Consumer medicine information

1. Why am I using Bortezomib Baxter?

Bortezomib Baxter contains the active ingredient bortezomib. Bortezomib Baxter is used to treat adults with multiple myeloma (cancer of the bone marrow). It is prescribed for patients who have not been previously treated for multiple myeloma. It is also prescribed for patients who have received one or more prior treatments and whose cancer is still progressing. Bortezomib Baxter 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 Baxter? in the full CMI.

2. What should I know before I use Bortezomib Baxter?

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 Baxter? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Bortezomib Baxter and affect how it works. Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop. 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 Baxter?

Overall treatment with Bortezomib Baxter must be done under the supervision of a doctor. Your treatment with Bortezomib Baxter may be given by a healthcare professional (eg doctor or nurse) experienced in the administration of oncology medicines. More instructions can be found in Section 4. How do I use Bortezomib Baxter? in the full CMI.

5. What should I know while using Bortezomib Baxter?

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Bortezomib.

2 Qualitative and Quantitative Composition

Bortezomib Baxter (bortezomib) is an antineoplastic agent for intravenous injection (IV) or subcutaneous (SC) use only. Each single dose vial contains:
3.5 mg of bortezomib as a sterile lyophilised powder. It also contains 35 mg mannitol.
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection. White to off-white cake or powder.

4 Clinical Particulars

4.9 Overdose

Cardiovascular safety pharmacology studies in monkeys and dogs showed that IV doses approximately two to three times the recommended clinical dose on a mg/m² basis are associated with increases in heart rate, decreases in contractility, hypotension and death. The decreased cardiac contractility and hypotension responded to acute intervention with positive ionotropic or pressor agents. In dog studies, a slight increase in the corrected QT interval was observed at a lethal dose.
In patients, overdosage more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes. There is no known specific antidote for bortezomib overdosage. In the event of overdosage, patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or ionotropic agents) and body temperature (see Section 4.2 Dose and Method of Administration; Section 4.4 Special Warnings and Precautions for Use).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Bortezomib showed clastogenic activity at a high concentration (3 microgram/mL) in an in vitro chromosomal aberration assay using Chinese hamster ovary cells. Clastogenic activity was not observed in vivo in a mouse micronucleus test using intravenous doses of up to 3 mg/m². Bortezomib was not genotoxic in in vitro tests for bacterial gene mutation.
Carcinogenicity. Carcinogenicity studies have not been conducted with bortezomib.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

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 drug substance exists in its cyclic anhydride form as a trimeric boroxine.
The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1- [[(2S)- 1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl] 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.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBORTEZ.gif CAS number. 179324-69-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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