Simulect舒萊

Simulect

basiliximab

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Basiliximab
Indications/Uses
Prophylaxis of acute organ rejection in de novo renal transplantation & is to be used concomitantly w/ ciclosporin for microemulsion & corticosteroid-based immunosuppression or in a triple maintenance immunosuppressive regimen.
Dosage/Direction for Use
Adult 40 mg, given in 2 doses of 20 mg each. The 1st dose should be given w/in 2 hr prior to transplantation surgery. The 2nd dose should be given 4 days after transplantation. Adolescent & childn 1-17 yr (<35 kg) 20 mg given in 2 doses of 10 mg each. Administer as IV infusion over 20-30 min or as bolus inj.
Contraindications
Special Precautions
Discontinue if severe hypersensitivity occurs. Patients previously treated & are re-exposed to a subsequent course of therapy; increased risk of developing lymphoproliferative disorders (LPDs) & opportunistic infections. Pregnancy & lactation.
Adverse Reactions
Adult Following dual or triple therapy in both treatment groups (Simulect vs Placebo or ATG/ALG): Constipation, UTI, pain, nausea, peripheral oedema, HTN, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postop wound complication, increased wt, increased blood creatinine, hypophosphataemia, diarrhoea, upper resp tract infection. Ped patient Following dual therapy in both (<35 kg vs ≥35 kg) cohorts: UTI, hypertrichosis, rhinitis, pyrexia, HTN, upper resp tract & viral infection, sepsis & constipation.
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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