Each film-coated tablet contains
Saquinavir mesylate IP equivalent to
Saquinavir IP 500 mg
Colour: Red oxide of Iron

MAXIMUNE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV infection.

MAXIMUNE must be used in combination with ritonavir, because it significantly inhibits saquinavir`s metabolism to provide increased plasma saquinavir levels.

Adults (over the age of 16 years)

• MAXIMUNE 1000-mg b.i.d (2 x 500-mg tablets) in combination with ritonavir 100-mg bid.
• Ritonavir should be taken at the same time as MAXIMUNE
• MAXIMUNE and ritonavir should be taken within 2 hours after a meal.

Concomitant Therapy: MAXIMUNE with Lopinavir/Ritonavir
When administered with lopinavir/ritonavir 400/100 mg b.i.d, the appropriate dose of MAXIMUNE is 1000 mg b.i.d (with no additional ritonavir).

Monitoring of Patients
Clinical chemistry tests, viral load, and CD4 count should be performed prior to initiating MAXIMUNE therapy and at appropriate intervals thereafter. For comprehensive patient monitoring recommendations for other nucleoside analogues, physicians should refer to the complete product information for these drugs.

Dose Adjustment for Combination Therapy with MAXIMUNE
For serious toxicities that may be associated with MAXIMUNE , the drug should be interrupted. MAXIMUNE at doses less than 1000 mg with 100 mg ritonavir bid are not recommended since lower doses have not shown antiviral activity. For recipients of combination therapy with MAXIMUNE and ritonavir, dose adjustments may be necessary. These adjustments should be based on the known toxicity profile of the individual agent and the pharmacokinetic interaction between saquinavir and the co-administered drug (see Warnings and Precautions: Drug Interactions ). Physicians should refer to the complete product information for these drugs for comprehensive dose adjustment recommendations and drug-associated adverse reactions of nucleoside analogues.

MAXIMUNE must be used in combination with ritonavir, which significantly inhibits saquinavir`s metabolism and provides increased plasma saquinavir levels.

MAXIMUNE is contraindicated in patients with clinically significant hypersensitivity to saquinavir or to any of the components contained in the tablet.

MAXIMUNE/ 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 (see Warnings and Precautions: Drug Interactions ).

MAXIMUNE/ ritonavir should not be given together with rifampin, due to the risk of severe hepatocellular toxicity if the three drugs are given together (see Warnings and Precautions: Drug Interactions ).

MAXIMUNE when administered with ritonavir is contraindicated in patients with severe hepatic impairment.

MAXIMUNE should not be administered concurrently with drugs listed in Table 1 (also see Warnings and Precautions: Drug Interactions, Table 2 ) .

Table 1: Drugs That Are Contraindicated With MAXIMUNE /Ritonavir