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U.S. Department of Health and Human Services

Safety

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Prezista (darunavir) tablet

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

February 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Pediatric Patients
  • Do not administer PREZISTA/ritonavir in pediatric patients below 3 years of age in view of toxicity and mortality observed in juvenile rats dosed with darunavir (from 20 mg/kg to 1000 mg/kg) up to days 23 to 26 of age
 

ADVERSE REACTIONS

Clinical Trials Experience: Pediatric Patients
  • Prezista/ritonavir has been studied in combination with other antiretroviral agents in 3 Phase II trials. TMC114-C212, in which 80 antiretroviral treatment-experienced HIV-1-infected pediatric subjects 6 to less than 18 years of age and weighing at least 20 kg were included, TMC114-C228, in which 21 antiretroviral treatment-experienced HIV-1-infected pediatric subjects 3 to less than 6 years of age and weighing at least 10 kg were included,
 

DRUG INTERACTIONS

  • Antimalarials: artemether/lumefantrine – No change in darunavir exposures. Decrease in artemether and dihydroartemisinin exposures. Increase in lumefantrine exposures. The combination of Prezista and artemether/lumefantrine can be used without dose adjustments. However, the combination should be used with caution as increased lumefantrine exposure may increase the risk of QT prolongation.

 

June 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Severe Skin Reaction
  • During post-marketing experience toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been reported.

 

ADVERSE REACTIONS

Postmarketing Experience

  • In addition, toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been reported rarely

 

PATIENT PACKAGE INSERT

What should I tell my doctor before I take Prezista?
  • Especially tell your healthcare provider if you take: medicine to treat chronic hepatitis C such as boceprevir

 

February 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
  • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Prezista…
  • 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

 

DRUG INTERACTIONS

Established and Other Potentially Significant Drug Interactions (Table)

HMG-CoA Reductase Inhibitors:

  • Titrate atorvastatin, pravastatin or rosuvastatin dose carefully and Use the lowest necessary dose while monitoring for safety. Do not exceed atorvastatin dose exceeds 20 mg/day.

 

PATIENT COUNSELING INFORMATION

Information About Therapy with Prezista
  • Prezista is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1infection, including opportunistic infections. Patients should remain under the care of a physician when using Prezista.
  • Patients should be advised to avoid doing things that can spread HIV-1 infection to others… Do not share needles… Do not share personal items… Do not have any kind of sex without protection… Do not breastfeed…

 

October 2011

Summary View 

 

ADVERSE REACTIONS

Clinical Trials Experience: Treatment-Naïve Adults

Study TMC114-C211

  • The safety assessment......

 

PATIENT PACKAGE INSERT

“What are the possible side effects of PREZISTA?”
  • .....rash when PREZISTA is taken in combination with raltegravir.

 

December 2010

Summary View

 

PATIENT COUNSELING INFORMATION

Hepatotoxicity
  • Patients should be informed that Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA co-administered with 100 mg of ritonavir. Monitor liver function before and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases. Post-marketing cases of liver injury, including some fatalities, have been reported. Patients should be advised about the signs and symptoms of liver problems. These may include jaundice of the skin or eyes, dark(tea colored) urine, pale colored stools, nausea, vomiting, loss of appetite, or pain, aching or sensitivity in the right upper quadrant of the abdomen.
Severe Skin Reactions
  • Patients should be informed that skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, have been reported with PREZISTA co-administered with 100 mg of ritonavir. Patients should be advised to discontinue PREZISTA/ritonavir immediately if signs or symptoms of severe skin reactions develop. These can include but are not limited to severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.

 

April 2010

Summary View

 

CONTRAINDICATIONS

Table 2: Drugs That Are Contraindicated With PREZISTA/ritonavir
  • 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 Prezista/ritonavir. There is an increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).

 

PRECAUTIONS- DRUG INTERACTIONS

Table 7: 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 Prezista/ritonavir 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 Prezista/ritonavir.
  • 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 Prezista/ritonavir. 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.