GENGRAF® Oral Solution
(cyclosporine) Oral Solution, USP [MODIFIED]
Only physicians experienced in the management of systemic
immunosuppressive therapy for the indicated disease should prescribe Gengraf®
(cyclosporine oral solution, USP [MODIFIED]). At doses used in solid
organ transplantation, only physicians experienced in immunosuppressive therapy
and management of organ transplant recipients should prescribe Gengraf®.
Patients receiving the drug should be managed in facilities equipped and
staffed with adequate laboratory and supportive medical resources. The
physician responsible for maintenance therapy should have complete information
requisite for the follow-up of the patient.
Gengraf®, a systemic immunosuppressant, may increase the
susceptibility to infection and the development of neoplasia. In kidney, liver,
and heart transplant patients Gengraf® may be administered with other
immunosuppressive agents. Increased susceptibility to infection and the
possible development of lymphoma and other neoplasms may result from the
increase in the degree of immunosuppression in transplant patients.
Gengraf® (cyclosporine oral solution, USP [MODIFIED])
has increased bioavailability in comparison to Sandimmune®* (cyclosporine oral
solution, USP [Non-Modified]). Gengraf® and Sandimmune®* are not bioequivalent
and cannot be used interchangeably without physician supervision. For a given
trough concentration, cyclosporine exposure will be greater with Gengraf® than
with Sandimmune®*. If a patient who is receiving exceptionally high doses of
Sandimmune®* is converted to Gengraf®, particular caution should be exercised. Cyclosporine
blood concentrations should be monitored in transplant and rheumatoid arthritis
patients taking Gengraf® to avoid toxicity due to high concentrations. Dose
adjustments should be made in transplant patients to minimize possible organ
rejection due to low concentrations. Comparison of blood concentrations in the
published literature with blood concentrations obtained using current assays
must be done with detailed knowledge of the assay methods employed.
For Psoriasis Patients (see also BOXED WARNINGS above)
Psoriasis patients previously treated with PUVA and to a
lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar,
or radiation therapy, are at an increased risk of developing skin malignancies
when taking Gengraf® (cyclosporine oral solution, USP [MODIFIED]).
Cyclosporine, the active ingredient in Gengraf®, in
recommended dosages, can cause systemic hypertension and nephrotoxicity. The
risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of
cyclosporine, and therefore, renal function must be monitored during therapy.
Gengraf® (cyclosporine oral solution, USP [MODIFIED]) is a
modified oral formulation of cyclosporine that forms an aqueous dispersion in an aqueous environment.
Cyclosporine, the active principle in Gengraf® Oral
Solution, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the
fungus species Aphanocladium album.
Chemically, cyclosporine is designated as [R-[R*,
Gengraf® Oral Solution (cyclosporine oral solution, USP
[MODIFIED]) is available in 50 mL bottles. Each mL contains: cyclosporine 100 mg/mL.
Inactive Ingredients: Polyoxyl 40 hydrogenated castor oil NF,
propylene glycol USP, sorbitan monooleate NF.
The chemical structure for cyclosporine USP is:
What are the possible side effects of cyclosporine (Gengraf, Neoral, Sandimmune)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst;
- swelling, weight gain, feeling short of breath;
- blurred vision, headache or pain behind your eyes, sometimes with vomiting;
- seizure (convulsions);
- muscle pain or weakness, fast heart...
Read All Potential Side Effects and See Pictures of Gengraf Oral Solution »
Last reviewed on RxList: 5/7/2009
This monograph has been modified to include the generic and brand name in many instances.