National Celsentri Supply program - registration now open
Post date: 16 June 2008
Pfizer Australia Supply program for the CCR5 antagonist agent Maraviroc
Maraviroc, also known as Celsentri (or Selzentry in the US), is a chemokine receptor antagonist that acts as an entry inhibitor. It is designed to prevent HIV infection of CD4 cells by blocking chemokine receptor 5 (CCR5), a coreceptor necessary for HIV entry, from binding to HIV.(1) Celsentri is the first in a new class of oral HIV medicines in more than 10 years.
Pfizer Australia is providing a national supply program for Celsentri - a CCR5 antagonist agent. The Australian supply program includes criteria for the ordering of a tropism assay test, as part of the screening requirement for determining suitable treatment experienced patients with CCR5 tropic HIV - 1 infection. Other criteria will also be in place to be consistent with the intended licensing indications of the drug, and the requirements of the supply program itself.
If you would like further information about Celsentri, please contact Pfizer Medical Affairs on 1800 675 229 or, alternatively, contact Dr Alan Paul - Associate Medical Director at Pfizer Australia on 02 9850 3851 or Mobile: 0409 392 688.
If you would like to register for the supply program, please call the national toll free number to receive your registration pack. Call the Celsentri Supply program on 1800 981 112 - S100 HIV prescribers need to call this number to request a registration pack be sent to them.
Important Safety Information
Although there was no overall increase in serious liver function test abnormalities in patients treated with Celsentri, hepatotoxicity has been reported with Celsentri use. Evidence of a systemic allergic reaction (e.g., pruritic rash, eosinophilia or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of Celsentri should be evaluated immediately.
The safety and efficacy of Celsentri have not been specifically studied in patients with significant underlying liver disorders. However, caution should be used when administering Celsentri to patients with pre-existing liver dysfunction or who are co-infected with viral hepatitis B or C.
In clinical studies, more cardiovascular events, including myocardial ischemia and/or infarction, were observed in patients who received Celsentri as compared to placebo. However, these patients generally had cardiac disease or cardiac risk factors prior to Celsentri use, and the relative contribution of Celsentri to these events is not known. Celsentri should be used with caution in patients at increased risk for cardiovascular events.
Caution should be used when administering Celsentri in patients with a history of postural hypotension or who receive concomitant medication known to lower blood pressure. Patients should be advised that if they experience dizziness while receiving Celsentri, they should avoid driving or operating machinery. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. Celsentri antagonizes the CCR5 co-receptor located on some immune cells, and therefore could potentially increase the risk of developing infections and malignancy. For more information about Celsentri,please see full Prescribing Information (2).
References and links:
(1) AIDSinfo Maraviroc US Department of Health and Human Services 2007
http://www.aidsinfo.nih.gov/DrugsNew/DrugDetailT.aspx?int_id=408#FA1
(2) Product information for Celsentri (maraviroc) 150mg and 300mg film-coated tablets. Pfizer Australia Pty Ltd Link to pdf file:
http://www.ashm.org.au/uploads/pfpcelst10108.pdf
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