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GENGRAF ORAL SOLUTION
Arthritis/rheumatic disorders
Organ rejection prophylaxis
Psoriasis
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Drug Name:

GENGRAF ORAL SOLUTION Rx

Generic Name and Formulations:
Cyclosporine (modified) 100mg/mL.

Company:
AbbVie

Therapeutic Use:

Indications for GENGRAF ORAL SOLUTION:

Severe, active rheumatoid arthritis unresponsive to methotrexate alone.

Adult:

Give consistently with regard to meals and time of day. ≥18yrs: 1.25mg/kg twice daily; may increase by 0.5–0.75mg/kg per day after 8 weeks and again after 12 weeks; max 4mg/kg per day (many patients on concomitant methotrexate can be treated with doses of 3mg/kg per day or less). Dilute soln in a glass of room temp orange or apple juice. Reduce dose by 25–50% if adverse events (eg, hypertension or serum creatinine increases ≥30% above baseline) occur. Renal impairment: not recommended. Severe hepatic impairment: consider reducing dose. Discontinue if adverse events are severe or persistent, or if no benefit by Week 16.

Children:

<18yrs: not established.

Contraindications:

Renal impairment. Uncontrolled hypertension. Malignancies.

Warnings/Precautions:

Be fully familiar with immunosuppressive therapy before prescribing. Not bioequivalent to all other forms of cyclosporine; do not interchange without physician supervision. Increased risk of infections, lymphomas and other malignancies (eg, skin). Avoid sun or UV light exposure. Monitor renal and hepatic function, BP, CBC, serum magnesium, potassium, uric acid, lipids (see full labeling for monitoring frequency). Reduce dose if hypertension occurs; do not attempt to manage medically. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid other nephrotoxic drugs (eg, ciprofloxacin, gentamicin, tobramycin, vancomycin, SMX/TMP, melphalan, amphotericin B, ketoconazole, cimetidine, ranitidine, tacrolimus, NSAIDs, colchicine), fibric acid derivatives. Cyclosporine levels increased by CYP3A inhibitors (eg, calcium channel blockers, amiodarone, azithromycin, azole antifungals, erythromycin, clarithromycin, quinupristin/dalfopristin, boceprevir, telaprevir, methylprednisolone, allopurinol, colchicine, bromocriptine, danazol, metoclopramide, imatinib, nefazodone, oral contraceptives; probably indinavir, saquinavir, nelfinavir, ritonavir). Avoid alcohol, grapefruit juice. Cyclosporine levels decreased by CYP3A inducers (eg, nafcillin, rifampin, carbamazepine, oxcarbazepine, bosentan (avoid), phenobarbital, phenytoin, octreotide, terbinafine, ticlopidine, sulfinpyrazone, St. John's wort), orlistat. Avoid potassium-sparing diuretics. Concomitant repaglinide: monitor blood glucose. Concomitant aliskiren: not recommended. Concomitant sirolimus: separate by 4 hours. May decrease effectiveness of vaccines; avoid live attenuated vaccines. May increase levels of digoxin (monitor), colchicine, prednisolone, statins (reduce dose), ambrisentan, and anthracycline antibiotics, dabigatran (avoid). Gingival hyperplasia with nifedipine (avoid). Convulsions with high-dose methylprednisolone.

See Also:

GENGRAF

Pharmacological Class:

Immunosuppressant.

Adverse Reactions:

Renal dysfunction, hypertension, headache, diarrhea, nausea, vomiting, hirsutism, hypertrichosis, leg cramps, pain, tremor, paresthesia, edema, dizziness, gum hyperplasia, liver dysfunction; increased risk of infections or malignancies, progressive multifocal leukoencephalopathy, hyperkalemia, thrombotic microangiopathy, possible encephalopathy.

Metabolism:

Hepatic (CYP3A).

Elimination:

Biliary (primarily), renal.

Generic Availability:

YES

How Supplied:

Caps—30; Soln—50mL

Indications for GENGRAF ORAL SOLUTION:

Organ rejection prophylaxis in allogeneic kidney, liver, and heart transplant patients, in combination with azathioprine and corticosteroids.

Adult:

See full labeling. Give consistently with regard to meals and time of day. ≥18yrs: Give daily dose in two divided doses. Individualize. Give initial dose 4–12 hours prior to transplantation or post-op with corticosteroids. Adjust Gengraf dose to achieve a pre-defined cyclosporine blood concentration. Dilute soln in glass of room temp orange or apple juice. Conversion from Sandimmune: initially 1:1 dose conversion, then adjust to attain pre-conversion cyclosporine blood trough concentration; monitor every 4–7 days until pre-conversion value attained. Monitor serum creatinine and BP every 2 weeks during first two months after conversion. If initial dose >10mg/kg/day, monitor concentration daily until stabilized in desired range. Renal or severe hepatic impairment: consider reducing dose.

Children:

Not studied.

