Details for: PMS-BORTEZOMIB
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02466708 | PMS-BORTEZOMIB | BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) | 3.5 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02466708 | PMS-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
pms-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
- Previously untreated mantle cell lymphoma who are unsuitable for stem cell transplantation. pms-BORTEZOMIB will be given as part of a medically recognized combination therapy. Mantle cell lymphoma is a cancer of the blood that affects the white blood cells.
- Relapsed/refractory mantle cell lymphoma.
What it does
pms-BORTEZOMIB is a chemotherapy medicine, which is medicine used to kill cancer cells.
When it should not be used
Do not use pms-BORTEZOMIB if you are allergic
(hypersensitive) to bortezomib, boron or to any of the other
ingredients of pms-BORTEZOMIB.
pms-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
pms-BORTEZOMIB is available as a powder which will be
dissolved in a sterile sodium chloride solution before being
injected.
Each pack of pms-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
pms-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
pms-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 pms-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 pms-BORTEZOMIB;
- you are suffering from diarrhea, constipation, nausea or vomiting, as this may become worse during pms-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 pms-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 pms-BORTEZOMIB treatment)
- you are pregnant, planning to become pregnant or breast-feeding.
Contraception and pregnancy:
Both men and women must use effective contraception while receiving pms-BORTEZOMIB, and for 3 months after their treatment. You must make sure that you do not become pregnant while receiving pms-BORTEZOMIB but if you do, inform your doctor immediately. pms-BORTEZOMIB may cause harm to your unborn baby.
Breast-feeding:
It is advised that you do not breast-feed while you are receiving pms-BORTEZOMIB. If you wish to restart breast-feeding after your pms-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:
pms-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 pms-BORTEZOMIB treatment, check your blood
sugar level frequently. Call your doctor if you notice an unusual
change.
Proper use of this medication
pms-BORTEZOMIB is to be given to you as an injection. pms-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,
pms-BORTEZOMIB is given twice weekly on days 1, 4, 8, 11,
22, 25, 29 and 32. In cycles 5-9, pms-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 pms-BORTEZOMIB together with other medicines
as initial treatment before you receive high dose chemotherapy
and bone marrow transplantation. pms-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 melapsed/ refractory
mantle cell lymphoma
pms-BORTEZOMIB is given twice weekly on days 1, 4, 8 and
11 of a 3-week treatment cycle. In maintenance treatment,
pms-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.
Previously untreated mantle cell lymphoma
If you have not been treated before for mantle cell lymphoma
you will receive pms-BORTEZOMIB together with other
chemotherapy agents as prescribed by your doctor.
pms-BORTEZOMIB is given on days 1, 4, 8 and 11, followed
by a ‘rest period’ without treatment. The duration of a treatment
cycle is 21 days (3 weeks). You might receive up to 8 cycles (24
weeks).
Overdose
Missed Dose
If you think that you have missed a dose of pms-BORTEZOMIB, tell your healthcare provider immediately.
Side effects and what to do about them
Like all medicines, pms-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 pms-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, nurse, or pharmacist only if severe | Talk with your doctor, nurse, 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 pms-BORTEZOMIB, contact your doctor
or pharmacist.
How to store
pms-BORTEZOMIB contains no antimicrobial preservative.
Storage conditions for the powder for injection:
Unopened vials may be stored between 15ºC and 30ºC.
Retain in original package to protect from light.
Storage conditions for the reconstituted solution:
The reconstituted solution should be administered within eight
hours of preparation when stored in the original vial or in a
syringe at room temperature between 15ºC to 30ºC. The
reconstituted solution may be stored for up to 8 hours in the
original vial and/or the syringe prior to administration, but the
total storage time for the reconstituted solution must not exceed
8 hours when exposed to normal indoor lighting.
pms-BORTEZOMIB should be kept out of the reach and sight
of children.
Do not use after the expiry date stated on the vial and the carton.
Single-use vials. Discard unused portion.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals, can be obtained by contacting
Pharmascience Inc., at 1-888-550-6060.
This leaflet was prepared by
-
Pharmascience Inc.
Montréal, Canada
H4P 2T4
Last revised: March 8, 2019