Download HVPA Rx New Drug Update July 2004 Ketek® (telithromycin

HVPA Rx New Drug Update
July 2004
Ketek® (telithromycin) – Aventis
http://www.ketek.com
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Telithromycin will be the first ketolide antimicrobial agent marketed in the U.S.
The antibacterial spectrum of telithromycin will resemble that of the
macrolides.
It is approved to treat acute exacerbations of chronic bronchitis, acute
bacterial sinusitis, and mild to moderate community-acquired pneumonia,
including multi-drug resistant Strep. pneumoniae in patients age 18 and
older.
Safety Issues:
ƒ Product labeling includes a bolded precaution about the occurrence of
“visual disturbances” associated with the antibiotic, including blurred
vision, difficulty focusing and objects looking doubled. Patients should be
cautioned about the potential effects of these visual disturbances on driving a
vehicle, operating machinery or engaging in other potentially hazardous
activities.
ƒ Hepatic dysfunction, including increased liver enzymes and hepatitis, with
or without jaundice, has been reported with the use of telithromycin.
ƒ Significant Drug Interaction Potential:
• Patients taking telithromycin should avoid concomitant use of:
simvastatin, lovastatin, or atorvastatin. Patients should cease
taking these agents during therapy with telithromycin.
• In patients treated with metoprolol for heart failure, the increased
exposure to metoprolol may be of clinical importance. Therefore, coadministration of KETEK® and metoprolol in patients with heart
failure should be considered with caution.
Telithromycin also has the potential to prolong the QTc interval.
The recommended adult dose for the treatment of acute exacerbations of chronic
bronchitis or acute bacterial sinusitis is 800 mg QD for 5-days. In clinical trials,
treatment with 10-days was not superior to 5-days.
The dose for community-acquired pneumonia is 800 mg once daily for 7-10 days.
Ketek® is supplied as a 400-mg tablet. The AWP per 800-mg dose (2 tablets) is
approximately $11.50 per day. There is also a Ketek Pak containing 30 of the
400mg tablets.
HVPA P&T Committee Recommendation: Other therapeutic alternatives are available
until more definitive safety data is available. Potential vision changes are of particular
concern as well the drug interaction potential.
Spiriva® (tiotropium bromide) – Pfizer/Boehringer Ingelheim
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Spiriva® is a long-acting, once-daily anticholinergic bronchodilator approved for COPD.
The “Handihaler” delivery device utilizes dry powder capsules; one capsule (18 mcg) is
inhaled daily. This dose can be taken anytime during the day.
The Handihaler requires the patient to load the capsule into the device, close the
cover, presse the button on the Handihaler to pierce the capsule, then exhale out, then
bring Handihaler device to mouth, close lips tightly around mouthpiece then breath
slowly and deeply at a rate sufficient to hear the capsule vibrate, breathe in until lungs
are full then hold breath as long as comfortable. Resume normal breath. To ensure
patient receives full dose of Spiriva®, the patient is to repeat the inhalation steps.
After completion, the empty capsule needs to be removed after dose completed.
Patient Instructions for the use of the Spiriva Handihaler are posted at
http://www.hvpa.com/spiriva_handihaler_instruct.pdf
The amount of drug delivered will vary from patient to patient depending upon the
patient’s peak inspiratory flow.
Tiotropium is associated with a slightly higher incidence of dry mouth than ipratropium
(Atrovent®).
Cost Comparisons (AWP per 30-day supply)
Spiriva® 18mcg QD #30 = $120.00 ($4.00 per capsule)
• also comes in package of 6 = $32.52 (more expensive per capsule = $5.42)
Atrovent® Inhaler 200 doses = $62.58
2 puffs QID = $75.10 per month
Combivent Inhaler 200 doses = $65.55
2 puffs QID = $78.66 per month
Serevent 50mcg BID #60 = $101.30
Advair 100/50 BID #60 = $129.10
Advair 250/50 BID #60 = $163.41
Advair 500/50 BID #60 = $225.69
HVPA P&T Committee Comments: Tiotropium will likely replace ipratropium bromide
as the first-line agent for COPD treatment.
Patients should be carefully instructed on
the correct use of the Spiriva Handihaler.
http://www.spiriva.com
The 2004 American Thoracic Society (ATS) COPD Guidelines are available at:
http://www.thoracic.org/copd/
Per the ATS, a PDF version of the guidelines will be available soon.
A review article on COPD was also published in the New England Journal of Medicine June
24, 2004 pgs. 2689-2697 http://www.nejm.org
New Combination Products:
Caduet® and Symbax®
Medication-Errors and Waste Ready to Happen?
Caduet® - Pfizer
http://www.caduet.com
Caduet® is a combination of the long-acting dihydropyridine calcium channel blocker amlodipine
(Norvasc®) and the lipid-lowering agent atorvastatin (Lipitor®).
Caduet® Doses available:
Atorvastatin
Amlodipine
5 mg
10 mg
10 mg
10 mg
5 mg
20 mg
10 mg
20 mg
5 mg
40 mg
10 mg
40 mg
5 mg
80 mg
10 mg
80 mg
Caduet® AWP/30 days
$108.00
$108.00
$147.60
$147.60
$147.60
$147.60
$147.60
$147.60
HVPA P&T Recommendation:
Although use of this combination product will be less costly
than using the drugs individually, this product may be difficult to titrate and waste of drug may
be high.
The amlodipine component is associated with edema and renal outcomes are
being questioned in certain patient populations. Unless a patient is stabilized on individual doses
of amlodipine and atorvastatin, Caduet® is not recommended.
Symbyax® – Lilley
http://www.symbyax.com
Symbyax® is a combination of olanzapine (Zyprexa®) and fluoxetine (Prozac®). The doses
available in Symbyax® differ slightly to those commercially available in the individual drugs.
Symbyax® Doses Available
Olanzapine
6 mg
6 mg
12 mg
12 mg
Fluoxetine
25 mg
50 mg
25 mg
50 mg
Symbyax® AWP/30-days
$246.00
$246.00
$374.10
$374.10
HVPA P&T Recommendation:
This agent will be difficult to titrate due to the relatively high
incidence of adverse effects associated with each of the agents.
In addition, generic fluoxetine
is available (20 mg = $8/mo and 40 mg = $60/mo) and generic pricing is expected to continue
its downward trend.
Published by the HVPA Pharmacy Department: Lori Kostoff, Pharm. D. and Laurie Wesolowicz, Pharm.D.
Under the direction of Dr. Jeffrey Sanfield, Chairman of the HVPA Pharmacy and Therapeutics Committee