Details for: BORTEZOMIB
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02456176 | BORTEZOMIB | BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) | 3.5 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02456176 | BORTEZOMIB | BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) | 3.5 MG / VIAL | POWDER FOR SOLUTION | SUBCUTANEOUS |
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
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 medically recognized combination therapy for initial treatment prior to stem cell transplant.
- Relapsed MM
- Mantle cell lymphoma, which is a cancer of the blood that affects the white blood cells.
- Relapsed/refractory mantle cell lymphoma.
What it does
BORTEZOMIB is a chemotherapy medicine, which is medicine used to kill cancer cells.
When it should not be used
Do not use BORTEZOMIB if you are allergic
(hypersensitive) to bortezomib, boron or to any of the
other ingredients of BORTEZOMIB.
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
BORTEZOMIB is available as a powder which will be dissolved in a sterile sodium chloride solution before being injected. Each pack of BORTEZOMIB contains one glass vial. Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
Warnings and precautions
Serious Warnings and Precautions
BORTEZOMIB must be administered under the
supervision of a physician qualified in the use of anticancer drugs.
Overdosage (≥ 2X recommended dose) could result in
death.
Serious side effects that may occur with
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 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 BORTEZOMIB;
- you are suffering from diarrhea, constipation, nausea or vomiting, as this may become worse during 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 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 BORTEZOMIB treatment.)
- you are pregnant, planning to become pregnant or breast-feeding.
BORTEZOMIB has not been studied in children or
adolescents.
Contraception and Pregnancy:
Both men and women must use effective
contraception while receiving BORTEZOMIB, and
for 3 months after their treatment. You must make
sure that you do not become pregnant while receiving
BORTEZOMIB, but if you do, inform your doctor
immediately. BORTEZOMIB may cause harm to
your unborn baby.
Breast-feeding:
It is advised that you do not breast-feed while you are
receiving BORTEZOMIB. If you wish to restart
breast-feeding after your 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:
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 BORTEZOMIB treatment, check
your blood sugar level frequently. Call your doctor if
you notice an unusual change.
Proper use of this medication
BORTEZOMIB is to be given to you as an injection. BORTEZOMIB may be injected:
-
a. into the vein (intravenous injection). The injection
will take 3 to 5 seconds, or
b. 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.
Previously Untreated Multiple Myeloma
The treatment consists of nine 6-week treatment cycles. Each treatment cycle consists of 6 weeks. In cycles 1-4, BORTEZOMIB is given twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32. In cycles 5-9, 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 BORTEZOMIB together with other medicines as initial treatment before you receive high dose chemotherapy and bone marrow transplantation. 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
BORTEZOMIB is given twice weekly on days 1, 4, 8 and 11of a 3-week treatment cycle. In maintenance treatment, 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 BORTEZOMIB more frequently than you should, or too high a dose, or in case of drug overdose, contact a health care practitioner, 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 BORTEZOMIB, tell your healthcare provider immediately
Side effects and what to do about them
Like all medicines, BORTEZOMIB can have side effects. The following are the most commonly reported side effects (≥10%):
Blood and lymph disorders: Low red or 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 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 BORTEZOMIB, contact your doctor or pharmacist.
How to store
BORTEZOMIB should be kept out of the reach and
sight of children.
Unopened vials of 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 a
maximum of 8 hours at 25°C in the original vial or a
syringe prior to administration.
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 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
This leaflet is Part III of a three-part “Product Monograph” published when BORTEZOMIB was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about BORTEZOMIB. Contact your doctor or pharmacist if you have any questions about the drug.
If you want more information about BORTEZOMIB:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website www.canada.ca/en/health-canada.html. Find the Consumer Information on the manufacturer's website www.apotex.ca/products or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Last revised: February 15, 2019