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Side Effects

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Side effects may occur while taking ZERPIDIO

The following side effects have been reported in clinical trials with Zerpidio:

Very common (may affect more than 1 in 10 people)

  • Decreased number of white blood cells (neutrophils, leukocytes), decrease in the number of red blood cells, decrease in the number of platelets

  • Decreased appetite

  • Nausea

  • Reduced thyroid gland activity (can cause tiredness or weight gain)

  • Increased liver enzyme levels in the blood

​​

Common (may affect up to 1 in 10 people)

  • Low number of white blood cells (lymphocytes)

  • Decreased protein in the blood, decreased sodium, potassium, magnesium, phosphate, chloride, or calcium in the blood, increased uric acid in the blood, increased phosphate in the blood

  • Vomiting, constipation, diarrhoea, stomach pain, difficulty swallowing, abdominal distension, gastrointestinal disorder

  • Increased lipids in the blood, high blood sugar level or diabetes mellitus, overactive thyroid gland activity.

  • Skin rash, hair loss, itchiness, inflammation of the skin

  • Fever, weakness, feeling tired, overall discomfort, swelling

  • Inflammation of the lungs, chest discomfort, shortness of breath, cough

  • Abnormal heart rhythm, a regular cardiac rhythm in which heart beats faster than normal, conduction defects, heart failure

  • Increased blood bilirubin in the blood, liver injury

  • Infection of the lung, infection of urinary tract

  • Protein urine present, positive red blood cells in the urine, renal injury

  • Pain in muscles and bones, joint pain (arthralgia), pain in arms or legs

  • Change in the sense of touch, dizziness, headache

  • Trouble sleeping

  • Increased levels of alkaline phosphatase in the blood, increased levels of lactate dehydrogenase in the blood, weight decreased, abnormal electrocardiogram, abnormal thyroid function test, increased levels of myoglobin in the blood, increased levels of creatine phosphokinase in the blood, abnormal coagulation function test, abnormal cardiac enzyme test, abnormal kidney function test, increased level of brain natriuretic peptide which may be a sign of heart failure, abnormal lipoprotein in the blood

​​

Uncommon (may affect up to 1 in 100 people)

  • Increase in the number of platelets, Inflammation of the lymph node, Decrease in the number of white blood cell (lymphocytes), increase in the number of white blood cell (leukocytes, neutrophils), decline in bone marrow activity resulting in reduced red blood cell production.

  • Decreased calcium or magnesium in the blood, hypophosphatemia, low blood sugar level

  • Dry mouth, gastrointestinal disorder, inflammation of the mouth mucosa, inflammation of the intestines, inflammation of the stomach, mouth injury, inflammation of the pancreas, indigestion, gastroesophageal reflux disease, gingival bleeding

  • Decreased secretion of hormones produced by the adrenal glands, thyroid disorder, overactive adrenal gland activity, inflammation of the pituitary gland situated at the base of the brain, inflammation of thyroid gland

  • Chills, hyperthermia

  • Thickened, sometimes scaly, skin growth, excessive sweating, some troublesome in skin of colour, dry skin, pain of skin, herpes zoster

  • Presence of glucose in the urine, positive white blood cells in the urine

  • Dysphonia, tachypnoea, oropharyngeal pain, Lung collapse

  • Disease of heart muscle, pain or discomfort in the upper body

  • Inflammation of the brain, motion sickness, constant, recurrent episodes of extreme sleepiness, motor dysfunction, tremor, nervous system disorders leading to numbness, neurotoxicity, paresthesias, abnormal thought processes, memory loss.

  • Inflammation of the joint, inflammation of the muscles

  • High blood pressure, inflammation of the blood vessels

  • Allergic reaction (infusion-related reaction, hypersensitivity or anaphylaxis)

  • Blurred vision, glaucoma

  • Tinnitus

  • Infection of upper respiratory tract, severe infection, skin infection, infection of intestine, lip infection, infection of the brain and brain covering caused by herpes simplex virus, chalazion

  • Loss of personal independence in daily activities

  • Increased level of myocardial necrosis marker, abnormal lipoprotein in blood, monocyte count increased, monocyte count decreased

​

What to Do if You Experience a Side Effect

If you notice anything unusual or experience a potential side effect, your first and most important step is to contact your physician immediately. Your healthcare provider is your primary resource for any medical concerns and can provide the appropriate diagnosis and treatment. Please do not attempt to manage side effects by yourself.

 

How to Report a Side Effect

By reporting side effects, you can help provide more information about the safety of this medicine. You can report directly to our safety monitoring team by sending an email with the details of your experience to: pv.kgbio@kg-biologics.com

​

Reference: Zerpidio [patient information leaflet]. Jakarta, Indonesia; 2025.

