Taking NITYR® (nitisinone) Tablets

NITYR is one tablet for all life stages

A Hereditary Tyrosinemia Type 1 (HT-1) diagnosis can be challenging for patients and caregivers alike. NITYR adapts to each patient’s changing needs when they are ready, without having to change their prescription.

NITYR is designed to liberate your patients from medication restrictions, putting their needs first, both now and in the future.

Close Up Of Father Holding Newborn Baby Son In Nursery

Infants and preschool children

NITYR allows children the chance to be treated right from the start

Little boys playing in a lake in spring

Elementary school children

NITYR allows you the possibilities to adapt to each patient’s changing needs and navigate through life’s transitions

Group of students studying outside on campus

Teenagers and adults

NITYR helps teenagers properly self-manage as they become more independent, and adults embrace the opportunities and possibilities that life brings them

Ways to Take NITYR

NITYR (nitisinone) Tablets for Oral Suspension

With NITYR, caregivers can create a suspension whenever and wherever they want by dissolving a tablet in an oral syringe:

  • Quick preparation. Can be made as needed, with less than one minute of active preparation and administration time.
  • Greater flexibility with on-the-go preparation. Does not need refrigerating and can be administered up to 24 hours after preparation.
  • Accurate dosing each and every time. Patients receive the prescribed treatment without the risk of under or overdosing.
  • Unlike pre-made liquid suspensions, there is no cake or foam build-up.

NITYR (nitisinone) Tablets with Applesauce

As your child grows and moves onto semi-solids, NITYR tablets can be crushed and mixed with applesauce.

  • NITYR tablets do not need to be refrigerated.
  • Flexibility around mealtimes as the mixture can be taken within 2 hours of it being made.

NITYR (nitisinone) Tablets

NITYR tablets are very small and discreet2 and are available in 2 mg, 5 mg, and 10 mg strengths. They can be crushed and mixed with applesauce or taken on their own.

Many children prefer baby aspirin-sized tablets over solutions and suspensions3, and NITYR may also help minimize the natural challenges that come with the teenage years.

  • Convenience of once daily dosing for qualified patients to reduce the impact on their busy schedule.*
  • With NITYR there’s one less thing for your patients and caregivers to worry about as the medication doesn’t require refrigeration.
  • Flexibility for your patients to spend more time socializing and advancing their education and career without the burden of “take with food” restrictions.
  • Discretion when taking their medication around their friends due to the very small size of NITYR tablets.2
  • 80% of adults prefer to take multiple smaller pills than a single large one.4

Instructions for Use

  1. Use the reusable syringe provided. Remove the plunger, add one NITYR tablet and replace the plunger.
  2. Draw up 2.6 mL of room temperature water.
  3. Put the cap back on. If you are using the 2 mg tablet(s), let the syringe sit for at least 15 minutes. If you are using the 5 mg or 10 mg tablet(s), let the syringe sit for at least 60 minutes.
  4. Once you are ready to administer (you can administer up to 24 hours after adding water to the tablet), turn the oral syringe up and down for at least 30 seconds and check that no large lumps of tablet remain. If there are large lumps, let the syringe sit for a further 10 minutes, and then reinspect the syringe for any large lumps. Once no large lumps of tablet remain, turn the oral syringe up and down for at least 30 seconds before administering the medication.
  5. Take the cap off, place the syringe in the child’s mouth, and push down on the plunger until a small amount of air remains in the syringe. Do not press the plunger all the way to the end.
  6. Rinse the syringe by drawing up another 2 mL of water. Replace the cap and shake the syringe well.
  7. Take the cap off, place the syringe in the child’s mouth and push down on the plunger until it is completely empty.

