Nitisinone

What it is used for

ORFADIN ® is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. ORFADIN is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

More about this medicine

Important Information You Need to Know Before Taking NITYR Using an Oral Syringe

• Prepare only 1 or 2 NITYR tablets in an oral syringe at one time.
• Each tablet is white to beige in color and can have yellow to brown tiny specks.
• Use a 5 mL oral syringe with a cap (see below) to prepare NITYR tablets in an oral syringe. Ask your pharmacist for your oral syringe. You may need more than one 5 mL oral syringe if you take more than 2 NITYR tablets for your prescribed dose.
• Use only room temperature water to prepare NITYR tablets in an oral syringe.
• Wash your hands well before preparing NITYR tablets using an oral syringe.
• Talk to your healthcare provider or pharmacist if you have questions about NITYR tablets or how to use the oral syringe. You can also contact CYCLE VITA by calling the United States (U.S.) toll free phone number 1-888-360-8482.

Before preparing NITYR using an oral syringe

Lay out the prescribed number of NITYR tablets and syringes for your dose. Place the tablet or tablets on a clean flat surface.

How to prepare and take 1 NITYR tablet using a 5 mL oral syringe:

Step 16. After use, remove the plunger from the syringe barrel. Rinse the syringe and the plunger with water after each use and let it dry. Do not replace the plunger into the barrel of the oral syringe until ready to use again to allow it to dry. Do not throw away the oral syringe or plunger.

If you are not taking the water and NITYR tablet suspension as soon as it is prepared, complete steps 1 through 5. When you are ready to take the suspension, complete steps 6 through 16.

How to prepare and take 2 NITYR tablets using a 5 mL oral syringe:

Step 16. After use, remove the plunger from the oral syringe barrel. Rinse the oral syringe with water after each use and let it dry. Do not replace the plunger into the barrel of the oral syringe until ready to use again to allow it to dry. Do not throw away the oral syringe.

If you are not taking the water and NITYR tablets suspension as soon as it is prepared, complete steps 1 through 5. When you are ready to take the suspension, complete steps 6 through 16.

How to prepare and take more than 2 NITYR tablets using an oral syringe:

If more than two NITYR tablets are needed for the prescribed dose follow the instructions for “ How to prepare and take 1 NITYR tablet using an oral syringe ” and “ How to prepare and take 2 NITYR tablets using an oral syringe ” until you get your prescribed dose. You should not add more than 2 tablets to one syringe at a time.

How to prepare and take NITYR tablets in applesauce:

• Wash your hands well before preparing NITYR tablets in applesauce.
• Crush only 1 NITYR tablet at a time.

Storing NITYR

• NITYR tablets do not need to be refrigerated.
• Store NITYR tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Store NITYR tablets in the container that it comes in and keep the container tightly closed.
• Keep NITYR tablets and NITYR that has been prepared in an oral syringe with water or in applesauce out of direct sunlight.

After adding water to the tablet in the oral syringe you can keep NITYR tablet suspension at room temperature for 24 hours. Store the suspension in the oral syringe with the cap on and out of direct sunlight until use. The suspension does not need to be refrigerated. Throw away any suspension that is not used within 24 hours after adding water to the tablets in the oral syringe. Empty the syringe in the drain and throw away (dispose of) the syringe by placing it in a trash can.

Take the NITYR tablet and applesauce mixture within 2 hours after adding the NITYR tablet powder to the applesauce. Store the NITYR tablet and applesauce mixture at room temperature and out of direct sunlight until use. The mixture does not need to be refrigerated. Throw away any mixture that is not used within 2 hours after mixing in a trash can.

Keep NITYR and all medicines out of the reach of children.

Manufactured by:

PCI Pharma Services 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent NP22 3AA, United Kingdom

Rivopharm SA Centro Insema 6928 Manno, Switzerland

Marketed by: Cycle Pharmaceuticals Ltd The Broers Building 21 JJ Thomson Ave Cambridge, CB3 0FA, United Kingdom

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

Revised: 1/2024