Issue 3 July 2000
Medicare Immunosuppressant Coverage	Clinical Issues Tacrolimus-Based Therapy Minimizes Lipid Elevations	Recent FDA Approval Tequin® (Gatifloxacin)	MAP Status Report October 1999-July 2000

Medicare Immunosuppressant Coverage Beginning January 2000, eligible beneficiaries whose Medicare coverage for immunosuppressants expires during the year 2000 may receive an additional eight months of Medicare coverage beyond the 36 month period. Eligible transplant recipients whose Medicare benefits expire during the year 2001 will receive "at least" 8 months of additional coverage. Transplant recipients whose Medicare benefits for immunosuppressants have expired before January 1, 2000 are currently not eligible for the 8 month extension. In addition, coverage for transplant recipients whose Medicare eligibility is based solely on end-stage renal disease will terminate 36 months after kidney transplant and are not currently eligible for the 8 month extension. If a beneficiary immediately applies and is approved to age 65 and/or disability, that individual would then be eligible for the 8 month extension of immunosuppressant coverage. For more information contact HCFA at (410) 786-4635.

Clinical Issues Tacrolimus-Based Immunosuppression Minimizes Serum Lipid Elevations in Pediatric Cardiac Patients In a study of 23 pediatric cardiac transplant patients published by investigators at the University of Florida, tacrolimus had less effect on elevations of total cholesterol, LDL cholesterol, and triglycerides when combined with high-dose prednisone (> 0.1 mg/kg/day) than did cyclosporine with high-dose prednisone (J Heart Lung Transplant 1999;18:707-713). Patients were followed for a mean 2.8 years after transplant. There were no significant difference between tacrolimus and cyclosporine when given with low doses of prednisone (less than or equal to 0.1 mg/kg/day). Cyclosporine with high dose prednisone resulted in a mean increase in serum cholesterol of 74 mg/dl compared with 27.7 mg/dl with tacrolimus (p=0.0001). In addition, tacrolimus resulted in a significant increase in HDL cholesterol compared with cyclosporine. The doses of tacrolimus and cyclosporine were adjusted to maintain serum level targets of 5-15 ng/ml for tacrolimus and, for cyclosporine 300-450 ng/ml for the first 3 months post transplant, then 200-300 ng/ml for 9 months, then 150-200 ng/ml after one year. This study indicates that the effect of tacrolimus was independent of its steroid-sparing effects. The investigators suggest that in patients who require higher doses of prednisone, tacrolimus may lead to more favorable lipid profiles and minimize the risk of post-transplant coronary arteriopathy (although the latter was not demonstrated in this study).

Recent FDA Approval Tequin® (Gatifloxacin) Tequin® (Gatifloxacin) is a new fluoroquinolone manufactured by Bristol-Meyers Squibb for the treatment of community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, acute sinusitis, urinary tract infections and gonorrhea. Gatifloxacin is 2 to 4 times more active than Gatifloxacin against Streptococcus pneumonia including strains highly resistant to penicillin. Other organisms sensitive to this drug include some strains of Staphylococcus aureus and enterococci (but not methicillin-resistant Staphylococci and vancomycin-resistant enterococci), Legionella pneumophila, Chlamydia species, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Haemophilus influenza, and Moraxella catarrhalis. The usual recommended dose is 400 mg given as a single daily dose. Seventy percent of the drug is excreted unchanged in the urine and dosage reduction is recommended in patients with a creatinine clearance of less than 40 mL/min, including patients on hemodialysis and continuous ambulatory peritoneal dialysis. In these patients, the recommended dose is 400 mg initially, followed by 200 mg daily. Peak serum concentrations occur in 1 to 2 hours following administration and steady-state is achieved in 2 to 3 days. To date, studies have demonstrated a negligible effect of food on oral absorption, and therefore, may be administered without regard to food. Clinical trials have demonstrated that gatifloxacin is equally effective as ceftriaxone followed by clarithromycin in patients with severe community-acquired pneumonia; superior to cefuroxime axetil in patients with acute bacterial exacerbations of chronic bronchitis; and equally effective to ciprofloxacin for urinary tract infections and ofloxacin for gonorrhea. No changes in the dose are necessary when switching from intravenous to oral administration. Major adverse effects experienced with gatifloxacin include nausea, diarrhea, headache, dizziness and vaginitis. Significant drug-drug interactions with gatifloxacin include magnesium and aluminum containing antacids. These products have been shown to significantly decrease the area under the concentration-time curve of gatifloxacin and therefore these products should be given at least 4 hours after orally administered gatifloxacin. Contributing author William E. Wade, Pharm.D.

Medication Access Program The mission of the Medication Access Program (MAP) is to increase access to medications for solid-organ transplant patients who reside in the state of Georgia. From October 1999 to July 2000, MAP has aided over 125 Georgia solid-organ transplant patients in the enrollment process required to participate in medication assistance programs. Through MAP's services, these patients have received over $500,000 in medications (based on average wholesale prices). Approximately 60% of these medications represent immunosuppressants and the remaining 40% represent cardiovascular, antimicrobial, gastrointestinal, and other necessary prescription medications. MAP also serves as a valuable resource to health care professionals and transplant patients by providing the most up-to-date information concerning medication assistance programs. MAP is made available by the Carlos and Marguerite Mason Trust and the University of Georgia College of Pharmacy.

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.