nye-TIS-i-none
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Gastrointestinal Agent
Nitisinone is given along with a special diet to treat hereditary tyrosinemia, type 1. This disease is caused by too much tyrosine in the blood. It may cause damage to the liver, kidneys, eyes, skin, and nervous system. Treatment with nitisinone and diet may slow the disease, but it will not cure it.
nitisinone is available only with your or your child's doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nitisinone, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to nitisinone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
nitisinone has been tested in children and, in effective doses, has not been shown to cause specific problems.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of nitisinone in the elderly with use in other age groups.
Pregnancy Category | Explanation | |
---|---|---|
All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
To use:
The dose of nitisinone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of nitisinone. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of nitisinone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
While taking nitisinone,it is important that you or your child maintain a diet with restricted amounts of tyrosine and phenylalanine A nutritionist may be able to help you with the special diet needed to treat you. A nutritionist that has special training with children may help with a diet for your child.
Call your doctor right away for any redness, swelling, or burning of your or your child's eyes, an unusual rash, bleeding, or if your or your child's skin is yellow.
It is very important that the doctor check you or your child at regular visits to see how the medicine is working and increase the dose if needed. The doctor may test your your child's blood often.
A special examination of your or your child's eyes should be done before nitisinone is started.
Wearing sunglasses that block ultraviolet light is recommended. Nitisinone may cause sensitivity of the eyes to the sunlight.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More commonSome side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common or rareOther side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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