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Kaletra and Viramune (Nevirapine Tablets)

Determining the interaction of Kaletra and Viramune (Nevirapine Tablets) and the possibility of their joint administration.

Check result:
Kaletra <> Viramune (Nevirapine Tablets)
Relevance: 06.08.2022 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Talk to your doctor before using lopinavir together with nevirapine. Combining these medications can decrease the blood levels of lopinavir, which may reduce its effectiveness in treating HIV infection. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

ADJUST DOSE: Coadministration with nevirapine may decrease the plasma concentrations of lopinavir, even in the presence of low-dose ritonavir as a pharmacokinetic booster. The proposed mechanism is nevirapine induction of lopinavir metabolism via CYP450 3A4. In a parallel group study consisting of HIV-1 positive adult subjects, coadministration of lopinavir-ritonavir (400 mg-100 mg capsule twice a day) with nevirapine (200 mg twice a day) to steady-state resulted in a 19% relative decrease in lopinavir peak plasma concentration (Cmax), a 27% relative decrease in systemic exposure (AUC), and a 51% relative decrease in trough plasma concentration (Cmin) in 22 subjects compared to administration of lopinavir-ritonavir alone in 19 subjects. Similar results were reported when the interaction was studied in a pediatric population of HIV-infected subjects ranging in age from 6 months to 12 years. In addition, the pharmacokinetics of lopinavir-ritonavir oral solution 300 mg-75 mg/m2 twice daily with nevirapine (7 mg/kg twice daily in patients 6 months to 8 years and 4 mg/kg twice daily in patients older than 8 years) and 230 mg-57.5 mg/m2 twice daily without nevirapine have been studied in a total of 53 pediatric patients ranging in age from 6 months to 12 years. Both regimens provided lopinavir plasma concentrations similar to those obtained in adult patients receiving the 400 mg-100 mg twice daily regimen without nevirapine. In healthy volunteers, lopinavir-ritonavir did not significantly affect the plasma concentrations of nevirapine. However, due to study discontinuations, there was limited power to detect changes in nevirapine pharmacokinetics in the presence of lopinavir-ritonavir.

MANAGEMENT: A dosage increase is recommended for lopinavir-ritonavir when used in combination with nevirapine. For adults, the dosage should be increased to 500 mg-125 mg (two 200 mg-50 mg tablets and one 100 mg-25 mg tablet) twice daily for the tablets and 533 mg-133 mg (6.5 mL) twice daily for the oral solution. Lopinavir-ritonavir should not be administered as a once daily regimen in combination with nevirapine. For pediatric patients 6 months to 18 years of age, the dosage should be increased to 300 mg-75 mg/m2 twice daily for the oral solution in both treatment-naive and treatment-experienced patients, not to exceed the recommended adult dosage of 533 mg-133 mg (6.5 mL) twice daily. If weight-based dosing is preferred, the recommended dosage is 13 mg-3.25 mg/kg given twice daily for patients under 15 kg and 11 mg-2.75 mg/kg given twice daily for patients 15 kg to 45 kg. Pediatric patients weighing more than 45 kg should receive the adult dosage of lopinavir-ritonavir. Please consult the manufacturer's product labeling for pediatric dosing of the tablet formulation. Lopinavir-ritonavir should not be administered in combination with nevirapine in patients under 6 months of age due to the lack of clinical data.

References
  • Back D, Gibbons S, Khoo S "Pharmacokinetic drug interactions with nevirapine." J Acquir Immune Defic Syndr 34 Suppl 1 (2003): S8-14
  • Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  • "Product Information. Kaletra (lopinavir-ritonavir)" Abbott Pharmaceutical, Abbott Park, IL.
  • Benson CA, Deeks SG, Brun SC, et al. "Safety and antiviral activity at 48 weeks of lopinavir/ritonavir plus nevirapine and 2 nucleoside reverse-transcriptase inhibitors in human immunodeficiency virus type 1--infected protease inhibitor--experienced patients." J Infect Dis 185 (2002): 599-607
  • Canadian Pharmacists Association "e-CPS. Available from: URL: http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink."
Kaletra

Generic Name: lopinavir / ritonavir

Brand name: Kaletra

Synonyms: n.a.

Viramune (Nevirapine Tablets)

Generic Name: nevirapine

Brand name: Viramune, Viramune XR

Synonyms: Viramune

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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