Eton Pharmaceuticals Announces Commercial Availability of Ultra-Rare Disease Product Nitisinone Capsules - Seite 2

What is the most important information I should know about Nitisinone?
Tell your doctor or nurse right away if you have any of these symptoms with Nitisinone:
Increased levels of plasma tyrosine, eye symptoms, developmental delay, and skin changes:

• Inadequate restriction of tyrosine and phenylalanine intake can result in raising plasma tyrosine levels.
• Plasma tyrosine levels above 500 micromol/L may lead to eye signs and symptoms like corneal ulcers, corneal cloudiness, inflammation of the cornea (keratitis), pink eye (conjunctivitis), eye pain, and sensitivity to light (photophobia), intellectual disability and developmental delay or painful thickening of the skin (hyperkeratotic plaques) on the soles and palms.
• Your healthcare provider should not adjust Nitisinone dosage in order to lower the levels of tyrosine in the blood.
  

Changes in blood profile

• You may develop a reduction in the number of white blood cells, which form part of the immune system (leukopenia) and abnormally low levels of platelets, which help the blood to clot (severe thrombocytopenia).
  

Do not take Nitisinone if:

• you are allergic to Nitisinone or any other ingredients. Stop using Nitisinone and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of the face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
  

Before taking Nitisinone, tell your doctor if you:

• are pregnant or plan to become pregnant. Nitisinone may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with Nitisinone.
• are breastfeeding or plan to breastfeed. It is not known if Nitisinone passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with Nitisinone.
• are aged 65 and older. Your doctor may need to adjust the dose of Nitisinone based on your requirements.
• are taking other medicines since Nitisinone can interfere with their effect. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements.

What are the possible side effects of Nitisinone?