Patient Medication Information: uses, side effects, how to take - Mylan-Imatinib
What is Mylan-Imatinib used for?
Mylan-Imatinib is used to treat several SOLID TUMOUR or BLOOD CANCER indications. They are described in more detail below. Ask your doctor if you are not sure why Mylan-Imatinib has been prescribed for you. Mylan-Imatinib can be used in children for one indication.
Blood Cancers
Adults and children two years old and older with a new diagnosis of:
Philadelphia chromosome-positive chronic myeloid leukemia (Ph-positive CML). The cancer is in an early phase. It is called chronic phase.
- cancer of white blood cells
- certain abnormal cells (called myeloid cells) are growing out of control
Blood Cancers
Adults
Philadelphia chromosome-positive chronic myeloid leukemia (Ph-positive CML)
- cancer of white blood cells
- certain abnormal cells (called myeloid cells) are growing out of control
- in chronic phase after failure of other treatment, it is called interferon
- or in accelerated phase, or blast crisis. The blood cancer grows faster in these phases than in chronic phase.
Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph-positive ALL)
- cancer of white blood cells
- certain abnormal cells (called lymphoblasts) are growing out of control
- first treatment in newly diagnosed Ph-positive ALL
- or when cancer has come back after treatment
- or when cancer was not successfully treated with other treatment.
Myelodysplastic/myeloproliferative diseases (MDS/MPD)
- a group of blood diseases
- too many abnormal blood cells are made
- Mylan-Imatinib is used in a certain sub-type of these diseases
Aggressive systemic mastocytosis (ASM), and systemic mastocytosis with an associated clonal haematological non-mast-cell disorder (SM-AHNMD)
- cancer of white blood cells
- certain abnormal cells (called mast cells) are growing out of control
- Mylan-Imatinib is used in certain sub-types of these diseases
Advanced hypereosinophilic syndrome (HES), and chronic eosinophilic leukemia (CEL)
- blood diseases
- certain abnormal blood cells (called eosinophils) are growing out of control
- Mylan-Imatinib is used in a certain sub-type of these diseases
Solid Tumours
Adults:
Dermatofibrosarcoma protuberans (DFSP)
- a cancer of the tissue beneath the skin
- some abnormal cells are growing out of control
Serious Warnings and Precautions
Take Mylan-Imatinib only under the care of a doctor who knows how to use anti-cancer drugs. They should be trained in how to treat solid tumours or blood cancers. Mylan-Imatinib can cause severe side effects,
The symptoms are listed in the “Serious side effects and what to do about them box”. It is found later in this leaflet. |
How does Mylan-Imatinib work?
Mylan-Imatinib helps slow down or stop the growth of cancer cells in your body.
What are the ingredients in Mylan-Imatinib?
Medicinal ingredients: imatinib mesylate
Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide.
Mylan-Imatinib comes in the following dosage forms:
Tablet 100 mg, 400 mg
Do not use Mylan-Imatinib if:
You are allergic to imatinib or any of the non-medicinal ingredients found in Mylan-Imatinib.
You are breast-feeding. You must stop breast-feeding before taking Mylan-Imatinib. It can get into breast milk and harm your baby.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Mylan-Imatinib. Talk about any health conditions or problems you may have, or have ever had, including:
- heart, liver, kidney, stomach or bowel problems;
- bleeding problems;
- bleeding from your stomach, small bowel, or large bowel;
- had your thyroid removed and take a thyroid hormone such as levothyroxine;
- if you are pregnant or are planning to get pregnant. Mylan-Imatinib can harm your unborn baby. Your healthcare professional might want you to take a pregnancy test before you take Mylan-Imatinib. You should use highly effective birth control if you might get pregnant while taking Mylan-Imatinib. If you become pregnant while taking Mylan-Imatinib, or think you might be, tell your healthcare professional right away;
- Tumour Lysis Syndrome (TLS) is a serious side effect. It usually occurs after treatment of a large or fast-growing cancer. As tumour cells die certain chemicals are released into the blood. This may cause damage to organs. Before they start Mylan-Imatinib, some people are at increased risk of Tumour Lysis Syndrome (TLS). If this is true for you, the doctor might give you treatments that may decrease the risk of TLS;
- if you are a man and are trying to have a child. Your healthcare professional may advise you not to start treatment with Mylan-Imatinib while you are trying to have a child. Your healthcare professional may advise you to stop taking Mylan-Imatinib before you try to have a child;
- if you have ever had or might now have a hepatitis B virus infection (a viral infection of the liver). This is because during treatment with Mylan-Imatinib, hepatitis B may become active again, which can be fatal in some cases. Your doctor will check for signs of this infection before and during treatment with Mylan-Imatinib.
