- Company Voluntarily Ceases Sale and Distribution of Fortovase(R)
In the U.S. -
NUTLEY, N.J., Feb. 6 /PRNewswire/ -- Roche today announced that effective
February 15, 2006, the company will discontinue the U.S. sale and distribution
of Fortovase(R), the soft-gel formulation of the HIV protease inhibitor
saquinavir, due to the continued availability of the INVIRASE(R) 500 mg tablet
formulation -- a decision previously communicated by the company in mid-2005.
INVIRASE is the optimal formulation for patients because it requires fewer
pills each day and is associated with fewer stomach-related side effects, and
does not require refrigeration. The INVIRASE 500 mg tablet formulation
requires only four tablets daily -- two in the morning and two in the evening,
taken with ritonavir. INVIRASE, which must be taken with a small dose (100
mg) of ritonavir, will continue to be available in both 500 mg tablets and 200
mg capsules. The removal of Fortovase by Roche is completely voluntary and is
not due to any safety or efficacy issues.
INVIRASE/ritonavir was listed as a recommended component of initial
antiretroviral regimens in the most recent International AIDS Society-USA
antiretroviral guidelines. The guidelines, published in the Journal of the
American Medical Association, gave INVIRASE/ritonavir the highest rating,
based on the strength of its clinical data. In addition, in an article
published in the Jan. 6, 2005 issue of the New England Journal of Medicine,
authors Grinspoon et al. list a change to an INVIRASE-containing regimen as a
potential intervention for patients who need an alternative PI regimen due to
hyperlipidemia.
Roche has taken this action due to a significant decline in the demand for
Fortovase as well as in response to the updated HIV treatment guidelines from
the U.S. Department of Health and Human Services (DHHS), which no longer
recommend Fortovase as a component of a preferred or alternative initial
treatment regimen. Roche first announced the discontinuation of Fortovase in
May 2005 to allow physicians and patients adequate time to consider a
transition to boosted INVIRASE or alternative treatment options, and to give
pharmacists and wholesalers sufficient lead time to adjust their stock. Since
that time, Roche has been actively encouraging physicians to refrain from
starting Fortovase treatment in their HIV-positive patients.
"The Fortovase formulation of saquinavir no longer meets the demands of
convenience and tolerability expected by patients today. In keeping with our
research focus to optimize delivery of current therapies and develop novel
treatments for people living with HIV/AIDS, we have determined that it is time
to focus our resources on the availability of INVIRASE, which offers
significant improvements in convenience and GI tolerance," said Frederick
Schmid, Vice President, Virology/HIV, Roche. "We've taken great care to plan
this discontinuation in such a manner as to allow physicians and patients
adequate time to consider and transition to boosted INVIRASE or other
therapies."
Since it was approved as the first protease inhibitor in December 1995,
more than a decade of continued research and development have helped establish
INVIRASE as an important treatment option for HIV-infected individuals. In
2003, INVIRASE was approved for twice-daily, "boosted" dosing in combination
with ritonavir (1,000 mg INVIRASE with 100 mg ritonavir). Boosting is a
treatment strategy which provides potent levels of INVIRASE in the blood and
allows for twice-daily dosing. The most recent development in December 2004
was approval of the INVIRASE 500 mg film-coated tablet.
About INVIRASE
INVIRASE in combination with ritonavir and other antiretroviral agents is
indicated for the treatment of HIV infection. The twice-daily administration
of INVIRASE in combination with ritonavir is supported by safety data from the
MaxCMin 1 study and pharmacokinetic data. The efficacy of INVIRASE with
ritonavir or Fortovase (with or without ritonavir coadministration) has not
been compared against the efficacy of antiretroviral regimens currently
considered standard of care.
INVIRASE(R) (saquinavir mesylate) capsules and Fortovase(R) (saquinavir)
soft gelatin capsules are not bioequivalent and cannot be used
interchangeably. INVIRASE may be used only if it is combined with ritonavir,
which significantly inhibits saquinavir's metabolism to provide plasma
saquinavir levels at least equal to those achieved with Fortovase. When using
saquinavir as the sole protease inhibitor in an antiviral regimen, Fortovase
is the recommended formulation.
