Charisse Henderson, RN, BSN, liver transplant coordinator, and Erin Ticehurst, PharmD, transplant pharmacist, highlight the risks and benefits of generic drugs for liver transplant patients.
Generic versions of many anti-rejection medications are now available for liver transplant patients. These generic drugs usually save patients money as they are generally less expensive than brand-name prescriptions.
Just like brand-name medications, all generic drugs manufactured in the United States are produced under the good manufacturing practice regulations and strict guidelines of the U.S. Food and Drug Administration (FDA). All generic medications also must be approved by the FDA before they are marketed to the public.
In order for a generic medication to be approved by the FDA, it must be identical to the brand-name medication in:
- Active ingredient(s)
- Form
- Strength
- Quality
- Purity
- Stability
- How it is taken
- The way it works
- The way it should be used
The following generic anti-rejection medications have been approved by the FDA for liver transplant patients:
- Cyclosporine (brand name Sandimmune®)
- Cyclosporine modified (brand name Neoral®)
- Tacrolimus (brand name Prograf®)
- Azathioprine (brand name Imuran®)
- Mycophenolate mofetil (brand name CellCept®)
- Prednisone (brand name Deltasone®)
Risks associated with generic anti-rejection medications
Although the Penn Liver Transplant Program approves the use of generic immunosuppressive medications, it is important to be aware of the risks.
Generic medications are tested in healthy adults before they are approved by the FDA. The drugs may react differently in patients who have had a liver transplant. For this reason, the transition from a brand-name medication to a generic must be closely monitored by the transplant team.
Patients who take anti-rejection medications should notify their transplant coordinators if they encounter any changes in their prescription. Differences in the name of the drug manufacturer, or the shape or color of the pills can signal a change in the medication. Manufacturer information can be found on the prescription label or on the packaging used to distribute the medication.
Patients should ask their pharmacists to verify the medication is the same version received the last time the prescription was filled. A transplant coordinator can also help identify these changes and schedule additional lab tests as necessary.
Many states, including Pennsylvania, New Jersey and Delaware, permit pharmacists to dispense generic medications unless the brand-name medication is specifically requested by the prescribing physician.
Patients who wish to continue on a brand-name product should notify their transplant coordinator so the prescription order is written correctly. The pharmacy will fill the prescription with the generic medication unless the prescription contains the statement "brand medically necessary." Many prescription insurance plans also require higher co-pays for brand-name medications.
