INVIRASE Film-coated tablet Ref.[8793] Active ingredients: Saquinavir

Posology

Therapy with Invirase should be initiated by a physician experienced in the management of HIV infection.

In combination with ritonavir

The recommended dose of Invirase is 1000 mg (2 × 500 mg film-coated tablets) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents. For treatment-naive patients initiating treatment with Invirase/ritonavir, the starting recommended dose of Invirase is 500 mg (1 × 500 mg film-coated tablet) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents for the first 7 days of treatment. After 7 days, the recommended dose of Invirase is 1000 mg two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents. Patients switching immediately from treatment with another protease inhibitor taken with ritonavir or from a non-nucleoside reverse transcriptase inhibitor based regimen, except rilpivirine (see section 4.5), without a wash-out period, should however initiate and continue Invirase at the standard recommended dose of 1000 mg two times daily with ritonavir 100 mg two times daily.

Renal impairment

No dosage adjustment is necessary for patients with mild to moderate renal impairment. Caution should be exercised in patients with severe renal impairment (see section 4.4).

Hepatic impairment

No dosage adjustment is necessary for HIV-infected patients with mild hepatic impairment. No dosage adjustment seems warranted for patients with moderate hepatic impairment based on limited data.

Close monitoring of safety (including signs of cardiac arrhythmia) and of virologic response is recommended due to increased variability of the exposure in this population. Invirase/ritonavir is contraindicated in patients with decompensated hepatic impairment (see sections 4.3 and 4.4).

Paediatric population

The safety and activity of saquinavir boosted with ritonavir in HIV-infected patients less than 2 years have not been established. No dose recommendations for paediatric patients ≥2 years of age could be established that are both effective and below thresholds of concern for QT and PR interval prolongation.

Adults over 60 years

The experience with Invirase in adults over 60 years is limited.

Method of administration

Invirase film-coated tablets should be swallowed whole and taken at the same time as ritonavir with or after food (see section 5.2).

There is limited experience of overdose with saquinavir. Whereas acute or chronic overdose of saquinavir alone did not result in major complications, in combination with other protease inhibitors, overdose symptoms and signs such as general weakness, fatigue, diarrhoea, nausea, vomiting, hair loss, dry mouth, hyponatraemia, weight loss and orthostatic hypotension have been observed. There is no specific antidote for overdose with saquinavir. Treatment of overdose with saquinavir should consist of general supportive measures, including monitoring of vital signs and ECG, and observations of the patient’s clinical status. If indicated, prevention of further absorption can be considered. Since saquinavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

Plastic bottles (HDPE) containing 120 tablets.

No special requirements for disposal.