Abrammune is a generic formulation of cyclosporine A available in Egypt as an oral syrup (50 mg/mL and 100 mg/mL) and softgel capsules (25 mg and 50 mg strengths) for immunosuppressive therapy . The syrup is priced at 220 EGP (50 mg/mL) and 410 EGP (100 mg/mL), while capsules cost 24 EGP for 25 mg and 44 EGP for 50 mg . Cyclosporine exerts its effect by binding cyclophilin and inhibiting the phosphatase calcineurin, thereby blocking IL‑2 transcription and T‑cell activation . It is indicated for prophylaxis of graft rejection in solid‑organ transplants and for treatment of autoimmune disorders such as rheumatoid arthritis, psoriasis, nephrotic syndrome, and Crohn’s disease .
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Composition and Formulation
Syrup
Active Ingredient: Cyclosporine A at 50 mg/mL or 100 mg/mL in an oral solution .
Vehicle: Aqueous syrup base (details proprietary to manufacturer).
Capsules
Active Ingredient: Cyclosporine A 25 mg or 50 mg per soft gelatin capsule .
Excipients: Oil‑based fill within a gelatin shell to enhance bioavailability.
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Indications and Uses
Abrammune is used primarily for:
Transplant Prophylaxis: Prevention of rejection in kidney, liver, and heart allogeneic transplants, often in combination with corticosteroids and azathioprine .
Autoimmune Conditions: Management of severe rheumatoid arthritis refractory to DMARDs, plaque psoriasis, minimal change and focal segmental glomerulosclerosis nephrotic syndromes, and Crohn’s disease .
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Mechanism of Action
Cyclosporine A forms a complex with cyclophilin, which inhibits calcineurin phosphatase activity; this prevents dephosphorylation of nuclear factor of activated T‑cells (NF‑AT), blocking transcription of IL‑2 and other cytokines, thereby suppressing T‑lymphocyte activation and proliferation .
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Pharmacokinetics
Absorption: Oral bioavailability is highly variable (≈30%) and influenced by food and bile flow .
Distribution: Extensive binding to erythrocytes and plasma lipoproteins.
Metabolism: Hepatic biotransformation by CYP3A4 into multiple metabolites with ≤10% of parent activity .
Elimination: Primarily biliary (fecal) excretion; elimination half‑life ≈24 h .
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Dosage and Administration
Transplant Prophylaxis
Induction: Single oral dose of 15 mg/kg 4–12 h before transplantation.
Maintenance: 15 mg/kg/day divided BID for 1–2 weeks, then taper by 5% per week to 5–10 mg/kg/day .
Autoimmune Disorders
Initial Dose: 1.25 mg/kg orally BID (2.5 mg/kg/day).
Titration: Increase by 0.5–0.75 mg/kg/day at 4–8 week intervals up to a maximum of 4 mg/kg/day based on response and tolerability .
Monitoring: Adjust dose to maintain target trough levels (e.g., 150–200 ng/mL in transplant patients).
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Side Effects and Precautions
Common Adverse Effects: Nephrotoxicity (elevated creatinine), hypertension, hirsutism, gingival hyperplasia, tremor, headache, hyperlipidemia, and hyperglycemia .
Serious Risks: Increased susceptibility to infections and malignancies (e.g., lymphoma, skin cancer).
Precautions: Regular monitoring of renal/hepatic function and blood pressure; avoid concomitant grapefruit; use caution in pregnancy and breastfeeding; contraindicated in severe infections and malignancy history .
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Storage and Packaging
Packaging: Syrup in glass bottles; capsules in blister packs of 10 (25 mg & 50 mg) and 50 (100 mg) .
Storage: Store at 15–25 °C, protect from light and moisture, and keep out of reach of children .
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Pricing and Availability
Syrup (Egypt):
50 mg/mL bottle: 220 EGP
100 mg/mL bottle: 410 EGP
Capsules (Egypt):
25 mg: 24 EGP per capsule
50 mg: 44 EGP per capsule
100 mg (50‑c
ount pack): 410 EGP
Abrammune is widely available through retail pharmacies and major online platforms in Egypt.