Indications for NORVIR ORAL SOLUTION:
HIV-1 infection, in combination with other antiretroviral agents.
Swallow tabs whole. Take with meals. Oral soln: may be mixed with chocolate milk, Ensure, or Advera within 1hour of dosing. Also, can be given via silicone/PVC feeding tubes. Initially at least 300mg twice daily, increase every 2‒3 days by 100mg twice daily to 600mg twice daily. Concomitant other PIs (eg, atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir); reduce ritonavir dose. Pregnant women: avoid oral soln. See full labeling.
<1month or before postmenstrual age <44weeks: not recommended. Swallow tabs whole. Take with meals. Oral soln: may be mixed with chocolate milk, Ensure, or Advera within 1hour of dosing. Also, can be given via silicone/PVC feeding tubes. >1month: initially 250mg/m2 twice daily, increase every 2‒3 days by 50mg/m2 twice daily to 350‒400mg/m2 twice daily; max 600mg twice daily. Consider alternative therapy if 400mg/m2 twice daily is not tolerated. Concomitant other PIs (eg, atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir); reduce ritonavir dose. See full labeling.
NORVIR ORAL SOLUTION Contraindications:
Concomitant alfuzosin HCl, ranolazine, amiodarone, dronedarone, flecainide, quinidine, propafenone, voriconazole (w. ritonavir ≥400mg every 12hrs), colchicine (in renal and/or hepatic impairment), lurasidone, pimozide, ergots, cisapride, lomitapide, lovastatin, simvastatin, sildenafil (as Revatio for PAH), oral midazolam, triazolam, apalutamide, St. John's Wort.
Drug-drug interactions leading to potentially serious and/or life-threatening reactions.
NORVIR ORAL SOLUTION Warnings/Precautions:
Potentially life-threatening drug-drug interactions (see Contraindications). Pre-existing liver disease, liver enzyme abnormalities, or hepatitis; consider monitoring ALT/AST, GGT (esp. during first 3 months of therapy). Severe hepatic impairment: not recommended. Discontinue if pancreatitis or severe hypersensitivity occurs. Increased risk of cardiac conduction abnormalities in patients with ischemic heart or underlying structural heart disease, pre-existing conduction abnormalities, cardiomyopathies. Monitor blood, CPK, uric acid, triglycerides, and cholesterol prior to initiation and periodically during therapy. Monitor for hyperglycemia and new onset/exacerbation of diabetes. Monitor for increased bleeding in hemophilia. Oral soln: avoid with polyurethane feeding tubes. Toxicity in preterm neonates (see full labeling). Elderly. Pregnancy. Nursing mothers: not recommended.
NORVIR ORAL SOLUTION Classification:
HIV-1 protease inhibitor.
NORVIR ORAL SOLUTION Interactions:
See Contraindications. Concomitant glecaprevir/pibrentasvir, simeprevir, salmeterol, high-dose or long-term meperidine, ketoconazole or itraconazole >200mg/day, elagolix 400mg/day for >1 month: not recommended. May affect or be affected by CYP3A, 2D6, 2C9, 1A2, 2C19, 2B6, or glucuronyl transferase substrates. Potentiates other protease inhibitors, maraviroc, tramadol, propoxyphene, antidepressants (eg, SSRIs, tricyclics, nefazodone, desipramine, trazodone), dronabinol, quinine, bosentan, β-blockers (eg, metoprolol, timolol), CCBs (eg, diltiazem, nifedipine, verapamil), PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil), antipsychotics (eg, perphenazine, risperidone, thioridazine), sedative/hypnotics (eg, buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem), statins (eg, atorvastatin, rosuvastatin), methamphetamine; may need dose reductions. Potentiates anticancer agents (eg, abemaciclib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine); avoid or reduce doses (see full labeling). Increases levels of disopyramide, lidocaine, mexiletine, carbamazepine, clonazepam, ethosuximide, digoxin, immunosuppressants, glucocorticoids (eg, dexamethasone, betamethasone, fluticasone, budesonide, prednisone; consider alternatives); monitor. Antagonizes raltegravir, divalproex, lamotrigine, phenytoin, bupropion, atovaquone, theophylline (monitor), methadone (consider dose increase), oral contraceptives (consider alternatives). Antagonized by rifampin. Potentiated by delavirdine. Avoid metronidazole, disulfiram, rivaroxaban (increased bleeding risk). Reduce rifabutin dose by at least ¾, quetiapine to ⅙ of current dose, clarithromycin dose in renal dysfunction. Concomitant bedaquiline: use only if benefit outweighs the risk. Monitor fentanyl, parenteral midazolam, warfarin. See full labeling.
Diarrhea, nausea, vomiting, abdominal pain, paresthesias, fatigue/asthenia, rash (may be serious), cough; hepatotoxicity, pancreatitis, immune reconstitution syndrome, lipid disorders, fat redistribution, hyperglycemia, anaphylaxis, PR interval prolongation.
Register pregnant patients exposed to ritonavir by calling (800) 258-4263.
Hepatic (CYP3A; CYP2D6).
Fecal (primarily); renal.
Generic Drug Availability:
Tabs—30; Soln—240mL; Pwd—30 packets