Understanding your treatment with Zerpidio

  • Badan POM-Approved Indications

    Serplulimab is approved by BPOM Indonesia for Extensive-Stage Small Cell Lung Cancer and Squamous Non-Small Cell Lung Cancer

    NMPA-Approved Indications

    Serplulimab is approved by NMPA China for MSI-H solid tumors, Extensive-Stage Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer, Non-squamous Non-Small Cell Lung Cancer, and esophageal squamous cell carcinoma

    EMA-Approved Indications

    Serplulimab is approved by the European Medicines Agency (EMA) for Extensive-Stage Small Cell Lung Cancer

    FDA-Approved as orphan drug

    Serplulimab approved by United States Food and Drug Administration (US FDA) as an orphan drug for Extensive-Stage Small Cell Lung Cancer

    Thai FDA-Approved Indications

    Serplulimab is approved by Thai FDA for Extensive-Stage Small Cell Lung Cancer and Squamous Non-Small Cell Lung Cancer

    NPRA-Approved Indications

    Serplulimab is approved by National Pharmaceutical Regulatory Agency (NPRA) for Extensive-Stage Small Cell Lung Cancer

    HSA SG-Approved Indications

    Serplulimab is approved by Health Science Authority (HSA) for Extensive-Stage Small Cell Lung Cancer

    MHRA UK-Approved Indications

    Serplulimab is approved by Medicines and Healthcare products Regulatory Agency (MHRA) UK for Extensive-Stage Small Cell Lung Cancer

    CDSCO India-Approved Indications

    Serplulimab is approved by Central Drugs Standard Control Organization (CDSCO) India for Extensive-Stage Small Cell Lung Cancer

    MOH Cambodia-Approved Indications

    Serplulimab is approved by Ministry of Health (MoH) Cambodia for Extensive-Stage Small Cell Lung Cancer

  • Tell your doctor if:

    • You have a history of :

      • Allergic reaction to other monoclonal antibody therapies

      • Kidney damage

      • Autoimmune disease

      • Organ transplant

      • Lung problems or breathing problems

      • Liver problems

    • You are pregnant or plan to become pregnant

    • You are allergic to any other medicines or any other substances such as foods, preservatives or dyes.


    Tell your doctor or nurse immediately if you have any signs or symptoms below:

    • Inflammation of the lungs: new or worsening cough, shortness of breath, or chest pain;

    • Inflammation of the liver: nausea or vomiting, feeling less hungry, pain on the right side of your stomach, yellowing of skin or whites of eyes, drowsiness, dark urine or bleeding or bruising more easily than normal;

    • Inflammation of the intestines: diarrhoea or more bowel movements than usual, or stools that are black, tarry or sticky with blood or mucus, severe stomach pain or tenderness;

    • Inflammation of glands (especially the thyroid, adrenal, pituitary and pancreas): fast heart rate, extreme tiredness, weight gain or weight loss, dizziness or fainting, hair loss, feeling cold, constipation, headaches that will not go away or unusual headaches, abdominal pain, nausea and vomiting;

    • Type 1 diabetes: high blood sugar, feeling more hungry or thirsty than usual, passing urine more often than usual, fast and deep breathing, confusion, or a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat;

    • Inflammation of the kidneys: decrease in the amount of urine you pass;

    • Inflammation of the skin: rash, itching, skin blistering, or ulcers in the mouth or on another moist surfaces;

    • Inflammation of the heart muscle: chest pain, shortness of breath, or irregular heartbeat;

    • Inflammation of the eyes;

    • Inflammation or problem of the muscles: muscle pain, or weakness, or rapid fatigue of the muscles;

    • Infusion-related reactions: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness or fever ;

    • Inflammation of the brain (encephalitis) or inflammation of the membrane around the spinal cord and brain (meningitis): seizure, neck stiffness, headache, fever, chills, vomiting, eye sensitivity to light, confusion and sleepiness;

    • Inflammation of the nerves: pain, weakness, and paralysis in the extremities (Guillain-Barre syndrome)

    • Low number of platelets: bleeding (nose or gum bleeding) and/or bruising.

    ​

    Zerpidio should not be used in children and adolescents under 18 years of age. The safety and efficacy of Zerpidio in children and adolescents below 18 years of age have not been established. No data are available.


    The use of Zerpidio during pregnancy and breast-feeding is not recommended. If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.


    The most frequent adverse events of Zerpidio in combination with carboplatin and etoposide for treatment in adults with extensive-stage small cell lung cancer include neutropenia, leukopenia, and anemia.


    ​The most frequent adverse events of Zerpidio in combination with carboplatin and nanoparticle albumin bound paclitaxel for treatment in adult patients with advanced squamous non-small cell lung cancer (metastasis/locally advanced) include anaemia, neutrophil count decreased, and white blood cell count decreased.

    ​

    These are not all the possible side effects of Zerpidio. Talk to your health care provider for medical advice about side effects.


    ​Please read the accompanying Medication Guide for Zerpidio and discuss it with your doctor. The physician Prescribing Information also is available.


    Reference: Zerpidio [package insert and patient information leaflet]. Jakarta, Indonesia; 2025.


