Medication-info.com Search Menu

Nulibry: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
9.5 mg
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Nulibry

INSTRUCTIONS FOR USE

NULIBRY ® [noo lye bree]

(fosdenopterin) for injection

for intravenous use

This Instructions for Use contains information on how to prepare and give NULIBRY.

Read this Instructions for Use before you mix and give a dose of NULIBRY for the first time and each time you get a NULIBRY refill. There may be new information. This information does not take the place of talking to your healthcare provider about your child's medical condition or their treatment.

Your healthcare provider should show you the right way to mix and give your child's prescribed dose of NULIBRY before you do this for the first time.

NULIBRY is given into your child's vein (intravenously), through a special access catheter or port placed by your healthcare provider. Always follow the specific instructions given by your healthcare provider.

  • If you have questions about preparing or giving NULIBRY, call Sentynl Cares | NULIBRY Patient Support Services at 1-888-251-2800.

Important information you need to know before preparing and giving NULIBRY:

  • Your child's dose of NULIBRY is based on their weight. Your healthcare provider will prescribe the amount of NULIBRY needed for each dose for your child. The amount of NULIBRY needed for each dose and the number of vials needed to prepare each dose may change at each visit with your healthcare provider. The dose will be measured as the amount (volume) of solution needed in milliliters (mL).

  • Keep a treatment log sheet and write down the:

    • number of vials used to prepare each dose
    • date of each dose of NULIBRY
    • lot number from each NULIBRY vial used
    • total amount (volume) of NULIBRY that was given
    • start time of the dose and the time that the dose was finished

    Be sure to keep this information up-to-date when the dose changes. Bring your treatment log sheets to each follow-up visit with your healthcare provider. Be sure to have your healthcare provider or pharmacist fill in the following information on your treatment log sheet:

    • your child's dose of NULIBRY in milliliters (mL)
    • number of vials needed to prepare each dose

  • NULIBRY comes as a powder or cake in a vial. Each vial of NULIBRY must be mixed with Sterile Water for Injection to mix (dissolve) the powder or cake before use.

    Do not mix NULIBRY with anything other than Sterile Water for Injection.

NULIBRY must be given within 4 hours of mixing. You may keep the mixed solution of NULIBRY at room temperature or refrigerated, for up to 4 hours, until you are ready to give the dose. If you do not give the prepared dose of NULIBRY within 4 hours, all mixed medicine must be thrown away. See “How should I store NULIBRY?” below.

  • Do not put NULIBRY back in the freezer after it has been mixed. Do not shake NULIBRY after it has been mixed.
  • If your child misses a dose of NULIBRY, give the dose as soon as possible. Give the next scheduled dose at least 6 hours after you finish giving the missed dose.
  • Avoid exposing NULIBRY to any heat source, such as a microwave or hot water.
  • Do not share needles and syringes. See the section “ How should I throw away (dispose of) used needles and syringes?”

How should I store NULIBRY?

Frozen vials:

  • Store NULIBRY in the freezer between −13°F to 14°F (−25°C to −10°C).
  • Keep NULIBRY vials in the original carton to protect from light until you are ready to use it.

Vials of NULIBRY after mixing:

  • Store vials of NULIBRY that have been mixed at room temperature 59°F to 77°F (15°C to 25°C) or in the refrigerator at 36°F to 46 °F (2°C to 8°C), until you are ready to give the dose.

Vials of NULIBRY are for 1 time use only. Throw the vial away after use, even if there is medicine left in the vial. Do not save for later use. Used vials may be thrown away in your household trash.

Preparing to give NULIBRY

Step 1: Gather Supplies

  • Use a clean, flat work surface.
  • Remove from the freezer the NULIBRY vials needed to prepare your child's prescribed dose. You may need more than 1 vial to prepare the total amount needed for 1 dose. Allow the NULIBRY vials to reach room temperature. This can be done by rolling each vial gently between your hands for 3 to 5 minutes as shown, or by allowing the vials to sit at room temperature for about 30 minutes.

  • Gather supplies needed to prepare and administer a dose of NULIBRY:

    • 1 vial of Sterile Water for Injection for each vial of NULIBRY needed for 1 dose.

      • Check the expiration date on the vial. Do not use the vial if the expiration date has passed.
      • Do not use the vial if the flip-off seal on the vial is broken or missing.
    • 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. Your healthcare provider should tell you what size and type of syringe to use.
    • sterile needles (18-gauge recommended)
    • alcohol wipes
    • 1 sharps disposal container for throwing away used needles and syringes. See “ How should I throw away (dispose of) used needles, and syringes? ”
    • gloves, if your healthcare provider instructs you to wear gloves when preparing and giving NULIBRY
    • 1 intravenous administration set with non-DEHP tubing and a 0.2 micron filter
    • 1 infusion pump used to give the dose of NULIBRY as instructed by your healthcare provider
    • other materials, if recommended by your healthcare provider to properly care for your child's intravenous access line or port before and after giving a dose of NULIBRY

Step 2: Wash your hands

  • Wash your hands well with soap and water. Use a clean towel to dry your hands or allow them to air dry.
  • If you have been told to wear gloves to prepare and give NULIBRY, put them on now.

