Health Guide
Drug Guide

Nitisinone (Oral route)

Pronunciation:

nye-TIS-i-none

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Gastrointestinal Agent

Uses of This Medicine:

Nitisinone is used to treat hereditary tyrosinemia type 1, which is too much tyrosine in the blood. It helps to prevent high levels of tyrosine in the blood. Treatment with nitisinone and diet changes may slow the progression of the disease, but will not cure it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nitisinone in children.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitisinone in the elderly.

Breast-feeding

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.

Other medicines

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Other interactions

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.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Carefully follow your doctor's instructions about a special diet.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the capsule:

To use the suspension:

Dosing

The dose of this medicine 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 this medicine. 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.

Missed dose

If you miss a dose of this medicine, 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.

Storage

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.

Store in the refrigerator. Do not freeze.

Once opened, you may store the bottle at room temperature for up to 60 days. Throw away any unused medicine after 60 days.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if blurred vision, difficulty seeing at night, or any other vision change occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Nitisinone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. Avoid people with infections and check with your doctor if you have symptoms of an infection such as a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination. Call your doctor if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

The oral suspension contains glycerol and may cause diarrhea, an upset stomach, or headaches. Let your doctor know if you have these symptoms.

Side Effects of This Medicine:

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:

Less common
Black, tarry stools
bleeding gums
blindness
blood in the urine or stools
bloody nose
blurred vision
burning, dry, or itching eyes
change in color vision
chest pain or discomfort
chills
cough
decreased vision
difficulty seeing at night
excessive eye tearing
eye redness, irritation, or pain
fever
increased sensitivity of the eyes to sunlight
painful or difficult urination
pinpoint red spots on the skin
redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
sore throat
sores, ulcers, or white spots on the lips or in the mouth
swollen or painful glands
unusual bleeding or bruising
unusual tiredness or weakness
Rare
Agitation
back pain
bluish color of the fingernails, lips, skin, palms, or nail beds
confusion
cough with mucus
difficulty breathing
dizziness
drowsiness
hallucinations
headache
irritability
seizures
stiff neck
tightness in the chest
vomiting

Some 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
Dry skin
hair loss or thinning
itching or skin rash
red, swollen skin
scaly skin
Rare
Abdominal pain
cold sweats
cool, pale skin
depression
fast heartbeat
headache
increased hunger
nausea
nightmares
seizures
shakiness
slurred speech

Other 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.


Last Updated: 10/12/2016

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