    Important Safety Information


  • Badan POM-Approved Indications

    Serplulimab is approved by BPOM Indonesia for Extensive-Stage Small Cell Lung Cancer and Squamous Non-Small Cell Lung Cancer

    NMPA-Approved Indications

    Serplulimab is approved by NMPA China for MSI-H solid tumors, Extensive-Stage Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer, Non-squamous Non-Small Cell Lung Cancer, and esophageal squamous cell carcinoma

    EMA-Approved Indications

    Serplulimab is approved by the European Medicines Agency (EMA) for Extensive-Stage Small Cell Lung Cancer

    FDA-Approved as orphan drug

    Serplulimab approved by United States Food and Drug Administration (US FDA) as an orphan drug for Extensive-Stage Small Cell Lung Cancer

    Thai FDA-Approved Indications

    Serplulimab is approved by Thai FDA for Extensive-Stage Small Cell Lung Cancer and Squamous Non-Small Cell Lung Cancer

    NPRA-Approved Indications

    Serplulimab is approved by National Pharmaceutical Regulatory Agency (NPRA) for Extensive-Stage Small Cell Lung Cancer

    HSA SG-Approved Indications

    Serplulimab is approved by Health Science Authority (HSA) for Extensive-Stage Small Cell Lung Cancer

    MHRA UK-Approved Indications

    Serplulimab is approved by Medicines and Healthcare products Regulatory Agency (MHRA) UK for Extensive-Stage Small Cell Lung Cancer

    CDSCO India-Approved Indications

    Serplulimab is approved by Central Drugs Standard Control Organization (CDSCO) India for Extensive-Stage Small Cell Lung Cancer

    MOH Cambodia-Approved Indications

    Serplulimab is approved by Ministry of Health (MoH) Cambodia for Extensive-Stage Small Cell Lung Cancer


  • Important Safety Information


    Tell your doctor if:

    • You have a history of :

      • Allergic reaction to other monoclonal antibody therapies

      • Kidney damage

      • Autoimmune disease

      • Organ transplant

      • Lung problems or breathing problems

      • Liver problems

    • You are pregnant or plan to become pregnant

    • You are allergic to any other medicines or any other substances such as foods, preservatives or dyes.


    Tell your doctor or nurse immediately if you have any signs or symptoms below:

    • Inflammation of the lungs: new or worsening cough, shortness of breath, or chest pain;

    • Inflammation of the liver: nausea or vomiting, feeling less hungry, pain on the right side of your stomach, yellowing of skin or whites of eyes, drowsiness, dark urine or bleeding or bruising more easily than normal;

    • Inflammation of the intestines: diarrhoea or more bowel movements than usual, or stools that are black, tarry or sticky with blood or mucus, severe stomach pain or tenderness;

    • Inflammation of glands (especially the thyroid, adrenal, pituitary and pancreas): fast heart rate, extreme tiredness, weight gain or weight loss, dizziness or fainting, hair loss, feeling cold, constipation, headaches that will not go away or unusual headaches, abdominal pain, nausea and vomiting;

    • Type 1 diabetes: high blood sugar, feeling more hungry or thirsty than usual, passing urine more often than usual, fast and deep breathing, confusion, or a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat;

    • Inflammation of the kidneys: decrease in the amount of urine you pass;

    • Inflammation of the skin: rash, itching, skin blistering, or ulcers in the mouth or on another moist surfaces;

    • Inflammation of the heart muscle: chest pain, shortness of breath, or irregular heartbeat;

    • Inflammation of the eyes;

    • Inflammation or problem of the muscles: muscle pain, or weakness, or rapid fatigue of the muscles;

    • Infusion-related reactions: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness or fever ;

    • Inflammation of the brain (encephalitis) or inflammation of the membrane around the spinal cord and brain (meningitis): seizure, neck stiffness, headache, fever, chills, vomiting, eye sensitivity to light, confusion and sleepiness;

    • Inflammation of the nerves: pain, weakness, and paralysis in the extremities (Guillain-Barre syndrome)

    • Low number of platelets: bleeding (nose or gum bleeding) and/or bruising.

    ​

    Zerpidio should not be used in children and adolescents under 18 years of age. The safety and efficacy of Zerpidio in children and adolescents below 18 years of age have not been established. No data are available.


    The use of Zerpidio during pregnancy and breast-feeding is not recommended. If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.


    The most frequent adverse events of Zerpidio in combination with carboplatin and etoposide for treatment in adults with extensive-stage small cell lung cancer include neutropenia, leukopenia, and anemia.


    ​The most frequent adverse events of Zerpidio in combination with carboplatin and nanoparticle albumin bound paclitaxel for treatment in adult patients with advanced squamous non-small cell lung cancer (metastasis/locally advanced) include anaemia, neutrophil count decreased, and white blood cell count decreased.

    ​

    These are not all the possible side effects of Zerpidio. Talk to your health care provider for medical advice about side effects.


    ​Please read the accompanying Medication Guide for Zerpidio and discuss it with your doctor. The physician Prescribing Information also is available.


    Reference: Zerpidio [package insert and patient information leaflet]. Jakarta, Indonesia; 2025.

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