ONGUARD Contained Medication System
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B. Braun Medical Inc's (Bethlehem,
PA) ONGUARD Contained Medication
System is a drug admixture and
delivery system that provides a new
level of hazard protection and passive
needle-stick prevention for pharmacists
and nurses at the front line of
chemotherapy preparation and administration.
The American Society of
Health-System Pharmacists, the National
Institute for Occupational Safety
and Health, and the United States
Pharmacopeia <797> have each recommended
the use of protective devices
for the preparation of hazardous
medications. The system with TEVADAPTOR
components provides protection
from hazardous vapors, particles,
and aerosols, by means of a hydrophobic
0.2-µm sterilizing grade membrane
and the TOXIGUARD activated charcoal
drug-binding matrix. Independent laboratory
studies using chemotherapy
medications demonstrate this system
effectively prevents hazardous vapors
from escaping by binding them within
the activated charcoal matrix while
also preventing nonsterile air from
entering the medication vial. The
ONGUARD Contained Medication
System further protects workers and
the patient care environment from
admixture to delivery by preventing liquid
droplets from exiting the dispensing
units during use. For more information,
visit www.bbraunusa.com, or call
800-854-6851.
Thyrogen (thyrotropin alfa for injection)
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Genzyme Corp (Cambridge,
MA) recently received
FDA approval for
a supplemental indication for Thyrogen
to be used in combination with radioiodine
to ablate, or destroy, the remaining
thyroid tissue in patients who have
had their cancerous thyroids removed.
The product was initially approved in
the United States in 1998 for use as an
adjunctive diagnostic tool for serum
thyroglobulin testing with or without
radioiodine imaging in the follow-up of
patients with well-differentiated thyroid
cancer. A 2-injection regimen is
recommended. The 2-injection regimen
is Thyrogen 0.9 mg intramuscularly
(IM), followed by a second 0.9-mg IM
injection 24 hours later. After reconstitution
with 1.2 mL sterile water for
injection, a 1.0-mL solution (0.9 mg thyrotropin
alfa) is administered by IM
injection to the buttock. For radioiodine
imaging or remnant ablation,
radioiodine should be administered 24
hours following the final Thyrogen
injection. The product is supplied as a
sterile, nonpyrogenic, lypophilized product.
It is available in a 2- or 4-vial kit.
The 2-vial kit contains two 1.1-mg vials
of Thyrogen. The 4-vial kit contains two
1.1-mg vials of Thyrogen as well as two
10-mL vials of sterile water for injection
USP. For more information, visit
www.thyrogen.com, or call 88-THYROGEN
(888-497-6436).
Paclitaxel Injection USP
Parenta Pharmaceuticals (West
Columbia, SC), the US subsidiary of
Austrian-based Ebewe Pharma, recently
launched Paclitaxel Injection USP.
The product is the generic equivalent
of Bristol-Myers Squibb Co's Taxol
Injection. Paclitaxel Injection USP is
indicated as first-line and subsequent
therapy for the treatment of advanced
carcinoma of the ovary. As first-line
therapy, the product is indicated in
combination with cisplatin. Paclitaxel
Injection USP also is indicated for the
adjuvant treatment of node-positive
breast cancer administered sequentially
to standard doxorubicin-containing
combination chemotherapy. The product
is AP-rated, bar-coded, and supplied
in latex-free vials in the following
presentations: 30-mg/5-mL, 100-mg/
16.7-mL, and 300-mg/50-mL multidose
vials. For more information, visit www.parentarx.com, or call 800-898-9948.
Tysabri (natalizumab)
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Elan Pharmaceuticals Inc (South
San Francisco, CA) and Biogen Idec
Inc (Cambridge, MA) recently received
FDA approval for a supplemental biologics
license application for Tysabri.
The product is now approved for inducing
and maintaining clinical response
and remission in adult patients with
moderate-to-severe active Crohn's disease
(CD), with evidence of inflammation,
who have had an inadequate
response to, or are unable to tolerate,
conventional CD therapies and inhibitors
of tumor necrosis factor-alpha.
Tysabri will be available for the treatment
of CD upon the completion of key
implementation activities related to the
approved risk management plan.
Tysabri is prescribed only by physicians
enrolled in the Tysabri Outreach: Unified
Commitment to Health (TOUCH)
Prescribing Program, infused at an infusion
center that is enrolled in the program,
and given to patients who are
enrolled in the program. The TOUCH
Prescribing Program has been implemented
for patients receiving Tysabri
therapy for multiple sclerosis. For more
information, visit www.tysabri.com, or
call 800-456-2255.
