Dosing and uses of Simulect (basiliximab)
Adult dosage forms and strengths
powder for injection
- 10mg
- 20mg
Prophylaxis of Renal Transplant Rejection
20 mg IV within 2 hr prior to transplant surgery, THEn
20 mg IV 4 days after transplant
Used in regimen containing cyclosporine and corticosteroids
Pediatric dosage forms and strengths
powder for injection
- 10mg
- 20mg
Prophylaxis of Renal Transplant Rejection
>35 kg: Administer as in adults; 20 mg IV within 2 hr prior to transplant surgery, THEN, 20 mg IV 4 days after transplant
<35 kg: 10 mg IV within 2 hr prior to transplant surgery, THEN 10 mg IV 4 days after transplant
Used in regimen containing cyclosporine and corticosteroids
Note: Difficult to distinguish from adverse events associated with organ transplantation
>10%
Abdominal pain
Acne
Anemia
Constipation
Diarrhea
Dyspepsia
Fever
Headache
Hypo- or hyperkalemia
Hyperglycemia
Hyperuricemia
Hypophosphatemia
Hypercholesterolemia
Hypertension
Insomnia
Nausea
Pain
Peripheral edema
Tremor
UTI
Viral infection
Vomiting
Wound healing complications
1-10%
Acidosis
Agitation
Angina
Anxiety
Arthralgia
Arrhythmia
Atrial fibrillation
Bronchitis
Bronchospasm
Cardiac failure
Chest pain
Cough
Cyst
Dehydration
Depression
Dizziness
Edema
Fatigue
Flatulence
Gingival hyperplasia
GI hemorrhage
Hematoma
Hemorrhage
Hypotension
Hypomagnesemia
Hyponatremia
Hyper or hypocalcemia
Hyperlidpidemia
Hypertrichosis
Increased glucocorticoids
Infections
Neuropathy
Pruritus
Rash
Leukopenia
Lymphoproliferative disorders
Oliguria
Polycythemia
Pulmonary edema
Renal function abnormalities
Skin ulceration
Stomatitis
Tachycardia
Thrombocytopenia
Thrombosis
Urinary frequency
Urinary retention
Vision abnormalities
Warnings
Black box warnings
Should be prescribed only by physicians who have experience with immunosuppression in organ transplant recipients and can provide necessary follow-up and appropriate monitoring
Contraindications
Hypersensitivity
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown whether excreted in milk; because of the potential for adverse reactions, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Simulect (basiliximab)
Half-Life: 7.2 d
Duration: unknown
Peak Plasma:
Time: 30 min
Concentration: 7.1 mg/L
Other Information
Vd: 8.6 L
Metabolism: unknown
Clearance: 41 mL/hr
Excretion: unknown
Mechanism of action
Interleukin-2 receptor antagonist
Administration
IV Preparation
Reconstitute vials with 5 mL SWI
Dilute reconstituted contents in 50 mL NS or D5W
IV Administration
For central or intravenous administration only
Infuse over 20-30 min
Storage
Store vials under refrigeration 2-8°C (36-46°F)
Reconstituted vials are stable under refrigeration for 24 hr, but only 4 hr at Rt
