KEYTRUDA pembrolizumab (rch) 100mg/4 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pembrolizumab, Quantity: 100 mg

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

pembrolizumab

Pharmaceutical form:

Injection, concentrated

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Melanoma,KEYTRUDA? (pembrolizumab) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults.,KEYTRUDA? (pembrolizumab) is indicated for the adjuvant treatment of adult and adolescent (12 years and older) patients with Stage IIB, IIC, or III melanoma who have undergone complete resection.,Non-small cell lung cancer (NSCLC),,KEYTRUDA? (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations.,KEYTRUDA? (pembrolizumab), in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.,KEYTRUDA? (pembrolizumab) is indicated as monotherapy for the first-line treatment of patients with NSCLC expressing PD-L1 [tumour proportion score (TPS) greater than or equal 1%] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and is,,? stage III where patients are not candidates for surgical resection or definitive chemoradiation, or,,? metastatic.,KEYTRUDA? (pembrolizumab) is indicated as monotherapy for the treatment of patients with advanced NSCLC whose tumours express PD-L1 with a greater than or equal 1% TPS as determined by a validated test and who have received platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving KEYTRUDA.,KEYTRUDA? (pembrolizumab) is indicated as monotherapy for the adjuvant treatment of patients with Stage IB (T2a greater than or equal 4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.,Head and Neck Squamous Cell Cancer (HNSCC),,KEYTRUDA? (pembrolizumab), as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and whose tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal 1] as determined by a validated test.,KEYTRUDA? (pembrolizumab) is indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum-containing chemotherapy and whose tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal 1] as determined by a validated test.,Classical Hodgkin Lymphoma (cHL),KEYTRUDA? (pembrolizumab) is indicated as monotherapy for the treatment of adult and paediatric patients with relapsed or refractory classical Hodgkin Lymphoma (cHL):,1. following autologous stem cell transplant (ASCT) or,,2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.,The approval of this indication in paediatric patients is on the basis of objective response rate from patients aged 11 years and older from single arm trial data and extrapolation from adult data (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).,Primary mediastinal B-Cell Lymphoma (PMBCL),,KEYTRUDA? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. The approval of this indication is on the basis of objective response rate (ORR) and duration of response from non-randomised studies. See Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials.,Urothelial carcinoma,,KEYTRUDA? (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy. This indication is approved based on overall response rate and duration of response in a single-arm study. Improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,KEYTRUDA? (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy.,Endometrial carcinoma,,KEYTRUDA? (pembrolizumab), in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.,Cervical Cancer,KEYTRUDA? (pembrolizumab) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal 1] as determined by a validated test.,Renal Cell Carcinoma (RCC),KEYTRUDA? (pembrolizumab), in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).,KEYTRUDA? in combination with LENVIMA? (lenvatinib) is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).,KEYTRUDA? (pembrolizumab), as monotherapy, is indicated for the adjuvant treatment of patients with RCC with a clear cell component who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (see section 5.1, Clinical Trials: Renal Cell Carcinoma).,Oesophageal Cancer,KEYTRUDA? (pembrolizumab), in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or HER2 negative gastroesophageal junction adenocarcinoma (tumour centre 1 to 5 centimetres above the gastroesophageal junction) that is not amenable to surgical resection or definitive chemoradiation.,Triple-Negative Breast Cancer,KEYTRUDA? (pembrolizumab) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.,KEYTRUDA? (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS greater than or equal 10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease. Urothelial carcinoma,KEYTRUDA? (pembrolizumab) is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.,This indication was approved via the provisional approval pathway based on complete response rate and duration of response. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.,Cutaneous Squamous Cell Carcinoma,,KEYTRUDA? (pembrolizumab) is indicated as monotherapy for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.,This indication was approved via the provisional approval pathway based on objective response rate and duration of response from a single-arm study. Improvements in overall survival, progression-free survival, or healthrelated quality of life have not been established. Full registration for this indication depends on submission of further clinical data to confirm the clinical benefit of the medicine.,Tumour Mutational Burden-High (TMB-H) cancer,KEYTRUDA? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) [greater than or equal 10 mutations/megabase (mut/Mb)] solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.,This indication was approved via the provisional approval pathway, based on the pooling of data on objective response rate and response duration across multiple different tissue types in a single-arm trial. The assumption that TMB-H status is predictive of the treatment effect of KEYTRUDA for every tissue type has not been verified. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) Cancer,KEYTRUDA? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic solid tumours that are MSI-H or dMMR, as determined by a validated test, that have progressed following prior treatment and when there are no satisfactory alternative treatment options.,Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) Colorectal Cancer,KEYTRUDA? (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a validated test.

