Figure 5. Mean Change from Baseline in CD4 Cell Count (cells/µL) During Study 245

Figure 6. Mean Change from Baseline in HIV RNA (log copies/mL) During Study 245

CONTRAINDICATIONS
When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information.

NORVIR is contraindicated in patients with known hypersensitivity to ritonavir or any of its ingredients.

Co-administration of NORVIR is contraindicated with the drugs listed in Table 4 (also see PRECAUTIONS - Table 5. Drugs that Should Not be Co-administered with NORVIR) because ritonavir mediated CYP3A inhibition can result in serious and/or life-threatening reactions. Voriconazole and St. John’s Wort are exceptions in that co-administration of NORVIR and voriconazole results in a significant decrease in plasma concentrations of voriconazole, and co-administration of NORVIR with St. John’s Wort may result in decreased ritonavir plasma concentrations.

Table 4. Drugs that are Contraindicated with NORVIR Drug Class Drugs Within Class That Are CONTRAINDICATED With NORVIR**
*see WARNINGS - Drug Interactions and PRECAUTIONS – Table 6. Established and Other Potentially Significant Drug Interactions for coadministration of sildenafil in patients with erectile dysfunction.

** For additional information for these contraindicated drugs, see also PRECAUTIONS –Table 5. Drugs that Should Not be Co-administered with NORVIR.
 
Alpha1-adrenoreceptor antagonist Alfuzosin HCL
Antiarrhythmics Amiodarone, bepridil, flecainide, propafenone, quinidine
Antifungal Voriconazole
Ergot Derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine
GI Motility Agent Cisapride
Herbal Products St. John’s Wort (hypericum perforatum)
HMG-CoA
Reductase Inhibitors: Lovastatin, simvastatin
Neuroleptic Pimozide
PDE5 enzyme inhibitor Sildenafil* (Revatio®) only when used for the treatment of pulmonary arterial hypertension (PAH)
Sedative/hypnotics Oral midazolam, triazolam

WARNINGS
ALERT: Find out about medicines that should NOT be taken with NORVIR. This statement is included on the product's bottle label.

When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including WARNINGS.

Drug Interactions
See CONTRAINDICATIONS- Table 4 for a listing of drugs that are contraindicated with NORVIR due to potentially life-threatening adverse events, significant drug interactions, or loss of virologic activity. Also, see PRECAUTIONS – Table 5 and Table 6 for drugs that should not be co-administered with NORVIR and for a listing of drugs with established and other significant drug interactions.

Allergic Reactions
Allergic reactions including urticaria, mild skin eruptions, bronchospasm, and angioedema have been reported. Rare cases of anaphylaxis and Stevens-Johnson syndrome have also been reported.

Hepatic Reactions
Hepatic transaminase elevations exceeding 5 times the upper limit of normal, clinical hepatitis, and jaundice have occurred in patients receiving NORVIR alone or in combination with other antiretroviral drugs (s