Nulojix

(belatacept)
belatacept 250 MG Injection [Nulojix]

Dosage & administration

Dosing of NULOJIX for Kidney Transplant Recipients (2.1)

Dosing for Initial Phase

Dose

   Day 1 (day of transplantation, prior to implantation) and Day 5 (approximately 96 hours after Day 1 dose)

10 mg per kg

   End of Week 2 and Week 4 after transplantation

10 mg per kg

   End of Week 8 and Week 12 after transplantation

10 mg per kg

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


drug label

Nulojix prescribing information

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prior authorization

Nulojix Prior authorization resources

Complete Letter of Medical Necessity

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Coverage Authorization Request
Coverage Authorization Appeals
Commercial Claim Denial Appeal/Redetermination Letter
Medically Unlikely Edit (MUE) Appeal Template Letter
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Benefits investigation

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Reimbursement help (FRM)

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financial assistance

Nulojix Financial assistance options

Co-pay savings program

commercial only
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Nulojix Enrollment Form - Spanish
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Bridge program

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Foundation programs

under insured
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goverment insurance
65+
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patient education

Nulojix Patient education

Getting started on Nulojix

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Instructions For Use: Kidney Transplant Organ Rejection Prophylaxis

Patient toolkit

About Nulojix
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Nulojix Pricing Information
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Patient Brochure
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Patient Brochure - Spanish
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people also ask

Nulojix FAQs

Is NULOJIX safe to use during pregnancy?The data with NULOJIX use in pregnant women are insufficient to inform on drug-associated risk. Belatacept is known to cross the placenta of animals. Administration of belatacept to pregnant rats and rabbits during the period of organogenesis was not teratogenic at exposures approximately 16 and 19 times greater than that observed at the maximum recommended human dose (MRHD) of 10 mg per kg body weight administered over the first month of treatment, based on area under the concentration-time curve (AUC). In a pre- and postnatal development study in rats, treatment-related infections in dams were associated with increased pup mortality, presumably secondary to deteriorating maternal health, at exposures 3 times higher than that observed at MRHD. The background risk of major birth defects and miscarriage for the indicated population is unknown. To monitor maternal-fetal outcomes of pregnant women who have received immunosuppressants including NULOJIX or whose partners have received NULOJIX, healthcare providers are strongly encouraged to register pregnant patients in the Transplant Pregnancy Registry International (TPR) by calling 1-877-955-6877.
Can breastfeeding mothers use NULOJIX?There are no data on the presence of NULOJIX in human milk or the effects of NULOJIX on breastfed infants or human milk production to inform risk of NULOJIX to an infant during lactation. Belatacept is excreted in rat milk after intravenous administration, and it is possible that the drug will be present in human milk. However, absorption of intact belatacept from the nursing infant’s gastrointestinal tract has not been studied. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NULOJIX and any potential adverse effects on the breastfed child from NULOJIX or from the underlying maternal conditions.
Is NULOJIX safe for use in pediatric patients?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.
Can NULOJIX be used in elderly patients?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.
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