INVIRASE is contraindicated in patients with clinically significant
hypersensitivity to saquinavir or to any of the components contained in the
capsule. INVIRASE/ritonavir should not be administered concurrently with
terfenadine, cisapride, astemizole, pimozide, triazolam, midazolam or ergot
derivatives. Inhibition of CYP3A4 by saquinavir could result in elevated
plasma concentrations of these drugs, potentially causing serious or life-
threatening reactions, such as cardiac arrhythmias or prolonged sedation.
INVIRASE when administered with ritonavir is contraindicated in patients
with severe hepatic impairment. Patients with hepatic impairment have not been
studied and caution should be exercised when prescribing saquinavir in this
population. Concomitant use of INVIRASE with lovastatin or simvastatin is not
recommended. Caution should be exercised if HIV protease inhibitors, including
INVIRASE, are used concurrently with other HMG-CoA reductase inhibitors that
are also metabolized by the CYP3A4 pathway (eg, atorvastatin).
Concomitant use of INVIRASE and St. John's wort (hypericum perforatum) or
products containing St. John's wort is not recommended. Garlic capsules should
not be used while taking saquinavir as the sole protease inhibitor, due to the
risk of decreased saquinavir plasma concentrations. For a complete list of
drugs that should not be taken with saquinavir, please see TABLE 5 in the
summary of complete product information.
New-onset diabetes mellitus, exacerbation of preexisting diabetes mellitus
and hyperglycemia have been reported during postmarketing surveillance in
HIV-infected patients receiving protease-inhibitor therapy. No initial dose
adjustment is necessary for patients with renal impairment. However, patients
with severe renal impairment have not been studied, and caution should be
exercised when prescribing saquinavir in this population. There have been
reports of spontaneous bleeding in patients with hemophilia A and B treated
with protease inhibitors.
Elevated cholesterol and/or triglyceride levels have been observed in some
patients taking saquinavir in combination with ritonavir.
Redistribution/accumulation of body fat has been observed in patients
receiving antiretroviral therapy. A causal relationship between protease-
inhibitor therapy and these events has not been established, and the long-term
consequences are currently unknown.
Varying degrees of cross-resistance among protease inhibitors have been
observed. In clinical trials with saquinavir (1000 mg) in combination with
ritonavir (100 mg) and other antiretrovirals, the grade 2, 3 and 4 adverse
events occurring in greater than or equal to 2% of 148 patients (considered at
least possibly related to study drug or of unknown relationship): abdominal
pain (6.1%), back pain (2%), bronchitis (2.7%), constipation (2%), diarrhea
(8.1%), diabetes mellitus/hyperglycemia (2.7%), dry lips/skin (2%), eczema
(2%), fatigue (6.1%), fever (3.4%), influenza (2.7%), lipodystrophy (5.4%),
nausea (10.8%), pneumonia (5.4%), pruritus (3.4%), rash (3.4%), sinusitis
(2.7%) and vomiting (7.4%).
INVIRASE is not a cure for HIV infection or AIDS. INVIRASE does not
prevent the transmission of HIV.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years, the Roche Group has been committed
to developing innovative products and services that address prevention,
diagnosis and treatment of diseases, thus enhancing people's health and
quality of life. An employer of choice, in 2005, Roche was named one of
Fortune magazine's Best Companies to Work For in America, one of the Top 20
Employers (Science magazine), ranked as the No. 3 Best Company to Work For in
NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one
of AARP's Top Companies for Older Workers. For additional information about
the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com
or http://www.roche.us.
Ritonavir is manufactured by Abbott Laboratories.
SOURCE Roche
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Related links:
http://www.rocheusa.com
http://www.roche.us
CONTACT:
Mike Nelson, of Roche, +1-973-562-2409,
mike.nelson@roche.com; or Joe St. Martin, of Manning Selvage &
Lee, +1-212-468-3731, joe.stmartin@mslpr.com
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