Keytruda (pembrolizumab) is a medication used for the treatment of advanced melanoma, metastatic nonsquamous NSCLC, 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.
|Disease||Urothelial Carcinoma, Gastric Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Skin Cancer|
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 cells.
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-L
- 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 mutation
- May 2017, for relapsed or refractory classical Hodgkin lymphoma (cHL)
- July 20, 2017, for locally advanced or metastatic urothelial carcinoma
- 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 carcinoma
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 is1,2,3:
- 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 section1,2,3.
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 include
- musculoskeletal pain
- decreased appetite
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:
- 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 system1,2,3.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information
For more information contact drugs99.com.
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