Details for: MDK-NITISINONE
Company: MENDELIKABS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02457717 | MDK-NITISINONE | NITISINONE | 2 MG | CAPSULE | ORAL |
| 02457725 | MDK-NITISINONE | NITISINONE | 5 MG | CAPSULE | ORAL |
| 02457733 | MDK-NITISINONE | NITISINONE | 10 MG | CAPSULE | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
MDK-Nitisinone is used for the treatment of hereditary tyrosinemia type 1 (HT-1), in addition to limiting the amount of tyrosine and phenylalanine in the diet.
What it does
MDK-Nitisinone stops the build-up of toxic substances which cause the severe liver and kidney problems in patients with HT-1. By doing that, it also prevents the porphyric crises associated with HT-1.
When it should not be used
- are allergic (hypersensitive) to nitisinone or any of the other ingredients in MDK-Nitisinone.
- are breast-feeding. Do not breast feed while taking MDK-Nitisinone.
What the medicinal ingredient is
nitisinone.
What the non-medicinal ingredients are
corn starch, gelatine, iron oxide, shellac glaze, titanium dioxide.
What dosage form it comes in
Capsules: 2 mg, 5 mg or 10 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MDK-Nitisinone. Talk about any health conditions or problems you may have, including if you:
- are pregnant or planning to become pregnant.
Other warnings you should know about:
Dietary Changes
Taking MDK-Nitisinone can cause high levels of tyrosine in your blood which can be toxic. As a result, while you are taking MDK-Nitisinone you must limit the amount of tyrosine and phenylalanine in your diet. Talk to your healthcare professional about which foods are safe to eat and which foods should be avoided.
Eye Problems
Your healthcare professional will check your eyes before starting treatment with MDK-Nitisinone. If you develop eye problems while taking MDK-Nitisinone, including sensitivity to light, eye pain, redness, swelling or burning, talk to your healthcare professional immediately.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Proper use of this medication
- MDK-Nitisinone is usually taken twice a day.
- MDK-Nitisinone can be taken with or without food however, it should always be taken the same way. Therefore, if you start taking MDK-Nitisinone with food, you should always take it with food.
- For young children, MDK-Nitisinone capsules can be opened and the contents sprinkled into a small amount of water or formula immediately before use.
Usual dose
Your healthcare professional will tell you how much MDK-Nitisinone to take and when to take it.
Overdose
Missed Dose
If you miss a dose by less than 12 hours, take it as soon as you remember.
Side effects and what to do about them
These are not all the possible side effect you may feel when taking MDK-Nitisinone. If you experience any side effects not listed here, contact your healthcare professional.
MDK-Nitisinone can cause abnormal blood test results. While you are taking MDK-Nitisinone your healthcare professional will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| COMMON | |||
| Low Platelets: easy or unusual bruising. Bleeding into the skin causing a rash of pinpoint-sized reddish-purple spots, usually in the lower legs, prolonged bleeding from cuts, bleeding from your gums or nose, blood in urine or stools. | ✔ | ||
| Low White Blood Cells: infections, fatigue, weakness, fever, aches and pains, flu-like symptoms. | ✔ | ||
| Eye Problems: redness, eye discharge, itchy eyes, burning eyes, blurred vision, sensitivity to light, milky or cloudy area on the eye, eye pain, a feeling that there is something in your eye. | ✔ | ||
| RARE | |||
| Skin Problems: dry/cracked/scaly skin, rashes, small flat red bumps, itching that can be severe, blisters, draining fluid and crusting, swelling, burning, tenderness, loss of hair in patches. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store refrigerated between 2-8°C.
Opened bottles of 2 mg capsules can be stored for 1 month at room temperature (not above
25°C); then discarded.
Opened bottles of 5, 10 and 20 mg capsules can be stored for 3 months at room temperature (not
above 25°C); then discarded.
Keep out of reach and sight of children.
Reporting side effects
- You can report any suspected side effects associated with the use of health products to Health Canada by:Visiting the Web page on Adverse Reaction Reporting (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional. Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.mendelikabs.com, by calling 1-888-959-9987 or by sending an email to: contact@mendelikabs.com.
This leaflet was prepared by MendeliKABS Inc.
Last Revised: November 29, 2017