Patient Medication Information: uses, side effects, how to take - Taro-Deferiprone
What is Taro-Deferiprone used for?
Taro-Deferiprone is used to treat iron overload (too much iron in the body) from blood transfusions in patients with:
- thalassemia syndromes. They are used when other iron removal medicines do not work well enough.
- sickle cell disease or other anemias.
How does Taro-Deferiprone work?
Deferiprone, the ingredient in Taro-Deferiprone, is in a class of medicines called iron chelators. It works by removing excess iron from the body. By doing this, it protects your body against toxic effects of iron.
What are the ingredients in Taro-Deferiprone?
Medicinal ingredient: deferiprone
Non-medicinal ingredients: methylcellulose, crospovidone type B, magnesium stearate, purified water, white film coating (hypromellose 2910, copovidone K25-31, polydextrose, macrogol/PEG 3350, medium chain triglycerides, titanium dioxide)
Serious Warnings and Precautions
Taro-Deferiprone can cause a sudden severe drop in the neutrophil count. Some patients taking Taro-Deferiprone had a very low count of their neutrophils, a type of white blood cell that helps fight infections. This low count is called severe neutropenia or agranulocytosis. It can lead to a serious infection that can be deadly, if not treated.
Before you start Taro-Deferiprone your healthcare professional will order a blood test to check your neutrophil count. You will do this test every week while you are on Taro-Deferiprone. If your count is too low, this testing may need to be done every day until you recover.
If you develop signs of infection such as fever, chills, sore throat, mouth sores, or flu-like symptoms, stop taking Taro-Deferiprone and get medical help right away.
Taro-Deferiprone comes in the following dosage forms:
Tablets: 1000 mg
Do not use Taro-Deferiprone if:
- you are allergic to deferiprone or any of the ingredients in Taro-Deferiprone (see What are the ingredients in Taro-Deferiprone section above)
- you are pregnant or breast-feeding
- you have a very low neutrophil count. Your healthcare professional will only start you on Taro-Deferiprone if you have enough neutrophils.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Taro-Deferiprone. Talk about any health conditions or problems you may have, including if you have:
- liver problems
- hepatitis C
- a weak immune system
- low zinc in your blood. Taro-Deferiprone may cause low levels of zinc in your blood.
- ever had a low white blood cell count during past use of Taro-Deferiprone.
Other warnings you should know about:
Neutropenia:
- If you get neutropenia, avoid contact with other people. This may help to lower the risk of infection.
- If you get a very low neutrophil count you may need to be treated in a hospital.
- Do not use Taro-Deferiprone if you have Diamond-Blackfan anemia. You may have a higher risk of neutropenia if treated with Taro-Deferiprone.
Wallet Card
You will receive a wallet card every time you get a shipment of Taro-Deferiprone. This card has important safety information about the serious side effects of Taro-Deferiprone that you and any other healthcare professional involved in your care should know.
- Carry this card with you at all times
- If you become ill or consult a healthcare professional for any reason:
- Show the card to any healthcare professional you consult
- Explain that the card has important information about the serious side effects of the medicine you take.
Cancer:
- Taro-Deferiprone is likely to cause cancer in rodents. Talk with your healthcare professional to learn more about this.
Children
- Children taking Taro-Deferiprone may have more certain side effects than adults.
These side effects include:
- belly, bone and throat pain
- low neutrophil count
Pregnancy, Breastfeeding and Fertility
If you are a woman:
Pregnancy and birth control:
- Taro-Deferiprone can harm an unborn baby.
- Do not take Taro-Deferiprone if you are pregnant
If you are a woman on Taro-Deferiprone who may become pregnant:
- do not get pregnant
- use highly effective birth control during treatment with Taro-Deferiprone and for at least 6 months after the last dose. Talk with your healthcare professional about how to choose an effective birth control
- If you become pregnant, tell your healthcare professional right away.
- tell your healthcare professional if you plan to become pregnant.
Breastfeeding:
- It is possible that Taro-Deferiprone passes into breast milk.
- you must not breast-feed while you take Taro-Deferiprone
- If you want to breastfeed, discuss with your healthcare professional
If you are a man:
- if your partner can get pregnant, use highly effective birth control during treatment with Taro-Deferiprone tablets and for at least 3 months after the last dose. Talk to your healthcare professional about how to choose an effective birth control
- if your partner gets pregnant, tell your healthcare professional right away
Monitoring, laboratory and blood tests:
Your healthcare professional may do blood tests before you take Taro-Deferiprone and/or during treatment. These tests may check:
- the level of white blood cells in your body.
- that your liver is working properly.
- the iron or zinc levels in your blood.
- Taro-Deferiprone may cause problems with certain lab tests. Tell all of your healthcare professional that you take Taro-Deferiprone
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Taro-Deferiprone:
- other medicines that can decrease your neutrophil count
- antacids, multivitamins or mineral supplements that contain iron, aluminum, or zinc. Take them at least 4 hours before or 4 hours after you take Taro-Deferiprone.
How to take Taro-Deferiprone:
Take Taro-Deferiprone tablets:
- 3 times a day
with or without food. Taking Taro-Deferiprone with meals may help reduce nausea. If you have nausea, vomiting or abdominal pain, your healthcare professional may lower your dose for 1 to 2 weeks.
