AJOVY fremanezumab 225 mg/1.5 mL solution for injection in an autoinjector

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

Fremanezumab, Quantity: 225 mg

제공처:

Teva Pharma Australia Pty Ltd

약제 형태:

Injection, solution

구성:

Excipient Ingredients: histidine; disodium edetate; histidine hydrochloride monohydrate; polysorbate 80; sucrose; water for injections

관리 경로:

Subcutaneous

패키지 단위:

3 Autoinjectors, 1 Autoinjector

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

AJOVY is indicated for the preventive treatment of migraine in adults.

제품 요약:

Visual Identification: Sterile-filtered, preservative-free, clear/opalescent, colorless/slightly yellow solution. Aseptically filled into single-use autoinjector (AI); Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

승인 상태:

Registered

승인 날짜:

2021-06-02

환자 정보 전단

AJOVY
®
A
J
O
V
Y
®
V
3
.
0
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.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING AJOVY?
AJOVY contains the active ingredient fremanezumab. AJOVY is used to
prevent migraine in adults.
For more information, see Section 1. Why am I using AJOVY? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AJOVY?
Do not use if you have ever had an allergic reaction to AJOVY 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
AJOVY? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AJOVY 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 AJOVY?
•
Follow all directions given to you by your doctor or pharmacist
carefully.
•
AJOVY must only be given by subcutaneous injection.
More instructions can be found in Section 4. How do I use AJOVY? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AJOVY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
AJOVY.
•
Keep all of your doctor’s appointments so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not take AJOVY to treat any other complaints unless your doctor
tells you to.
•
Do not administer AJOVY by any other method or route other than
subcutaneous injection.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how AJOVY
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Store in a refrigerator (2°c to 8°c). Do not freeze.
•
AJOVY may be stored unrefrigerated for up to 7 days

제품 특성 요약

Teva Pharma Australia Pty Limited
Version 5.0
1
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse events. See
Section 4.8 for how to report adverse events.
AUSTRALIAN PI – AJOVY
®
(FREMANEZUMAB) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Fremanezumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 225 mg fremanezumab in 1.5 mL (150
mg/mL).
One autoinjector contains 225 mg fremanezumab in 1.5 mL (150 mg/mL).
Fremanezumab is a fully humanised monoclonal antibody produced in
Chinese Hamster Ovary (CHO) cells
by recombinant DNA technology.
For the full list of excipients, see Section 6.1 “List of
excipients”.
3.
PHARMACEUTICAL FORM
AJOVY is a sterile, preservative-free solution for injection available
as follows:
•
225 mg/1.5 mL in a single-dose autoinjector
•
225 mg/1.5 mL in a single-dose pre-filled syringe.
AJOVY is a clear to opalescent, colourless to slightly yellow solution
with a pH of 5.5 and an osmolality of
300-450 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AJOVY is indicated for the preventive treatment of migraine in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
AJOVY should be initiated by a physician experienced in the diagnosis
and treatment of migraine.
AJOVY should ONLY be administered by subcutaneous injection.
Two dosing options are available:
•
225 mg once monthly (monthly dosing); or
•
675 mg every three months (quarterly dosing)
When switching dosing regimens, the first dose of the new regimen
should be administered on the next
scheduled dosing date of the prior regimen.
The treatment benefit should be assessed 8-12 weeks after initiation
of treatment. Any further decision to
continue treatment should be taken on an individual patient basis.
Evaluation of the need to continue
treatment is recommended regularly thereafter.
Teva Pharma Australia Pty Limited
Version 5.0
2
_Missed dose_
If