BORTEZOMIB ACCORD bortezomib 3.5 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bortezomib, Quantity: 3.5 mg

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: mannitol

Administration route:

Intravenous, Subcutaneous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bortezomib, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,Bortezomib, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,Bortezomib is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Product summary:

Visual Identification: A white to off-white cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-02-09

Patient Information leaflet

Bortezomib Accord - version 1
1
BORTEZOMIB ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BORTEZOMIB ACCORD?
Bortezomib Accord contains the active ingredient bortezomib.
Bortezomib Accord is used to treat adults with multiple
myeloma (cancer of the bone marrow). Bortezomib Accord is also used
for the treatment of mantle cell lymphoma (a type of
cancer affecting the lymph nodes) in adults in combination with the
medicines rituximab, cyclophosphamide, doxorubicin and
prednisone, for patients whose disease has not been previously
treated.
For more information, see Section 1. Why am I using Bortezomib Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BORTEZOMIB ACCORD?
Do not use if you have ever had an allergic reaction to bortezomib or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Bortezomib Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Bortezomib Accord and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE BORTEZOMIB ACCORD?
Bortezomib Accord is an injection and will be given to you by your
doctor or nurse.
More instructions can be found in Section 4. How do I use Bortezomib
Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BORTEZOMIB ACCORD?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Bortezomib Accord.
•
Be sure to keep all your doctor's appointments so your progress can be
checked.
•
Keep follow up appointments with your doctor. It is important to have
your follow-up doses of
Bortezomib Accord at the appropriate times to get the b

Summary of Product characteristics

Page 1 of 38
AUSTRALIAN PRODUCT INFORMATION
BORTEZOMIB ACCORD (BORTEZOMIB) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Bortezomib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bortezomib
Accord
(bortezomib)
is
an
antineoplastic
agent
for
intravenous
injection
(IV)
or
subcutaneous (SC) use only. Each single dose vial contains 1 mg or 3.5
mg of bortezomib.
Bortezomib is a modified dipeptidyl boronic acid. The product is
provided as a mannitol boronic ester
which, in reconstituted form, consists of the mannitol ester in
equilibrium with its hydrolysis product,
the monomeric boronic acid.
The solubility of bortezomib, as the monomeric boronic acid, in water
is: 3.3 - 3.8 mg/mL in a pH range
of 2 - 6.5.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Each single dose vial contains bortezomib as a sterile lyophilised
powder.
The 1 mg bortezomib for solution product is for IV injection only. The
3.5 mg product for solution is for
IV or SC injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Bortezomib Accord, in combination with melphalan and prednisone is
indicated for the treatment of
patients with previously untreated multiple myeloma who are not
candidates for high dose chemotherapy.
Bortezomib Accord, as part of combination therapy, is indicated for
induction therapy prior to high dose
chemotherapy with autologous stem cell rescue for patients under 65
years of age with previously
untreated multiple myeloma.
Bortezomib Accord is also indicated for the treatment of multiple
myeloma patients who have received
at least one prior therapy, and who have progressive disease.
Bortezomib Accord in combination with rituximab, cyclophosphamide,
doxorubicin and prednisone is
indicated for the treatment of adult patients with previously
untreated mantle cell lymphoma.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Bortezomib Accord may be administered:
•
Intravenously (at a concentration of 1 mg/mL) as a 3-5 second bolus
injection or
•
Subcutaneously (at a concentration of 2.5 mg/m