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Preparing and administering NULIBRY

NULIBRY is administered as a daily IV infusion, after reconstitution. It must be reconstituted with Sterile Water for Injection USP. Dosing is individualized based on the patient’s weight and may be administered at home by the child's caregiver if deemed appropriate by a healthcare provider. NULIBRY comes as a powder in vials that must stay frozen until ready to be used (between -13ºF and 14ºF/-25ºC and -10ºC); then it needs to be brought to room temperature (between 59ºF and 77ºF/15ºC and 25ºC) when reconstituted. Reconstituted NULIBRY may be stored at room temperature 59°F to 77°F (15°C to 25°C) or refrigerated 36°F to 46°F (2°C to 8°C) for up to 4 hours including infusion time. Do not shake the NULIBRY vial, do not expose it to heat, and do not freeze after reconstitution.1

NULIBRY is delivered by a specialty pharmacy. Because NULIBRY requires cold chain storage, a medical-grade freezer will either be provided by the child’s insurance company or loaned by ForgingBridges | NULIBRY Access and Support program for the entirety of the child’s time on therapy if not covered by their insurance.

Start NULIBRY if the patient has a diagnosis or presumptive diagnosis of MoCD Type A. Discontinue NULIBRY if the MoCD Type A diagnosis is not confirmed by genetic testing.

See table below for weight-based dosing of patients <1 year of age.

The Instructions for Use for NULIBRY can be downloaded and printed here.

Please see Important Safety Information below.

  • NULIBRY dosing is based on the weight of the child, so you may need to reconstitute more than 1 vial1
    Recommended initial dosage and titration schedule of NULIBRY for patients less than one year of age by gestational age
    Titration Schedule Preterm Neonates (Gestational Age <37 weeks) mg/kg once daily Term Neonates (Gestational Age ≥37 weeks) mg/kg once daily
    Initial Dosage 0.4 0.55
    Dosage at Month 1 0.7 0.75
    Dosage at Month 3 0.9 0.9
  • NULIBRY needs to be stored in the medical-grade freezer that will be provided. The vials of NULIBRY need to be kept in the original carton to protect them from light until ready for use
  • NULIBRY must be reconstituted before being administered and it can only be reconstituted with Sterile Water for Injection
  • Inject NULIBRY within 4 hours of reconstituting it. Discard all unused reconstituted NULIBRY 4 hours after reconstitution
  • NULIBRY should never be exposed to any heat source (eg, microwave or hot water)
  • Vials of NULIBRY are for 1-time use only. The vials should be thrown away after use, even if there is unused liquid left in the vial

The NULIBRY delivery comes with:

  • 28-day supply of 9.5-mg clear glass vials of NULIBRY powder
  • The full Prescribing Information and Instructions for Use for NULIBRY
  • A treatment log to keep track of your patient’s treatments. The caregiver should bring this to each appointment

Additional supplies needed to prepare and administer NULIBRY (please see Instructions for Use for NULIBRY for details):

  • 1 vial of Sterile Water for Injection for each vial of NULIBRY needed for 1 dose
  • 1 sterile 5 mL syringe for each vial of NULIBRY needed for 1 dose to mix (dissolve) NULIBRY with Sterile Water for Injection
  • 1 sterile syringe large enough to hold the total amount of NULIBRY needed for one dose
  • Sterile needles (18-gauge recommended)
  • Alcohol wipes
  • 1 sharps disposal container for throwing away used needles and syringes
  • Gloves, if you require the caregiver to wear them
  • 1 intravenous administration set with non-DEHP tubing and a 0.2 micron filter
  • 1 infusion pump used to give the dose of NULIBRY per your instructions
  • Other materials, if recommended by you for the caregiver to properly care for the child’s intravenous access line or port before and after giving a dose of NULIBRY

Please refer to Instructions For Use for detailed steps regarding the preparation and administration of NULIBRY.

Download the full list of preparation steps

Important things caregivers need to know when administering NULIBRY for IV infusion:

  • NULIBRY is injected through a special IV access catheter or port
  • NULIBRY must be at room temperature to be administered
  • Reconstituted NULIBRY should NOT be shaken and should NOT be exposed to heat
  • Instruct caregivers to call you right away with any concerns about side effects

How used supplies and equipment are disposed of is very important:

  • Make sure caregivers have been properly educated on how to dispose of used needles and syringes
  • They should put their used needles and syringes in an FDA-cleared sharps disposal container right away after use
  • If they do not have an FDA-cleared sharps disposal container, they may use a household container that is:
    • made of heavy-duty plastic
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
    • upright and stable during use
    • leak-resistant
    • properly labeled to warn of hazardous waste inside the container

Please have the caregiver refer to their Caregiver Welcome Pack for full details.

Enroll your patients in ForgingBridges | NULIBRY for assistance accessing NULIBRY.

Reference: 

  1. NULIBRY [prescribing information]. Boston, MA: Origin Biosciences, Inc.; February 2021.
ForgingBridges | NULIBRY
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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

NULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential for Photosensitivity

NULIBRY can make the patient oversensitive to sunlight. NULIBRY-treated patients or their caregivers are advised to avoid or minimize patient exposure to sunlight and artificial UV light and adopt precautionary measures when exposed to the sun, including wearing protective clothing and sunglasses, and use broad-spectrum sunscreen with high SPF in patients 6 months of age and older. If photosensitivity occurs, caregivers/patients are advised to seek medical attention immediately and consider a dermatological evaluation.

ADVERSE REACTIONS

The most common adverse reactions in NULIBRY-treated patients were infusion catheter–related complications (89%), pyrexia (fever) (78%), viral infection (56%), pneumonia (44%), otitis media (ear infection) (44%), vomiting (44%), and cough/sneezing (44%). Adverse reactions for rcPMP-treated patients were similar to the NULIBRY-treated patients.

PATIENT COUNSELING INFORMATION

Please read the FDA-approved NULIBRY Prescribing Information and Instructions for Use and follow the instructions on how to prepare and administer NULIBRY.

NULIBRY has a potential for photosensitivity; see Warnings and Precautions. Seek medical attention immediately if the patient develops a rash or if they notice symptoms of photosensitivity reactions (redness, burning sensation of the skin, blisters).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information for NULIBRY.