Patient Medication Information: uses, side effects, how to take - Thiotepa for Injection USP
Serious Warnings and Precautions
Thiotepa for Injection USP administration must be supervised by a doctor experienced in the use of anticancer medicines.
Thiotepa for Injection USP 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 Thiotepa for Injection USP. 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 Thiotepa for Injection USP 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. Thiotepa for Injection USP should NOT be used during pregnancy because it can harm your baby.
For the following indication Thiotepa for Injection USP has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada. For more information, talk to your healthcare professional.
- Thiotepa for Injection USP 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.
What is Thiotepa for Injection USP used for?
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c to actively monitor the drug’s performance after it has been sold, to report their findings to Health Canada, and in some circumstances, to complete more testing to make sure the drug works the way it should.
How does Thiotepa for Injection USP work?
Thiotepa for Injection USP belongs to a group of medicines known as cytotoxic agents. It is used in combination with other drugs to treat cancer. It treats cancer by stopping the cancer cells from growing which eventually kills them.
What are the ingredients in Thiotepa for Injection USP?
Medicinal ingredients: thiotepa.
Non-medicinal ingredients: Thiotepa for Injection USP does not contain any other ingredients.
Thiotepa for Injection USP comes in the following dosage forms:
15 mg or 100 mg: Powder in a glass vial.
- Serious interactions with other medicines. See section The following may interact with Thiotepa for Injection USP, below, for information about these medicines.
Do not use Thiotepa for Injection USP if:
- you are allergic (hypersensitive) to thiotepa or other ingredients in Thiotepa for Injection USP;
- 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 Thiotepa for Injection USP. 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 Thiotepa for Injection USP 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:
- Thiotepa for Injection USP 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 Thiotepa for Injection USP.
- Your healthcare professional may recommend you to drink more fluids to stay hydrated during treatment with Thiotepa for Injection USP.
Infections
Thiotepa for Injection USP weakens your immune system. Your doctor may prescribe you anti-infective medicines to prevent and manage infections.
Cancer
Thiotepa for Injection USP may cause another type of cancer in the future. Your doctor will discuss this risk with you.
Female patients
Pregnancy and birth control
- Thiotepa for Injection USP must NOT be used during pregnancy because it may cause harm to an unborn baby.
- You must tell your doctor if you are or think you may be pregnant before you receive Thiotepa for Injection USP. There are specific risks you should discuss with your healthcare professional.
If you are able to become pregnant:
- Your doctor will give you a pregnancy test before you receive Thiotepa for Injection USP. This is to make sure that you are not pregnant.
- Avoid becoming pregnant while receiving Thiotepa for Injection USP.
- You must use an effective birth control method while receiving Thiotepa for Injection USP. Talk to your doctor for advice on effective methods of birth control.
- Tell your doctor right away if you become pregnant during treatment with Thiotepa for Injection USP.
Breastfeeding
- Do NOT breastfeed while receiving Thiotepa for Injection USP. 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 Thiotepa for Injection USP.
Male patients
- Do NOT father a child during treatment with Thiotepa for Injection USP.
- Use effective birth control method while receiving Thiotepa for Injection USP. Talk to your doctor for advice on effective methods of birth control.
Fertility in Males and Females
Thiotepa for Injection USP may decrease your ability to have children in both male and female patients. If you plan to have children, talk to your doctor before you start treatment with Thiotepa for Injection USP. Your doctor will discuss fertility preservation options with you.
Blood tests and monitoring
You will have to have regular blood tests before and during treatment to check your blood cell counts. Your doctor will also monitor the functioning of your heart and your kidneys during treatment with Thiotepa for Injection USP. They will also monitor the functioning of your liver by checking your liver enzyme levels during treatment with Thiotepa for Injection USP.
Driving and using machines
Thiotepa for Injection USP can cause spasms, confusion, dizziness, or vision problems.
Serious Drug Interactions
While taking Thiotepa for Injection USP, avoid:
- 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.
Before you drive or do tasks that require special attention, wait until you know how you respond to Thiotepa for Injection USP.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may also interact with Thiotepa for Injection USP:
- 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 Thiotepa for Injection USP:
Thiotepa for Injection USP 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 doctor will decide how much Thiotepa for Injection USP you should receive based on your height and your weight.
You will receive a Thiotepa for Injection USP infusion once or twice a day. You will receive Thiotepa for Injection USP for 2 to 3 days in a row before you are given a stem cell transplant. Thiotepa for Injection USP will be given to you along with other anticancer medicines. Your doctor will decide how often and for how long you should receive Thiotepa for Injection USP.
Overdose:
| In the event you should be accidentally administered a higher dose of Thiotepa for Injection USP than that prescribed, your doctor will decide whether to perform blood tests and to undertake supportive care, if necessary. |
|---|
What are possible side effects from using Thiotepa for Injection USP?
These are not all the possible side effects you may feel when taking Thiotepa for Injection USP. If you experience any side effects not listed here, contact your healthcare professional.
- Anorexia, decreased appetite, weight loss
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Changes in muscle tone: back pain, joint pain
- Pain or inflammation at the injection site
- Cough
- Erythema (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
- Amenorrhea (having no menstrual periods)
- Loss of fertility in men and women
Thiotepa for Injection USP may cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
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 | |||
Myelosuppression (a large decrease in the production of blood cell and platelets by the bone marrow): bleeding, bruising, chills, fatigue, fever, infections, weakness. | X | ||
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 | ||
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 | ||
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, shortness of breath (can be sudden), blood clot in lungs. | X | ||
| 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 | ||
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 | ||
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 | ||
Allergic (hypersensitivity) 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, talk to your healthcare professional.
Storage:
Thiotepa for Injection USP will be managed and stored by healthcare professionals. The information on how to store Thiotepa for Injection USP is meant for your healthcare professional.
Store powder refrigerated (2°C to 8°C). Do not freeze. Keep out of the reach and sight of children.
If you want more information about Thiotepa for Injection USP:
- 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.sterimaxinc.com, or by calling 1-800-881-3550.
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.