KALETRA ORAL SOLUTION Rx

Indications for KALETRA ORAL SOLUTION:

HIV-1 infection, in combination with other antiretroviral agents.

Adult:

Swallow tabs whole; take oral soln with food. ≥18yrs: lopinavir/ritonavir 400/100mg (two 200/50mg tabs or 5mL) twice daily or 800/200mg (four 200/50mg tabs or 10mL) once daily (in patients with <3 lopinavir resistance-associated substitutions). Once-daily administration not recommended if ≥3 lopinavir resistance-associated substitutions or if given in combination with carbamazepine, phenobarbital, phenytoin, efavirenz, nevirapine, nelfinavir, or if pregnant (avoid oral soln). Concomitant efavirenz, nevirapine, or nelfinavir: 500/125mg (two 200/50mg tabs + one 100/25mg tab) or 520/130mg (6.5mL) twice daily.

Children:

May use tabs if able to swallow whole and ≥15kg. Take oral soln with food. Postnatal age <14days or postmenstrual age of <42weeks: not recommended. 14days–6months: lopinavir/ritonavir 16/4mg/kg or 300/75mg/m² twice daily. Do not administer with efavirenz, nevirapine, or nelfinavir. >6months–<18yrs: lopinavir/ritonavir 230/57.5mg/m² twice daily, or if <15kg: 12/3mg/kg twice daily; ≥15–40kg: 10/2.5mg/kg twice daily; >40kg: max 400/100mg twice daily. Concomitant efavirenz, nevirapine, or nelfinavir: >6months–<18yrs: 300/75mg/m² twice daily, or if <15kg: 13/3.25mg/kg twice daily; ≥15–45kg: 11/2.75mg/kg twice daily; >45kg: max oral soln: 533/133mg (6.5mL) twice daily; or max tabs: 500/125mg twice daily. See full labeling.

Contraindications:

Concomitant alfuzosin, ranolazine, dronedarone, colchicine (in renal and/or hepatic impairment), rifampin, lurasidone, pimozide, ergots, cisapride, elbasvir/grazoprevir, St. John's wort, lovastatin, simvastatin, sildenafil [as Revatio for PAH], oral midazolam, triazolam.

Warnings/Precautions:

Suspend if pancreatitis occurs. History of, or risk factors for, pancreatitis (eg, elevated triglycerides). Underlying hepatitis B or C, or marked LFT elevations; monitor for hepatotoxicity. Monitor LFTs at baseline and during treatment (esp. in chronic hepatitis or cirrhosis). Avoid in congenital long QT syndrome or hypokalemia. Underlying structural heart disease. Pre-existing conduction system abnormalities. Ischemic heart disease. Cardiomyopathies. Monitor for hyperglycemia, or new onset/exacerbation of diabetes. Obtain baseline triglyceride, cholesterol; monitor periodically. Hemophilia. Oral soln: do not use with polyurethane feeding tubes. Toxicity in preterm neonates (see full labeling). Elderly. Pregnancy. Nursing mothers: not recommended.

Interactions:

See Contraindications. Salmeterol, boceprevir, simeprevir, ombitasvir/parataprevir/ritonavir and dasabuvir: not recommended. Avoid oral soln with metronidazole, disulfiram. Potentiates statins metabolized by CYP3A; use atorvastatin with caution and at the lowest necessary doses; do not exceed rosuvastatin 10mg daily. Potentiates sildenafil, vardenafil, tadalafil (reduce dose of these); avanafil, fluticasone (avoid). Potentiates fentanyl, parenteral midazolam; monitor. Potentiates anticancer agents (eg, vincristine, vinblastine, dasatinib, nilotinib); may need dose adjustment (see full labeling). Risk of tumor lysis syndrome with venetoclax. Concomitant colchicine (see full labeling). Potentiates bosentan (see full labeling). Increases levels of antiarrhythmics (eg, amiodarone, bepridil, systemic lidocaine, quinidine), dihydropyridine CCBs, immunosuppressants (monitor); ketoconazole, itraconazole (avoid high doses), isavuconazonium sulfate (caution); bedaquiline (use only if benefit outweighs the risk); rifabutin (reduce rifabutin dose and monitor); clarithromycin (reduce clarithromycin dose in renal dysfunction), trazodone (reduce trazodone dose), maraviroc (give max maraviroc 150mg twice daily), quetiapine (reduce dose). Monitor other antiretrovirals, warfarin. Avoid concomitant rivaroxaban; increased bleeding risk. Decrease levels of atovaquone, methadone, bupropion, estrogen-containing oral contraceptives (use other or back-up contraception), voriconazole (avoid and use alternatives). Lopinavir levels decreased by anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), efavirenz, nevirapine. Lopinavir levels may be increased by delavirdine, CYP3A inhibitors. Antagonized by corticosteroids (eg, oral dexamethasone, betamethasone, budesonide); consider alternatives. May decrease lamotrigine, valproate, zidovudine or abacavir levels. Give didanosine 1 hour before or 2 hours after. Avoid concomitant with other drugs that prolong the QT interval. See full labeling.

See Also:

KALETRA

Pharmacological Class:

Protease inhibitor.

Adverse Reactions:

Diarrhea, nausea, vomiting, hypertriglyceridemia, hypercholesterolemia; pancreatitis, fat redistribution, immune reconstitution syndrome, PR & QT prolongation.

How Supplied:

100mg/25mg—60; 200mg/50mg—120; Soln—160mL (w. dose cup)