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U.S. Department of Health and Human Services

Safety

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Selzentry (maraviroc) tablets

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

 

March 2014

Summary View

WARNINGS AND PRECAUTIONS

Cardiovascular Events
  • Caution should be used when administering SELZENTRY in patients with a history of or risk factors for postural hypotension, cardiovascular comorbidities, or on concomitant medication known to lower blood pressure. Patients with cardiovascular comorbidities could be at increased risk of cardiovascular adverse events triggered by postural hypotension.
     

 

February 2013  

Summary View

WARNINGS AND PRECAUTIONS

Severe Skin and Hypersensitivity Reactions
  • Severe, potentially life-threatening skin and hypersensitivity reactions have been reported in patients taking Selzentry, in most cases concomitantly with other drugs associated with these reactions. These include cases of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS). The cases were characterized by features including rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. Discontinue Selzentry and other suspected agents immediately if signs or symptoms of severe skin or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, malaise, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, lip swelling, eosinophilia). Delay in stopping treatment with Selzentry or other suspect drugs after the onset of rash may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated.
 

ADVERSE REACTIONS

  • Severe Skin and Hypersensitivity Reactions

 

August 2012

Summary View


WARNINGS AND PRECAUTIONS

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

 

PATIENT COUNSELING INFORMATION

  • Patients should be informed that SELZENTRY 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 Selzentry.  Patients should be advised to avoid doing things that can spread HIV-1 infection to others…
  • Patients should be advised that it is important to take all their anti-HIV medicines as prescribed and at the same time(s) each day.  Selzentry must always be used in combination with other antiretroviral drugs…

 

MEDICATION GUIDE

General information about Selzentry
  • Selzentry does not cure HIV-1 infection 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 Selzentry.
  • Avoid doing things that can spread HIV-1 infection…
Before you take Selzentry, tell your healthcare provider if you:
  • Do not breastfeed. We do not know if Selzentry 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…

 

October 2011

Summary View

 

BOXED WARNING

  • Hepatotoxicity (new)

 

WARNINGS AND PRECAUTIONS

Hepatotoxicity
  • Hepatotoxicity with allergic features including life-threatening events has been reported in clinical trials and postmarketing. Severe rash or evidence of systemic allergic reaction including drug-related rash with.....

 

May 2010

Summary View

 

CONTRAINDICATIONS

  • Selzentry should not be used in patients with severe renal impairment or end-stage renal disease (ESRD) (CrCl < 30 mL/min) who are taking potent CYP3A inhibitors or inducers.

WARNINGS AND PRECAUTIONS

  • Postural Hypotension in Patients with Renal Impairment Patients with impaired renal function may have cardiovascular co-morbidities and could be at increased risk of cardiovascular adverse events triggered by postural hypotension. An increased risk of postural hypotension may occur in patients with severe renal insufficiency or in those with end-stage renal disease (ESRD) due to increased maraviroc exposure in some patients. Selzentry should be used in patients with severe renal impairment or ESRD only if they are not receiving a concomitant potent CYP3A inhibitor or inducer. However, the use of Selzentry in these patients should only be considered when no alternative treatment options are available. If patients with severe renal impairment or ESRD experience any symptoms of postural hypotension while taking 300 mg twice daily the dose should be reduced to 150 mg twice daily.

USE IN SPECIFIC POPULATIONS

Renal Impairment
  • Recommended doses of Selzentery for patients with impaired renal function (CrCl ≤ 80 mL/min) are based on the results of a pharmacokinetic study conducted in healthy subjects with various degrees of renal impairment. The pharmacokinetics of maraviroc in subjects with mild and moderate renal impairment was similar to that in subjects with normal renal function. A limited number of subjects with mild and moderate renal impairment in the Phase 3 clinical trials (n= 131 and n= 12, respectively) received the same dose of Selzentry as that administered to subjects with normal renal function. In these subjects there was no apparent difference in the adverse event profile for maraviroc compared to subjects with normal renal function.
  • If patients with severe renal impairment or end-stage renal disease (ESRD) not receiving a concomitant potent CYP3A inhibitor or inducer experience any symptoms of postural hypotension while taking Selzentery 300 mg twice daily, the dose should be reduced to 150 mg twice daily. No studies have been performed in subjects with severe renal impairment or ESRD co-treated with potent CYP3A inhibitors or inducers. Hence, no dose of Selzentery can be recommended, and Selzentery is contraindicated for these patients.
Hepatic Impairment
  • Maraviroc concentrations are higher when Selzentery 150 mg is administered with a potent CYP3A inhibitor compared to following administration of 300 mg without a CYP3A inhibitor, so patients with moderate hepatic impairment who receive Selzentery 150 mg with a potent CYP3A inhibitor should be monitored closely for maraviroc-associated adverse events.