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Details for: PMS-BORTEZOMIB

Company: PHARMASCIENCE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02466708PMS-BORTEZOMIBBORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)3.5 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
02466708PMS-BORTEZOMIBBORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)3.5 MG / VIALPOWDER FOR SOLUTIONSUBCUTANEOUS
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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.
pms-BORTEZOMIB has not been studied in children or adolescents.

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:

  1. into the vein (intravenous injection). The injection will take 3 to 5 seconds, or
  2. 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

If you think that you have been given pms-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 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.

Serious side effects, how often they happen and what to do about them
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
www.pharmascience.com

Last revised: March 8, 2019

Date modified: