Kyprolis

দেশ: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Carfilzomib 60mg;  ;  

থেকে পাওয়া:

Amgen New Zealand Limited

ডোজ:

60 mg

ফার্মাসিউটিকাল ফর্ম:

Powder for infusion

রচনা:

Active: Carfilzomib 60mg     Excipient: Citric acid Sodium hydroxide Sulfobutyl betadex sodium

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক ইঙ্গিত:

Kyprolis in combination with either lenalidomide and dexamethasone, or dexamethasone alone, is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Vial, glass, single dose, Type 1 in outer cardboard carton - 60 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 hours reconstituted (not refrigerated) stored at or below 25°C protect from light

অনুমোদন তারিখ:

2017-07-19

তথ্য লিফলেট

KYPROLIS
®
1
KYPROLIS
®
_Carfilzomib (kar FILZ oh mib) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Kyprolis. It does not
contain all the available information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Kyprolis
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT KYPROLIS IS USED
FOR
Kyprolis is a type of medicine used
to treat patients with multiple
myeloma (cancer of blood cells).
Kyprolis will be given to you in
combination with other medicines
that are also used to treat multiple
myeloma.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE KYPROLIS IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
carfilzomib
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT USE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK.
If you use it after the expiry date has
passed, it may not work as well.
DO NOT USE IT IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF TAMPERING.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE, TALK
TO YOUR DOCTOR, NURSE OR
PHARMACIST.
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR DYES.
TELL YOUR DOCTOR OR NURSE IF YOU
HAVE, OR HAVE HAD, ANY OF THE
FOLLOWING MEDICAL CONDITIONS
BEFORE HAVING KYPROLIS:
•
heart problems, including a
history of chest pain (angina),
heart attack, irregular he

পণ্য বৈশিষ্ট্য

NEW ZEALAND DATA SHEET
KYPROLIS CDS V20 DATA SHEET
PAGE 1 OF 38
1.
KYPROLIS
Kyprolis 30 mg powder for infusion
Kyprolis 60 mg powder for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carfilzomib 30 mg
Carfilzomib 60 mg
Excipient(s) with known effect
Each mL of reconstituted solution contains 7 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sterile, white to off-white lyophilised powder for infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kyprolis in combination with either lenalidomide and dexamethasone, or
dexamethasone
alone, is indicated for the treatment of adult patients with relapsed
or refractory multiple
myeloma who have received at least one prior therapy
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Kyprolis is administered intravenously (IV) as a 10 or a 30 minute
infusion either once or
twice weekly based on the selected regimen (see Table 1). Treatment
may be continued
until disease progression or until unacceptable toxicity occurs
TABLE 1: KYPROLIS DOSING INFORMATION
REGIMEN
KYPROLIS STARTING
DOSE
IF TOLERATED, INCREASE
KYPROLIS DOSE ON DAY
8 OF CYCLE1 TO
KYPROLIS
INFUSION TIME
A
Kyprolis in
combination with
lenalidomide and
dexamethasone
20 mg /m
2
27 mg /m
2
twice weekly
10 minutes
20 mg /m
2
56 mg /m
2
twice weekly
30 minutes
NEW ZEALAND DATA SHEET
KYPROLIS CDS V20 DATA SHEET
PAGE 2 OF 38
Kyprolis in
combination with
dexamethasone
20 mg /m
2
70 mg /m
2
once weekly
30 minutes
a
Infusion time remains consistent throughout each regimen
The dose is calculated using the patient’s baseline body surface
area (BSA). Patients
with a BSA of greater than 2.2 m
2
should receive a dose based upon a BSA of 2.2 m
2
.
Dose adjustments do not need to be made for weight changes of less
than or equal to
20
%
.
Kyprolis in combination with lenalidomide and dexamethasone
Kyprolis is administered at a starting dose of 20 mg/m
2
in cycle 1 on days 1 and 2. If
tolerated, the dose should be increased to 27 mg/m
2
on day 8 of cycle 1. Kyprolis is
omitted on Days 8