Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Simulect Generic Name & Formulations
Legal Class
Rx
General Description
Basiliximab (recombinant) 10mg, 20mg; per vial; pwd for IV inj or infusion after reconstitution/dilution; contains mannitol; preservative-free.
Pharmacological Class
Interleukin-2 antagonist.
How Supplied
Single-use vial—1
Manufacturer
Simulect Indications
Indications
Organ rejection prophylaxis in renal transplant patients, in combination with cyclosporine and corticosteroids.
Simulect Dosage and Administration
Adults and Children
Give by bolus inj or IV infusion over 20–30 minutes. <35kg: initially 10mg within 2 hours prior to transplantation, then 10mg 4 days post-transplantation for a total of 2 doses. ≥35kg: initially 20mg within 2 hours prior to transplantation, then 20mg 4 days post-transplantation for a total of 2 doses. Withhold 2nd dose if severe hypersensitivity reactions or graft loss occurs.
Simulect Contraindications
Not Applicable
Simulect Boxed Warnings
Boxed Warning
Prescribe only by physicians experienced in immunosuppression therapy and management of organ transplantation patients.
Simulect Warnings/Precautions
Warnings/Precautions
Should be administered under qualified medical supervision. Risk of lymphoproliferative disorders and opportunistic infections; monitor. Previously-treated with basiliximab; monitor for severe hypersensitivity reactions in subsequent treatment. Elderly. Pregnancy (Cat.B); use effective contraception before, during and for 4 months after therapy. Nursing mothers: not recommended.
Simulect Pharmacokinetics
See Literature
Simulect Interactions
Interactions
Concomitant vaccines: immune response may be impaired.
Simulect Adverse Reactions
Adverse Reactions
GI upset, constipation, peripheral edema, fever, hyper or hypokalemia, hyperglycemia, dyspnea, hypertension, headache, tremor, insomnia, anemia; infections, antibody formation, severe hypersensitivity reactions (discontinue if occurs).
Simulect Clinical Trials
See Literature
Simulect Note
Not Applicable
Simulect Patient Counseling
See Literature
