Generic name: Nitisinone Capsules [ ni-TIS-i-known ]
Drug class: Miscellaneous metabolic agents
Medically reviewed by Drugs.com. Last updated on Feb 5, 2023.
Uses of Orfadin:
- It is used to treat hereditary tyrosinemia type 1 (HT-1).
What do I need to tell my doctor BEFORE I take Orfadin?
- If you have an allergy to nitisinone or any other part of Orfadin (nitisinone capsules).
- If you are allergic to Orfadin (nitisinone capsules); any part of Orfadin (nitisinone capsules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Orfadin (nitisinone capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Orfadin?
- Tell all of your health care providers that you take Orfadin (nitisinone capsules). This includes your doctors, nurses, pharmacists, and dentists.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Have your urine checked as you have been told by your doctor.
- Have an eye exam as you have been told by your doctor.
- Nitisinone must be used with a special diet that is low in tyrosine and phenylalanine.
- Follow the diet plan that your doctor told you about.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
How is this medicine (Orfadin) best taken?
Use Orfadin (nitisinone capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take on an empty stomach. Take 1 hour before or 2 hours after meals.
- Keep taking Orfadin (nitisinone capsules) as you have been told by your doctor or other health care provider, even if you feel well.
- Capsules may be opened and contents mixed with a small amount of water, formula, or applesauce.
- If mixed, swallow the mixed drug right away. Do not store for use at a later time.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Change in skin on hands or feet.
- Change in eyesight, eye pain, or very bad eye irritation.
- Eye is bothered by bright light.
- Feeling confused.
- Fever, chills, or sore throat.
- Any unexplained bruising or bleeding.
What are some other side effects of Orfadin?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Orfadin?
- Store in a refrigerator. Do not freeze.
- If needed, you may store at room temperature for up to 45 days. If stored at room temperature and not used within 45 days, throw Orfadin (nitisinone capsules) away.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Orfadin (nitisinone capsules), please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
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