The Pharmacy and Therapeutics Committee voted to add tigecycline to the inpatient
formulary with Antimicrobial Restrictions, effective March 2006. In order to make
this medication available as a formulary agent for the general medical staff, to
ensure appropriate usage, and to protect the medical staff from medical/legal considerations,
the Pharmacy and Therapeutics Committee has approved the following requirements
for tigecycline use:
- Use of this drug, without Antimicrobial Restrictions, is allowed for FDA-labeled
indications only. (see below)
- A written indication for use must accompany ALL
tigecycline orders in the permanent medical record. Empiric orders should include
site of infection and possible infecting organism(s).
-
- Any off-label use will require review and approval for continued use by the Infectious
Disease (ID) Service. The ordering physician is responsible for contacting the ID
service. Only the loading dose and first maintenance dose will be dispensed pending
ID response; therefore, the review must be initiated within 24 hours of the original
order.
- If off-label use is approved, the ID Service will relay this information
to the ordering physician as well as to the pharmacy for continued administration
of tigecycline. If tigecycline is thought to be inappropriate, the ID Service will
provide alternative recommendations and communicate these recommendations to the
physician originating the tigecycline order.
If you have any questions regarding this policy, please direct them to the Antimicrobial
Stewardship Program (ASP) by contacting Elizabeth D. Hermsen, Pharm.D., M.B.A. via
email at ehermsen@nebraskamed.com or telephone at 402-559-4287.
Tigecycline Review
Tigecycline is the first FDA-approved agent in a new class of antibiotics, glycylcyclines,
a class closely related to the tetracyclines. Tigecycline was developed to provide
broad-spectrum coverage while overcoming two of the common resistance mechanisms
associated with tetracycline antibiotics: drug efflux and ribosomal protection.
Tigecycline has activity against a number of Gram-positive organisms, including
methicillin-resistant Staphylococcus aureus (MRSA) and Enterococcus faecalis, and
Gram-negative organisms, including ESBL-producing bacteria, Acinetobacter spp.,
and Stenotrophomonas spp. Of note, tigecycline does not have antipseudomonal activity.
Tigecycline also possesses antianaerobic activity.
Due to the high volume of distribution, tigecycline achieves drug concentrations
in the tissues many times higher than that in the blood. For this reason, tigecycline
is FDA-approved for treatment of complicated skin and skin-structure infections
(cSSSI) as well as complicated intra-abdominal infections. Currently a Phase III
trial is evaluating the use of tigecycline for the treatment of hospital-acquired
pneumonia. Tigecycline should not be used for endovascular infections, such as primary
bacteremia or endocarditis, due to this very high volume of distribution and low
serum concentrations (approximately 0.6 mg/L).
Tigecycline is not indicated for use during pregnancy or in children under 8 years
old as it may interfere with proper bone formation and cause permanent tooth discoloration.
When considering use in these populations, all risks should be weighed against the
potential benefits to the patient. Adverse reactions that were reported in >10%
of patients in clinical trials with tigecycline include; nausea (29.5%), vomiting
(19.7%), and diarrhea (12.7%).
The recommended dose of tigecycline is 100 mg IV bolus followed by 50 mg IV every
12 hours to be delivered over 30 to 60 minutes. Usual duration of therapy is 5 -
14 days, although actual duration should be dictated by the site and severity of
infection and the patient's overall clinical status. For those with severe hepatic
disease (Child-Pugh C), dose should be initiated at 100 mg IV bolus followed by
25 mg IV every 12 hours for the duration of therapy. Use in this population should
be cautious, with frequent monitoring for treatment response and toxicity.
|
Drug Regimen |
Daily Cost |
|
Tigecycline 50 mg IV q12h |
$91.30 |
|
Imipenem 500 mg IV q6h |
$100.65 |
|
Vancomycin 1 g IV q12h + Aztreonam 2 g IV q12h |
$101.30 |
|
Ceftriaxone 1 g IV q12h + Metronidazole 500 mg IV q8h |
$20.24 |
|
Piperacillin/tazobactam 3.375 g IV q6h |
$59.24 |
|
Ampicillin/sulbactam 1.5 g IV q6h |
$18.96 |
|
Daptomycin 280 mg IV q24h |
$85.12 ($152 for vial) |
|
Linezolid 600 mg IV/PO q12h |
$133.44 IV/$105.62 PO |