Details for: ACH-IMATINIB

Company: ACCORD HEALTHCARE INC

DIN	DIN name	Active Ingredient(s)	Strength	Dosage Form	Route of Administration
02490986	ACH-IMATINIB	IMATINIB (IMATINIB MESYLATE)	100 MG	TABLET	ORAL
02490994	ACH-IMATINIB	IMATINIB (IMATINIB MESYLATE)	400 MG	TABLET	ORAL

Search Reported Side Effects Report a Side Effect

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

ACH-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 ACH-IMATINIB has been prescribed for you. ACH-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
ACH-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
ACH-IMATINIB is used in certain sub-types 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

What it does

ACH-IMATINIB helps slow down or stop the growth of cancer cells in your body.

When it should not be used

Do not use ACH-IMATINIB if

You are allergic to imatinib or any of the non-medicinal ingredients found in ACH-IMATINIB. You are breast-feeding. You must stop breast-feeding before taking ACH-IMATINIB and 15 days after the last dose. It can get into breast milk and harm your baby.

What the medicinal ingredient is

imatinib mesylate

What the non-medicinal ingredients are

Colloidal anhydrous silica, crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol & talc.

What dosage form it comes in

Film-Coated Tablet 100 mg, 400 mg

Warnings and precautions

Serious Warnings and Precautions

Take ACH-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.

ACH-IMATINIB can cause severe side effects,

Heart disease or problems where your heart is unable to pump enough blood to meet the body’s needs. These include:

Left ventricular dysfunction

Congestive heart failure

Cardiogenic shock

Water retention: a build-up of water in your body
Side effects caused by water retention. These include:

Pleural effusion

Pulmonary edema

Pericardial effusion

Ascites

Rhabdomyolysis: a rapid breakdown of muscle. It may lead to sudden kidney failure.
Severe bleeding
Liver disorder, jaundice, toxicity or failure. In some patients, liver failure has led to death.
Gastrointestinal perforation: a hole in the wall of your stomach, small or large bowel. In some patients, it has led to death.

The symptoms are listed in the “Serious side effects and what to do about them” box. It is found later in this leaflet.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ACH-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. ACH-IMATINIB can harm your unborn baby. Your healthcare professional might want you to take a pregnancy test before you take ACH-IMATINIB. You should use highly effective birth control if you might get pregnant while taking ACH-IMATINIB and for 15 days after ending treatment. If you become pregnant while taking ACH-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 ACH-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 ACH-IMATINIB while you are trying to have a child. Your healthcare professional may advise you to stop taking ACH-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 ACH-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 ACH-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.

Interactions with this medication

The following list contains some of the drugs that may interact with ACH-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 ACH-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 ACH-IMATINIB

If you are already taking ACH-IMATINIB, tell your healthcare professional if you are prescribed a new medicine.

Proper use of this medication

Take ACH-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 ACH-IMATINIB by mouth, with food and a large glass of water.

You can take ACH-IMATINIB in one of these two ways:

Swallow ACH-IMATINIB:

Whole with a large glass of water.
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

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 ACH-IMATINIB is working.

Age Group	Indication	Daily Dose	Instructions for Use
Adults	Philadelphia chromosome-positive chronic myeloid leukemia (Phpositive 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) without a certain mutation (called D816V c-Kit). status of a certain mutation (called D816V c-Kit) is unknown and, response to other therapies has not been good enough. associated with an abnormal increase in certain blood cells (called eosinophils).	400 mg Starting dose: 100 mg. May be increased to 400 mg depending on how you respond to treatment.	Take once a day
	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 ACH-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.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking ACH-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.

ACH-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 ACH-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 ACH-IMATINIB, you will be weighed regularly.

Children and teenagers may grow more slowly when taking ACH-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 ACH-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 Only if severe	Talk to your healthcare professional In all cases	Stop taking drug and get immediate medical help
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, fatigue, fever, aches, pains, and flu- like symptoms.		✔
Anemia (Decreased red blood cells): fatigue, loss of energy, weakness, and shortness of breath.		✔
Musculoskeletal pain after discontinuing treatment with ACH-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.		✔
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 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 erythrody saesthesia 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 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 sunexposed skin; sunburn–type rash).		✔

These are not all the possible side effects you may feel when taking ACH-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.

How to store

Keep out of sight and reach of children.
Keep tablets in their original package.
Store the medication package at room temperature (15°C to 30°C).
Protect the tablets from moisture. Make sure the 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.

Reporting side effects

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 ( https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html ) 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.

More information

If you want more information about ACH-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 ( https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html ); or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.

This leaflet was prepared by:
Accord Healthcare Inc.
3535 boul. St. Charles suite 704
Kirkland, QC, H9H 5B9
Canada

Last revised: December 4, 2019

Date modified:: 2016-04-13

Language selection

Search and menus

Search