Some recent updates from the American Society of Health-Systems Pharmacists of interest to people with colon and rectal cancer:

• Fluorouracil (5-FU) as of 8/31/11: On back order from Teva, APP Pharmaceuticals, and Mylan Institutional.  Manufacturing delays at Teva appear to have caused increased demand from other companies.
• Leucovorin as of 8/31/11:   Bedford has some powderized sizes available and limited allocations of others.  Teva is importing folinic acid solution and it is available for drop shipment, but powdered leucovorin is on back order. APP is releasing powderized leucovorin as it becomes available.
• Irinotecan as of 8/26/11:  Teva and Sandoz have back orders of some doses because of manufacturing problems.  Hospira shortages are due to increased demand.  Some dosage vials are available from APP and as Camptosar from Pfizer.  Three generic manufacturers stopped making irinotecan in 2010 and another one did so in May 2011.
• Fusilev as of 6/21/11:  Although it was in shortage previously, Spectrum has announced that they have ample supplies currently and for the future.  ASHP reminds physicians and pharmacists that dosing errors can occur when substituting Fusilev (levoleucovorin) for leucovorin.

Check the links to ASHP updated sites for more detailed information about which sizes are available, reasons given for shortages, and when shortages are expected to be resolved.

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APP Pharmaceuticals has voluntarily recalled five lots of irinotecan for injection.

Some customers discovered small particles of foreign material in one lot of the irinotecan vials.  Further inspection found fungal microbes in the vials they sent back.

It is unlikely that you as a patient would see the recalled vials or particles directly since irinotecan is diluted before your IV infusion.  However, you might develop an infection or other adverse event.  If that happens, call your doctor immediately! Read the rest of this entry »

Irinotecan (also called CPT-11 and/or Camptosar) is often used to treat advanced colorectal cancer. But it causes diarrhea in most patients–severe in 30 percent—that often limits the dose a patient can tolerate.

Now researchers at the University of North Carolina at Chapel Hill have found a way to block one specific troublemaking enzyme thought to play a big role in causing the diarrhea.

Irinotecan is complicated: After it has killed tumor cells, the drug is filtered out of the bloodstream by the liver, where it’s changed to an inactive compound and discharged into the intestine to be excreted. But in the intestine, the drug can be reactivated by an enzyme that is made by bacteria that normally live in the gut. The reactivated toxic drug then damages the intestinal lining—leading to severe diarrhea.

Matthew Redinbo, PhD, and his team wanted to block the enzyme that reactivates irinotecan, yet not kill the intestinal bacteria, because it’s vital for digestion, vitamin manufacturing and fighting infections. Sorting through a database of 10,000 chemical compounds, the research team found four chemicals that, at least in a test tube, blocked the enzyme without harming the bacteria. They tested one compound in mice: Those given irinotecan plus the compound had far less severe diarrhea than mice given just irinotecan.

Read the rest of this entry »

About 15 percent of people with stage III colon cancer may have fewer recurrences and better survival when they are treated with irinotecan. Although all stage III colon cancers don’t have an additional benefit when irinotecan is added to bolus 5-FU and leucovorin in a treatment called IFL, this smaller group does.

About 15 percent of colon cancers develop when damaged DNA is not repaired and mutated cells grow into malignant tumors.  So-called deficient mismatch repair (dMMR) tumors have features different from most colorectal cancer, including a better prognosis.  They also have a very poor response to 5-FU-based chemotherapy.

However, researchers studying tumor tissue from patients enrolled in a clinical trial comparing 5-FU and leucovorin alone to 5-FU, leucovorin, and irinotecan found that those with deficient mismatch repair tumors who received irinotecan had better disease-free survival and overall survival at five years than patients whose mismatch repair genes were working.  Those with dMMR on the 5-FU-only arm of the trial had no similar benefit. Read the rest of this entry »

Five years after surgery, there was no improvement in either disease-free survival or overall survival when irinotecan was added to standard 5-FU treatments delivered via continous infusion for patients with stage III colon cancer.  Adding irinotecan increased the rate of serious side effects.

The PETACC-3  (Pan European Trial Adjuvant Colon Cancer)  trial was designed to see if adding irinotecan to 5-FU and leucovorin could increase the percentage of stage III patients who were alive and cancer-free (disease-free survival).  It also studied overall survival and relapse-free survival. Read the rest of this entry »