Abridged Prescribing Information: VIREM Tablet 300 mg/ 600 mg

Composition:

Each film-coated tablet contains: Darunavir Ethanolate equivalent to Darunavir 300 mg/ 600 mg.


Indication:

For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor when co-administered with 100 mg ritonavir, and with other antiretroviral agents.


Dosage:

The recommended dosage of darunavir is 600 mg twice daily (b.i.d.) taken with ritonavir 100 mg b.i.d. and with food.


Contraindications:

Darunavir and ritonavir are both inhibitors of the CYP3A isoform and should not be coadministered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index).


Warnings and Precautions:

Darunavir should be coadministered with ritonavir and food, hepatotoxicity, severe skin reactions, sulfa allergy, diabetes mellitus/hyperglycemia, fat redistribution, immune reconstitution syndrome, hemophilia, resistance/cross resistance may occur.


Adverse Effects:

Serious: Abdominal pain, acute hepatitis, acute pancreatitis, anorexia, asthenia, diabetes mellitus, diarrhea, fatigue, headache, hepatic enzyme increased, hypercholesterolemia, hyperglycemia, hypertriglyceridemia, immune reconstitution syndrome, low density lipoprotein increased, nausea, pancreatic enzyme increased, rash, Stevens-Johnson syndrome, and vomiting.
Common adverse reactions (incidence ? 2%): Abdominal pain, diarrhoea, nausea, vomiting, abdominal distension, dyspepsia, fatigue, asthenia, anorexia, diabetes mellitus, headache, rash.


Use in Special Population:

Pregnancy: Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk.
Lactation: Mothers receiving darunavir should not breastfeed.
Hepatic impairment: Not recommended in severe hepatic impairment.
Renal impairment: Not recommended in severe renal impairment.


Overdosage:

General supportive measures including monitoring of vital signs and observation of the clinical status of the patient. If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.


Storage:

Store in a cool and dry place. Keep out of reach of children.


Presentation:

HDPE bottle containing 120 tablets of Virem 300 or 60 tablets of Virem 600. For further details, please consult the full prescribing information.

Updated by Dr. Aditi Apte on 16-06-2012