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(Gengraf®)
Cyclosporine 25 mg, 100 mg capsules Abbott Laboratories
All orders and prescriptions for
cyclosporine products must specify the brand name as Gengrafā, Neoralā,
or Sandimmuneā Gengraf®
is a modified cyclosporine capsule indicated for use in the prevention of organ
rejection (kidney, liver and heart transplantation), rheumatoid arthritis, and
psoriasis. Gengraf® and Neoral® are considered generic
equivalents. Gengraf® is a hard gelatin capsule while Neoral®
is a soft gelatin capsule. Gengraf®
capsules have less odor than Neoral®, and thus, are preferable to
patients. Gengraf® is also available as a 25 mg and 100 mg capsule,
but not as a liquid formulation. Gengraf® capsules are approximately
27% less expensive than Neoral® formulations. Gengraf® has been given an
"AB" rating to Neoral® by the FDA indicating the products
are considered bioequivalent and interchangeable. A concerning issue for the
bioequivalency rating of Gengraf® to Neoral® is that the
data is unpublished. Manufacturer correspondence includes two single-dose
studies enrolling a total of 113 healthy subjects and one conversion study
(Neoral® to Gengraf®)
with 50 stable renal transplant patients. Based on the limited bioequivalency
data at this time and the potential outcome of organ rejection, it is recommended at KUMC that there will
be no automatic generic substitution of Gengraf® for Neoral®. Physicians are required to prescribe
cyclosporine products by brand name. The daily dose
for Gengraf® should always be divided into BID dosing on a
consistent schedule in regards to meals (as food can affect the
bioavailability). However, it can be given without regards to meals as long as
the regimen is consistent. Grapefruit and grapefruit juice should be avoided as
co-administration can increase Gengraf® blood concentrations. For
new transplant recipients, the initial dose can be administered 4 to 12 hours
prior to transplantation or postoperatively. Gengraf® is dosed
identically to Neoral® (range 4 to 12 mg/kg/day depending on
transplant) and the target range for trough concentration is identical. Like
Neoral®, a patient can be converted from Sandimmune® to
Gengraf® using a 1:1 dose conversion followed by trough
monitoring. Gengraf® dose
reduction may be required to achieve trough concentrations equivalent to those
prior to conversion. The
adverse reaction and drug interaction profile for Gengraf® does not
differ from previously available cyclosporine products, which includes
nephrotoxicity, hepatotoxicity, seizures, hypertension, gingival hyperplasia,
tremor, hirsutism, and hypertension.
Immunosuppression with cyclosporine may result in an increased
susceptibility to infection. Adjust
dosage to avoid toxicity or possible organ rejection via cyclosporine blood
concentration monitoring.
The
contraindications and precautions do not differ from previously available
cyclosporine products. Cyclosporine is
designated a pregnancy category C and there are no adequate or well-controlled
studies in pregnant women. Cyclosporine is excreted in breast milk. Use in
nursing mothers should be avoided. FOOD/DRUG INTERACTION: Gengraf® may be administered with or without meals as long as the regimen is consistent, as food may affect bioavailability. However, grapefruit and grapefruit juice should be avoided.
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