ZakAria (Pembrolizumab) for Cancer

ZakAria (Pembrolizumab) is a monoclonal antibody directed against human cell surface receptor PD-1 with potential immune checkpoint inhibitory and antineoplastic activities.

ZakAria is used alone or in combination with other medicines to treat certain types of cancer including:

• Lung cancer

• Head and neck cancer

• Skin cancer (Melanoma and Merkel cell carcinoma)

• Cancer of the kidney, bladder, and urinary tract

• Certain types of lymphoma (Hodgkin and large B-cell)

• Colorectal cancer

• Breast cancer

• Cancer of the cervix or uterus

• Liver cancer

• Advanced stomach or esophageal cancer

Do not use ZakAria if you have hypersensitivity reactions to pembrolizumab or any component of the formulation.

Before using ZakAria, tell your doctor if you:

• are allergic to this drug; any other drugs or any part of this drug; foods, or substances.

• are taking any of these drugs: Pomalidomide, lenalidomide, or thalidomide.

• are pregnant, may be pregnant, or planning to become pregnant. ZakAria may cause harm to your unborn baby. A pregnancy test will be done before you start treatment with ZakAria to show that you are not pregnant. You must use effective birth control while taking this drug and for some time after the last dose. You can ask your doctor for how long to use birth control.

• are breastfeeding or planning to breastfeed. Do not breastfeed while you take this drug or for 4 months after your last dose.

This drug is given as an infusion into a vein over a period of time by your doctor.

The most common side effects of ZakAria may include:

• Diarrhea, stomach pain, constipation, upset stomach, throwing up, or feeling less hungry

• Back, bone, joint, or muscle pain

• Headache

• Weight loss

• Hair loss

• Change in taste

• Trouble sleeping

• Signs of a common cold

• Cough

• Flu-like signs

• Dyspnea

• Itchy skin, skin rash, vitiligo

• Feeling tired

ZakAria may cause serious side effects that you need to call your doctor about right away, including:

• Signs of bowel problems like bloody, black, or tarry stools; fever; throwing up blood or throw up that looks like coffee grounds; mucus in the stools; or very bad stomach pain, constipation, or diarrhea.

• allergic reaction, like itching, red, rash, hives, swollen, blistered, or peeling skin with or without fever; tightness in the chest or throat; wheezing; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

• Signs of electrolyte problems like a heartbeat that does not feel normal, mood changes, confusion, muscle pain or weakness, seizures, not hungry, or very bad upset stomach or throwing up.

• Signs of lung or breathing problems like shortness of breath, trouble breathing, cough, or fever

• Signs of a spinal cord problem (myelitis) like numbness, pain, tingling, or weakness in the arms or legs; bladder problems like passing urine more often, trouble passing urine, leaking of urine; or bowel problems like severe constipation

• Chest pain or pressure

• Fast or abnormal heartbeat

• Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak

• Change in eyesight, eye pain, or very bad eye irritation

• Swollen gland

• Dizziness or passing out

• Flushing

• Sweating a lot

• A burning, numbness, or tingling feeling that is not normal

• Not able to move

• White patches on the skin

• Signs of a urinary tract infection (UTI) like burning or pain when passing urine, blood in the urine, feeling the need to pass urine often or right away, fever, pelvic pain, or lower stomach pain.

• If you need to store this drug at home, Store it in a refrigerator (2°C – 8°C).

• Do not freeze.

• Store in the original carton in order to protect it from light.

• Keep this medicine out of reach of children.