Basiliximab

L04A - Immunosuppressants ATC L04AC02 Antibody approved 1998 Parenteral Black-box warning

JFDA label: Simulect 20mg/vial Powder & Solvent for Solution for Injection or Infusion

⚠ Black-Box Warning

Experienced physician:

Mechanism of Action

Inhibitor of Interleukin-2 receptor — Interleukin-2 receptor inhibitor

Target	Action	Gene / class
Interleukin-2 receptor efficacy	INHIBITOR

Indications

Approved

Renal transplant (prophylaxis of acute rejection)

Off-label

Acute graft-versus-host disease, refractory (treatment)
Heart transplant (prophylaxis of acute rejection)
Liver transplant (prophylaxis of acute rejection)
Lung transplant (prophylaxis of acute rejection)

Contraindications

Source: Lexicomp

Known hypersensitivity to basiliximab or any component of the formulation Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (11)

Very Common Hypertension · peripheral edema

Common Abnormal heart sounds · angina pectoris · atrial fibrillation · cardiac arrhythmia · cardiac failure · chest pain · hypotension · tachycardia · thrombosis

Nervous system disorders (11)

Very Common Headache · insomnia · pain

Common Agitation · anxiety · depression · dizziness · fatigue · hypoesthesia · malaise · rigors

Renal and urinary disorders (12)

Very Common Urinary tract infection

Common Bladder dysfunction · dysuria · genital edema (male) · hematuria · impotence · oliguria · Renal insufficiency · renal tubular necrosis · ureteral disease · urinary frequency · urinary retention

Blood and lymphatic system disorders (8)

Very Common Anemia

Common Hematoma · hemorrhage · hypoproteinemia · leukopenia · polycythemia · purpura · thrombocytopenia

Metabolism and nutrition disorders (22)

Very Common Hypercholesterolemia · hyperglycemia · hyperkalemia · hyperuricemia · hypokalemia · hypophosphatemia

Common Acidosis · albuminuria · anasarca · dehydration · diabetes mellitus · hypercalcemia · hyperlipidemia · hypertriglyceridemia · hypervolemia · hypocalcemia · hypoglycemia · hypomagnesemia · hyponatremia · increased nonprotein nitrogen · increased serum glucocorticoids · weight gain

Gastrointestinal disorders (16)

Very Common Abdominal pain · constipation · diarrhea · dyspepsia · nausea · vomiting

Common Enlargement of abdomen · esophagitis · flatulence · gastroenteritis · gastrointestinal hemorrhage · GI moniliasis · gingival hyperplasia · hernia · melena · stomatitis (including ulcerative)

Skin and subcutaneous tissue disorders (6)

Very Common Acne vulgaris

Common Dermal ulcer · dermatological disease · hypertrichosis · pruritus · skin rash

Musculoskeletal and connective tissue disorders (11)

Very Common Tremor

Common Arthralgia · arthropathy · back pain · bone fracture · leg pain · muscle cramps · myalgia · neuropathy · paresthesia · weakness

Eye disorders (3)

Common Cataract · conjunctivitis · visual disturbance

Infections and infestations (5)

Very Common Viral infection

Common Cytomegalovirus disease · herpes virus infection (simplex and zoster) · infection · sepsis

General disorders and administration site conditions (4)

Very Common Fever · postoperative wound complication

Common Accidental injury · cyst

Respiratory, thoracic and mediastinal disorders (10)

Very Common Dyspnea · upper respiratory infection

Common Bronchitis · bronchospasm · cough · pharyngitis · pneumonia · pulmonary edema · rhinitis · sinusitis

Dosing

Source: Lexicomp

Note: Patients previously administered basiliximab should only be re-exposed to a subsequent course of therapy with extreme caution. Renal transplant (prophylaxis of acute rejection): IV: 20 mg within 2 hours prior to transplant surgery, followed by a second 20 mg dose 4 days after transplantation (in combination with other immunosuppressants). The second dose should be withheld if complications occur (including severe hypersensitivity reactions or graft loss). Timing of basiliximab dosing may vary based on clinical and institutional factors; refer to institutional protocol for specific information. Acute graft-versus-host disease (aGVHD), refractory (treatment) (off-label use): IV: 20 mg on days 1 and 4; may repeat for recurrent acute GVHD (Schmidt-Hieber 2005). Additional data may be necessary to further define the role of basiliximab in this condition. Heart transplant (prophylaxis of acute rejection) (off-label use): IV: 20 mg on the day of transplant, followed by a second 20 mg dose on day 4 post-transplantation (in combination with other immunosuppressants) (Mehra 2005). The first dose is usually administered immediately prior to transplant or within the first hours postoperatively. Liver transplant (prophylaxis of acute rejection) (off-label use): IV: 20 mg on the day of transplant (day 0), followed by a second 20 mg dose on day 4 post-transplantation (in combination with other immunosuppressants) (Neuhaus 2002; Trunecka 2015). In clinical trials, the first dose was administered during the procedure once hemostasis was achieved or immediately post-transplant, or within 6 hours of organ reperfusion. Lung transplant (prophylaxis of acute rejection) (off-label use): IV: 20 mg prior to transplantation, followed by a second 20 mg dose 4 days after transplantation (in combination with other immunosuppressants) (Clinckart 2009; Swarup 2011). Additional trials may be necessary to further define the role of basiliximab in this condition.

