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For Healthcare Professionals

Information for Healthcare Professionals about INVIRASE 500

Roche Laboratories is committed to keeping healthcare providers updated about the use of INVIRASE in the care and treatment of their patients.

Boosted INVIRASE is recommended by IAS-USA Guidelines for use in initial regimens that include a protease inhibitor ¹
Switching to Boosted INVIRASE is recommended as an intervention for patients with hyperlipidemia and insulin resistance ²
INVIRASE is generally well tolerated and "appears to be much better tolerated" in terms of GI side effects compared with Fortovase® ³
In clinical trials with FORTOVASE (1000 mg) in combination with ritonavir (100 mg) and other antiretrovirals, the grade 2, 3 and 4 adverse events occurring in ≥ 5% of patients included: lipodystrophy (5.4%), nausea (10.8%), vomiting (7.4%), diarrhea (8.1%), abdominal pain (6.1%), fatigue (6.1%) and pneumonia (5.4%)
Therapeutic levels of boosted INVIRASE are maintained in the presence of proton pump inhibitors (PPIs like omeprazole) that treat heartburn and GERD ⁴
Additionally, levels of INVIRASE do not decrease in the presence of H2 antagonists (like Zantac®)
New phenotypic and virtual phenotype clinical cut-offs more accurately predict clinical response to ritonavir-boosted saquinavir than previous versions
The PhenoSense^TM (Monogram Biosciences) defines a 12.0-fold change in IC₅₀ as the upper clinical cut-off for boosted INVIRASE. Loss of virologic response (>80%) to ritonavir-boosted saquinavir is expected only in virus samples exceeding this 12.0-fold change ⁵
The updated resistance profile supports boosted INVIRASE as a powerful option for an initial boosted-PI based regimen
The 500mg tablet formulation reduces pill count to two pills twice daily when boosted with 100 mg or ritonavir

500mg tablet

Recommendations for Use of ARV Drugs in Pregnant HIV-1-Infected Women state that "Based upon pharmacokinetic data and moderate experience with use in pregnancy, ritonavir-boosted saquinavir can be considered a preferred PI for combination regimens in pregnancy" ^6*
With more than 10 years of study and experience, INVIRASE offers you and your patients a well-characterized safety profile

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In the resources section, you will find downloadable pdfs that provide an overview of INVIRASE 500 and how it can meet the different needs of your patients:

More and more, healthcare providers and patients confront issues surrounding healthcare coverage and access to therapy. As a service to both healthcare providers and their patients, Roche offers the Roche HIV Therapy Assistance Program, which is described in detail in Patient Assistance.

Finally, from this section you can link directly to the complete INVIRASE prescribing information.

Your patients are welcome to review various areas of this Web site for information about HIV symptoms, HIV treatment, treatment-related side effects, and much more. Roche is pleased to provide information to support your efforts to achieve their goals in the fight against HIV.

More Than 10 Years of Study and Clinical Experience With Saquinavir

*Recommendation refers to the softgel formulation.

Zantac is a registered trademark of GlaxoSmithKline.

Ritonavir is manufactured by Abbott Laboratories.

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	Click here for Complete Product Information. Indication 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. Important Safety Information
	WARNING: INVIRASE® (saquinavir mesylate) capsules and tablets and FORTOVASE® (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 unboosted saquinavir, 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 FORTOVASE (1000 mg) in combination with ritonavir (100 mg) and other antiretrovirals, the grade 2, 3 and 4 adverse events occurring in ≥ 5% of patients included: lipodystrophy (5.4%), nausea (10.8%), vomiting (7.4%), diarrhea (8.1%), abdominal pain (6.1%), fatigue (6.1%) and pneumonia (5.4%) INVIRASE is not a cure for HIV infection or AIDS. INVIRASE does not prevent the transmission of HIV.
	THIS SITE IS INTENDED FOR U.S. AUDIENCES ONLY. Copyright © 2004-2008 Roche Laboratories Inc. All rights reserved. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Statement.


	Click here for Complete Product Information.

	THIS SITE IS INTENDED FOR U.S. AUDIENCES ONLY. Copyright © 2004-2008 Roche Laboratories Inc. All rights reserved. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Statement.
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