Pembrolizumab

Pembrolizumab is used in the treatment of melanoma, non-small cell lung cancer, head and neck cancer, and cervical cancer. Pembrolizumab is given as an infusion into the vein by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. Some common side effects of this medicine include rash, fatigue, fever, nausea and muscle pain. Some serious side effects which may occur during infusion include chills or shaking, itching, rash, flushing, difficulty breathing and dizziness. Hence, your doctor will check you timely after infusion for allergic reaction. Before taking it, tell your doctor if you have lung disease, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy. Pembrolizumab is an anti-cancer medication. It works in certain cancer by working with immune system thereby activating T-cell mediated immune responses against tumor cells.

• Melanoma • Non-small cell lung cancer • Head and neck cancer • Cervical cancer

Pembrolizumab is a humanised immunoglobulin G4 monoclonal antibody which binds to the cell surface receptor programmed death-1 (PD-1), a negative immunoregulatory protein, and prevents it from interacting with ligands PD-L1 and PD-L2. Blockade of the PD-1 pathway results in the reactivation of T-lymphocytes and induction of immune response to tumour cells.

Adult Dose: Intravenous Metastatic melanoma, Unresectable melanoma Adult: 2 mg/kg or 200 mg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur. Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma Adult: In patients who have been treated with chemotherapy: 2 mg/kg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur. Metastatic non-small cell lung carcinoma Adult: As first-line treatment: 200 mg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (or 35 cycles) in patients without disease progression. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur. Gastro-oesophageal junction adenocarcinoma, Locally advanced urothelial carcinoma, Metastatic gastric cancer, Metastatic microsatellite instability-high cancer, Metastatic squamous cell carcinoma of the head and neck, Metastatic urothelial carcinoma, Recurrent locally advanced gastric cancer, Recurrent squamous cell carcinoma of the head and neck, Refractory classical Hodgkin lymphoma, Relapsed classical Hodgkin lymphoma, Unresectable microsatellite instability-high cancer Adult: 200 mg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (or 35 cycles) in patients without disease progression. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur.

Your doctor or nurse will give you this medicine. Kindly do not self administer.

Common: • Rash • Fatigue • Fever • Musculoskeletal (bone, muscle or joint) pain • Stomach pain • Nausea • Itching • Constipation • Indigestion • Diarrhea • Decreased appetite • Cough

[CONSULT YOUR DOCTOR] It is not known whether Pembrolizumab alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react. Pembrolizumab helps your immune system fight cancer such as that of head, neck, lung, and skin. It is usually given through an infusion into your vein (IV) for about 30 minutes, every 3 weeks, by your doctor. It may make you feel tired or weak. Do not drive or use machines unless you are sure you are feeling well. Take adequate birth control measures while you are being treated with this medicine and for at least 4 months after your last dose, as it can cause harm to an unborn baby. Do not stop treatment without talking to your doctor first.

Use of systemic corticosteroids or immunosuppressants before starting therapy may cause interference with the pharmacodynamic activity and efficacy of pembrolizumab.

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Pembrolizumab. Please consult your doctor.

[CONSULT YOUR DOCTOR] Pembrolizumab may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[CONSULT YOUR DOCTOR] Pembrolizumab is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.

[CAUTION] Pembrolizumab should be used with caution in patients with kidney disease. Dose adjustment of Pembrolizumab may be needed. Please consult your doctor. [CAUTION] Pembrolizumab should be used with caution in patients with liver disease. Dose adjustment of Pembrolizumab may be needed. Please consult your doctor.

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