(For additional information see "Basiliximab: Pediatric drug information") Note: Patients previously administered basiliximab should only be re-exposed to a subsequent course of therapy with extreme caution. Renal transplant (prophylaxis of acute rejection): IV: Children 10 mg within 2 hours prior to transplant surgery, followed by a second 10 mg dose 4 days after transplantation; the second dose should be withheld if complications occur (including severe hypersensitivity reactions or graft loss). Timing of basiliximab dosing may vary based on clinical and institutional factors; refer to institutional protocol for specific information. Children and Adolescents ≥35 kg: Refer to adult dosing

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling.

Warnings & Precautions

Source: Lexicomp

Anaphylactoid/hypersensitivity reactions

Severe hypersensitivity reactions, occurring within 24 hours, have been reported. Reactions, including anaphylaxis, have occurred both with the initial exposure and/or following re-exposure after several months; use caution during re-exposure to a subsequent course of therapy in a patient who has previously received basiliximab. Patients in whom concomitant immunosuppression was prematurely discontinued due to abandoned transplantation or early graft loss are at increased risk for developing a severe hypersensitivity reaction upon re-exposure. Discontinue permanently if a severe reaction occurs. Medications for the treatment of hypersensitivity reactions should be available for immediate use.

Diabetes

In renal transplant patients receiving basiliximab plus prednisone, cyclosporine, and mycophenolate, new-onset diabetes, glucose intolerance, and impaired fasting glucose were observed at rates significantly higher than observed in patients receiving prednisone, cyclosporine, and mycophenolate without basiliximab (Aasebo 2010).

Human antimurine antibodies (HAMA)

Treatment may result in the development of HAMA; however, limited evidence suggesting the use of muromonab-CD3 or other murine products is not precluded.

Lymphoproliferative disorders

The incidence of lymphoproliferative disorders may be increased by immunosuppressive therapy.

Opportunistic infections

The incidence of opportunistic infections may be increased by immunosuppressive therapy. Concurrent drug therapy issues:

Drug-drug interactions

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions:

Appropriate use

To be used as a component of an immunosuppressive regimen which includes cyclosporine and corticosteroids.

Experienced physician

Should be administered under the supervision of a physician experienced in immunosuppression therapy and organ transplant management.

Pregnancy & Lactation

Pregnancy

FDA category B

Adverse effects were not observed in animal reproduction studies. Basiliximab is a monoclonal IgG antibody which targets IL-2 receptors. IgG is known to cross the placenta; IL-2 receptors play an important role in the development of the immune system. Women of childbearing potential should use effective contraceptive measures before beginning treatment, during, and for 4 months after completion of basiliximab treatment. The National Transplantation Pregnancy Registry (NTPR) is a registry which follows pregnancies which occur in maternal transplant recipients or those fathered by male transplant recipients. The NTPR encourages reporting of pregnancies following solid organ transplant by contacting them at 877-955-6877 or NTPR@giftoflifeinstitute.org.

Lactation

It is not known if basiliximab is present in human milk. Because many immunoglobulins are secreted in milk and the potential for serious adverse reactions exists, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Monitoring

Clinical pearl	Monitor for signs and symptoms of acute rejection; hypersensitivity, infection

Biology & Pharmacokinetics

Pharmacokinetics

Half-life	Children 1 to 11 years: 9.5 ± 4.5 days; Adolescents 12 to 16 years: 9.1 ± 3.9 days; Adults: Mean: 7.2 ± 3.2 days

Drug–drug interactions (68, DDInter)

Interacting drug	Severity	Management
Adalimumab	major
Bacillus calmette-guerin substrain tice live antigen	major
Baricitinib	major
Certolizumab pegol	major
Cladribine	major
Etanercept	major
Fingolimod	major
Golimumab	major
Infliximab	major
Leflunomide	major
Measles virus vaccine live attenuated	major
Mumps virus strain B level jeryl lynn live antigen	major
Natalizumab	major
Ozanimod	major
Rotavirus vaccine	major
Rubella virus vaccine	major
Siponimod	major
Smallpox (Vaccinia) Vaccine, Live	major
Talimogene laherparepvec	major
Teriflunomide	major
Tofacitinib	major
Typhoid vaccine (live)	major
Upadacitinib	major
Varicella Zoster Vaccine (Recombinant)	major
Yellow Fever Vaccine	major
Alefacept	moderate
Alemtuzumab	moderate
Anakinra	moderate
Anthrax vaccine	moderate
Azathioprine	moderate
Bifidobacterium longum infantis	moderate
Canakinumab	moderate
Candida albicans	moderate
Clostridium tetani toxoid antigen (formaldehyde inactivated)	moderate
Coccidioides immitis spherule	moderate
Denosumab	moderate
Dimethyl fumarate	moderate
Diroximel fumarate	moderate
Efalizumab	moderate
Hepatitis A Vaccine	moderate

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Registered Products (1)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Simulect 20mg/vial Powder & Solvent for Solution for Injection or Infusion	Infusion 20 mg	1 vial	The Jordan Drugstore Co	—