Details for: ACT BORTEZOMIB
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02438399 | ACT BORTEZOMIB | BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) | 3.5 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02438399 | ACT BORTEZOMIB | BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) | 3.5 MG / VIAL | POWDER FOR SOLUTION | SUBCUTANEOUS |
Summary Reports
Summary Safety Review - Bortezomib (VELCADE and Generics) - Assessing a Potential Link with Flesh-Eating Disease (Necrotising Fasciitis)
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
ACT BORTEZOMIB is used for the treatment of adult patients with:
- Previously untreated Multiple Myeloma (MM) who are unsuitable for stem cell transplantation as part of combination therapy. MM is a cancer of the bone marrow
- Previously untreated MM who are suitable for stem cell transplantation as part of a medically recognized combination therapy for initial treatment prior to stem cell transplant.
- Relapsed MM
- Mantle cell lymphoma. Mantle cell lymphoma is a cancer of the blood that affects the white blood cells.
- Relapsed/refractory mantle cell lymphoma.
What it does
ACT BORTEZOMIB is a chemotherapy medicine, which is medicine used to kill cancer cells.
When it should not be used
Do not use ACT BORTEZOMIB if you are allergic (hypersensitive) to bortezomib, boron or to any of the other ingredients of ACT BORTEZOMIB.
ACT BORTEZOMIB must not be given intrathecally.
What the medicinal ingredient is
bortezomib mannitol boronic ester
What the non-medicinal ingredients are
mannitol
What dosage form it comes in
ACT BORTEZOMIB is available as a powder which will be dissolved in a sterile sodium chloride solution before being injected.
Each pack of ACT BORTEZOMIB contains one glass vial. Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
The vial stopper is free of natural rubber latex.
Warnings and precautions
Serious Warnings and Precautions
ACT BORTEZOMIB must be administered under the supervision of a physician qualified in the use of anticancer drugs.
Overdose (≥ 2X recommended dose) could result in death.
Serious side effects that may occur with ACT BORTEZOMIB include:
- Low blood pressure and other serious heart disorders
- Bleeding into the brain or gastrointestinal tract (stomach or bowel)
- Muscle weakness due to nerve damage (severe motor neuropathy)
- Acute lung disease (acute diffuse infiltrative pulmonary disease)
BEFORE you use ACT BORTEZOMIB, talk to your doctor or pharmacist if:
- you have had any bleeding problems, a low level of red blood cells, platelets, or white blood cells, as these conditions may become worse during treatment with ACT BORTEZOMIB;
- you are suffering from diarrhea, constipation, nausea or vomiting, as this may become worse during ACT BORTEZOMIB treatment;
- you have any problems with your heart or blood pressure including a history of fainting, dizziness or light-headedness;
- you have any problems with your kidneys;
- you have any problems with your liver;
- you have had any problems in the past with numbness, tingling, or pain in the hands or feet neuropathy); (This effect may become worse during ACT BORTEZOMIB treatment.);
- you have been diagnosed in the past with a condition called amyloidosis (abnormal protein deposition in tissues);
- you have shortness of breath with activity (progressively worsens), cough, and difficulty breathing; (Symptoms may develop or worsen during ACT BORTEZOMIB treatment.)
- you are pregnant, planning to become pregnant or breastfeeding.
Contraception and Pregnancy:
Both men and women must use effective contraception while receiving ACT BORTEZOMIB, and for 3 months after their treatment. You must make sure that you do not become pregnant while receiving ACT BORTEZOMIB, but if you do, inform your doctor immediately. ACT BORTEZOMIB may cause harm to your unborn baby.
Breast-feeding:
It is advised that you do not breast-feed while you are receiving ACT BORTEZOMIB. If you wish to restart breastfeeding after your ACT BORTEZOMIB treatment, you must discuss this with your doctor or nurse, who will tell you when it is safe to do so.
Driving and using machines:
ACT BORTEZOMIB might cause low blood pressure that may lead to tiredness, dizziness, fainting, or blurred vision. Do not drive or operate any dangerous tools or machines if you experience such side effects. Even if you have not felt these effects, you must still be cautious.
Interactions with this medication
Inform your doctor, medical health personnel or pharmacist about all medicines you are taking, whether prescribed for you or bought without a prescription.
If you are a patient on oral antidiabetic medication while receiving ACT BORTEZOMIB treatment, check your blood sugar level frequently. Call your doctor if you notice an unusual change.
Proper use of this medication
ACT BORTEZOMIB is to be given to you as an injection.
ACT BORTEZOMIB may be injected:
- into the vein (intravenous injection). The injection will take 3 to 5 seconds, or
- under the skin (subcutaneous injection) of the thigh (right or left) or abdomen (right or left). The site of injection should be rotated for each following injection. New injections should be at least one inch (2.5 cm) from an old site and never into the areas where the site is tender, bruised, red, or hard.
Usual Dose
The dose will be calculated from your height and weight. The usual dose is 1.3 mg/m2 body surface area.
Frequency of treatment
Previously Untreated Multiple Myeloma
The treatment consists of nine 6-week treatment cycles. Each treatment cycle consists of 6 weeks. In cycles 1-4, ACT BORTEZOMIB is given twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32. In cycles 5-9, ACT BORTEZOMIB is given once a week on days 1, 8, 22 and 29.
Patients Suitable for Stem Cell Transplantation
If you have not been treated before for multiple myeloma, you will receive ACT BORTEZOMIB together with other medicines as initial treatment before you receive high dose chemotherapy and bone marrow transplantation. ACT BORTEZOMIB will be given on days 1, 4, 8 and 11, followed by a rest period without treatment. The dose may be adjusted based on how you respond to the treatment.