Other warnings you should know about:
Driving and using machines: Before doing tasks which require special attention, wait until you are feeling well again. Blurred vision and being dizzy or drowsy can occur.
The following list contains some of the drugs that may interact with Mylan-Imatinib. 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 Mylan-Imatinib:
- some medicines used to treat fungal infections, like ketoconazole, itraconazole
- some medicines used to treat bacterial infections, like erythromycin, or clarithromycin
- some medicines used to treat epilepsy, like carbamazepine, oxcarbazepine, phenobarbital, phenytoin, fosphenytoin, or primidone
- some medicines used to treat high cholesterol like simvastatin
- some medicines used to treat mental health disorders like pimozide
- some medicines used to treat high blood pressure or heart disorders. This includes metoprolol or a group of medicines called calcium channel blockers
- rifampicin a medicine used to treat tuberculosis (TB)
- St. John’s Wort (Hypericum perforatum), a herbal product used to treat depression and other conditions
- dexamethasone, a medicine to treat inflammation
- cyclosporine, a medicine that keeps the immune system from rejecting a new organ after a transplant
- acetaminophen, a medicine used to reduce pain or fever — acetaminophen is also included in many cold and flu remedies, so check the label
- warfarin, a medicine used to treat or prevent blood clots
- levothyroxine, if you had your thyroid removed
- Do NOT drink grapefruit juice at any time while you are on Mylan-Imatinib
If you are already taking Mylan-Imatinib, tell your healthcare professional if you are prescribed a new medicine.
How to take Mylan-Imatinib:
Take Mylan-Imatinib only as prescribed for you by your doctor.
If your dose is 800 mg a day, use only the 400 mg tablets to make up your dose. This will reduce how much iron you get.
Take Mylan-Imatinib by mouth, with food and a large glass of water.
You can take Mylan-Imatinib in one of these two ways:
- 1.
Swallow Mylan-Imatinib:
- a) Whole with a large glass of water.
- b)
If the 400 mg tablet is too large to swallow whole:
- Break it in two pieces
- Swallow each piece with water, one after the other
- 2.
If you cannot swallow a 400 mg tablet broken in two or a 100 mg tablet:
Place the tablet in a glass with water or apple juice.
100 mg tablet: use 50 mL or one-quarter cup
400 mg tablet: use 200 mL or a little less than 1 cup
- Stir with a spoon to completely dissolve the tablet
- Drink the whole drink right away
- Rinse the glass with a little more water or juice and drink that too
- No trace of the dissolved tablet should be left behind in the glass
Usual dose:
Your dose depends on if you are an adult or a child, and on your medical condition. Your healthcare professional will regularly monitor your condition. Your dose may change depending on how well Mylan-Imatinib is working.
| Age Group | Indication | Daily Dose | Instructions for Use |
| Adults | Philadelphia chromosome-positive chronic myeloid leukemia (Ph-positive CML) | Usual dose: 400 mg or 600 mg Depending on how you respond to treatment you may get a higher or lower dose. If your dose is 800 mg per day | Take once a day Take twice a day. A 400 mg tablet in the morning and another 400 mg tablet in the evening. |
| Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) | 600 mg | Take once a day | |
| Myelodysplastic/myeloproliferative diseases (MDS/MPD) | 400 mg | Take once a day | |
Aggressive systemic mastocytosis (ASM) and systemic mastocytosis with associated clonal hematological non-mast cell lineage disease (SM-AHNMD)
| 400mg 400mg | Take once a day |
associated with an abnormal increase in certain blood cells (called eosinophils). | Starting dose: 100 mg. May be increased to 400 mg depending on how you respond to treatment. | |
| Hypereosinophilic syndrome (HES) or chronic eosinophilic leukemia (CEL) | Starting dose: 100 mg. May be increased to 400 mg depending on how you respond to treatment | Take once a day |
| Dermatofibrosarcoma protuberans (DFSP) | 800 mg | Take twice a day. A 400 mg tablet in the morning and another 400 mg tablet in the evening |
| Children: 2 years of age and older | ||
| Philadelphia chromosome-positive chronic myeloid leukemia (Ph-positive CML) | Depending on the child’s weight and height, 100 mg to 600 mg | As prescribed by the doctor: Take once a day OR split into two doses, one in the morning and one in the evening |
Overdose:
| If you think you have taken too much Mylan-Imatinib, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If you or your child:
- missed a dose OR threw up after taking the last dose. Do NOT take another dose or double dose. Instead, wait until it is time for your next dose.
What are possible side effects from using Mylan-Imatinib?
These are not all the possible side effects you may feel when taking Mylan-Imatinib. If you experience any side effects not listed here, contact your healthcare professional. Please also read the box called “Serious Warnings and Precautions”.
Side effects may include:
- weight loss, no appetite, change in taste, dry mouth, sores in mouth
- heartburn, indigestion
- constipation, gas, feel bloated
- headache, dizziness
- difficulty sleeping, drowsiness
- weakness, feeling tired
- nosebleeds
- skin dry, itchy or less sensitive to touch
- skin more sensitive to sun
- night sweats, red in the face or other areas of the skin
- unusual hair loss or thinning
- muscle tension, cramps, pain
- bone pain
- joint pain and swelling
- tingling, pain, or numbness in hands, feet, legs
- cough
If any of these affects you severely, tell your healthcare professional.
Mylan-Imatinib can cause abnormal blood test results. You may have blood thyroid hormone levels that are not normal. This occurs when your thyroid has been removed and you are on a drug such as levothyroxine.
Children who take Mylan-Imatinib may have the following side effects more often than adults:
- Low blood levels of calcium, sugar, phosphates, albumin protein and sodium
- High blood levels of sugar
Your doctor will decide when to perform tests and will interpret the results.
While you are taking Mylan-Imatinib, you will be weighed regularly.
Children and teenagers may grow more slowly when taking Mylan-Imatinib. The healthcare professional will measure their growth at regular visits.
Your doctor may do blood and/or urine tests to check how well your kidneys are working. This will be done before you start taking Mylan-Imatinib and during your treatment.
You have had hepatitis B (a viral infection of the liver) in the past.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Water retention: rapid weight gain, swelling of your hands, ankles, feet, face, or eyelids, or your whole body. | √ | ||
| Decreased Platelets: bruising, bleeding, fatigue and weakness. | √ | ||
| Decreased White Blood Cells: infections, | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases |
|---|---|
| fatigue, fever, aches, pains, and flu-like symptoms. | |
| Anemia (Decreased red blood cells): fatigue, loss of energy, weakness, shortness of breath. | |
| √ | |
| Musculoskeletal pain after discontinuing treatment with Mylan-Imatinib: muscle pain, limb pain, joint pain and bone pain. |
| √ | |||
| COMMON | |||
| Pleural effusion (fluid around the lungs): chest pain. Difficult or painful breathing, cough. | √ | ||
| Pulmonary edema (fluid in the air spaces of the lungs): difficult breathing that is worse when you lie down. Cough up blood or blood-tinged froth. | √ | ||
| Pericardial effusion (fluid around the heart): chest pain that feels better when you sit up rather than lie down. Feel light-headed or pass out. Irregular, fast, or forceful heartbeat. Difficult or painful breathing, cough. | √ | ||
| Ascites (fluid in the abdomen): feeling of fullness, abdominal pain, shortness of breath. | √ | ||
| Bleeding or swelling in the brain: severe headache. Weak or cannot move arms, legs or face. Difficulty talking, fainting or passing out. Dizziness, blurred vision, seizure (fit). | √ | ||
| Pneumonia (infection in the lungs): shortness of breath. Difficult and painful breathing, cough, wheezing, or fever. | √ | ||
| Shortness of Breath | √ | ||
| Chest Pain | √ | ||
| Inflammatory bowel disease: nausea, vomiting, diarrhea, abdominal pain, fever. | √ | ||
| Liver disorder, jaundice, toxicity, or failure: yellow skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite. | √ | ||
| Vomiting | √ | ||
| Diarrhea | √ | ||
| Nausea | √ | ||
| Pain in the abdomen | √ | ||
| Fever | √ | ||
| Less urine, urinate less often. | √ | ||
| Eye Infection (conjunctivitis): itchy, red eyes with discharge, and swelling. | √ |
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Increased tears in the eyes, dry eyes. | √ | ||
| Swelling around the eyes or in the eyelids. | √ | ||
| UNCOMMON | |||
| Bleeding in the stomach or bowels: severe abdominal pain, vomit blood, black or bloody bowel movement, swelling of the abdomen. Feel dizzy or weak, loss of consciousness. Shortness of breath. | √ | ||
| Gastrointestinal perforation (a hole in the wall of your stomach or bowels): severe abdominal pain, nausea, vomiting, chills or fever. | √ | ||
| Decreased or increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell. | √ | ||
| Interstitial lung disease (diseases that inflame or scar lung tissue): shortness of breath, tiredness, dry cough. | √ | ||
