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Nitisinone capsules

What are nitisinone capsules?

NITISINONE (Orfadin®) is used to treat a rare disease called hereditary tyrosinemia type I (HT-1). Nitisinone helps to prevent or slow the development of some of the serious outcomes of this disease. Nitisinone must be used in combination with certain diet restrictions. Generic nitisinone capsules are not available; however, financial assistance is available for qualifying families in the US (call 1?800?999?NORD).

What should my health care professional know before I take nitisinone?

They need to know if you have any of these conditions:

  • pregnant or planning to become pregnant

  • breast-feeding

  • an unusual or allergic reaction to nitisinone, other medicines, foods, dyes, or preservatives

How should I use this medicine?

Nitisinone capsules are taken by mouth in the morning and evenings. Follow the directions on the prescription label. Swallow the capsules with a drink of water. For young children, the capsules may be opened and the contents mixed in a small amount of water, formula, or apple sauce immediately before use. Give the doses at regular intervals. Do not give the medicine more often than directed. Do not stop giving the capsules except on your prescriber's advice.

What if I miss a dose?

If you miss a dose, take it as soon as you can. Do not take double or extra doses without advice.

What drug(s) may interact with nitisinone?

No drug-drug interactions have been reported with nitisinone.

Tell your prescriber or other health care professional about all other medicines you are taking including non-prescription medicines, nutritional supplements, or herbal products. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medications.

What should I watch for while taking nitisinone?

Visit your prescriber or health care professional for regular checks on your progress. During nitisinone treatment your prescriber will monitor certain blood and urine tests to make sure your treatment is appropriate.

During nitisinone treatment, it is important to restrict dietary intake of foods or drinks containing tyrosine or phenylalanine. That usually means you need to eat a low protein diet. Foods that contain significant amounts of tyrosine include many protein-sources, such as aged cheeses; meats and fish; protein extracts. Products containing phenylalanine include any product containing the sweetener aspartame (Nutrasweet®). Ask your prescriber or health care professional, pharmacist, or nutritionist for a complete listing of tyrosine- or pheylalanine-containing foods.

What side effects may I notice from receiving nitisinone?

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • dark colored urine

  • eye symptoms such as eye pain, irritation, sensitivity to light, or inflammation

  • signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

  • skin rash

  • yellowing of skin or eyes

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

  • dry skin

  • hair loss

Where can I keep my medicine?

Keep out of reach of children.

Nitisinone capsules should be stored in the refrigerator at 2?8 degrees C (36?46 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.


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