Your doctor will choose the other chemotherapy medicines for you.
Relapsed Multiple Myeloma and Relapsed/Refractory Mantle Cell Lymphoma
ACT BORTEZOMIB is given twice weekly on days 1, 4, 8 and 11 of a 3-week treatment cycle. In maintenance treatment, ACT BORTEZOMIB is given once a week for 4 weeks on days 1, 8, 15 and 22.
Your doctor may change the dosage during the treatment, and will decide the total number of cycles that you need. It all depends on your response to the treatment.
Overdose
If you think that you have been given ACT BORTEZOMIB more frequently than you should, or too high a dose, or in case of drug overdose, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you think that you have missed a dose of ACT BORTEZOMIB, tell your healthcare provider immediately.
Side effects and what to do about them
Like all medicines, ACT BORTEZOMIB can have side effects. The following are the most commonly reported side effects (≥10%):
Blood and lymph disorders: Low red blood cells, white blood cells or platelets causing anemia, bruising or bleeding
Eye disorders: blurred vision
Gastrointestinal disorders: feeling sick in the stomach or loss of appetite, diarrhea, constipation, vomiting, abdominal pain, heartburn, stomach ulcers
General disorders: general ill feeling, tiredness, or a feeling of weakness, fever, swelling (around the arms, legs or face), shivering
Infections: shingles (herpes zoster virus), flu-like symptoms, chest and other infections
Metabolism and nutrition disorders: dehydration, losing weight
Musculoskeletal disorders: joint or muscle stiffness, muscle cramps, muscle or bone pain, back pain
Nervous system disorders: numbness, tingling or burning sensation in the hands or feet, headache, dizziness
Psychiatric disorders: difficulty in sleeping, anxiety or depression (feeling down), confusion
Respiratory disorders: shortness of breath, cough
Skin disorders: rash and/or itching, hives, redness, pain at the injection site when injected under the skin
Cardiovascular disorders: sudden fall of blood pressure on standing which may lead to fainting, pericarditis or inflammation of the lining around the heart, increase in blood pressure
The types of side effects that may be experienced are similar whether ACT BORTEZOMIB is given by subcutaneous injection or by intravenous injection.
If you notice these or any other effects not mentioned in this leaflet, inform your doctor or pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | |
|---|---|---|---|
| Common | |||
| Fever | ✔ | ||
| Chest and other infections including shingles | ✔ | ||
| Diarrhea | ✔ | ||
| Vomiting | ✔ | ||
| Dehydration (dry mouth, excessive thirst, dark yellow urine) | ✔ | ||
| Nausea | ✔ | ||
| Difficulty breathing/breathlessness | ✔ | ||
| Altered sensation/pins and needles in hands or feet | ✔ | ||
| Pain and altered sensation | ✔ | ||
| Bleeding from gums or other sites or abnormal bruising | ✔ | ||
| Tiredness/lethargy | ✔ | ||
| Joint pain and muscle cramps | ✔ | ||
| Headache | ✔ | ||
| Low blood pressure (dizziness or fainting) | ✔ | ||
| Increase in blood pressure | ✔ | ||
| Uncommon | |||
| Swelling of face or neck | ✔ | ||
| Swelling of ankles | ✔ | ||
| Chest palpitations/awareness of abnormal heart rhythm/abnormal electrical signal from an electrocardiogram (ECG) reading | ✔ | ||
| Angina (chest pain) | ✔ | ||
| Loss of appetite | ✔ | ||
| Severe abdominal pain with or without bleeding | ✔ | ||
| Constipation | ✔ | ||
| Yellowing of skin or whites of eyes | ✔ | ||
| Skin rash | ✔ | ||
| Difficulty moving limbs, walking or speaking, stroke | ✔ | ||
| Confusion | ✔ | ||
| Seizure (fits) | ✔ | ||
| Loss of control or inability to pass urine | ✔ | ||
| Muscle weakness | ✔ | ||
| New onset or worsening neurological signs or symptoms such as confusion or problems thinking, loss of balance, blurred vision or loss of vision, decreased strength or weakness in an arm or leg or change in the way of walking or talking (these may be signs of a serious brain infections and your doctor may suggest further testing and follow-up) | ✔ | ||
| Anaphylactic (allergic) reaction | ✔ | ||
| Rare | |||
| Red and swollen eyelids (blepharitis) or cyst in the eyelid (chalazion) | ✔ | ||
| Very Rare | |||
| Blood clot in very small blood vessels (also called ‘thrombotic microangiopathy’), which is usually associated with bleeding, bruising, and kidney injury. | ✔ | ||
Two cases of sudden death have been reported in clinical trials with bortezomib.
This is not a complete list of side effects. For any unexpected effects while taking ACT BORTEZOMIB, contact your doctor or pharmacist.
How to store
ACT BORTEZOMIB should be kept out of the reach and sight of children.
ACT BORTEZOMIB should be stored between 15 to 30°C. Keep the container in the outer carton in order to protect it from light. Do not use after the expiry date stated on the vial and the carton.
The reconstituted solution may be stored for 8 hours at 25°C in the original vial or a syringe prior to administration, with a maximum of 8 hours in the syringe.
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/healthcanada/services/drugs-health-products/medeffectcanada/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 ACT BORTEZOMIB:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for
healthcare professionals and includes the Consumer
Information by visiting the Health Canada website
(https://health-products.canada.ca/dpd-bdpp/indexeng.jsp); or by contacting the sponsor, Teva Canada
Limited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court