Simulect 20 mg/vial (IV Infusion)

Indications

• immunosuppressant agent
• prevent transplant rejection
• treatment for lichen planus
• alternative therapy to ciclosporin

Pharmacology

• IL-2 receptor antagonist
• high affinity binding to IL-2Rα
• inhibits IL-2-mediated activation of lymphocytes
• impairs immune system response to antigenic challenges

Dosage

• recommended doses for adults and pediatric patients
• dosage adjustments based on weight
• timing of doses in relation to transplantation surgery

Administration

• intravenous administration only
• methods of reconstitution and dilution
• inspection for particulate matter and discoloration
• assurance of sterility

Interaction

• diminishes response to inactivated vaccines
• enhances adverse/toxic effect of live vaccines
• avoid concomitant administration

Contraindications

• known hypersensitivity to basiliximab or any component of the formulation

Side Effects

• pain or burning during urination
• easy bruising or bleeding
• tremors and shaking
• fever, chills, body aches, flu symptoms
• trouble breathing
• pale skin and rapid heart rate

Pregnancy & Lactation

• Pregnancy Category B
• limited studies in pregnant women
• use in pregnant women when potential benefit justifies risk to fetus
• unknown excretion in human milk

Precautions & Warnings

• re-exposure to subsequent therapy
• considerations for children, pregnancy, and lactation

Use in Special Populations

• lack of dosage adjustments for renal and hepatic impairment

Overdose Effects

• no determined maximum tolerated dose
• administration in adults and pediatric patients without serious adverse events

Therapeutic Class

• Cytotoxic immunosuppressants

Duration of Treatment

• 36 days ± 14 days

Reconstitution

• reconstitution with sterile water for injection
• further dilution with saline or dextrose solution for infusion

Storage Conditions

• recommended temperature range for storage
• time limits for storage of reconstituted solution

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