Effective October 4, 2010, Topotarget is offering oncology infusion centers
the opportunity to participate in a test market for Totect® Urgent Treatment
Kit. The test market participants will be eligible to purchase Totect® from
one of our authorized distributors (http://www.totect.com/PDF/Ordering.pdf)
at $6,500 and receive one
replacement kit, should the kit expire before use. Totect® has a
shelf life of 24 months from the date of manufacturing. Product at our
authorized distributors currently has a shelf life of 16 to 19 months.
Totect® (dexrazoxane for injection) is packaged in an
Urgent Treatment Kit for single patient use and includes
10 vials of Totect® powder 500mg each and 10 vials of
Totect® diluent 50mL each. Totect® is indicated for the
treatment of extravasation resulting from intravenous
anthracycline chemotherapy. Totect® demonstrated 98.2%1
efficacy based on two biopsy-confirmed clinical trials
and should be proactively stocked onsite and infused as
soon as possible and within six hours of an
anthracycline extravasation.
It is important to note that there is no generic to
Totect® for the treatment of anthracycline
extravasation. Totect is the only FDA approved product
for the treatment of anthracycline extravasation.
Topotarget Regional Business Managers (RBM) are deployed
strategically throughout the country to provide
immediate assistance should you experience an
anthracycline extravasation, conduct in-service training
programs, etc. Topotarget also has a dedicated
anthracycline extravasation Medical Hotline (866)
914-2922 and offers reimbursement and other educational
support through our website at
www.Totect.com. In
addition, Topotarget provides grants for continuing
education programs live and web-based (www.mlicme.org/P09019.html)
that have yielded over 4,100 participants. Only
Topotarget can provide you with these services as we
have the only FDA approved product for the treatment of
anthracycline extravasation.
Totect® was approved by the FDA in September 2007 and is
designated as an Orphan Drug. Since launch, Totect® has
been adopted by many facilities, both institutional and
private practice/community cancer centers, for treating
anthracycline extravasations.
Anthracycline extravasations occur when an anthracycline
chemotherapy infusion leaks out of a vein (whether
peripheral or port access) into the surrounding healthy
tissue. The symptoms of an anthracycline extravasation
may include, but not limited to, redness, pain and
swelling followed by blistering, tissue necrosis and
possible surgical debridement. If surgical debridement
is required, the patient is forced to postpone his or
her chemotherapy treatment until the surgical wound
heals. The costs to a facility associated with an
anthracycline extravasation prior to the availability of
Totect® included extended hospital stay, surgical
debridement and possible long term rehabilitation as
well as any litigation that may follow. The cost to the
patient is the human toll of pain and suffering and
postponement of cancer treatment.
Totect® was approved by the FDA based on two
biopsy-confirmed clinical trials where 98.2% of patients
treated with Totect®, as soon as possible and within six
hours of an anthracycline extravasation, did not require
surgical debridement. In addition, 71%1 of the patients
treated with Totect® continued with their next scheduled
chemotherapy infusion without delay.
Since 2008, professional oncology nursing societies have
updated their guidelines to include Totect® for the
treatment of extravasation resulting from intravenous
anthracycline chemotherapy. In October 2008,
extravasation of vesicant chemotherapy was assigned an
ICD-9 code of 999.81. Also in 2009, extravasation
management was included as a chemotherapy administration
safety standard. If you have not reviewed your
extravasation policies and procedures, now is a good
time.
Topotarget is proud to have served the worldwide
oncology community for over 10 years. It is our mission
to continue to research and develop novel treatments in
both the therapeutic and supportive care categories in
providing answers for cancer.
For further information, please see full prescribing
information on our website at
www.totect.com/PDF/Prescribing_Information.pdf. .
If you have any questions, you may contact me at (973)
895-6902.
Sincerely,
John L.
Parsons, Jr.
Chief
Commercial Officer Topotarget A/S
President Topotarget
USA
1. Mouridsen HT et al. Treatment of anthracycline
extravasation with savene (dexrazoxane). Results from
two prospective clinical multicentre studies. Ann Oncol
2007; 18:546-550.
Contraindications: None. Warnings and Precautions:
Totect® is a cytotoxic drug. Myelosuppression:
Dexrazoxane is associated with leukopenia, neutropenia,
and thrombocytopenia. Perform hematological
monitoring. Use In Pregnancy: Pregnancy Category D.
Fetal harm can occur when administered to a pregnant
woman. Apprise women of potential harm to the fetus.
Adverse Reactions: the most common adverse reactions
(>16%) are nausea, pyrexia, injections site pain and
vomiting. Drug Interactions: Dimethylsulfoxide. Based
on anecdotal reports concurrent use of topical
dimethlysulfoxide (DMSO) at the site of tissue injury
may reduce the benefit of Totect. Use in Specific
Populations: Nursing Mothers: Discontinue drug or
nursing, taking into consideration the importance of
drug to the mother. Renal impairment: Reduce the
Totect dose by 50% in patients with creatinine clearance
values <40 mL/min. | 
