Label Changes for:

Crixivan (indinavir sulfate) Capsules

February 2012

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010 and February 2012

 

February 2012 

 

CONTRAINDICATIONS

Drug Interactions With Crixivan: Contraindicated Drugs (Table)
  • HMG-CoA Reductase Inhibitors: lovastatin, simvastatin

 

WARNINGS

Drug Interactions
  • Concomitant use of Crixivan with lovastatin, or simvastatin is contraindicated due to increased risk of myopathy including rhabdomyolysis. Caution should be exercised if Crixivan is used concurrently with atorvastatin or rosuvastatin. Titrate the atorvastatin and rosuvastatin doses carefully and use the lowest necessary dose with Crixivan (see PRECAUTIONS, Drug Interactions).

 

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

  • Crixivan 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 Crixivan.
  • 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. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
  • Do not breastfeed. We do not know if Crixivan can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

 

Drug Interactions

Drugs That Should Not Be Coadministered With Crixivan (Table)

  • HMG-CoA Reductase inhibitors: lovastatin, simvastatin: CONTRAINDICATED due to an increased risk for serious reactions such as myopathy including rhabdomyolysis.
  • Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction (Table)
  • HMG-CoA Reductase Inhibitors: atorvastatin, rosuvastatin: ↑ atorvastatin concentration, rosuvastatin concentration: The atorvastatin and rosuvastatin doses should be carefully titrated; use the lowest dose necessary with careful monitoring. Dduring treatment with Crixivan.

 

Patient Prescribing Information

Does Crixivan cure HIV or AIDS?

  • Crixivan 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 Crixivan.
  • 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…

“What other medical problems or conditions should I discuss with my doctor?”

Talk to your doctor if:

  • You are breast-feeding. Do not breastfeed. We do not know if Crixivan can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

 

MEDICINES YOU SHOULD NOT TAKE WITH Crixivan

  • Zocor (simvastatin), Mevacor (lovastatin)
  • Taking Crixivan with the above medications could result in serious or life-threatening problems (such as irregular heartbeat or excessive sleepiness).

In addition, you should not take Crixivan with the following: Rifampin, known as Rifadin, Rifamate, Rofater, or Rimactane.

  • There is also an increased risk of drug interactions between Crixivan and Lipitor (atorvastatin) and Crestor (rosuvastatin); talk to your doctor before you take any of these cholesterol-reducing drugs with Crixivan.

 

MEDICINES YOU CAN TAKE WITH CRIXIVAN (Table)

  • Retrovir (zidovudine, ZDV also called AZT), Epivir (lamivudine, 3TC), Zerit (stavudine, d4T), isoniazid (INH)

 

April 2010

 

CONTRAINDICATIONS

Table 7: Drug Interactions With Crixivan: Contraindicated Drugs
  • Alpha 1-adrenoreceptor antagonist: alfuzosin
  • PDE5 Inhibitors: Revatio (sildenafil) [for treatment of pulmonary arterial hypertension]

PRECAUTIONS

Table 9: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction
  • salmeterol: should not be coadministered
  • Bosentan: Co-administration of bosentan in patients on Crixivan or coadministration of Crixivan in patients on bosentan: Start at or adjust bosentan to 62.5 mg once daily or every other day based upon individual tolerability.
  • Tadalafil: Use of tadalafil for pulmonary arterial hypertension (PAH), the following dose adjustments are recommended for use of Adcirca (tadalafil) with Crixivan: Co-administration of Adcirca in patients on Crixivan or coadministration of Crixivan in patients on Adcirca: Start at or adjust Adcirca to 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.
  • Colchicine: The addition of new dosing recommendations when prescribed for the treatment of familial Mediterranean fever or gout.  Addition of new dosing recommendations for colchicine when prescribed for the prophylaxis of gout and the addition of the recommendation that colchicine should not be coadministered with Crixivan (indinavir sulfate) in patients with hepatic or renal impairment.

 

 
 

 

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