Keytruda 25 mg/ml 4 ml Vial ( Refrigerator )

Pembrolizumab 100 mg/4 mL (25 mg/mL) solution in a single-dose vial injection

What is Pembrolizumab used for :

Pembrolizumab is a medication that is used to treat the following indications:

• • Melanoma (type of skin cancer); when cancer cannot be removed by surgery or has spread in the body, or to prevent your skin cancer from returning after its surgical removal.

• • Non-small cell lung cancer (NSCLC; a type of lung cancer); in combination with other chemotherapy medicines (platinum and pemetrexed) when your cancer does not have an abnormal “ALK” or “EGFR” gene, has spread and is of a specific type called “non-squamous”.

• • This medicine may also be used in combination with the chemotherapy medicines carboplatin and either paclitaxel or paclitaxel as your primary treatment when your lung cancer has already spread and of a specific type called “squamous”.

• • It may additionally be used alone as your primary treatment when you have stage 3 lung cancer (has not spread outside your chest) that cannot be treated with surgery or chemotherapy with radiation or when your NSCLC has already spread to other parts of your body and your tumor does not have an abnormal “EGFR” or “ALK” gene and is positive for “PD-L1”.

• • This medication may be used alone when you already have undergone chemotherapy (containing platinum) to treat your advanced NSCLC, and your therapy was not effective or is no longer effective and your tumor is positive for “PD-L1” with an abnormal “EGFR” or “ALK” gene for which you have taken an EGFR or ALK inhibitor medication that was not effective or is no longer effective.

• • Small cell lung cancer (SCLC; a type of lung cancer); when your lung cancer is advanced (has already spread) and you have already taken two or more types of chemotherapy (including one chemotherapy medicine that has platinum, and that was not effective or is no longer effective).

• • A type of cancer known as head and neck squamous cell cancer (HNSCC); when used with the chemotherapy medications a platinum and fluorouracil as your primary treatment and your neck and head cancer has already spread or came back and you cannot undergo a surgical removal for it.

• • It may also be used alone as your primary treatment when your tumor is positive for “PD-L1” and your head and neck cancer has already spread or came back and you cannot undergo a surgical removal for it.

• • This medicine may also be used alone when your head and neck cancer has already spread or came back and you have already undergone chemotherapy (containing platinum) that was not effective or is no longer effective.

• • Classical Hodgkin lymphoma (cHL; a type of cancer); when used in adults and children who have already received a treatment that was not effective or is no longer effective or their cancer came back after they have undergone three or more types of therapy.

• • Primary mediastinal B-cell lymphoma (PMBCL; a type of cancer); when used in adults and children who have already received a treatment that was not effective or is no longer effective or when the cancer came back after receiving two or more types of therapy.

• • Urothelial carcinoma (a type of bladder and urinary tract cancer); when your cancer is at high risk for spreading to other tissues but has not spread yet and your tumor belongs to a type known as “carcinoma in situ”, and you have already received Bacillus Calmette-Guerin (BCG) that was not effective and you cannot undergo surgical removal of your bladder.

• • It may also be used when your bladder or urinary tract cancer has already spread or you are not able to remove it by surgery and chemotherapy (containing cisplatin), and your tumor is positive for “PD-L1”, or you cannot take cisplatin or carboplatin (cancer medicines), or you have already undergone chemotherapy (containing platinum) that was not effective or is no longer effective.

• • A type of cancer that is proven by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor; when used in adults and children to treat cancer that has already spread or cannot be surgically removed, and has advanced after therapy, and who did not have satisfactory therapy alternatives, or who have rectal or colon cancer, and have already undergone chemotherapy (with oxaliplatin, fluoropyrimidine and irinotecan) that was not effective or is no longer effective.

• • It is not clear yet if this medicine is effective and safe in children who have MSI-H cancers of the spinal cord or brain.

• • Gastric or gastroesophageal junction (GEJ) adenocarcinoma (type of stomach cancer); when your tumor tests positive for “PD-L1” and came back or has already spread and you have undergone two or more types of chemotherapy (including platinum and fluoropyrimidine) that was not effective or is no longer effective, and if your tumor contains an abnormal “HER2/neu” gene and you have also taken a HER2/neu-targeted medication that was not effective or is no longer effective.

• • Squamous cell carcinoma of the esophagus (a type of cancer); when your cancer came back or has already spread, and your tumor is positive for “PD-L1” and you have taken one or more types of therapy that was not effective or is no longer effective.

Do not take Pembrolizumab :

• • If you are allergic to Pembrolizumab or any of the ingredients in this medicine.

Other medicines and Pembrolizumab :

Tell your doctor or pharmacist if you are:

• • Taking, have recently taken or might take any other medications including vitamins, prescription medicines, over-the-counter medicines and herbal supplements.

• • keep a list of the medications that you take.

How to take Pembrolizumab :

• • Your doctor will be giving you your pembrolizumab doses intravenously (into your vein) through an intravenous (IV) line over a period of 30 minutes.

• • This medicine is usually given every 3 weeks.

• • Your doctor will determine the number of treatments that you need.

• • Your doctor will ask for blood tests to monitor you for any side effects.

How to store Pembrolizumab :

• • Store medication in its original container in the refrigerator at 2° to 8°C until time of use.

• • Do not freeze the medication.

• Protect medication from direct sunlight.