Step 3: Prepare the vials

  • Remove the flip-off cap from each vial of Sterile Water for Injection needed to prepare 1 dose.
  • Clean the rubber stopper of each vial with an alcohol wipe and allow to air dry. Do not blow on the stopper to dry it faster.

Note: If you touch the vial stopper, you will need to clean it again with an alcohol wipe.

Step 4: Prepare the syringe used for drawing up Sterile Water for Injection

  • Open the wrapper that contains 1 needle. Do not remove the needle cover yet.
  • Open the wrapper that contains a 5 mL syringe. Attach the needle to the syringe tip with a screw action in the direction of the arrow as shown. Your needle and syringe may look different than shown.

Step 5: Fill syringe with sterile water for injection

  • Remove the needle cover by pulling the cover straight off. Do not touch the needle or let the needle touch any surface.
  • Hold the syringe with one hand. Use your other hand to pull back the plunger of the syringe until the top of the plunger reaches the 5 mL line on the syringe.
  • Hold the vial of Sterile Water for Injection firmly on your work surface and insert the needle into the center of the vial stopper.
  • Slowly turn the vial upside down. Check that the tip of the needle is not in the solution. Then, push up on the plunger to push all of the air from the syringe into the vial.
  • Next, move the needle so that the tip is in the solution. Slowly pull down on the plunger of the syringe to fill the syringe with 5 mL of Sterile Water for Injection.
  • Tap the syringe with your fingers until any air bubbles rise to the top of the syringe then gently push up on the plunger to push the air out of the syringe.
  • After removing the air bubbles, check the syringe to be sure that 5 mL of solution is in the syringe before removing the needle from the vial.

Step 6: Mix (dissolve) NULIBRY

  • Remove the flip-off cap from the vial of NULIBRY.
  • Wipe the rubber stopper on the vial of NULIBRY with a new alcohol wipe.
  • Hold the NULIBRY vial firmly on your work surface. Take the syringe with the Sterile Water for Injection and slowly insert the needle into the center of the vial stopper.

  • Slowly push down on the plunger all the way to push the Sterile Water for Injection into the vial. Then carefully remove the needle from the vial. Throw away (dispose of) the used needle and syringe in your sharps disposal container right away. Do not try to recap the needle.

    See the section “How should I throw away (dispose of) used needles and syringes?”

  • Gently swirl the vial continuously until the powder is completely dissolved. Do not shake the vial.
  • Repeat steps 4 through 6 if more than 1 vial of NULIBRY is needed to prepare your child's prescribed NULIBRY dose. Use a new 5 mL syringe and new needle for each vial of NULIBRY.

Note: When mixed, the NULIBRY solution should be clear, and colorless to pale yellow.

  • Do not use the solution if it is discolored or cloudy, or if there are any particles in it. If the solution is discolored or cloudy or there are particles in it:

    • Do not throw the vial away because the pharmacist may ask that you return it.
    • tell your pharmacist and ask for a replacement vial.

Step 7: Prepare a syringe with the prescribed dose of NULIBRY

  • If you stored the mixed NULIBRY solution in the refrigerator, remove the vials of mixed NULIBRY solution from the refrigerator and allow them to reach room temperature. This can be done by rolling each vial gently between your hands for 3 to 5 minutes as shown, or by allowing the vials to sit at room temperature for about 30 minutes.
  • Open the wrapper that contains a new sterile needle. Do not remove the needle cover yet.
  • Open the wrapper that contains a sterile disposable syringe that is large enough to hold the total volume of NULIBRY needed for one dose. Attach the needle to the syringe tip with a screw action. Do not remove the needle cover yet.
  • Wipe the vial stopper of each mixed NULIBRY vial with a new alcohol wipe.
  • Remove the needle cover by pulling the cover straight off. Do not touch the needle or let the needle touch any surface.
  • Hold the syringe with one hand. Insert the needle into the center of the NULIBRY vial stopper then slowly turn the vial upside down.
  • Next, move the needle so that the tip is in the NULIBRY solution. Slowly pull back on the syringe plunger to fill the syringe with the amount of NULIBRY solution in mL for your child's prescribed dose.
  • Remove any air bubbles from the syringe. Tap on the syringe barrel so that any bubbles rise to the top of the vial. Push up on the plunger to push any air bubbles back into the vial. Check to make sure that the correct amount of NULIBRY solution has been drawn into the syringe. If needed, pull down slightly on the plunger until the prescribed amount of NULIBRY solution is in the syringe.

Follow the steps below if more than 1 vial of NULIBRY is needed to make up the total amount of solution needed for 1 daily dose.

  • Remove the needle and syringe from the first vial of NULIBRY. Hold the syringe with one hand. Insert the needle into the center of the next NULIBRY vial stopper then slowly turn the vial upside down.
  • Next, move the needle so that the tip is in the NULIBRY solution. Slowly pull back on the syringe plunger to fill the syringe with the amount of NULIBRY solution in mL for your child's prescribed dose.
  • Remove any air bubbles from the syringe. Tap on the syringe barrel so that any bubbles rise to the top of the vial. Push up on the plunger to push any air bubbles back into the vial. Then check to be sure that the prescribed amount of NULIBRY solution has been drawn into the syringe. If needed, pull down slightly on the plunger until the total prescribed amount of NULIBRY solution is in the syringe.
  • Repeat this step if additional vials of NULIBRY are needed to make up your child's dose.
  • When the needle is removed from the last vial of NULIBRY, all of the mixed dose of NULIBRY is in 1 syringe.
  • Replace the needle cover before removing the needle from the syringe by placing the cover on a flat surface and sliding the needle into the cover as shown. With one hand, hold the syringe and use the needle to “scoop up” the cover. Once the cover is on the needle, use the other hand to secure the cover on the needle hub.
  • Remove the covered needle from the syringe tip with a screw action in the direction of the arrow as shown.
  • Do not touch the tip of the syringe after removing the needle.
  • Throw away (dispose of) the needle in the sharps disposal container right away. See “How should I throw away (dispose of) used needles and syringes?”
  • Throw away the used NULIBRY vial(s) after use, even if there is medicine left in the vial.
  • The dose of NULIBRY is now ready to be given to your child.

Step 8: Giving a dose of NULIBRY

  • NULIBRY is given into your child's vein (intravenously) through a special access catheter or port placed by your healthcare provider.
  • When NULIBRY is given through an infusion pump, infuse NULIBRY at a rate of 1.5 mL per minute.
  • If the amount (volume) in mL for your child's prescribed dose of NULIBRY is less than 2 mL, your healthcare provider may tell you to give NULIBRY by a slow intravenous push using a syringe. Follow your healthcare provider's instructions for how to give your child's dose of NULIBRY by slow intravenous push over 1 to 2 minutes.
  • Follow your healthcare provider's instructions for proper care of your child's intravenous access catheter or port before and after giving a dose of NULIBRY.

Step 9: Record the Infusion

After giving each dose of NULIBRY, record information about the dose in the treatment log sheet. See the section of this Instructions for Use called “ Important information you need to know before preparing and giving NULIBRY.”

How should I throw away (dispose of) used needles and syringes?

Put your used needles and syringes in an FDA-cleared sharps disposal container right away after use.

  • If you do not have an FDA-cleared sharps disposal container, you 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, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
  • Keep the sharps disposal container out of the reach of children.

What should I avoid during treatment with NULIBRY?

NULIBRY may cause skin reactions.

  • Limit or avoid your child's exposure or time in sunlight and artificial ultraviolet (UV) light, such as UVA or UVB phototherapy.
  • Your child should wear clothing, a hat, and sunglasses that protect against sun exposure.
  • If your child is 6 months of age or older apply a broad spectrum sunscreen with high sun protection factor.

Get medical help right away if your child develops a rash, or if you notice symptoms of a skin reaction, including: skin redness, blisters, or if your child feels like their skin is burning.

What are the ingredients in NULIBRY?

Active ingredient: fosdenopterin

Inactive ingredients: ascorbic acid, mannitol, sucrose. Sodium hydroxide and hydrochloric acid are used to adjust the pH.

For more information, call 1-888-507-5206 or go to www.NULIBRY.com.

Manufactured by:

Alcami Carolinas Corporation

Charleston, SC 29405

Distributed by:

Sentynl Therapeutics, Inc.

Solana Beach, CA 92075

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 5/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 214018 · View the label on DailyMed

Revision date stated in the text: May 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Nulibry

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Cyclic Pyranopterin Monophosphate
Active ingredient Fosdenopterin hydrobromide 9.5 mg
Dosage form Injection, powder, lyophilized, for solution
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) SENTYNL THERAPS INC
FDA approval NDA 214018New Drug Application (NDA) Approved February 26, 2021
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
9.5 mg – 1 in 1 vial, single-dose / 1 in 1 carton

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.