Label Changes for:

Kaletra (lopinavir/ritonavir) 80/20 mg/mL oral solution and 100/25mg and 200/50mg tablets

January 2013

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

 

January 2013

7 DRUG INTERACTIONS

7.3 Established and Other Potentially Significant Drug Interactions
  • information pertaining to the co-administration of Kaletra with avanafil, boceprevir, budesonide, lamotrigine, raltegravir, rivaroxaban, telaprevir, and valproate

17 PATIENT COUNSELING INFORMATION

Information For Patient
  • Drug Interactions
     

MEDICATION GUIDE

  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines interact with KALETRA
  • Especially tell your doctor if you take:
     

 

 

February 2012

 

Kaletra (lopinavir/ritonavir) Capsules

 

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.
Information for Patients
  • 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…

 

Patient Information Labeling

Does Kaletra cure HIV or AIDS?

  • 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…
Medicines You Should Not Take with Kaletra
  • Do not take Kaletra with the cholesterol-lowering medicines Mevacor® (lovastatin) or Zocor (simvastatin) because of possible serious reactions.
Medicines that require dosage adjustment
  • If you are taking the cholesterol lowering medicines Lipitor (atorvastatin) or Crestor (rosuvastatin), your doctor may need to lower your dose of Lipitor or Crestor while you are taking Kaletra.
What should I tell my doctor before taking Kaletra?
  • If you are breast-feeding: Do not breastfeed. We do not know if Kaletra can be passed to your the baby in through your breast milk and whether it could harm your the baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

 

April 2010

 

CONTRAINDICATIONS

Table 10 (Capsules) : Drugs That Are Contraindicated With Kaletra (Table 3- Tablets and Oral Solution)
  • Alpha 1-adrenoreceptor antagonist- alfuzosin: Potential for serious and/or life-threatening reactions such as hypotension.
  • PDE5 Inhibitors: Sildenafil for treatment of pulmonary arterial hypertension; A safe and effective dose for the treatment of pulmonary arterial hypertension has not been established with Kaletra. There is an increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).

PRECAUTIONS- DRUG INTERACTIONS

Table 11 (Capsules) and Table 9(Tablets and Oral Solution): Established and Other Potentially Significant Drug Interactions: Alterations in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction
  • Inhaled beta agonist-salmeterol: Concurrent administration of salmeterol and Kaletra is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia. 
  • Endothelin receptor antagonists-Bosentan: new dosing recommendations for bosentan when prescribed with Kaletra.
  • PDE5 inhibitors: Use of PDE5 inhibitors for pulmonary arterial hypertension (PAH): Use of Revatio, (sildenafil) for the treatment of pulmonary hypertension dosing recommendations in table.
  • Colchicine (Antigout): Patients with renal or hepatic impairment should not be given colchicine with Kaletra. Addition of new dosing recommendations for colchicine when prescribed for the prophylaxis of gout and for for the treatment of familial Mediterranean fever or gout.

 

 

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