Roche Laboratories,
Inc. has updated their package insert for their protease
inhibitor, Invirase (saquinavir) to include the following drug
interaction information and include new warnings regarding
coadministration of Invirase/ritonavir and digoxin (used in the
treatment of various cardiac conditions).
Updated drug interaction information has been added on five
products in the product package insert revision:
1. Digoxin (see Warnings; see also Clinical Pharmacology Table
2, Precautions, Drug Interactions, Table 6) A new Warning has
been added. Caution should be exercised when Invirase and
digoxin are coadministered. Coadministration results in a
significant increase in serum concentration of digoxin;
therefore, the serum concentration of digoxin should be
monitored and the dose of digoxin may need to be reduced.
2. Garlic capsules (see Warnings; see also Precautions, Drug
Interactions) No data are available for the coadministration of
Invirase/ritonavir with garlic capsules. A Warning has been
added that the coadministration of garlic capsules and
saquinavir is not
recommended due to the potential for garlic capsules to induce
the metabolism of saquinavir, which may result in subtherapeutic
saquinavir concentrations.
3. Methadone (see Precautions, Drug Interactions; see also
Clinical pharmacology, Table 2) Methadone levels are decreased
and the dosage of methadone may need to be increased when
coadministered with Invirase/ritonavir.
4. Tipranavir/ritonavir (see Precautions, Drug Interactions)
Combining saquinavir with tipranavir/ritonavir is not
recommended due to a
decrease in saquinavir levels with coadministration.
5. Omeprazole (see Precautions, Drug Interactions) When
Invirase/ritonavir is coadministered with omeprazole, saquinavir
concentrations are increased significantly. If omeprazole or
another proton pump inhibitor is taken concomitantly with
Invirase/ritonavir, caution is advised and monitoring for
potential saquinavir toxicities is recommended, particularly
gastrointestinal symptoms, increased triglycerides, and deep
vein thrombosis.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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