Step 1

Use the reusable syringe provided. Remove the plunger, add one NITYR tablet and replace the plunger

Step 2

Draw up 2.6 mL of room temperature water

Step 3

Put the cap back on and let the syringe sit for at least 60 minutes

Step 4

Once you are ready to administer (you can administer up to 24 hours after adding water to the tablet), turn the oral syringe up and down for at least 30 seconds and check that no large lumps of tablet remain. If there are large lumps, let the syringe sit for a further 10 minutes, and then reinspect the syringe for any large lumps. Once no large lumps of tablet remain, turn the oral syringe up and down for at least 30 seconds before administering the medication

Step 5

Take the cap off, place the syringe in the child’s mouth, and push down on the plunger until a small amount of air remains in the syringe. Do not press the plunger all the way to the end

Step 6

Rinse the syringe by drawing up another 2 mL of water. Replace the cap and shake the syringe well

Step 7

Take the cap off, place the syringe in the child’s mouth, and push down on the plunger until a small amount of air remains in the syringe. Do not press the plunger all the way to the end

"It is so simple. The water does the job."

Sana: Mom of Alina
(NITYR patient, 1 year old)

For more information see the Full Instructions for Use.

Follow the same instructions for How to Give One NITYR Tablet Using an Oral Syringe, except:

  • In step 1, remove the plunger from the syringe and insert two tablets, then replace the plunger and
  • In step 2, draw up 5 mL of water at room temperature.

Step 1

Remove the plunger from the syringe and insert two tablets, then replace the plunger

Step 2

Draw up 5 mL of room temperature water
Information Icon
Note: More than two tablets should NOT be prepared in the same syringe.

If your healthcare provider advises you to give three tablets, follow the instructions to prepare one syringe with one tablet and another syringe with two tablets. The same instructions apply to more than three tablets.

For more information see the Full Instructions for Use.

  1. Crush one NITYR tablet at a time by placing it between two teaspoons and pushing down lightly on the top spoon. Press, rotate, and look at the tablet. If large particles are still there, repeat until finely crushed.
  2. Add all the crushed tablet powder to one full teaspoon of applesauce in a clean glass or bowl.
  3. If giving more than one tablet, repeat the process above, adding the powder to the same applesauce.
  4. Mix well.
  5. Feed the mixture to your child using a teaspoon.
  6. To make sure you give your child all the medicine, add another full teaspoon of applesauce to the same glass or bowl and stir. Again, feed the mixture to your child.
  7. Use the NITYR-applesauce mixture within two hours of preparation.

Step 1

Crush one NITYR tablet at a time by placing it between two teaspoons and pushing down lightly on the top spoon. Press, rotate, and look at the tablet. If large particles are still there, repeat until finely crushed

Step 2

Add all the crushed tablet powder to one full teaspoon of applesauce in a clean glass or bowl

Step 3

If giving more than one tablet, repeat the process above, adding the powder to the same applesauce

Step 4

Mix well

Step 5

Feed the mixture to your child using a teaspoon

Step 6

Use the NITYR-applesauce mixture within two hours of preparation

Tablet crushers are available via Cycle Vita™. For more information, please call the team on 1-888-360-848.

Administration of NITYR with other liquids or foods has not been studied and is not recommended.

For more information see the Full Instructions for Use.

Starter Kits

These kits are designed for new patients and contain all the items needed to kick-start a successful journey with their new treatment.

You can order some kits to have at the clinic for when a new patient with HT-1 is prescribed NITYR. Please send us an email to hello@cyclevita.life and our patient support hub, Cycle Vita™, will deliver them to you.

NITYR Newborn Patient Support Kit Box

Newborn Kit

Some of the items in the Newborn kit:

  • Oral syringe and spoon for infant administration
  • Tablet crusher
  • A travel bag
  • Educational material
NITYR Starter Kit Box

Kit for patients 6 months old and older

Some of the items in the 6 months old and older kit:

  • Pill box
  • Food digital scale
  • Travel bag
  • Body weight digital scale
  • Educational material

* For patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone.

References

1. Data on file: REF-00005
2. Data on file: REF-00041
3. van Riet-Nales DA, Schobben AF, Vromans H, Egberts TC, Rademaker CM. Safe and effective pharmacotherapy in infants and preschool children: importance of formulation aspects. Arch Dis Child. 2016 Jul;101(7):662–9. doi: 10.1136/archdischild-2015-308227
4. Fields J, Go JT, Schulze KS. Pill properties that cause dysphagia and treatment failure. Cur Ther Res. 2015;77:79–82