Classes
DEA Class; Rx
Common Brand Names; Norvir
- HIV, Protease Inhibitors
Description
Protease inhibitor (PI)
Used in combination with other antiretroviral agents for treatment of human immunodeficiency virus (HIV) infection
Commonly used to boost or enhance plasma concentrations of other PIs; many drug interactions
Indications
Not typically used as sole protease inhibitor (PI), but as pharmacokinetic enhancer of other PIs
Indicated in combination with other antiretroviral agents for the treatment of HIV-infection
Contraindications
Known hypersensitivity to ritonavir (eg, toxic epidermal necrolysis, Stevens- Johnson syndrome)
Coadministration with drugs highly dependent on CYP3A for clearance or that significantly reduce ritonavir
Coadministration of ritonavir with the following drugs is contraindicated: alfuzosin, amiodarone, flecainide, propafenone, quinidine, voriconazole, rifampin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lomitapide, lovastatin, simvastatin, lurasidone, apalutamide, pimozide, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, carbamazepine, ranolazine, dronedarone, flecainide, colchicine, phenobarbital, phenytoin, and St. John’s wort
Adverse Effects
- Increased triglycerides (17-34%)
- Diarrhea (15-23%)
- Nausea (26-30%)
- Taste perversion (7-11%)
- Vomiting (14-17%)
- Weakness (10-15%)
- Increased GGT (5-20%)
- Increased creatinine phosphokinase (9-12%)
- Abdominal pain (6%)
- Anorexia (2-8%)
- Dizziness (3-4%)
- Dyspepsia (6%)
- Eosinophilia
- Fever (1-2%)
- Flatulence (1-2%)
- Headache (6-7%)
- Insomnia (2-3%)
- Increased uric acid (4%)
- Increased LFTs (6-10%)
- Local throat irritation (2-3%)
- Malaise (1-2%)
- Myalgia (2%)
Warnings
Do not administer with antacids; separate from didanosine by 2 hr
Potent inhibitor of CYP3A4 (but also induces CYP450 enzymes)
Monitor: monthly neurologic evaluation
Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs
Risks of hemolytic anemia and hyperbilirubinemia if used in combination with other antiretroviral drugs
Capsules must be kept refrigerated
Allergic reactions have been reported and include anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson Syndrome, bronchospasm and angioedema; discontinue treatment if severe reactions develop
Consider drug-drug interaction potential to reduce risk of serious or life-threatening adverse reactions
Oral solution not for administration in preterm neonates in the immediate postnatal period; may cause toxicity; safety and efficacy not established
Monitor liver function before and during therapy, especially in patients with underlying hepatic disease, including hepatitis B and hepatitis C, or marked transaminase elevations; fatalities resulting from hepatic reactions reported
Fatalities resulting from pancreatitis reported; suspend therapy as clinically appropriate
PR interval prolongation reported in some patients; cases of second and third degree heart block reported; use with caution with patients with preexisting conduction system disease, ischemic heart disease, cardiomyopathy, underlying structural heart disease or when administering with other drugs that may prolong the PR interval
Pregnancy and Lactation
Advise pregnant women not to use oral solution during pregnancy owing to its alcohol content
Excreted in human milk
Maximum Dosage
NOTE: The following maximum dosage limits apply for typical ritonavir use; maximum dosage limits may be altered based on certain individual patient circumstances, such as in the case of specific drug interactions.
1200 mg/day PO.
1200 mg/day PO.
Refer to dosage recommendations when used as a pharmacokinetic enhancer (specific dose varies significantly depending on patient age/weight and concomitant protease inhibitor); 800 mg/m2/day PO (Max: 1200 mg/day) when used as the sole protease inhibitor.
Refer to dosage recommendations when used as a pharmacokinetic enhancer (specific dose varies significantly depending on patient age/weight and concomitant protease inhibitor); 800 mg/m2/day PO (Max: 1200 mg/day) when used as the sole protease inhibitor.
1 month and older: Refer to dosage recommendations when used as a pharmacokinetic enhancer (specific dose varies significantly depending on patient age/weight and concomitant protease inhibitor); 800 mg/m2/day PO when used as the sole protease inhibitor.
Postmenstrual age less than 44 weeks: Use not recommended.
Safety and efficacy have not been established.
How supplied
Ritonavir
capsule
- 100mg
tablet
- 100mg
oral solution
- 80mg/mL
oral powder
- 100mg/packet