ZakAria®


(Pembrolizumab)

What is it?

What is ZakAria®?

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

Indications

What is ZakAria® used for?

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

  • Skin cancer (Melanoma and Merkel cell carcinoma);
  • Lung cancer;
  • Head and neck cancer;
  • Certain types of lymphoma (Hodgkin and large B-cell)
  • Cancer of the kidney, bladder, and urinary tract;
  • Colorectal cancer;
  • Liver cancer;
  • Breast cancer;
  • Cancer of the cervix or uterus;
  • Advanced stomach or esophageal cancer;

 

Contraindications

Who should not use ZakAria®?

Do not use ZakAria® if:

  • You have hypersensitivity to pembrolizumab or any component of the formulation.

Important information

What should I tell my health care provider before using ZakAria®?

Before using ZakAria®, tell your health care provider if you:

  • are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • are taking any of these drugs: Lenalidomide, pomalidomide, or thalidomide.
  • are pregnant or may be pregnant. This drug may cause harm to an unborn baby. A pregnancy test will be done before you start this drug to show that you are NOT pregnant. If you may become pregnant, you must use birth control while taking this drug and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
  • are breast-feeding. Do not breast-feed while you take this drug or for 4 months after your last dose.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How to Use?

How should I use ZakAria®?

  • This drug is given as an infusion into a vein over a period of time by your physician. Read all information given to you. Follow all instructions closely.

Side Effects

What are the possible side effects of ZakAria®?

The most common side effects of ZakAria® may include:

  • Constipation, diarrhea, stomach pain, 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.
  • Flu-like signs.
  • Cough
  • Dyspnea
  • Feeling tired
  • Itchy skin, skin rash, vitiligo

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

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

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bowel problems like black, tarry, or bloody stools; fever; mucus in the stools; throwing up blood or throw up that looks like coffee grounds; or very bad stomach pain, constipation, or diarrhea.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  •  Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
  • Signs of a spinal cord problem (myelitis) like pain, numbness, tingling, or weakness in the arms or legs; bladder problems like passing urine more often, leaking of urine, or trouble passing 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 blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.

Storage

Storage

  • If you need to store this drug at home, Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original carton in order to protect from light.
  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
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