KEYTRUDA (Pembrolizumab) 100 mg/4 mL Injection

KEYTRUDA® (pembrolizumab) 100 mg/4 mL is an intravenous immunotherapy medicine containing pembrolizumab, a humanized monoclonal antibody that targets the PD-1 (programmed death receptor-1) pathway. It is used in the treatment of several types of cancer, depending on the patient's cancer type, stage, biomarker results, and treatment history.

KEYTRUDA works by blocking the interaction of PD-1 with its ligands PD-L1 and PD-L2, helping restore T-cell immune activity against cancer cells.

Active Ingredient

• Generic Name: Pembrolizumab
• Brand Name: KEYTRUDA®
• Strength: 100 mg/4 mL
• Concentration: 25 mg/mL
• Dosage Form: Injection/infusion solution
• Route: Intravenous (IV)
• Manufacturer: Merck/MSD

Each single-dose vial contains 100 mg of pembrolizumab in 4 mL of solution.

How KEYTRUDA Works

Pembrolizumab is a PD-1 immune checkpoint inhibitor. Some cancer cells can use the PD-1 pathway to reduce the immune system's ability to recognize and attack them.

KEYTRUDA blocks PD-1 from interacting with PD-L1 and PD-L2. This can remove an immune-system "brake" and allow T cells to recognize and attack tumor cells.

Uses and Indications

Depending on the approved indication and patient's clinical circumstances, KEYTRUDA may be used for various cancers, including:

• Melanoma
• Non-small cell lung cancer (NSCLC)
• Head and neck squamous cell carcinoma (HNSCC)
• Classical Hodgkin lymphoma
• Urothelial carcinoma
• Gastric and gastroesophageal junction cancers
• Esophageal cancer
• Cervical cancer
• Hepatocellular carcinoma
• Biliary tract cancer
• Merkel cell carcinoma
• Renal cell carcinoma
• Endometrial carcinoma
• Certain cancers with MSI-H/dMMR biomarkers
• Other specifically approved cancer indications depending on the applicable regulatory label.

The exact indication can depend on factors such as PD-L1 expression, MSI-H/dMMR status, tumor type, disease stage, previous treatment and other molecular characteristics.

Strength & Pack Information

KEYTRUDA 100 mg/4 mL is supplied as a single-dose vial containing 100 mg of pembrolizumab in 4 mL of solution.

Important: KEYTRUDA 100 mg/4 mL is an oncology medicine intended for administration by qualified healthcare professionals in an appropriate clinical setting.

Dosage & Administration

The dose and treatment schedule depend on the specific cancer indication and the patient's age and clinical condition.

For many adult indications, the current prescribing information includes:

• 200 mg intravenously every 3 weeks, or
• 400 mg intravenously every 6 weeks.

Certain pediatric indications may use weight-based dosing.

KEYTRUDA is administered by intravenous infusion, generally over approximately 30 minutes according to the prescribing information.

Do not self-administer. The prescribing oncologist should determine the appropriate dose, frequency and duration.

Important Safety Information

KEYTRUDA can cause immune-mediated adverse reactions because activation of the immune system may also affect normal organs and tissues.

Potential serious reactions can involve:

• Lungs — pneumonitis
• Colon — colitis
• Liver — hepatitis
• Kidneys — nephritis
• Endocrine glands — thyroid disorders, adrenal insufficiency, hypophysitis and other hormonal abnormalities
• Skin — severe skin reactions
• Other organs and tissues

Patients should be monitored for symptoms and laboratory abnormalities during treatment. Treatment interruption or discontinuation may be required for serious immune-mediated reactions.

Common Side Effects

Depending on the treatment regimen and cancer type, side effects may include:

• Fatigue
• Rash
• Itching
• Diarrhea
• Nausea
• Decreased appetite
• Fever
• Cough
• Shortness of breath
• Musculoskeletal pain
• Constipation

Because KEYTRUDA stimulates immune activity, immune-mediated side effects can sometimes be serious or life-threatening.

Precautions

Before receiving KEYTRUDA, the treating doctor should be informed about:

• Previous immune-related reactions to cancer immunotherapy
• Autoimmune conditions
• Organ transplantation
• Previous or current lung problems
• Liver or kidney problems
• Thyroid or other endocrine disorders
• Current medicines and cancer treatments
• Pregnancy or plans to become pregnant
• Breastfeeding

The oncology team may perform blood tests and other investigations before and during treatment.

Storage

KEYTRUDA should be stored and handled according to the manufacturer's official storage requirements and applicable pharmaceutical regulations.

Do not use the product if the vial, solution or packaging appears damaged or compromised.

Prescription & Medical Supervision

KEYTRUDA is a prescription oncology medicine. It should only be prescribed and administered under the supervision of a qualified oncologist or other appropriately trained healthcare professional.

The correct indication, dose and treatment duration must be determined individually for each patient.

Availability in Pakistan

KEYTRUDA (Pembrolizumab) 100 mg/4 mL may be sourced through specialized oncology medicine suppliers and pharmacies in Pakistan, subject to availability and applicable regulatory requirements.

Availability may vary by city and supplier. It can be requested in major cities including:

Lahore, Karachi, Islamabad, Rawalpindi, Multan, Faisalabad, Peshawar, Gujranwala, Hyderabad, Bahawalpur, Sialkot, Sukkur, Larkana and other major cities of Pakistan.