Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Nonnucleoside reverse transcriptase inhibitors (etravirine and rilpivirine)… hepatitis C virus protease inhibitor, simeprevir
USE IN SPECIFIC POPULATIONS
- Pediatric Use: A prospective multicenter, randomized, open-label study evaluated the efficacy and safety of twice-daily versus once-daily dosing of KALETRA tablets dosed by weight as part of combination antiretroviral therapy (cART) in virologically suppressed HIV-1 infected children (n=173). Children were eligible when they were aged < 18 years, = 15 kg in weight, receiving cART that included KALETRA, HIV-1 ribonucleic acid (RNA) < 50 copies/mL for at least 24 weeks and able to swallow tablets. At week 24, efficacy (defined as the proportion of subjects with plasma HIV-1 RNA less than 50 copies per mL) was significantly higher in subjects receiving twice daily dosing compared to subjects receiving once daily dosing. The safety profile was similar between the two treatment arms although there was a greater incidence of diarrhea in the once daily treated subjects.
- Tell your doctor about all the medicines you take… simeprevir (Olysio)
WARNINGS AND PRECAUTIONS
Immune Reconstitution Syndrome
- Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.
Established and Other Potentially Significant Drug Interactions (Table)
HMG-CoA Reductase Inhibitors: atorvastatin, rosuvastatin
- Use atorvastatin with caution and at the lowest necessary dose. Titrate rosuvastatin dose carefully and use the lowest necessary dose; do not exceed rosuvastatin 10 mg/day.
Drugs with No Observed or Predicted Interactions with Kaletra:
- Drug interaction studies reveal no clinically significant interaction between Kaletra and… pitavastatin...
PATIENT COUNSELING INFORMATION
- Kaletra is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using Kaletra.
- Patients should be advised to avoid doing things that can spread HIV-1 infection to others…Do not share needles or other injection equipment…Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades…Do not have any kind of sex without protection…Do not breastfeed.
What is Kaletra?
- Kaletra is a prescription anti-human immunodeficiency virus (HIV) HIV medicine that contains two medicines: lopinavir and ritonavir.
What should I tell my doctor before taking Kaletra?
Kaletra may not be right for you. Tell your doctor about all your medical conditions, including if you:
- are breast-feeding... Do not breastfeed…
General Information about Kaletra
- Kaletra does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using Kaletra.
- Avoid doing things that can spread HIV-1 infection…Do not share needles or other injection equipment…Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades…Do not have any kind of sex without protection…
WARNINGS AND PRECAUTIONS
Toxicity in Preterm Neonates
- Kaletra oral solution contains the excipients alcohol (42.4% v/v) and propylene glycol (15.3% w/v). When administered concomitantly with propylene glycol, ethanol competitively inhibits the metabolism of propylene glycol-associated adverse events due to diminished ability to metabolize propylene glycol, thereby leading to accumulation and potential adverse events. Postmarketing life-threatening cases of cardiac toxicity (including complete AV block, bradycardia, and cardiomyopathy), lactic acidosis, acute renal failure, CNS depression and respiratory complications leading to death have been reported, predominantly in preterm neonates receiving Kaletra oral solution. Kaletra oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. A safe and effective dose of Kaletra oral solution in this patient population has not been established….
- Information added on the use of Kaletra oral solution in preterm infants and infants.
- Kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis)...
- Skin and Appendages: Toxic epidermal necrolysis (TEN)
Table 9. Established and Other Potentially Significant Drug Interactions
- add information regarding fentanyl, nilotinib, and dasatinib