- If you are taking Taro-Deferiprone tablets and your dose includes taking half of a tablet, cut or break the tablet along the score line on the tablet
Usual dose:
Your healthcare professional will decide the right dose of Taro-Deferiprone. It will be based on how much you weigh.
Ask your healthcare professional if you are not sure. Do not change your dose or how often you take this medicine unless your healthcare professional tells you to.
Overdose:
Missed Dose:
If you forget a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and then continue with your regular schedule. Do not try to catch-up or take 2 doses at the same time to make up for a missed dose.
What are possible side effects from using Taro-Deferiprone?
These are not all the possible side effects you may have when taking Taro-Deferiprone. If you experience any side effects not listed here, tell your healthcare professional. Please also see Warnings and Precautions.
The most common side effects of Taro-Deferiprone include:
If you think you, or a person you are caring for, have taken too much Taro-Deferiprone contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
- belly pain, diarrhea, nausea, upset stomach, vomiting
- arm, back, bone, joint, or leg pain
- fever
- headache
- appetite too low or high, weight gain
- sore throat
- red or brown discoloration of your pee (urine). This is due to your body getting rid of iron. It is not harmful and is expected during treatment with Taro-Deferiprone
- Increase liver enzyme
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Serious side effects and what to do about them | |||
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Neutropenia ((low neutrophil count, / agranulocytosis (severe neutropenia): Signs of Infection: Fever, chills, sore throat, mouth sores, flu-like symptoms | ✓ | ||
| Sickle cell anemia crisis (sickle shaped red blood cells lump together): pain in chest, abdomen, bones of spine, arms and legs. | ✓ | ||
| Neurological Side Effects: shaking, walking problems, double vision, involuntary muscle contractions, problems with movement coordination. | ✓ | ||
| UNKNOWN | |||
| Allergic reactions: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat | ✓ | ||
| Henoch-Schönlein purpura: reddish-purple spots that look like bruises especially on the buttocks, legs and feet; swollen and sore joints; belly pain, or bloody urine | ✓ | ||
| Thrombocytosis (higher than normal platelet counts in the blood): headache, chest pain, burning pain in hands or feet, nosebleeds, bruising, bleeding from your mouth or gums, bloody stool. | ✓ | ||
Heart problems
| ✓ | ||
Gastrointestinal (stomach or bowel) problems:
| ✓ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen | ✓ | ||
| Cerebral hemorrhage (bleeding in the brain): sudden, severe headache; confusion; nausea and vomiting; | ✓ | ||
| seizures; loss of consciousness | |||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide. If you have a history of depression, your depression may become worse | ✓ | ||
Obsessive-compulsive disorder repeated, persistent and unwanted thoughts, behaviours such as hand washing/cleaning, checking on things that may interfere with daily activities and cause distress or anxiety | ✓ | ||
| Acute Respiratory Distress Syndrome (ARDS): severe difficulty breathing, including shortness of breath at rest or with activity, rapid breathing, wheezing or cough | ✓ | ||
| Pulmonary embolism (blood clot in the lung): chest pain that may increase with deep breathing, cough, coughing up bloody sputum, shortness of breath | ✓ | ||
| Hemoptysis: coughing up blood | ✓ | ||
| Sepsis and septic shock (infection of the blood): fever or dizziness, chills, high or very low body temperature, little or no urine, low blood pressure, palpitations, rapid breathing, rapid heartbeat | ✓ | ||
| Multi-organ Dysfunction Syndrome (failure of multiple organs): failure of multiple organs (e.g. lung, kidney, heart) at the same time including passing less urine, difficulty breathing (including shortness of breath at rest or with activity), rapid breathing, wheezing or cough; yellowing of your skin and eyes, stomach pain or swelling, nausea or vomiting; chest pain (angina), shortness of breath, rapid, strong or irregular heartbeat, or if there is swelling of your ankles and feet | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Storage:
Do not use Taro-Deferiprone after the expiry date, which is stated on the package after EXP.
Keep out of reach and sight of children.
Store at room temperature (15 to 30°C).
Sun360
Taro-Deferiprone is only available through the program Sun360. The program will help manage the risk of low white blood cell counts in patients taking Taro-Deferiprone.
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
DOCTOR
Only doctors registered in the program can prescribe Taro-Deferiprone.
PHARMACIST
Only pharmacists registered in the program can dispense Taro-Deferiprone. They do this by shipping the medication to you. In each shipment, you will receive:
- Wallet card
A month supply of Taro-Deferiprone. The tablets may be sent to you:
- in the bottle produced by the manufacturer
- you may get a combination of these.
Patient Medication Information
- may come on loose printed papers
- may be attached to the manufacturer’s bottle
- if there are changes to this information, you will receive information on a separate sheet. The sheet will be in a different colour.
If you need to talk to the pharmacist call 1-833-791-3539 or log onto www.sun360psp.ca. You can only receive drug counselling by phone.
PATIENT
Taro-Deferiprone can only be dispensed to patients enrolled in Sun360. If you need more Taro-Deferiprone for any reason such as travel, spills or lost tablets, call 1-833-791-3539 or log onto www.sun360psp.ca. Resupply is arranged on a case by case basis.
If you want more information about Taro-Deferiprone:
- 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: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html; the manufacturer’s website (www.taro.ca), or by calling 1-800-268-1975.