FDA approves changes to the Kaletra label
FDA approved changes to the Kaletra (lopinavir/ritonavir) tablet and oral solution labels. These changes include updates to the following sections:
Section 2: DOSAGE and ADMINISTRATION with information about use of the oral solution with a feeding tube.
2.1 General Administration Recommendations
Because KALETRA oral solution contains ethanol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility.
Section 4: CONTRAINDICATIONS was updated with the anti-angina drug, ranolazine
Section 7: DRUG INTERACTIONS was updated as follows:
The MEDICATION GUIDE's "Who should not take KELETRA?" section was updated with ranolazine information, and the "Tell your doctor all the medicines you take" section with triamcinolone and venetoclax information.
Similar changes were made to the Kaletra (lopinavir/ritonavir) Capsule label.
Additionally subsections 8.1 through 8.3 were updated to be compliant with the "Pregnancy and Lactation Labeling Rule" (PLLR). Addittionally Section 12, CLINICAL PHARMACOLOGY sub section 12.3 was updated with pregnancy information as follows:
In an open-label pharmacokinetic study, 12 HIV-infected pregnant women received KALETRA 400 mg/100 mg (200/50 mg tablets) twice daily as part of an antiretroviral regimen. Plasma concentrations of lopinavir were measured over 12-hour periods during the second trimester (20-24 weeks gestation), the third trimester (30 weeks gestation) and at 8 weeks post-partum. The C12h values of lopinavir were lower during the second and third trimester by approximately 40% as compared to post-partum, but this decrease is not considered clinically relevant in patients with no documented KALETRA-associated resistance substitutions receiving 400 mg/100 mg twice daily.
The updated labels will soon be available
Click here to view updated FDA labels
Webinar June 22: Pharmacy-based Preexposure Porpylaxis for the Preventionof HIV: Innovative Service Delivery Model
PrEP in Pharmacies
Thursday, June 22, 2017
10:00 AM CDT- 11:00 AM CDT
Click here to register
Describe an innovative practice model for delivery of preexposure propylaxis (PrEP) for the prevention of HIV in community pharmacies.
Describe the difference in services provided between a traditional Provider-based model of PrEP and a Pharmacy-based model of PrEP.
Recognize how pharmacy practice influences the type of model that can be offered: Provider Status, Collaborative Practice Agreements.
Discuss the situations where a Pharmacy-based model of PrEP would be advantageous to patients and providers.
Rupa Patel, MD MPH DTM&H
Assistant Professor, Division of Infectious Diseases
Director, PrEP Program Washington University in St. Louis, St. Louis, MO
Stuart Federman, PharmD, AAHIVP
PrEP Program Director
Gateway Apothecary, St. Louis, MO
Elyse Tung, PharmD, BCACP
Director of Clinical Services
Kelley-Ross Pharmacy at the Polyclinic, Seattle, WA
Dan Scales, PharmD, Owner/Founder
Scales Pharmacy, Denver, CO
Hosts: Paul J Weidle, PharmD, MPH and Dawn Smith, MD, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention.