Patient Medication Information: uses, side effects, how to take - Tepadina
Serious warnings and precautions box
What TEPADINA is used for:
- TEPADINA is used to treat adult patients with central nervous system (CNS) lymphoma. It is used in combination with other anticancer medicines and is followed by stem cell transplantation.
TEPADINA administration must be supervised by a doctor experienced in the use of anticancer medicines.
TEPADINA can cause severe side effects, which include:
Myelosuppression (bone marrow suppression) which causes a large decrease in the production of blood cells and platelets by the bone marrow. This occurs in all patients receiving TEPADINA. It causes severe cases of any combination of the following conditions. These conditions may lead to death.
- Neutropenia: a low amount of neutrophils, which are a type of white blood cell.
- Thrombocytopenia: a low amount of platelets. Platelets help your blood clot.
- Anemia: a low amount of red blood cells or hemoglobin.
- Cardiac toxicity: damage to the heart.
- Liver toxicity: damage to the liver.
- Hepatic veno occlusive disease (VOD): a condition where liver veins are blocked. Patients who have received radiation therapy in the past, those who have received chemotherapy in the past or those who have received stem cell transplantation in the past have a greater risk of getting hepatic veno occlusive disease (VOD).
- Pulmonary toxicity: damage to the lungs. This effect may be increased when TEPADINA is used with other anticancer medicines like busulfan, fludarabine and cyclophosphamide.
- Neurotoxicity: damage to the nervous system. Patients who have received prior radiation therapy of the brain, skull or the spine can experience more severe damage to the nervous system.
- Kidney toxicity: damage to the kidneys.
- Harm to an unborn baby. TEPADINA should NOT be used during pregnancy because it can harm your baby.
- Serious interactions with other medicines. See section The following may also interact with TEPADINA, below, for information about these medicines.
How TEPADINA works:
TEPADINA belongs to a group of medicines known as cytotoxic agents. It is used in combination with other medicines to treat cancer. It treats cancer by stopping the cancer cells from growing which eventually kills them.
The ingredients in TEPADINA are:
TEPADINA 15 mg and 100 mg (vial)
Medicinal ingredients: thiotepa.
Non-medicinal ingredients: TEPADINA does not contain any other ingredients.
TEPADINA 200 mg and 400 mg (dual chamber bag)
Medicinal ingredients: thiotepa.
Non-medicinal ingredients: sodium chloride, water for injections.
TEPADINA comes in the following dosage forms:
Powder for solution for infusion (vial):
- 15 mg
- 100 mg
Powder and solvent for solution for infusion (dual chamber bag):
- 200 mg thiotepa with 200 mL sodium chloride 9 mg/mL (0.9% solution for injection)
400 mg thiotepa with 400 mL sodium chloride 9 mg/mL (0.9% solution for injection)
Note: Thiotepa powder and solvent (sodium chloride) are in separate chambers in a dual chamber bag.
Do not use TEPADINA if:
- you are allergic to thiotepa or other ingredients in TEPADINA;
- you are pregnant;
- you are breastfeeding;
- you are receiving a live virus or a live bacterial vaccine, including yellow fever vaccine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEPADINA. Talk about any health conditions or problems you may have, including if you:
- have or have had liver problems;
- have or have had kidney problems;
- have or have had heart problems;
- have lung problems;
- have or have had problems with your bladder;
- have received radiation therapy in the past;
- have received chemotherapy in the past;
- have received stem cell transplantation in the past;
- have an active infection;
- have or have had in the past, an active infection with cytomegalovirus (CMV). This is because TEPADINA can cause your CMV to become active again;
- have seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin);
- are planning to receive any vaccine;
- are obese;
- are older than 65 years of age.
Other warnings you should know about:
- TEPADINA can come through your skin when you sweat. You will be instructed by your healthcare professional to bathe often and to avoid touching others while receiving TEPADINA.
- Your healthcare professional may recommend you to drink more fluids to stay hydrated during treatment with TEPADINA.
Infections
- TEPADINA weakens your immune system and can increase your risk of infections. To prevent and manage infections, your healthcare professional may prescribe you anti-infective medicines.
Cancer
- TEPADINA may cause another type of cancer in the future. Your healthcare professional will discuss this risk with you.
Female patients
Pregnancy and birth control
- TEPADINA must NOT be used during pregnancy because it may cause harm to an unborn baby.
- You must tell your healthcare professional if you are or think you may be pregnant before you receive TEPADINA. There are specific risks you should discuss with your healthcare professional.
If you are able to become pregnant:
- Your healthcare professional will give you a pregnancy test before you receive TEPADINA. This is to make sure that you are not pregnant.
- Avoid becoming pregnant while receiving TEPADINA.
- You must use an effective birth control method while receiving TEPADINA. Talk to your healthcare professional for advice on effective methods of birth control.
- Tell your healthcare professional right away if you become pregnant during treatment with TEPADINA.
Breastfeeding
- Do NOT breastfeed while receiving TEPADINA. It may pass into the breast milk and harm your baby.
- Talk to your healthcare professional about the best way to feed your baby during treatment with TEPADINA.
- Male patients
- Do NOT father a child during treatment with TEPADINA.
- Use effective birth control method while receiving TEPADINA. Talk to your healthcare professional for advice on effective methods of birth control.
- Fertility in Males and Females
- TEPADINA may reduce your ability to have children in both male and female patients.
- If you plan to have children, talk to your healthcare professional before you start treatment with TEPADINA. Your healthcare professional will discuss fertility preservation options with you.
- Check-ups and testing
You will have visits with your healthcare professional to monitor your health. They will:
- do regular blood tests before and during treatment to check your blood cell counts.
- monitor the functioning of your heart and your kidneys during treatment with TEPADINA.
- monitor the functioning of your liver by checking your liver enzyme levels during treatment with TEPADINA.
Driving and using machines
- TEPADINA can cause spasms, confusion, dizziness, or vision problems. Before you drive or do tasks that require special attention, wait until you know how you respond to TEPADINA.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions:
Serious drug interactions with TEPADINA include:
- Live attenuated virus or bacterial vaccines, including yellow fever vaccine;
- Phenytoin, a medicine used to treat seizures;
Anticancer medicines that cause bone-marrow suppression (myelosuppression), including:
- Cyclophosphamide
- Melphalan, busulfan, fludarabine, treosulfan, etc.
The following may also interact with TEPADINA:
- Cyclosporin, a medicine that suppresses the immune system and is used to prevent organ rejection following transplantation. It is also used to treat rheumatoid arthritis and psoriasis;
- Tacrolimus, a medicine used to prevent organ rejection following transplantation;
- Succinylcholine is a medicine used as part of general anesthesia for surgery;
- Anticoagulants taken by mouth, which are medicines that prevent blood clotting.
How to take TEPADINA:
TEPADINA will be given to you by a healthcare professional. It will be infused directly into your vein. Each infusion will last 2 to 4 hours.
Usual dose:
Your healthcare professional will decide how much TEPADINA you should receive based on
your height and your weight.
- You will receive a TEPADINA infusion once or twice a day. You will receive TEPADINA for 2 to 3 days in a row before you are given a stem cell transplant. TEPADINA will be given to you along with other anticancer medicines.
- Your healthcare professional will decide how often and for how long you should receive TEPADINA.
Overdose:
In the event you were accidentally given a higher dose of TEPADINA than prescribed, your healthcare professional will decide whether to perform blood tests and to undertake supportive care, if necessary.
If you think you, or a person you are caring for, have been given too much TEPADINA, 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.
Possible side effects from using TEPADINA:
These are not all the possible side effects you may have when taking TEPADINA. If you experience any side effects not listed here, tell your healthcare professional.
- Anorexia, decreased appetite, weight loss
- Joint pain
- Muscle pain
- Changes in muscle tone: back pain, joint pain
- Pain or inflammation at the injection site
- Cough
- Redness of the skin
- Skin colour disorder (patches of skin become darker in color than the normal surrounding skin. Do not confuse with jaundice)
- Hair loss
- Weight gain
- Having no menstrual periods
- Loss of fertility in men and women
TEPADINA may cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | 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 | ||
| Very common | |||
| Myelosuppression (a large decrease in the production of blood cell and platelets by the bone marrow): | X | ||
| bleeding, bruising, chills, fatigue, fever, infections, weakness. | |||
| Edema / water retention (excess fluid in body tissues): swelling of the body in the hands, feet or legs or elsewhere. | X | ||
| Gastrointestinal problems (damage to the gastrointestinal system): abdominal pain, bloating, blood in stool, constipation, decreased appetite, diarrhea, nausea, vomiting, vomiting blood. | X | ||
| Mucositis (inflammation and ulceration of the mucous membranes lining the digestive tract): painful ulcers, sores and blisters of the mouth, throat, stomach and intestines. | X | ||
| Nervous system disorders (damage to the nervous system): agitation, blurred vision, confusion, convulsions, difficulty speaking, dizziness, hallucinations, headache, impaired thinking, loss of control of body movements, memory loss, mental status changes, nervousness, numbness and tingling, vision loss, muscle weakness, seizures. | X | ||
| Sepsis and septic shock (life-threatening complication of an infection): chills, high or very low body temperature, little or no urine, low blood pressure, palpitations, rapid breathing, rapid heartbeat. | X | ||
| Common | |||
| Cardiac problems (damage to the heart): chest pain, fatigue, heart stops beating, palpitations, shortness of breath, swelling in the legs and ankles, weakness. | X | ||
| Engraftment syndrome (an inflammatory condition occurring after the transplant): diarrhea, difficulty breathing that is worse when lying down, fever, skin rash, weight gain. | X | ||
| Kidney problems (damage to the kidneys): back and abdominal pain, change in the colour of urine (pale or dark) decrease in amount of urine produced, pain or discomfort when urinating, swelling of the legs and ankles. | X | ||
| Liver problems (damage to the liver): abdominal pain, dark urine, fatigue, loss of appetite, nausea, vomiting, yellowing of the skin or eyes (jaundice). | X | ||
| Lung problems (damage to the lungs): coughing up blood, difficulty breathing, sharp pain in the chest, | X | ||
| shortness of breath (can be sudden), blood clot in lungs. | |||
| Uncommon | |||
| Dehydration | X | ||
| Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (life-threatening skin conditions): blisters, rash, skin peeling, especially in mouth and eyes. | X | ||
| Unknown | |||
| Stroke: disturbance of vision or speech, facial weakness, dizziness, fainting, numbness or weakness in an arm or leg, sudden severe headache, vomiting. | X | ||
| Erythrodermic psoriasis (inflammation and scaling of the skin): severe redness, scaling and shedding of the skin over a large area of the body. | X | ||
| Bladder infection: blood in urine, difficulty or increased need to urinate; pain or burning sensation when passing urine; urine that appears cloudy; pain in the pelvis; or mid-back pain. | X | ||
| Graft versus host disease (a condition where the transplanted cells attack your body): abdominal pain, diarrhea, itching, nausea, skin rash, redness and blistering, vomiting, yellowing of the skin and eyes (jaundice). | X | ||
| Thromboembolism (blood clot): pain, redness or swelling in the legs or feet that may be warm to the touch. | X | ||
| High blood pressure: shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin. | X | ||
| Hyperglycemia (high blood sugar): increased thirst, frequent urination. | X | ||
| Cataract (a clouding of the lens in the eye which leads to a decrease in vision): vision disturbances. | X | ||
| Hearing loss and ringing in the ears. | X | ||
| Symptoms of menopause: hot flashes, irregular periods. | X | ||
| Hypothyroidism (underactivity of the thyroid gland) in children: fatigue, weakness, weight gain. | X | ||
| Hypopituitarism (underactivity of the pituitary gland): abdominal pain, fatigue, weakness, weight loss. | X | ||
| Growth retardation (delaying in weight and height increase) in children. | X | ||
| Hyponatremia (low level of sodium in the blood): coma, confusion, headaches, nausea, poor balance, seizure. | X | ||
| Hypersensitivity (allergic reaction): hives, rash, swelling of the face, lips or throat that may cause difficulty in breathing or swallowing. | X | ||
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.
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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
TEPADINA will be managed and stored by healthcare professionals.
If you want more information about TEPADINA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.adienne.com or by calling 1-800-217-7405.
Andone Pharmaceutical Inc.
Date of Authorization: 2026-03-27