E-DRUG: Viracept (nelfinavir) recall by Roche
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8 June 2007
WHO STATEMENT ON ROCHE'S VIRACEPT® RECALL
ROCHE have informed WHO today (08 June 2007) of the global recall their
nelfinavir products (Viracept®) in accordance with European Medicines Agency (EMEA) and Swissmedic requirements (except USA, Canada and Japan).
The reason for the recall is identification of an unexpected contaminant in some batches of Viracept®. The contaminant is a known genotoxic substance. For further information,
please see the EMEA statement at:
http://www.emea.europa.eu/pdfs/general/direct/pr/25128307en.pdf .
Current stocks of Viracept® should be quarantined.
Adults or children currently taking Viracept® should not interrupt their
therapy, that is they should not stop any of the antiretroviral (ARV) medications. However, they should see their antiretroviral therapy provider as soon as possible to change from Viracept® to a
suitable alternative.
Nelfinavir belongs to the Protease Inhibitor (PI) class of antiretroviral
medicines. The PI class should be reserved for second-line therapy wherever possible, particularly in settings of limited ARV formularies. In choosing the PI for second-line therapy for adults and children a PI boosted by ritonavir (/r) is recommended for antiviral potency.
Adequate within-class substitutions for Viracept® are any of the following
protease inhibitors - Lopinavir/ritonavir (LPV/r), Indinavir/ritonavir (IDV/r), Saquinavir/ritonavir (SQV/r), Atazanavir/ritonavir (ATV/r), and Fosamprenavir/ritonavir (FPV/r). LPV/r is the preferred boosted PI, as it has the advantage of being available as a fixed dose combination and has recently been approved in a new heat stable formulation, which
eliminates the need for refrigeration. In children, SQV is only licensed for use in children over 25kg and ATV and FPV are not yet approved for use.
Nelfinavir may exceptionally be being used as part of initial therapy for
pregnant women. If it is the case and no other PI is available, then substitution of Viracept® by another active ARV from another class of drugs will need to be considered. Non-nucleoside reverse transcriptase inhibitors drugs need to be used with caution in pregnant women.
Nevirapine may be associated with toxicity in women with CD4 counts above
250 cells/mm3. Efavirenz should be avoided in the 1st trimester of pregnancy because of potential for birth defects and in children less than 3 years of age. Abacavir as part of a triple nucleoside regimen may also be considered.
In summary for patients needing to substitute Viracept®, options include:
. a boosted protease inhibitor;
. Nevirapine - with close observation for toxicity if CD4 is above 250
cells/mm3 :
. Efavirenz - unless in the first trimester of pregnancy;
. triple nucleoside therapy.
For further details of current treatment recommendations, please refer to
the following
web link: http://www.who.int/entity/hiv/pub/guidelines/en.