RYBREVANT amivantamab 350 mg/7 mL concentrate for solution for infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amivantamab, Quantity: 350 mg

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RYBREVANT has provisional approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has an activating epidermal-growth factor receptor (EGFR) exon 20 insertion mutation, whose disease has progressed on or after platinum-based chemotherapy.,The decision to approve this indication has been made on the basis of objective response rate and duration of response in a single arm study. Continued approval of this indication depends on verification and description of benefit in a confirmatory study.

Product summary:

Visual Identification: Colourless to pale yellow preservative-free liquid concentrate for intravenous infusion after dilution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-12-01

Patient Information leaflet

RYBREVANT® (221201) ACMI
1
RYBREVANT®
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. Please report side effects. See the full CMI for
further details.
1.
WHY AM I RECEIVING RYBREVANT?
RYBREVANT contains the active ingredient amivantamab.
RYBREVANT is used in adults with a type of cancer called ‘non-small
cell lung cancer’. It is used when the cancer has spread in
your body and has gone through certain cancer changes (Exon 20
insertion mutations) in a gene called ‘EGFR’.
For more information, see Section 1. Why am I receiving RYBREVANT?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I RECEIVE RYBREVANT?
Do not receive if you have ever had an allergic reaction to any of the
ingredients listed at the end of the full CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT, PLAN TO BECOME
PREGNANT, ARE TRYING TO MAKE YOUR PARTNER PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I
receive RYBREVANT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with RYBREVANT and affect how it works.
For more information, see Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I RECEIVE RYBREVANT?
RYBREVANT will be given to you by a doctor or nurse. It is given as a
drip into a vein (‘intravenous infusion’) over several hours.
Your doctor will work out your dose of RYBREVANT. The dose of
RYBREVANT will depend on your body weight at the start of your
therapy.
More information can be found in Section 4. How do I receive
RYBREVANT?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING RYBREVANT?
THINGS YOU
SHOULD DO
•
CALL YOUR DOCTOR OR NURSE STRAIGHT AWAY IF YOU EXPERIENCE ANY OF THE
FOLLOWING: any side effect
during the intravenous infusion (drip into a vein) of RYBREVANT;
sudden difficulty in breathing,
cough,

Summary of Product characteristics

This medicine is subject to additional monitoring in Australia. This
will allow quick identification of new
safety
information.
Healthcare
professionals
are
asked
to
report
any
suspected
adverse
events
at
www.tga.gov.au/reporting-problems.
2.211116
Page 1 of 15
RYBREVANT (221201) API
▼
AUSTRALIAN PRODUCT INFORMATION
RYBREVANT
® (AMIVANTAMAB)
CONCENTRATE FOR SOLUTION FOR INFUSION
1. NAME OF THE MEDICINE
Amivantamab
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use vial contains 350 mg of amivantamab per 7 mL vial (or
50 mg of amivantamab per
mL).
Amivantamab is a fully-human immunoglobulin G1 (IgG1)-based bispecific
antibody directed against
the
epidermal
growth
factor
(EGF)
and
mesenchymal-epidermal
transition
(MET)
receptors,
produced by a mammalian cell line (Chinese Hamster Ovary [CHO]) using
recombinant DNA
technology (see Section 5.1 Mechanism of action).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion (injection).
RYBREVANT is available as a colourless to pale yellow
preservative-free liquid concentrate for
intravenous infusion after dilution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RYBREVANT has PROVISIONAL APPROVAL for the treatment of patients with
locally advanced or
metastatic non-small cell lung cancer (NSCLC) that has an activating
epidermal-growth factor
receptor (EGFR) exon 20 insertion mutation, whose disease has
progressed on or after platinum-
based chemotherapy.
The decision to approve this indication has been made on the basis of
objective response rate and
duration of response in a single arm study. Continued approval of this
indication depends on
verification and description of benefit in a confirmatory study.
2.211116
Page 2 of 15
RYBREVANT (221201) API
4.2 DOSE AND METHOD OF ADMINISTRATION
RYBREVANT should be administered by a healthcare professional in a
setting with appropriate
medical support for the management of infusion-related reactions
(IRRs), including equipment for
cardiorespiratory resuscitat