Issue 10 April 2002
Enoxaparin and Aspirin Use in Tranplant Patients Updates on Patient Assistance Programs Recent FDA Approvals: Advicor® American Transplant Congress Meeting
Increased Bleeding in Kidney Transplant Patients Taking Enoxaparin and Aspirin
Thrombosis can occur in up to 7% of kidney transplant patients, and it may lead to graft loss. Patients who take aspirin along with the low-molecular weight heparin enoxaparin have an increased risk of bleeding. A retrospective study (n=13) revealed that a high frequency (69%) of post-transplant hemorrhages occurred in patients who received both enoxaparin and aspirin within 10 days of a kidney or kidney-pancreas transplant. In this study, a major bleed was defined as intracranial or retroperitoneal bleeding, or a decrease in hemoglobin of more than 2g/dl confirmed by repeat measurement. All patients received an aspirin dose of 81mg/day, and all but two patients received an enoxaparin dose of 30mg twice/day. Two patients received 70mg twice/day of enoxaparin and experienced a major bleed. All patients had a similar immunosuppressive regimen, and no other anticoagulant medications were used. One death occurred several months post-transplant, but it was not related to bleeding. Since enoxaparin is renally excreted, the drug may accumulate shortly after transplant. Twice daily dosing of enoxaparin may be excessive in kidney transplant patients. To avoid major bleeding problems, the dosage of enoxaparin should be 30mg/day for most patients. See the study for more details (Pharmacotherapy. February 2002, 184-186).
Authored by Amber Wilkerson
Updates on Patient Assistance Programs
Pfizer, Eli Lilly and Novartis have changed their program's application process. They now have hotline numbers that the patients can call to get an application mailed to them. If the patient qualifies, a card will be mailed to them to use at their local pharmacy. The companies can be contacted at the following numbers: Pfizer Share Card Program at 1-800-717-6005 and Lilly Answers Card Program at 1-877-RX-LILLY (1-877-795-4559). The Novartis Care Card Program (Immunosuppressants excluded) at 1-866-974-2273 will be activated until June 2002. After which, the "Together Rx Card Program" consisting of seven major pharmaceutical companies (Abbott Labs., AstraZeneca, Aventis, Bristol-Myers, GlaxoSmithkline, Janssen, Novartis and Ortho-McNeil) will cover many medications manufactured by these companies. The "Together Rx Card Program" will offer qualifying patients medications at different co-payment fees. These fees will be established by the individual companies. Several patient assistance programs are no longer available. These programs include the following medications: Tenormin (Astra-Zeneca), Calan and Aldactone (Searle), and Clonidine and Reglan (Wyeth).
Recent FDA Approvals
Advicor® (lovastatin/extended-release niacin)
A combination of lovastatin and extended-release niacin, Advicor®, is available by Kos Pharmaceuticals. The medication is available in three strengths of extended-release niacin (500mg, 750mg, and 1000mg), each with 20mg of lovastatin. It is indicated for the treatment of primary hypercholesterolemia and mixed dyslipidemia. Patients who may benefit from Advicor® include those who are already taking niacin to lower their triglycerides (TG) or increase their HDL-C, but who also need to decrease their LDL-C. Patients previously treated with lovastatin to decrease their LDL-C, but also need to increase their HDL-C and/or decrease their TG, may also benefit. Advicor® is not indicated as initial lipid-lowering therapy. It should not be used during pregnancy, as its pregnancy category is X. At the maximum recommended dosage, clinical trials have shown average reductions from baseline for LDL-C up to 42%, for TG up to 44%, and for lipoprotein-a up to 22%, while increasing HDL-C up to 30%. Doses of extended-release niacin should be started low (500mg niacin at bedtime) and titrated as needed. The maximum recommended total dose of Advicor® is 2000/40 mg (two 1000/20mg tablets). Combining Advicor® with fibrates, such as gemfibrozil or clofibrate, should be avoided unless the benefit outweighs the risk. Because of the risk of myopathy in combination with cyclosporine or fibrates, the maximum recommended dose of Advicor® is 1000/20mg. Monitoring parameters include liver function tests, uric acid and glucose levels, and assessing skin for flushing. A patient assistance program is available for Advicor®. For more information, please contact Kos Pharmaceuticals at (305) 577-3464. Authored by Amber Wilkerson
American Transplant Congress (Transplant 2002) Meeting To Be Held in Washington, DC April 26 - May 1, 2002
The American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (AST) will be hosting the American Transplant Congress Meeting. At this meeting, a variety of formats are planned that will encourage the exchange of scientific and clinical information. The meeting will be held at the Marriott Wardman Park Hotel in Washington, DC during April 26 - May 1, 2002. For more information, please contact the staff of the American Transplant Congress 2002 at 856-439-0880, or visit their web site at http://www.atcmeeting.org.
The MAP newsletter is published quarterly to present topics of interest to the transplant
community. If you would like to submit material to be considered for publication in the
newsletter, please contact MAP at:
Medication Access Program
University of Georgia at the Medical College of Georgia
Clinical Pharmacy Program
CJ-1020
Augusta, Georgia 30912-2450
(706) 721-0131 or 1-800-736-2273 ext. 0131
E-mail -
map@mapuga.com
The Medication Access Program is a statewide program for solid-organ transplant patients in Georgia that offers information about medication assistance programs and helps with the enrollment into these programs.