Totecttm Efficacy

TM Totect Efficacy (dexrazoxane for injection)

In two multicenter clinical studies,1 treatment with Totect was highly effective in reducing biopsy-confirmed tissue necrosis. In study 1, none of the 19 evaluable patients required surgical intervention and none had serious late sequelae. In study 2, one of the 38 evaluable patients required surgery. One additional non-evaluable patient required surgery for tissue necrosis. Thirteen patients had late sequelae at the extravasation site, such as pain, fibrosis, atrophy, and local sensory disturbance; all were judged as mild except in the one patient who required surgery. None of the 4 patients with a central venous 2 access device required surgical intervention. Before treatment with Totect

Percentage of patients not requiring surgical intervention due to anthracycline-induced necrosis overall 100

90 100% 97. 4% 98.2% 19/19 37/38 56/57 80

30 20 After treatment with Totect

% patients 10

Study 1 Study 2 Studies 1 and 2 combined

Adverse Reactions Planned Chemotherapy Adverse events of nausea/vomiting, diar- In the first study, 12 patients (67%) did not planned chemotherapy delayed; delays rhea, stomatitis, neutropenia, thrombocy- experience a delay in planned chemother- ranged from 7-15 days (mean 10 days). topenia, elevated liver enzyme levels, and apy following anthracycline extravasation The patient who required surgery despite infusion site burning have been observed. and Totect treatment. Planned chemother- Totect treatment did not receive further These adverse events have been reversible. apy needed to be delayed for 6 patients chemotherapy. Treatment delay was (33%); delays ranged from 2-24 days (mean caused by reversible neutropenia in 8.7 days). In the second study, 26 patients six patients.1 (72%) received chemotherapy as planned following anthracycline extravasation and Totect treatment. Ten patients (28%) had Full prescribing information can be found in the package insert or at www.totect.com Can you afford to be unprepared?

Although the incidence of anthracycline extravasation is very low,3,4 even one case is one too many.

When an anthracycline extravasation occurs, there’s a lot at stake – not only for the patient, but for the healthcare organization as well.

Consequences of an anthracycline extravasation may include:

Interruption in chemotherapy treatment Chemotherapy may need to be postponed while the patient Day 14 undergoes anthracycline extravasation treatment. A treatment delay may affect the course of the patient’s disease.

Surgical Intervention Anthracycline extravasation treatment may require debridement followed by a skin graft or flap. Wound care, antibiotic therapy, and pain management also may be needed.

Follow-Up Care The patient may require follow-up visits, home care, physical therapy, occupa- tional therapy, or other services following anthracycline extravasation treatment.

Potential Liability Allegations of negligence in anthracycline chemotherapy administration are sometimes made by patients following an anthracycline extravasation injury. Considering that a patient is at risk for extravasation every time an anthracycline is administered, how can you afford not to be prepared?

Totect™ is a trademark of Manufactured for: References TopoTarget A/S TopoTarget A/S 1. Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane). Results from US Patent No. 6,727,253B2 Symbion Science Park two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550. NDC 38423-110-01 Fruebjergvej 3 2. Totect™ package insert. TopoTarget USA, Inc., 2007. DK-2 100 Copenhagen 3. Langstein HN et al. Retrospective study of the management of chemotherapeutic extravasation injury. Manufactured by: Denmark Ann Plast Surg 2002; 49:369-374. Ben Venue Laboratories, Inc. 4. Barlock AL et al. Nursing management of adriamycin extravasation. Am J Nurs 1979;79:94-96 Bedford, OH 44146 Marketed by: TopoTarget USA Inc. Hameln Pharmaceuticals GmbH 100 Enterprise Drive Port photo: ONCOLOGY NURSING FORUM by Lisa Schulmeister & Dawn Camp-Sorrell. 31789 Hameln Rockaway, New Jersey 07866 Copyright 2000 by ONCOLOGY NURSING SOC. Reproduced with permission of Germany www.totect.com ONCOLOGY NURSING SOC in the format Brochure via Copyright Clearance Center. 866-478-8274