Lopinavir-Ritonavir (Kaletra) | Some data indicated in the product’s technical data sheet: Laboratory tests should be done before the start of therapy with lopinavir/ritonavir and close monitoring should be carried out during treatment. | During post-marketing, life-threatening cases of cardiac toxicity (including complete atrioventricular (AV) block, bradycardia, and cardiomyopathy), lactic acidosis, acute renal failure, CNS depression, and respiratory complications have been reported. | Potential cardiac effects of this drug in humans cannot be ruled out.|
4.1 Therapeutic indications
Kaletra is indicated, in combination with other antiretroviral drugs, for the treatment of adults, adolescents and children from 14 days of age and older, infected with the human immunodeficiency virus (HIV-1).
4.3 Contraindications
Kaletra oral solution is contraindicated in children younger than 14 days, pregnant women, patients with hepatic or renal insufficiency and in patients treated with disulfiram or metronidazole due to the potential risk of toxicity of the excipient propylene glycol.
Liver failure
The safety and efficacy of Kaletra in patients with liver disorders have not been established. Patients with hepatitis B or C are at increased risk of serious and life-threatening hepatic adverse reactions. >
Laboratory tests should be done before the start of lopinavir/ritonavir therapy and close monitoring should be carried out during treatment.</p >
Pancreatitis
Cases of pancreatitis have been reported in patients treated with Kaletra.
Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have been reported in the setting of immune reconstitution
PR interval prolongation
Lopinavir/ritonavir has been shown to cause asymptomatic modest prolongation of the PR interval in some healthy patients. Rare cases of 2nd or 3rd degree atrioventricular block have been reported in patients receiving lopinavir/ritonavir with underlying structural heart disease and pre-existing abnormalities in the conduction system or in patients receiving drugs with a prolonged effect. known PR interval.
Cardiac effects have been reported in preclinical trials with Kaletra; therefore, Kaletra cannot be ruled out as potentially causing cardiac adverse events (see sections 4.8 and 5.3).
Life-threatening cases of cardiac toxicity (including complete atrioventricular (AV) block, bradycardia and cardiomyopathy), lactic acidosis, renal failure have been reported in the postmarketing setting. acute, CNS depression and respiratory complications.
b. Tabulated list of adverse reactions
Adverse reactions from clinical trials and post-marketing experience in adult and pediatric patients:
frequency: very common (≥1/10), common (≥ 1/100 to < 1/10)
Common infections and infestations: Upper respiratory tract infection.
Prominent U waves in the electrocardiogram have been observed in dogs, associated with a prolongation of the PR interval and bradycardia. These effects are believed to be due to electrolytes. The clinical relevance of these preclinical data is unknown. However, potential cardiac effects of this drug in humans cannot be ruled out (see sections 4.4 and 4.8).