconstituted product from the vial prior to patient administration.

Please ensure your staff and any provider in your institution who may be involved in the reconstitution and administration of CATHFLO receives a copy of this letter and specifically reviews the attached 'Instructions for Administration' for a complete guide to preparation and instillation of CATHFLO.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Serious or unexpected adverse reactions in patients receiving CATHFLO should be reported to Roche or Health Canada.

Hoffmann-La Roche Limited
Drug Safety Department
2455 Meadowpine Boulevard
Mississauga, Ontario, L5N 6L7
or call toll free at: 1-888-762-4388
or fax at: 905-542-5864
or email to: mississauga.drug_safety@roche.com

To correct your mailing address or fax number, contact Hoffmann-La Roche Limited.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

For other health product inquires related to this communication, please contact Health Canada at:

Biologics and Genetic Therapies Directorate (BGTD)
E-mail: BGTD_DGO_Enquiries@hc-sc.gc.ca
Tel: (613) 946-7264
Fax: (613) 946-5214

Should you have any questions or require additional information regarding the use of CATHFLO, please contact the Drug Information Department at Hoffmann-La Roche Limited at 1-888-762-4388, Monday to Friday, between 8:30 a.m. and 4:30 p.m. (Eastern Standard Time).

original signed by

Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited

Instructions for Administration

(additions to current full Product Monograph Information in bold+italics)

Preparation of Solution

Reconstitute Cathflo^® 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, USP, for reconstitution as it has not been studied clinically.
2. Inject the 2.2 mL of Sterile Water for Injection, USP, into the Cathflo^® vial, directing the diluent stream into the powder. Slight foaming is not unusual; let the vial stand undisturbed to allow large bubbles to dissipate.
3. Mix by gently swirling until the contents are completely dissolved. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution containing 1 mg/mL Cathflo^® at a pH of approximately 7.3.
4. Cathflo^® contains no antibacterial preservatives and should be reconstituted immediately before use. The solution may be used within 8 hours following reconstitution when stored at 2−30°C.
5. Attach a 5 micron filter needle to an appropriately sized syringe.
6. Withdraw 2 mL (2 mg) of solution from the reconstituted vial
7. Remove the filter needle from syringe

No other medication should be added to solutions containing Cathflo^®.

Administration

1. Inspect the product prior to administration for foreign matter and discoloration.
2. Instill the appropriate dose of Cathflo^® (see Usual Dose) into the occluded catheter.
3. After 30 minutes of dwell time, assess catheter function by attempting to aspirate blood. If the catheter is functional, go to Step 6. If the catheter is not functional, go to Step 4.
4. After 120 minutes of dwell time, assess catheter function by attempting to aspirate blood and catheter contents. If the catheter is functional, go to Step 6. If the catheter is not functional, go to Step 5.
5. If catheter function is not restored after one dose of Cathflo^®, a second dose of equal amount may be instilled. Repeat the procedure beginning with Step 2.
6. If catheter function has been restored, aspirate 4-5 mL of blood to remove Cathflo^® and residual clot, discard aspirate and gently irrigate the catheter with 0.9% Sodium Chloride, USP.

Any unused solution should be discarded.