Basiliximab

Basiliximab
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

WARNING: See full prescribing information for complete Boxed Warning. WARNING: Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect® (basiliximab). The physician responsible for Simulectadministration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.

Overview

Basiliximab is a monoclonal antibody that is FDA approved for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Abdominal pain, Vomiting,.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids.

     The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.

Dosage

Simulect® (basiliximab) is used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids. Simulect is for central or peripheral intravenous administration only. Reconstituted Simulect should be given either as a bolus injection or diluted to a volume of 25 mL (10-mg vial) or 50 mL (20-mg vial) with normal saline or dextrose 5% and administered as an intravenous infusion over 20 to 30 minutes. Bolus administration may be associated with nausea, vomiting and local reactions, including pain.

     Simulect should only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression. Patients previously administered Simulect should only be re-exposed to a subsequent course of therapy with extreme caution due to the potential risk of hypersensitivity (see WARNINGS).

     Parenteral drug products should be inspected visually for particulate matter and discoloration before administration. After reconstitution, Simulect should be a clear-to-opalescent, colorless solution. If particulate matter is present or the solution is colored, do not use.      

     Care must be taken to assure sterility of the prepared solution because the drug product does not contain any antimicrobial preservatives or bacteriostatic agents.

     It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored at 2ºC to 8ºC for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours.

     No incompatibility between Simulect and polyvinyl chloride bags or infusion sets has been observed. No data are available on the compatibility of Simulect with other intravenous substances. Other drug substances should not be added or infused simultaneously through the same intravenous line.

Adults In adult patients, the recommended regimen is two doses of 20 mg each. The first 20-mg dose should be given within 2 hours prior to transplantation surgery. The recommended second 20-mg dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Simulect or graft loss occur.

Reconstitution of 10 mg Simulect® Vial To prepare the reconstituted solution, add 2.5 mL of Sterile Water for Injection, USP, using aseptic technique, to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder.

     The reconstituted solution is isotonic and may be given either as a bolus injection or diluted to a volume of 25 mL with normal saline or dextrose 5% for infusion. When mixing the solution, gently invert the bag in order to avoid foaming; DO NOT SHAKE.

Reconstitution of 20 mg Simulect® Vial To prepare the reconstituted solution, add 5 mL of Sterile Water for Injection, USP, using aseptic technique, to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder.

     The reconstituted solution is isotonic and may be given either as a bolus injection or diluted to a volume of 50 mL with normal saline or dextrose 5% for infusion. When mixing the solution, gently invert the bag in order to avoid foaming; DO NOT SHAKE.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Basiliximab in adult patients.

Non–Guideline-Supported Use

• Graft versus host disease
• Liver transplant rejection; Prophylaxis

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Pediatric dosage

• In pediatric patients weighing less than 35 kg, the recommended regimen is two doses of 10 mg each. In pediatric patients weighing 35 kg or more, the recommended regimen is two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. The recommended second dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Simulect or graft loss occur.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Basiliximab in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Basiliximab in pediatric patients.

Contraindications

• Condition1

Warnings

WARNING: See full prescribing information for complete Boxed Warning. WARNING: Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect® (basiliximab). The physician responsible for Simulectadministration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Basiliximab in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Basiliximab in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Basiliximab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Basiliximab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Basiliximab with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Basiliximab with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Basiliximab with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Basiliximab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Basiliximab with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Basiliximab in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Basiliximab in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Basiliximab in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Basiliximab in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Basiliximab in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Basiliximab in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Basiliximab in the drug label.

Pharmacology

There is limited information regarding Basiliximab Pharmacology in the drug label.

Mechanism of Action

Structure

File:Basiliximab01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Basiliximab in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Basiliximab in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Basiliximab in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Basiliximab in the drug label.

How Supplied

Storage

There is limited information regarding Basiliximab Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Basiliximab in the drug label.

Precautions with Alcohol

• Alcohol-Basiliximab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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