Warnings/Precautions:

Be fully familiar with immunosuppressive therapy before prescribing. Not bioequivalent to all other forms of cyclosporine; do not interchange without physician supervision. Increased risk of infections, lymphomas and other malignancies (eg, skin). Avoid sun or UV light exposure. Monitor renal and hepatic function, BP, CBC, serum magnesium, potassium, uric acid, lipids (see full labeling for monitoring frequency). Reduce dose if hypertension occurs; do not attempt to manage medically. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid other nephrotoxic drugs (eg, ciprofloxacin, gentamicin, tobramycin, vancomycin, SMX/TMP, melphalan, amphotericin B, ketoconazole, cimetidine, ranitidine, tacrolimus, NSAIDs, colchicine), fibric acid derivatives. Cyclosporine levels increased by CYP3A inhibitors (eg, calcium channel blockers, amiodarone, azithromycin, azole antifungals, erythromycin, clarithromycin, quinupristin/dalfopristin, boceprevir, telaprevir, methylprednisolone, allopurinol, colchicine, bromocriptine, danazol, metoclopramide, imatinib, nefazodone, oral contraceptives; probably indinavir, saquinavir, nelfinavir, ritonavir). Avoid alcohol, grapefruit juice. Cyclosporine levels decreased by CYP3A inducers (eg, nafcillin, rifampin, carbamazepine, oxcarbazepine, bosentan (avoid), phenobarbital, phenytoin, octreotide, terbinafine, ticlopidine, sulfinpyrazone, St. John's wort), orlistat. Avoid potassium-sparing diuretics. Concomitant repaglinide: monitor blood glucose. Concomitant aliskiren: not recommended. Concomitant sirolimus: separate by 4 hours. May decrease effectiveness of vaccines; avoid live attenuated vaccines. May increase levels of digoxin (monitor), colchicine, prednisolone, statins (reduce dose), ambrisentan, and anthracycline antibiotics, dabigatran (avoid). Gingival hyperplasia with nifedipine (avoid). Convulsions with high-dose methylprednisolone.

See Also:

GENGRAF

Pharmacological Class:

Immunosuppressant.

Adverse Reactions:

Renal dysfunction, hypertension, headache, diarrhea, nausea, vomiting, hirsutism, hypertrichosis, leg cramps, pain, tremor, paresthesia, edema, dizziness, gum hyperplasia, liver dysfunction; increased risk of infections or malignancies, progressive multifocal leukoencephalopathy, hyperkalemia, thrombotic microangiopathy, possible encephalopathy.

Metabolism:

Hepatic (CYP3A).

Elimination:

Biliary (primarily), renal.

Generic Availability:

YES

How Supplied:

Caps—30; Soln—50mL

Indications for GENGRAF ORAL SOLUTION:

Treatment of adult, non-immunocompromised patients with severe, recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy or in patients for whom other systemic therapies are contraindicated or intolerable.

Adult:

Give consistently with regard to meals and time of day. ≥18yrs: 1.25mg/kg twice daily; may increase after 4 weeks by 0.5mg/kg per day, then adjust at 2-week intervals; max 4mg/kg per day. Dilute soln in glass of room temp orange or apple juice. Reduce by 25–50% if adverse events (eg, hypertension or serum creatinine increases ≥25% above baseline) occur. Renal impairment: not recommended. Severe hepatic impairment: consider reducing dose. Discontinue if adverse events are severe or persistent.

Children:

<18yrs: not established.

Contraindications:

Concomitant PUVA or UVB therapy; methotrexate, other immunosuppressants, coal tar, or radiation therapy. Renal impairment. Uncontrolled hypertension. Malignancies.

Warnings/Precautions:

Be fully familiar with immunosuppressive therapy before prescribing. Not bioequivalent to all other forms of cyclosporine; do not interchange without physician supervision. Increased risk of infections, lymphomas and other malignancies (eg, skin). Avoid sun or UV light exposure. Monitor renal and hepatic function, BP, CBC, serum magnesium, potassium, uric acid, lipids (see full labeling for monitoring frequency). Reduce dose if hypertension occurs; do not attempt to manage medically. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid other nephrotoxic drugs (eg, ciprofloxacin, gentamicin, tobramycin, vancomycin, SMX/TMP, melphalan, amphotericin B, ketoconazole, cimetidine, ranitidine, tacrolimus, NSAIDs, colchicine), fibric acid derivatives. Cyclosporine levels increased by CYP3A inhibitors (eg, calcium channel blockers, amiodarone, azithromycin, azole antifungals, erythromycin, clarithromycin, quinupristin/dalfopristin, boceprevir, telaprevir, methylprednisolone, allopurinol, colchicine, bromocriptine, danazol, metoclopramide, imatinib, nefazodone, oral contraceptives; probably indinavir, saquinavir, nelfinavir, ritonavir). Avoid alcohol, grapefruit juice. Cyclosporine levels decreased by CYP3A inducers (eg, nafcillin, rifampin, carbamazepine, oxcarbazepine, bosentan (avoid), phenobarbital, phenytoin, octreotide, terbinafine, ticlopidine, sulfinpyrazone, St. John's wort), orlistat. Avoid potassium-sparing diuretics. Concomitant repaglinide: monitor blood glucose. Concomitant aliskiren: not recommended. Concomitant sirolimus: separate by 4 hours. May decrease effectiveness of vaccines; avoid live attenuated vaccines. May increase levels of digoxin (monitor), colchicine, prednisolone, statins (reduce dose), ambrisentan, and anthracycline antibiotics, dabigatran (avoid). Gingival hyperplasia with nifedipine (avoid). Convulsions with high-dose methylprednisolone.

See Also:

GENGRAF

Pharmacological Class:

Immunosuppressant.

Adverse Reactions:

Renal dysfunction, hypertension, headache, diarrhea, nausea, vomiting, hirsutism, hypertrichosis, leg cramps, pain, tremor, paresthesia, edema, dizziness, gum hyperplasia, liver dysfunction; increased risk of infections or malignancies, progressive multifocal leukoencephalopathy, hyperkalemia, thrombotic microangiopathy, possible encephalopathy.

Metabolism:

Hepatic (CYP3A).

Elimination:

Biliary (primarily), renal.

Generic Availability:

YES

How Supplied:

Caps—30; Soln—50mL

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