Belatacept

Revision as of 17:27, 12 February 2015 by Kiran Singh (talk | contribs)
Jump to navigation Jump to search

Belatacept
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]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS
See full prescribing information for complete Boxed Warning.
* Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use NULOJIX in transplant recipients who are EBV seronegative or with unknown EBV serostatus.
  • Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see WARNINGS AND PRECAUTIONS (5.2)].
  • Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression.
  • Use in liver transplant patients is not recommended due to an increased risk of graft loss and death.

Overview

Belatacept is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Adult Kidney Transplant Recipients

  • NULOJIX® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. NULOJIX is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.

Limitations of Use

  • Use NULOJIX only in patients who are EBV seropositive.
  • Use of NULOJIX for the prophylaxis of organ rejection in transplanted organs other than kidney has not been established.

Dosage

Dosage in Adult Kidney Transplant Recipients

  • NULOJIX should be administered in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids. In clinical trials the median (25th-75th percentile) corticosteroid doses were tapered to approximately 15 mg (10-20 mg) per day by the first 6 weeks and remained at approximately 10 mg (5-10 mg) per day for the first 6 months post-transplant. Corticosteroid utilization should be consistent with the NULOJIX clinical trial experience.
  • Due to an increased risk of post-transplant lymphoproliferative disorder (PTLD) predominantly involving the central nervous system (CNS), progressive multifocal leukoencephalopathy (PML), and serious CNS infections, administration of higher than the recommended doses or more frequent dosing of NULOJIX is not recommended.
  • NULOJIX is for intravenous infusion only. Patients do not require premedication prior to administration of NULOJIX.
  • Dosing instructions are provided in Table 1.
  • The total infusion dose of NULOJIX should be based on the actual body weight of the patient at the time of transplantation, and should not be modified during the course of therapy, unless there is a change in body weight of greater than 10%.
  • The prescribed dose of NULOJIX must be evenly divisible by 12.5 mg in order for the dose to be prepared accurately using the reconstituted solution and the silicone-free disposable syringe provided. Evenly divisible increments are 0, 12.5, 25, 37.5, 50, 62.5, 75, 87.5, and 100. For example:
  • A patient weighs 64 kg. The dose is 10 mg per kg.
  • Calculated Dose: 64 kg × 10 mg per kg = 640 mg
  • The closest doses evenly divisible by 12.5 mg below and above 640 mg are 637.5 mg and 650 mg.
  • The nearest dose to 640 mg is 637.5 mg.
  • Therefore, the actual prescribed dose for the patient should be 637.5 mg.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Belatacept in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Belatacept Contraindications in the drug label.

Warnings

WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS
See full prescribing information for complete Boxed Warning.
* Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use NULOJIX in transplant recipients who are EBV seronegative or with unknown EBV serostatus.
  • Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see WARNINGS AND PRECAUTIONS (5.2)].
  • Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression.
  • Use in liver transplant patients is not recommended due to an increased risk of graft loss and death.

There is limited information regarding Belatacept Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Belatacept Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Belatacept in women who are pregnant.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Intravenous

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

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

Mechanism of Action

There is limited information regarding Belatacept Mechanism of Action in the drug label.

Structure

There is limited information regarding Belatacept Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

{{#ask: Page Name::Belatacept |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Belatacept |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

  • NULOJIX

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ "http://www.ismp.org". External link in |title= (help)

{{#subobject: 

 |Page Name=Belatacept
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject: 

 |Label Page=Belatacept
 |Label Name=Belatacept11.png

}}

{{#subobject: 

 |Label Page=Belatacept
 |Label Name=Belatacept11.png

}}

Retrieved from "https://www.wikidoc.org/index.php?title=Belatacept&oldid=1067145"