Simulect

Simulect

basiliximab

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Basiliximab
Indications/Uses
Prophylaxis of acute organ rejection in de novo renal transplantation in adult & pediatric patients. In concomitant use w/ ciclosporin for microemulsion- & corticosteroid-based immunosuppression or in triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids & either azathioprine or mycophenolate mofetil.
Dosage/Direction for Use
IV Infuse over 20-30 min or as bolus inj. Adult Total dose: 40 mg (as 2 doses of 20 mg). 1st dose: Give 20 mg w/in 2 hr prior to transplantation surgery. 2nd dose: Give 20 mg 4 days after transplantation. Ped 1-17 yr weighing ≥35 kg Use adult dose, <35 kg Total dose: 20 mg (as 2 doses of 10 mg). 1st dose: Give 10 mg w/in 2 hr prior to transplantation surgery. 2nd dose: Give 10 mg 4 days after transplantation.
Contraindications
Special Precautions
Permanently discontinue treatment if severe hypersensitivity occurs. Severe acute (<24 hr) hypersensitivity & anaphylactoid type reactions eg, rash, urticaria, pruritus, sneezing, wheezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema, cardiac failure, resp failure & capillary leak syndrome. Increased risk of developing hypersensitivity reactions in patients w/ concomitant immunosuppression that was discontinued prematurely following initial administration of the drug; lymphoproliferative disorders (eg, lymphoma) & opportunistic infections (eg, cytomegalovirus) in transplant patients receiving immunosuppressive regimens. Re-exposure to subsequent course of therapy. Transmission of infection by live vaccines. Concomitant use w/ live & inactive vaccination. Women of child-bearing potential should use adequate contraception & continue for additional 4 mth after last dose. Pregnancy. Not to breastfeed for 4 mth following last dose. Elderly.
Adverse Reactions
UTI, HTN, URTI, constipation. Hypersensitivity/anaphylactoid reaction eg, rash, urticaria, pruritus, sneezing, wheezing, bronchospasm, dyspnea, pulmonary edema, cardiac failure, hypotension, tachycardia, resp failure, capillary leak syndrome, cytokine release syndrome. Adult: Pain, nausea, peripheral edema, anemia, headache, hyperkalemia, hypercholesterolemia, postop wound complication, increased wt & blood creatinine, hypophosphatemia, diarrhea. Ped: Hypertrichosis, rhinitis, pyrexia, viral infection, sepsis.
Drug Interactions
Reduced total body clearance w/ azathioprine or mycophenolate mofetil.
MIMS Class
Immunosuppressants
ATC Classification
L04AC02 - basiliximab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Simulect powd for inj 20 mg
Packing/Price
1's
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