Bortezomib-AFT

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Bortezomib 3.5mg (as a mannitol boronic ester)

Tillgänglig från:

AFT Pharmaceuticals Ltd

Dos:

3.5 mg

Läkemedelsform:

Powder for injection

Sammansättning:

Active: Bortezomib 3.5mg (as a mannitol boronic ester) Excipient: Mannitol

Receptbelagda typ:

Prescription

Terapeutiska indikationer:

Bortezomib-AFT, in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. Bortezomib-AFT, 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-AFT is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

Produktsammanfattning:

Package - Contents - Shelf Life: Vial, glass, Single use, Type 1 with bromobutyl stopper, Al overseal/plastic flip-off disc, in outer carton - 1 dose units - 24 months from date of manufacture stored at or below 30°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Tillstånd datum:

2020-10-21

Bipacksedel

New Zealand Consumer Medicine Information
BORTEZOMIB-AFT
BORTEZOMIB
3.5 mg Powder for injection
WHAT IS IN THIS LEAFLET
Please use this leaflet carefully before you are given Bortezomib-AFT.
This leaflet answers some common
questions about Bortezomib-AFT. It does not contain
all the available information. It
does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given Bortezomib-AFT against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with you. You may need to read it again.
WHAT BORTEZOMIB-AFT IS USED FOR
Bortezomib-AFT is used in adults to treat 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-AFT belongs to a group of medicines called antineoplastic
or cytotoxic medicines. You may also hear of these
being called chemotherapy medicines. These medicines are used to kill
cancer cells.
Your doctor may have prescribed Bortezomib-AFT for another reason.
Ask your doctor if you have any
questions about why Bortezomib-AFT have been
prescribed for you.
This medicine is available only with a doctor’s prescription.
This medicine is not addictive.
This medicine is not expected to affect your ability to drive a car or
operate machinery.
BEFORE YOU ARE GIVEN BORTEZOMIB-AFT
_WHEN YOU MUST NOT BE GIVEN IT _
Do not use Bortezomib-AFT if:
•
you know you are allergic (hypersensitive) to bortezomib or boron or
mannitol.
If you are not sure if you are allergic to any of the above, ask your
doctor.
Symptoms of an allergic reaction may include shortness of breath,
wheezing or difficulty breathing; swelling of the face,
lips, tongue or to other parts of the body; skin rash, itching or
hives.
_BEFORE YOU START TO USE IT _

Produktens egenskaper

NEW ZEALAND DATA SHEET
1.
BORTEZOMIB-AFT 3.5 MG POWDER FOR INJECTION
Bortezomib 3.5 mg powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bortezomib-AFT (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.
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.
When reconstituted, Bortezomib-AFT has a pH of 4.0 – 7.0.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Bortezomib-AFT, in combination with melphalan and prednisone is
indicated for the
treatment of patients with previously untreated multiple myeloma who
are not suitable
for high dose chemotherapy.
Bortezomib-AFT, 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-AFT is also indicated for the treatment of multiple myeloma
patients
who have received at least one prior therapy, and who have progressive
disease.
4.2.
DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
BORTEZOMIB-AFT IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY.
INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.
Bortezomib-AFT 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/mL)
BECAUSE
EACH
ROUTE
OF
ADMINISTRATION
HAS
A
DIFFERENT
RECONSTITUTED
CONCENTRATION,
CAUTION
SHOULD BE USED WHEN CALCULATING THE VOLUME TO BE
ADMINISTERED.
Bortezomib retreatment may be considered for multiple myeloma patients
who had
previously
responded
to
treatment
with
bortezomib
(see
SECTION
5.1
PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS).
_PREVIOUSLY UNTREATED MULTIPLE MYELOMA – TRANSPLANT ELIGIBLE _
1.
BORTEZOMIB-AFT PLUS THALIDOMIDE-DEXAMETHASONE
During the induction stage, Bortezomib-AF