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Orfadin Capsule (Nitisinone): Uses, Side Effects and Dosage

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

Patient information: uses, side effects, how to take - Orfadin Capsule

Instructions for Use

ORFADIN (OR-fuh-din)

(nitisinone)

oral suspension

4 mg/mL

Read this Instructions for Use before you start taking ORFADIN oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Important information about measuring ORFADIN oral suspension:

  • Use the oral syringe provided with your ORFADIN oral suspension to make sure you measure the right amount.

  • You will be provided with:

    • 1 bottle of ORFADIN oral suspension
    • 1 oral syringe
    • 1 adapter (The adapter may or may not be inserted in your bottle of ORFADIN oral suspension when you receive it.)

Figure A

If the adapter is not inserted in your bottle of ORFADIN oral suspension when you receive it, follow the instructions in “How to prepare a bottle of ORFADIN oral suspension if the adapter is not inserted.”

If the adapter is inserted in your bottle of ORFADIN oral suspension when you receive it, follow the instructions in “How to prepare a dose of ORFADIN oral suspension after the adapter is inserted.”

How to prepare a bottle of ORFADIN oral suspension if the adapter is not inserted:

See “How should I store ORFADIN oral suspension?” for instructions on how to store ORFADIN oral suspension if the adapter is not inserted.

  • Remove the ORFADIN oral suspension bottle from the refrigerator 30 minutes to 1 hour before using it to allow it to reach room temperature.

    ORFADIN oral suspension should be thrown away (discarded) 60 days after it is removed from the refrigerator and the adapter is inserted in the bottle. Write the discard date on the bottle label.

  • Shake the bottle well for at least 20 seconds until the solid cake of particles at the bottom of the bottle is dissolved (See Figure B). Check that there are no particles left at the bottom of the bottle. Foam will form in the bottle.

Figure B

  • Remove the child resistant screw cap by pushing it down firmly and turning it counter-clockwise (See Figure C).

Figure C

  • Place the open bottle upright on a flat surface. Push the ribbed end of the adapter firmly into the neck of the bottle as far as it will go (See Figure D). Replace the child resistant screw cap on the bottle. Do not remove the adapter from the bottle after it is inserted.

Figure D

  • Follow the instructions in “How to prepare a dose of ORFADIN oral suspension after the adapter is inserted.”

How to prepare a dose of ORFADIN oral suspension after the adapter is inserted

See “How should I store ORFADIN oral suspension?” for instructions on how to store ORFADIN oral suspension after the adapter is inserted.

  • Shake the ORFADIN oral suspension bottle well for at least 5 seconds (See Figure E). Check that there are no particles left at the bottom of the bottle. Foam will form in the bottle.

Figure E

  • Remove the child resistant screw cap right away by pushing it down firmly and turning it counter-clockwise (See Figure F).

Figure F

  • Hold the oral syringe in one hand. With your other hand, fully push down (depress) the plunger (See Figure G).

Figure G

  • Keeping the bottle in an upright position, insert the oral syringe firmly into the adapter (See Figure H).

Figure H

  • Carefully turn the bottle upside down with the oral syringe in place (See Figure I). Wait until you can see that the foam is at the top of the bottle to avoid withdrawing bubbles into the syringe.

Figure I

  • Pull back slowly on the oral syringe plunger until the top edge of the black ring is at the line marking the dose prescribed by your healthcare provider (See Figure J). Figure J shows a dose of 1 mL as an example. If you see air bubbles in the oral syringe, fully push in the plunger so that the oral suspension flows back into the bottle. Then, withdraw your prescribed dose of oral suspension.

Figure J

  • Leave the oral syringe in the adapter and turn the bottle to an upright position. Place the bottle onto a flat surface. Remove the oral syringe by gently twisting it out of the bottle (See Figure K). Do not pull straight up on the syringe to remove it from the bottle because this can cause the adapter to come out of the bottle.

Figure K

  • Place the oral syringe in your mouth right away. Slowly push on the plunger until the oral syringe is empty. See Figure L).

Figure L

  • Leave the adapter in the bottle. Put the child resistant screw cap back on the bottle (See Figure M).

Figure M

  • Remove the plunger from the oral syringe barrel. Rinse the oral syringe with water after each use and let it air dry. Do not replace the plunger into the barrel of the oral syringe until ready to use again for your next dose to allow it to dry. Do not throw away the oral syringe.
  • Talk to your healthcare provider or pharmacist if you have questions about how to use the oral syringe or if you lose the oral syringe.

How should I store ORFADIN oral suspension?

  • Store the ORFADIN oral suspension bottle in an upright position. Keep the oral syringe with your medicine.

Before the adapter is inserted into the bottle:

  • If the adapter has not been inserted into the bottle, store ORFADIN oral suspension in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze ORFADIN oral suspension.

After the adapter is inserted into the bottle:

  • After the adapter has been inserted into the bottle, store ORFADIN oral suspension at room temperature, 77°F (25°C) or below.
  • Throw away (discard) ORFADIN oral suspension 60 days after the adapter is inserted in the bottle. You or your pharmacist should write the discard date on the bottle label.

What are the ingredients in ORFADIN oral suspension?

Active ingredient: nitisinone

Inactive ingredients: hydroxypropyl methylcellulose, glycerol, polysorbate 80, sodium benzoate, citric acid monohydrate, trisodium citrate dihydrate, strawberry aroma (artificial) and purified water

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

Manufactured by:

Apotek Produktion & Laboratorier AB, Sweden

Marketed by:

Sobi, Inc

890 Winter Street

Waltham, MA 02451

© Swedish Orphan Biovitrum AB (publ). All rights reserved.

Issued: April 2016

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 021232 · View the label on DailyMed

Revision date stated in the text: April 2016

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

Drug information for Orfadin Capsule

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Active ingredient Nitisinone
Dosage form Capsule
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) SWEDISH ORPHAN
FDA approval NDA 021232New Drug Application (NDA) Approved January 18, 2002
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Nitisinone with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
2 mg – 60 in 1 bottle, plastic / 1 in 1 carton
5 mg – 60 in 1 bottle, plastic / 1 in 1 carton
10 mg – 60 in 1 bottle, plastic / 1 in 1 carton
20 mg – 60 in 1 bottle, plastic / 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.