The 500-mg Invirase tablets are beige and im-printed with “ROCHE” on one side and “SQV 500” on the other side. Also known as: Ro 31-8959, saquinavir mesylate, SQV Patient assistance. Roche offers a patient assistance program for Background and description. This drug is a protease inhibitor
those who qualify. For more information call 800.282.7780.
man u fac tured by F. Hoffmann-La Roche Ltd. and distributed by Roche Laboratories Inc. The US Food & Drug Administration Side effects and toxicity. The most common side effects seen with
(FDA) ap proved it in its fi rst formulation (the hard-gel for mu la tion
Fortovase/Invirase are gastrointestinal disturbances including nau sea,
Invirase) for use in combination with nucleoside reverse transcrip-
bloating, and diarrhea. Elevated liver function has been noted as well.
tase in hib i tors (NRTIs) in December 1995. Invirase was the fi rst
Metabolic (lipid and glucose) and morphologic (fat ac cu mu la tion and
FDA-approved protease inhibitor. Subsequently, the FDA approved
fat atrophy) abnormalities have been associated with protease inhibi-
a new soft-gel formulation (Fortovase) in November 1997. The maker of this drug has recently announced that the Fortovase (soft- Drug interactions. Fortovase/Invirase should not be taken with the fol- gel) formulation will no longer be available after 2005. The preferred way
lowing: Propulsid (cisapride), Halcion (triazolam), Versed (midazolam),
to administer this drug is as Norvir-boosted Invirase (see below).
ergot derivatives such as Wigraine and Cafergot, Zocor (simvastatin), Mevacor (lovastatin), Rifadin or Rimactane (rifampin), Mycobutin
Dose. The soft-gel Fortovase is dosed at 1200 mg (six 200 mg cap sules) 3
(rifabutin), Sustiva, and Crixivan.The use of St. John’s Wort (Hyperi-
times a day. The hard-gel Invirase is only rec om mend ed when combined
cum perforatum) is not recommended while taking either Fortovase
with Norvir. As of December 2003, the approved dosing with Norvir is
1000 mg of Fortovase or Invirase with 100 mg of Norvir twice a day. The hard-gel formulation achieves higher therapeutic drug levels than the
Lipid-lowering drugs such as Lipitor (atorvastatin), Pravachol (pravas-
soft-gel formulation when com bined with Norvir. In December 2004, the
tatin), or Lescol (fl uvastatin) should be used with caution when com-
FDA approved a new 500-mg tablet formulation of Invirase.
bined with Fortovase/Invirase. Dose reductions of Viagra (sildenafi l), Cialis (tadalafi l), and Levitra (vardenafi l) are rec om mend ed when
Food restrictions. Soft-gel Fortovase should be taken with a meal
taken with Fortovase/Invirase. When combining Fortovase with Vi-
or up to 2 hours after a meal. Combining Fortovase or Invirase with
racept consideration should be given to dosing 750 mg Viracept with
800 mg of Fortovase 3 times a day. Rescriptor increases the levels of Fortovase with a mild decrease in Rescriptor levels. An increase in liver
Storage. Fortovase soft-gel capsules should be refrigerated at 36° to
toxicities has been observed with this combination and patients with
46°F in tightly closed bottles until dispensed. Refrigerated cap sules re-
hepatitis B or C should be monitored carefully, especially during the
main stable until the expiration date printed on the label. Once brought
fi rst 6 weeks of administration. Norvir in creas es the levels of Fortovase
to room temperature capsules should be used within 3 months. The
Invirase hard-gel capsules may be stored at room tem per a ture.
The Center for AIDS Information & Advocacy
Resistance and cross-resistance. Resistance to Invirase has been generally associated with mu- tations at positions 48 and 90. Resistance and treatment failure with Fortovase has been generally associated with mutations at positions 48, 54, and 82. In addition, a mutation at position 90 can occur with Fortovase. Resistance to Invirase or Fortovase results in potential cross-resistance to other protease inhibitors. Clinical data. Early trials studied saquinavir as monotherapy, in combination with Retrovir and Hivid and in high doses. All of these trials produced small virologic benefi ts. Invirase received approval on the basis of ACTG 229, a study comparing the combination of Invirase and Hivid versus monotherapy of either, in Retrovir-experienced patients. FDA approval was based on sur- rogate marker data, but longer-term follow-up confi rmed the clinical benefi t of Invirase.
Subsequent studies found Fortovase to have an 8 fold greater increase in drug exposure than Invirase. In a study comparing Fortovase/NRTIs versus Invirase/NRTIs, on-treatment analysis showed that at 16 weeks 67% of patients in the Fortovase arm compared to 37% of patients in the Invirase arm had viral load levels below 400 copies/mL. The mean viral load decreases were 2.0 log in the Fortovase group as compared to 1.6 log in the Invirase group.
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call 713.527.8219 or toll free 1407 HAWTHORNE STREET HOUSTON, TEXAS 77006 888.341.1788.
E-mail: [email protected]
The Center for AIDS Information & Advocacy
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