Belatacept-Nulojix -@- Genito-urinary product (June 2011)
Drug Name:Belatacept-Nulojix -@- Genito-urinary product (June 2011)
List Of Brands:
Indication Type Description:
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Indication:
NULOJIX (belatacept) For injection, for intravenous use
Initial U.S. Approval: 2011
WARNING:
POST-TRANSPLANT LYMPHOPROLIFERATIVE
DISORDER, OTHER MALIGNANCIES, AND SERIOUS
INFECTIONS
See full prescribing information for complete boxed warning.
Increased risk for developing post-transplant lymphoproliferativ
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 serostatus.
Only physicians experienced in immunosuppressive therapy and management
of kidney transplant patients should prescribe NULOJIX.
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.
Drug Name- Nulojix
Active Ingredient - Belatacept
To prevent acute rejection in adult patients who have had a kidney transplant
Indication-
To prevent acute rejection in adult patients who have had a kidney transplant
Approved by FDA on 15-6-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
Most common adverse reactions (20% on NULOJIX treatment) are anemia,
diarrhea, urinary tract infection, peripheral edema, constipation, hypertension,
pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia,
hyperkalemia, and leukopenia.
Contra-Indications:
CONTRAINDICATIONS
Patients who are EBV seronegative or with unknown EBV serostatus.
WARNINGS AND PRECAUTIONS
Post-Transplant Lymphoproliferative Disorder (PTLD): increased risk,
predominantly involving the CNS; monitor for new or worsening neurological,
cognitive, or behavioral signs and symptoms. (Boxed Warning )
Other malignancies: increased risk with all immunosuppressants; appears
related to intensity and duration of use.
Avoid prolonged exposure to UV light and sunlight.
Progressive Multifocal Leukoencephalopathy (PML): increased risk; consider
in the diagnosis of patients reporting new or worsening neurological, cognitive,
or behavioral signs and symptoms.
Recommended doses of immunosuppressants should not be exceeded.
Other serious infections: increased risk of bacterial, viral, fungal, and protozoal
infections, including opportunistic infections and tuberculosis. Some infections
were fatal.
Polyoma virus-associated nephropathy can lead to kidney graft loss;
consider reduction in immunosuppression. Evaluate for tuberculosis and
initiate treatment for latent infection prior to NULOJIX use.
Cytomegalovirus and pneumocystis prophylaxis are recommended
after transplantation.
Liver transplant: use is not recommended.
Acute Rejection and Graft Loss with Corticosteroid Minimization:
corticosteroid utilization should be consistent with the NULOJIX
clinical trial experience.
Immunizations: avoid use of live vaccines during treatment.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
NULOJIX is a selective T-cell costimulation blocker indicated for prophylaxis
of organ rejection in adult patients receiving a kidney transplant.
Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
Limitations of Use:
Use only in patients who are EBV seropositive.
Use has not been established for the prophylaxis of organ rejection in transplanted
organs other than the kidney.
DOSAGE AND ADMINISTRATION
Use of higher than recommended or more frequent dosing is not recommended
due to increased risk of serious infections and malignancy.
Dosing of NULOJIX for Kidney Transplant Recipients
Dosing for Initial Phase Dose
.
Day 1 (day of transplantation, prior to implantation) and 10 mg per kg
Day 5 (approximately 96 hours after Day 1 dose) importance of drug to mother.
End of Week 2 and Week 4 after transplantation 10 mg per kg
Dosing of NULOJIX for Kidney Transplant Recipients
Dosing for Maintenance Phase Dose
End of Week 16 after transplantation and every 4 weeks (plus or minus 3 days) thereafter
5 mg per kg
For intravenous infusion only; administer over 30 minutes.
Only use the enclosed silicone-free disposable syringe to prepare for administration.
DOSAGE FORMS AND STRENGTHS
Lyophilized powder for injection: 250 mg per vial
Patient Information:
PATIENT COUNSELING INFORMATION
Post-Transplant Lymphoproliferative Disorder
The overall risk of PTLD, especially CNS PTLD, was elevated in NULOJIX-treated
patients.
Instruct patients to immediately report any of the following neurological, cognitive,
or behavioral signs and symptoms during and after therapy with NULOJIX
1. changes in mood or usual behavior
2. confusion, problems thinking, loss of memory
3.changes in walking or talking
4.decreased strength or weakness on one side of the body
5.changes in vision
Pharmacology/ Pharmacokinetics:
1 Mechanism of Action
Belatacept, a selective T-cell (lymphocyte) costimulation blocker, binds to CD80
and CD86 on antigen-presenting cells thereby blocking CD28 mediated costimulation
of T lymphocytes. In vitro, belatacept inhibits T lymphocyte proliferation and
the production of the cytokines interleukin-2, interferon-ƒ×, interleukin-4,
and TNF-Ą. Activated T lymphocytes are the predominant mediators of immunologic
rejection
2. Pharmacokinetics
The pharmacokinetic parameters of belatacept in healthy adult subjects after a
single 10 mg per kg intravenous infusion; and in kidney transplant patients
after the 10 mg per kg intravenous infusion at Week 12, and after 5 mg per kg
intravenous infusion every 4 weeks at Month 12 post-transplant or later.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C
NULOJIX should not be used in pregnancy unless the potential benefit to the mother
outweighs the potential risk to the fetus. There are no studies of NULOJIX treatment
in pregnant women. Belatacept is known to cross the placenta of animals.
2. Nursing Mothers
It is not known whether belatacept is excreted in human milk or absorbed systemically
after ingestion by a nursing infant. However, belatacept is excreted in rat milk.
Because many drugs are excreted in human milk and because of the potential
for serious adverse reactions from NULOJIX in nursing infants, a decision should
be made whether to discontinue nursing or to discontinue the drug, taking
into account the importance of the drug to the mother.
3. Pediatric Use
The safety and efficacy of NULOJIX in patients under 18 years of age have not been
established. Because T cell development continues into the teenage years,
the potential concern for autoimmunity in neonates applies to pediatric
use as well
4. Geriatric Use
Of 401 patients treated with the recommended dosage regimen of NULOJIX, 15%
were 65 years of age and older, while 3% were 75 and older. No overall
differences in safety or effectiveness were observed between these subjects
and younger subjects, but greater sensitivity or less efficacy in older individuals
cannot be ruled out.
