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Keytruda Intravenous Powder For Injection

Keytruda (pembrolizumab) is a member of the Anti-PD-1 monoclonal antibodies drug class and is commonly used for Cervical      Cancer, Colorectal Cancer, Gastric Cancer, and others.

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What is Keytruda (pembrolizumab) for?

Keytruda (pembrolizumab) is a monoclonal antibody (immunotherapy) indicated for the treatment of people with:

advanced (unresectable or metastatic) melanoma
metastatic nonsquamous NSCLC as first-line treatment in combination with pemetrexed and carboplatin
recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
recurrent classical Hodgkin Lymphoma (cHL)
locally advanced or metastatic urothelial carcinoma
solid tumours having the biomarkers MSI-H or dMMR
recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma

How does Keytruda (pembrolizumab) work?

Keytruda (pembrolizumab) is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body. Keytruda (pembrolizumab) has been designed to attach to and block a receptor called ‘programmed cell death-1’ (PD-1), which switches off the activity of certain cells of the immune system (the body’s natural defences) called T cells. By blocking PD-1, pembrolizumab prevents PD-1 from switching off these immune cells, thereby increasing the ability of the immune system to kill cancer cells1.


Where has Keytruda (pembrolizumab) been approved?

Keytruda (pembrolizumab) was approved by:

Food and Drug Administration (FDA), USA:

September 4, 2014, for advanced or unresectable melanoma

October 2, 2015, for advanced (metastatic) NSCLC which progressed after other treatments and with tumours that express a protein called PD-L14

August 8, 2016, for recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HBSCC)

October 24, 2016, as first-line treatment for metastatic NSCLC with PD-L1 expression on ≥ 50 % of cells as determined by an FDA-approved test; in absence of EGFR or ALK genomic tumour aberrations, and for patients with metastatic NSCLC whose tumours express PD-L1 on ≥ 1 % of cells with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on other therapies approved for these aberrations prior to receiving pembrolizumab

March 14, 2017, for adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy

May 10, 2017, in combination with pemetrexed and carboplatin, as first-line treatment for metastatic nonsquamous NSCLC

May 18, 2017, for locally advanced or metastatic urothelial carcinoma in patients who are not eligible to (first-line treatment) or have disease progression during or following (second-line treatment) certain chemotherapies

May 23, 2017, for adult and pediatric patients with unresectable or metastatic solid tumors having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The indication is for tumours that progressed following prior treatment and who have no satisfactory alternative treatment options

September 22, 2017, for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (PD-L1 Combined Positive Score (CPS) ≥1), with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy

European Medical Agency (EMA), European Union:

July 17, 2015, for advanced or unresectable melanoma

June 23, 2016, for locally advanced or metastatic NSCLC

January 31, 2017, as first-line treatment of patients with metastatic NSCLC with PD-L1 on ≥50% of cells and without EGFR or ALK mutation8,9

May 2017, for relapsed or refractory classical Hodgkin lymphoma (cHL)

July 20, 2017, for locally advanced or metastatic urothelial carcinoma17

Therapeutic Goods Administration (TGA), Australia:

April 16, 2015, for advanced melanoma

March 6, 2017, for as first-line treatment of patients with metastatic NSCLC with PD-L1 on ≥50% of cells and without EGFR or ALK mutation

March 7, 2017, for advanced non-small cell lung carcinoma (NSCLC)

March 21, 2017, for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

for relapsed or refractory classical Hodgkin Lymphoma (cHL)

for locally advanced or metastatic urothelial carcinoma3

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Keytruda (pembrolizumab) taken?

The standard dosage is


Melanoma: 200 mg every 3 weeks
NSCLC: 200 mg every 3 weeks
HNSCC: 200 mg every 3 weeks
cHL: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics
Urothelial Carcinoma: 200 mg every 3 weeks
MSI-H Cancer: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for children
Gastric Cancer: 200 mg every 3 weeks.
Administer as an intravenous infusion over 30 minutes.

Complete information about Keytruda (pembrolizumab) dosage and administration can be found in the official prescribing information listed in our resources section

Note: Please consult with your treating doctor for personalised dosing.


Are there any known adverse reactions or side effects of Keytruda (pembrolizumab)?
Common side effects

The most common adverse reactions ( ≥20% of patients) listed in the prescribing information include1,2,3:


fatigue
musculoskeletal pain
decreased appetite
pruritus
diarrhea
nausea
rash
pyrexia
cough
dyspnea
constipation.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include


immune-mediated pneumonitis
immune-mediated colitis
immune-mediated hepatitis
immune-mediated endocrinopathies:
Hypophysitis
Thyroid disorders
Type 1 diabetes mellitus
immune-mediated nephritis
immune-mediated skin adverse reactions including, StevensJohnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
Other immune-mediated adverse reactions: In organ transplant recipients
Infusion-related reactions
Complications of allogeneic HSCT.

Use in a specific population

Keytruda (pembrolizumab) can be fatal for a fetus; it is not advised for women who are pregnant or breast feeding

Avoid use in patients with a severely damaged immune system

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information

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