FDA labelling changes for indinavir (Crixivan)

The following revisions to the package insert in the US were approved by the FDA in January 2004.

Precautions section: Tubulointerstitial Nephritis

“Reports of tubulointerstitial nephritis with medullary calcification and cortical atrophy have been observed in patients with asymptomatic severe leukocyturia (>100 cells/high power field). Patients with asymptomatic severe leukocyturia should be followed closely and monitored frequently with urinalyses. Further diagnostic evaluation may be warranted, and discontinuation of indinavir should be considered in all patients with severe leukocyturia.”

Immune reconstitution syndrome

“Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy (CART), including indinavir. During the initial phase of treatment, patients responding to antiretroviral therapy whose immune system responds to CART may develop an inflammatory response to indolent or residual opportunistic infections (such as MAI, CMV, PCP, or TB), which may necessitate further evaluation and treatment.”

Drug interactions – contraindication with atazanavir (Reyataz)

“Both indinavir and atazanavir are associated with indirect (unconjugated) hyperbilirubinemia. Combinations of these drugs have not been studied and coadministration of indinavir and atazanavir is not recommended.”

Revisions to the patient package Insert (PPI)

The following wording was added to the “What are the possible side effects of indinavir?” section of the PPI:

“In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from opportunistic infections may occur when combination antiretroviral treatment is started.”

In the same section, under Marketing Experience, the words “and increased cholesterol” were added so that the revised text reads: “Other side effects reported since indinavir has been marketed include: allergic reactions; severe skin reactions; yellowing of the skin and/or eyes; heart problems including heart attack; stroke; abdominal swelling; indigestion; inflammation of the kidneys; inflammation of the pancreas; joint pain; depression; itching; hives; change in skin color; hair loss; ingrown toenails with or without infection; crystals in the urine; painful urination; numbness of the mouth and increased cholesterol.”

Source: FDA press release, January 2004

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