ba-sil-IX-i-mab

Therapeutic Classification: Immunosuppressant agents

Pharmacologic Classification: monoclonal antibodies

• Prevention of acute organ rejection in patients undergoing renal transplantation (in combination with corticosteroids and cyclosporine).

• Binds to and blocks specific interleukin-2 (IL-2) receptor sites on activated T lymphocytes.

• Prevention of acute organ rejection following renal transplantation.

Absorption: IV administration results in complete bioavailability.

Distribution: Moderately distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: 7.2 days.

(effect on immune function)

Contraindicated in:

• Hypersensitivity
• Lactation: Lactation.

Use Cautiously in:

• Rep: Women of reproductive potential
• OB: Safety not established in pregnancy.

Noted for patients receiving corticosteroids and cyclosporine in addition to basiliximab

CV: edema, hypertension, angina, arrhythmias, HF, hypotension.

Derm: acne, wound complications, hypertrichosis, pruritus.

EENT: abnormal vision, cataracts.

Endo: hyperglycemia, hypoglycemia.

F and E: acidosis, hyperkalemia, hypocalcemia, hypokalemia, hypophosphatemia.

GI: abdominal pain, constipation, diarrhea, dyspepsia, moniliasis, nausea, vomiting, gingival hyperplasia, stomatitis.

Hemat: BLEEDING, coagulation abnormalities.

Metab: ↑ weight, hypercholesterolemia, hyperuricemia.

MS: pain.

Neuro: dizziness, headache, insomnia, tremor, weakness, neuropathy, paresthesia.

Resp: cough.

Misc: infection, chills, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

• Immunosuppression may be ↑ with other immunosuppressants.

Drug-Natural Products:

• Concurrent use with echinacea and melatonin may interfere with immunosuppression.

• IV (Adults and Children ≥35 kg): 20 mg given 2 hr before transplantation; repeated 4 days after transplantation. Second dose should be withheld if complications or graft loss occurs.
• IV (Children <35 kg): 10 mg given 2 hr before transplantation; repeated 4 days after transplantation. Second dose should be withheld if complication or graft loss occurs.

• Powder for injection: 10 mg/vial; 20 mg/vial;

• Monitor for signs of anaphylactic or hypersensitivity reactions (hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, sneezing) at each dose. Onset of symptoms is usually within 24 hr. Resuscitation equipment and medications for treatment of severe hypersensitivity should be readily available. If a severe hypersensitivity reaction occurs, basiliximab therapy should be permanently discontinued. Patients who have previously received basiliximab should only receive subsequent therapy with extreme caution.
• Monitor for infection (fever, chills, rash, sore throat, purulent discharge, dysuria). Notify physician immediately if these symptoms occur; may necessitate discontinuation of therapy.

• May cause ↑ or ↓ hemoglobin, hematocrit, serum glucose, potassium, and calcium concentrations.
  • May cause ↑ serum cholesterol levels.
  • May cause ↑ BUN, serum creatinine, and uric acid concentrations.
  • May cause ↓ serum magnesium, phosphate, and platelet levels.

IV Administration:

• Basiliximab is usually administered concurrently with cyclosporine and corticosteroids.
  • Reconstitute with 2.5 mL or 5 mL of sterile water for injection for the 10 mg or 20 mg vial, respectively. Shake gently to dissolve powder.
• Diluent: May be administered undiluted. Bolus administration may be associated with nausea, vomiting, and local reactions (pain).Concentration: 4 mg/mL.IV Push
• Rate: : Administer over 20–30 min via peripheral or central line.
• Intermittent Infusion:
  Diluent: Dilute further with 25–50 mL of 0.9% NaCl or D5W. Gently invert bag to mix; do not shake, to avoid foaming. Solution is clear to opalescent and colorless; do not administer solutions that are discolored or contain particulate matter. Discard unused portion. Administer within 4 hr or may be refrigerated for up to 24 hr. Discard after 24 hr.Concentration: 0.08–0.16 mg/mL.
• Rate: Administer over 20–30 min via peripheral or central line.
• Additive Incompatibility: Do not admix; do not administer in IV line containing other medications.

• Explain purpose of medication to patient. Explain that patient will need to resume lifelong therapy with other immunosuppressive drugs after completion of basiliximab course.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response is known.
• Instruct patient to continue to avoid crowds and persons with known infections, because basiliximab also suppresses the immune system.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

• Prevention of acute organ rejection in patients receiving renal transplantation.

Simulect

NDC Code^*

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0331- Simulect
    • 0078-0331-84- 1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84) > 5 mL in 1 VIAL, SINGLE-USE

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0393- Simulect
    • 0078-0393-61- 1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61) > 2.5 mL in 1 VIAL, SINGLE-USE