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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“What to do when your doc is out of 5-FU“  

Frequently Asked Questions

What drugs for colorectal cancer patients are in short supply?

The list of drugs on the short supply list can change week to week, but there are two drugs that have been low for some time: leucovorin and fluorouracil (5-FU).

Leucovorin is a folic acid that has long been used with 5-FU to treat colorectal and other cancers. Leucovorin boosts the effectiveness of 5-FU, by lengthening the time that the very short-acting 5-FU works to kill cancer cells.

Why are there leucovorin and 5-FU shortages?

For several years, manufacturing problems at the US companies that make and distribute generic leucovorin and 5-FU and have limited the amount of the drug that they are able to ship to pharmacies and doctors.  Many oncologists now cannot obtain it at all.  Others can only get limited supplies, so they are reducing doses for patients. Additionally, one of the companies that makes 5-FU has blamed their shortage on manufacturing delays.

Both the FDA and the American Society of Health-System Pharmacists track drug shortages, the reasons for those shortages, and when the shortage for each drug might be resolved. But the national picture does not always reflect day-to-day shortages in specific parts of the country or individual cancer centers.

What choices do I have if my doctor doesn’t have leucovorin?

The National Comprehensive Cancer Network (NCCN), which provides cancer treatment guidelines, has recommended that doctors do one of the following:

• Use a lower dose of leucovorin for all patients. (Several studies have shown equivalent effectiveness at lower doses.)
• Use Fusilev® (levoleucovorin) a brand-name drug with a chemical structure similar to leucovorin. Although the dosage is different, levoleucovorin has the same effectiveness as leucovorin when combined with 5-FU.  It was approved by the FDA in April 2011 to treat advanced colorectal cancer.
• If there are no other options, “treatment without leucovorin would be reasonable.” For patients who can tolerate it without side effects, NCCN suggests increasing the bolus dose of 5-FU in the range of 10 percent.

The FDA has also approved temporarily importing injectable calcium folinate–the form of leucovorin most commonly used in Europe.

What choices do I have if my doctor doesn’t have 5-FU?

The Association of Health System Pharmacists recommends that doctors:

• Evaluate the health-care system’s total supply of fluorouracil before beginning patients on combination chemotherapy regimens containing fluorouracil. If adequate supplies are not available, select an alternative regimen.
• Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
• Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated.

What is Fight Colorectal Cancer doing to help patients, and to solve this problem?

• Our Research & Treatment News has been tracking this issue since 2008, and we will continue to keep you informed with frequent updates. Subscribe to receive our updates by email.
• The Answer Line (877-427-2111) has fielded over 100 calls on this topic and has assisted patients and families facing drug shortages.
• Fight Colorectal Cancer supports S. 296 and H.R. 2245, bills that would require manufacturers to report shortages as they arise and also require the FDA to take specific actions to ease drug shortage issues. Please email your Members of Congress in support of this legislation.
• Fight Colorectal Cancer continues to push both manufacturers and the FDA to increase the availability of generic oncology drugs.

Shortages of prescription drugs cost the United States more than $200 million.

In addition, shortages force doctors to delay or cancel treatment.  Patient safety is compromised when doctors have to use different or unfamiliar drugs when they can’t get the right ones.

In the six months from July to December of 2010, 240 drugs were either in short supply or completely unavailable.  More than 400 generics were back-ordered for more than five days.

Most of the medicines with shortages are necessary for emergency care, sedation, or chemotherapy — including leucovorin which is a backbone of most colorectal cancer treatment regimens. Read the rest of this entry »

Briefly: In research this week, human embryonic stem cells produced an immune response in mice with colon cancer, and discussing strong pain medicines with cancer patients reduces their pain by about 20 percent.

The Food and Drug Administration has found many dietary supplements contaminated with prescription drugs not listed on the label, some at several times higher than the recommended dose.  In other FDA news, Spectrum Pharmaceuticals was unable to get FDA approval for use of Fusilev® for metastatic colorectal cancer. Read the rest of this entry »