Product summary:

Visual Identification: Clear to slightly opalescent, colourless to slightly yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-03-08

Patient Information leaflet

KEYTRUDA
®
K
E
Y
T
R
U
D
A
®
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 KEYTRUDA?
KEYTRUDA contains the active ingredient pembrolizumab. KEYTRUDA is
used to treat multiple kinds of cancer.
For more information, see Section 1. Why am I using KEYTRUDA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KEYTRUDA?
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
KEYTRUDA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with KEYTRUDA 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 USE KEYTRUDA?
•
Your doctor will give you KEYTRUDA through an IV for about 30 minutes.
•
Most people get KEYTRUDA every 3 weeks or every 6 weeks, depending on
the dose you are given.
•
Your doctor will decide how many treatments you need.
More instructions can be found in Section 4. How do I use KEYTRUDA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KEYTRUDA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
KEYTRUDA.
•
If you miss a dose of KEYTRUDA, call your doctor right away to
reschedule your appointment
DRIVING
OR USING
MACHINES
Be careful before you drive or use any machines or tools until you
know how KEYTRUDA affects you.
•
Fatigue has been reported following administration of KEYTRUDA.
For more information, see Section 5. What should I know while using
KEYTRUDA? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Like all medicines, KEYTRUDA can cause side effects, although not
everybody gets them. Your doctor will discuss th

Summary of Product characteristics

1
This medicinal product is subject to additional monitoring in
Australia due to provisional
approval of an extension of indication. 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.
AUSTRALIAN PRODUCT INFORMATION – KEYTRUDA
®
(PEMBROLIZUMAB (RCH))
1 NAME OF THE MEDICINE
pembrolizumab (rch)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 100 mg of pembrolizumab in 4 mL of solution.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
KEYTRUDA 100 mg/4 mL concentrated injection is a sterile,
preservative-free, clear to slightly
opalescent, colourless to slightly yellow solution.
Not
for
direct
infusion
or
injection
(see
Section
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Melanoma
KEYTRUDA
®
(pembrolizumab) is indicated as monotherapy for the treatment of
unresectable
or metastatic melanoma in adults.
KEYTRUDA
®
(pembrolizumab) is indicated as monotherapy for the adjuvant treatment
of
patients with melanoma with lymph node involvement who have undergone
complete
resection.
Non-small cell lung cancer (NSCLC)
KEYTRUDA
®
(pembrolizumab), in combination with pemetrexed and platinum
chemotherapy,
is indicated for the first-line treatment of patients with metastatic
non-squamous NSCLC, with
no EGFR or ALK genomic tumour aberrations.
KEYTRUDA
®
(pembrolizumab), in combination with carboplatin and either paclitaxel
or nab-
paclitaxel, is indicated for the first-line treatment of patients with
metastatic squamous NSCLC.
▼

2
KEYTRUDA
®
(pembrolizumab) is indicated as monotherapy for the first-line
treatment of
patients with NSCLC expressing PD-L1 [tumour proportion score (TPS)
≥1%] as determined
by a validated test, with no EGFR or ALK genomic tumour aberrations,
and is
•
stage
III
where
patients
are
not
candidates
for
surgical
resection
or
definitive
chemoradiation, or
•
metastatic.
K