| Acute respiratory failure: sudden worsening of shortness of breath, bluish color on skin, lips, and fingernails, irregular heartbeats, feel sleepy, loss of consciousness. | √ | ||
| Low Blood Pressure: dizziness, fainting, light-headedness. | √ | ||
| Fainting or passing out | √ | ||
| Difficulty hearing | √ | ||
| Blood in urine | √ | ||
| Left ventricular dysfunction, Congestive heart failure (a weakness of the heart): tiredness, swollen ankles, shortness of breath especially when lying down. | √ | ||
| Heart attack (blood flow stops to part of the heart): sudden chest pain or pressure or discomfort, feeling faint, shortness of breath, possibly irregular heartbeat. | √ | ||
| Cardiogenic shock (heart is not able unable to pump enough blood to the organs of the body): breathe fast, fast heartbeat, loss of consciousness, sweating, pale skin, cold hands or feet. | √ | ||
| Angina: (not enough oxygen to the heart muscle): chest pain or pressure, usually coming during exercise or physical stress and relieved | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| by rest. | |||
| Raynaud’s syndrome: fingers and toes feel numb and cold in response to cold temperatures or stress. | √ | ||
| Cellulitis (infection under the skin): red, hot, painful and swollen area. | √ | ||
| Palmar-plantar erythrodysaesthesia syndrome: red or swollen palms of the hands and soles of the feet. You might feel a tingling or burning pain as well. | √ | ||
| Tumour lysis syndrome: nausea, shortness of breath, irregular heartbeat, cloudy urine, tiredness, or pain in joints | √ | ||
| RARE | |||
Eye Problems: blood in eye, trouble seeing, blurred vision. | √ | ||
| Pulmonary fibrosis (scarring of the lung tissues): shortness of breath, tiredness, dry cough. | √ | ||
| Seizure | √ | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the center. Possibly swollen lips. Mild itching or burning. | √ | ||
| Stevens Johnson syndrome, Toxic epidermal necrolysis (severe skin reaction): rash, red skin, red or purple skin patches possibly with blister or crust in the center, pus-filled rash, peeling skin, blisters on the lips, eyes, skin or in the mouth, itching, burning, flu-like feeling, fever. | √ | ||
| Breakdown of red blood cells: pale skin, feeling tired or out of breath, dark urine. | √ | ||
| UNKNOWN FREQUENCY | |||
| Allergic reactions: itch, rash, hives, swelling of the lips, tongue or throat, difficulty swallowing or breathing. | √ | ||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (severe reaction to a medicine. Your skin and one or more of the organs in your body are involved. You may only have some of the side effects that are listed here): fever, severe rash, swollen lymph | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinate less often, less urine. | |||
| Rhabdomyolysis (a rapid breakdown of muscle): unexplained muscle pain, tenderness or weakness. Dark brown urine. | √ | ||
| Blood clot in blood vessel: swelling, redness and pain in one part of the body. | √ | ||
| Gynecological disorder (problem in woman’s reproductive system): pain in lower abdomen or unexpected blood from the vagina or both. | √ | ||
| Avascular necrosis / Hip osteonecrosis (break down and collapse of bone tissue.): pain and difficulty while walking. | √ | ||
| Chronic Kidney Impairment (reduced kidney function). | √ | ||
| Hepatitis B virus reactivation (an active viral infection of the liver): Fever, skin rash, joint pain and inflammation as well as tiredness, loss of appetite, nausea, jaundice (yellowing of the skin or whites of eyes), pain in the upper right abdomen, pale stools and dark urine. | √ | ||
| Pseudoporphyria (painful blisters on sun-exposed skin; sunburn-type rash | √ | ||
These are not all the possible side effects you may feel when taking Mylan-Imatinib. If you are bothered by a side effect not listed here, talk to your healthcare professional. If you have a symptom or side effect that begins to affect your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
Store Mylan-Imatinib between 15ºC to 30ºC. Protect tablets from moisture.
- Keep out of reach and sight of children
- Keep tablets in their original package
- Make sure tablets do not get wet
- Use tablets before the expiry date on the box. Do NOT use tablets after that date
- If a package is damaged or shows signs of tampering, do NOT use the tablets
If you want more information about Mylan-Imatinib:
- 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, or by calling 1-844-596-9526.
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-844-596-9526.
Etobicoke, Ontario M8Z 2S6
Last Revised: April 11, 2018
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-844-596-9526 www.mylan.ca