FDA aproved changes to the Kaletra label

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA aproved changes to the Kaletra label

 

Information about FDA HIV product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.

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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

Drug Class	Drugs Within Class That are Contraindicated with KALETRA	Clinical Comments
Antianginal	Ranolazine	Potential for serious and/or life-threatening reactions.

 

Section 7: DRUG INTERACTIONS was updated as follows:

Concomitant Drug Class: Drug Name	Effect on Concentration of Lopinavir or Concomitant Drug	Clinical Comments
Anticancer Agents: venetoclax	↑ anticancer agents	Coadministration of venetoclax and KALETRA may increase the risk of tumor lysis syndrome.  Refer to the venetoclax prescribing information for dosing instructions.
Systemic/Inhaled/ Nasal/Ophthalmic Corticosteroids: e.g., betamethasone budesonide ciclesonide dexamethasone fluticasone methylprednisolone mometasone prednisone triamcinolone	↓ lopinavir       ↑ glucocorticoids	Coadministration with oral dexamethasone or other systemic corticosteroids that induce CYP3A may result in loss of therapeutic effect and development of resistance to lopinavir. Consider alternative corticosteroids.   Coadministration with corticosteroids whose exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression.   Alternative corticosteroids including beclomethasone and prednisolone (whose PK and/or PD are less affected by strong CYP3A inhibitors relative to other studied steroids) should be considered, particularly for long-term use.

The MEDICATION GUIDE’s “Who should not take KALETRA?” 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). Additionally Section 12, CLINCAL PHARMACOLOGY sub section 12.3 with was updated with pregnancy information as follows:

Pregnancy

In an open-label pharmacokinetic study, 12 HIV-infected pregnant women received KALETRA 400 mg/100 mg (two 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 drugs@fda or DailyMed

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

 

For more information about the HIV Liaison Program visit the FDA Patient Network

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