Tremelimumab – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 24 min read
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Tremelimumab, formerly known as ticilimumab, is a fully human IgG2 monoclonal antibody directed against cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a cell surface receptor expressed on activated T cells to act as a negative regulator for T cells. By binding to CTLA-4, tremelimumab enhances...

For severe symptoms, danger signs, pregnancy, child illness, or sudden worsening, seek urgent medical care.

বাংলা রোগী নোট এখনো যোগ করা হয়নি। পোস্ট এডিটরে “RX Bangla Patient Mode” বক্স থেকে সহজ বাংলা সারাংশ যোগ করুন।

এই তথ্য শিক্ষা ও সচেতনতার জন্য। এটি ডাক্তারি পরীক্ষা, রোগ নির্ণয় বা প্রেসক্রিপশনের বিকল্প নয়।

Article Summary

Tremelimumab, formerly known as ticilimumab, is a fully human IgG2 monoclonal antibody directed against cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a cell surface receptor expressed on activated T cells to act as a negative regulator for T cells. By binding to CTLA-4, tremelimumab enhances the T cell-mediated killing of tumors and reduces tumor growth.[rx] Because CTLA-4 is an immune checkpoint that plays a vital...

Key Takeaways

  • This article explains Mechanism of action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
Educational health guideWritten for patient understanding and clinical awareness.
Reviewed content workflowUse writer and reviewer profiles for stronger trust.
Emergency safety firstUrgent warning signs are highlighted below.

Seek urgent medical care if you notice

These warning signs are general safety guidance. Local emergency numbers and clinical judgment should always come first.

  • Severe symptoms, breathing difficulty, fainting, confusion, or rapidly worsening illness.
  • New weakness, severe pain, high fever, or symptoms after a serious injury.
  • Any symptom that feels urgent, unusual, or unsafe for the patient.
1

Emergency now

Use emergency care for severe, sudden, rapidly worsening, or life-threatening symptoms.

2

See a doctor

Book a professional medical evaluation if symptoms persist, worsen, recur often, affect daily activities, or occur in a high-risk patient.

3

Learn safely

Use this article to understand possible causes, tests, treatment options, prevention, and questions to ask your clinician.

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Definition

Tremelimumab, formerly known as ticilimumab, is a fully human IgG2 monoclonal antibody directed against cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a cell surface receptor expressed on activated T cells to act as a negative regulator for T cells. By binding to CTLA-4, tremelimumab enhances the T cell-mediated killing of tumors and reduces tumor growth.[rx] Because CTLA-4 is an immune checkpoint that plays a vital role in regulating T cell-mediated immune response, tremelimumab is considered an immune checkpoint inhibitor, which is an emerging cancer immunotherapy drug class.[rx]

A drug that binds to the protein CTLA-4 to help immune cells kill cancer cells better and is used to treat different types of cancer. Tremelimumab is used with durvalumab to treat adults with hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. It is also used with durvalumab and platinum chemotherapy to treat adults with non-small cell lung cancer that has spread to other parts of the body and does not have an abnormal EGFR or ALK gene. It is also being studied in the treatment of other types of cancer. Tremelimumab may block CTLA-4 and help the immune system kill cancer cells. It is a type of monoclonal antibody and a type of immune checkpoint inhibitor. Also called Imjudo.

Tremelimumab was first approved by the FDA in October 2022 to be used in combination with durvalumab to treat hepatocellular carcinoma.[rx] It is also being investigated in other cancers, such as colon cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), and malignant melanoma,[rx]

Mechanism of action

T-cell activation is influenced by several processes. T cell receptors (TCR), which are expressed on T cells, bind to the cognate antigen processed and presented by major histocompatibility complex (MHC) expressed on antigen-presenting cells (APC).[rx] This interaction generates a TCR signal to activate T cells. In addition to the TCR signal, optimal T cell activation requires a costimulatory signal, produced when CD80 and CD86, expressed on the surface of APCs, bind to receptors expressed on T cells.1 CD80 and CD86 are also referred to together as B7 molecules.[rx] In response to these signals, activated T cells can be further differentiated into specific T cell subtypes with specialized functions.[rx]

Immune checkpoints are proteins that control the intensity and duration of T cell activation and response. CD28 and CTLA-4 are homologous receptors expressed on CD4+ and CD8+ T cell surfaces.[rx] These immune checkpoints have opposing regulatory functions on T cell activity: CD28 is a positive regulator of T cell activity, while CTLA-4 is a negative regulator suppressing T cell activation and proliferation, as well as IL-2 gene transcription.[rx,rx] B7 molecules act as ligands to both of these receptors,[rx] and the balance between CD28 and CTLA-4 expression and signaling influences the extent of T cell activation. In cancer immunotherapy, CTLA-4 has been investigated as a therapeutic target as blocking this receptor can enhance the activation of tumor-specific T cells, allowing them to exert cytotoxic effects on tumor cells.[rx]

Tremelimumab is an antibody directed against CTLA-4. By binding to CTLA-4, tremelimumab blocks the interaction of CTLA-4 with its ligands, CD80 and CD86, limiting its negative regulatory effect on T-cell activation. Inhibition of CTLA-4 leads to increased proliferation of T cells in tumors and promotes T cell-mediated cytotoxicity.[rx]

Tremelimumab is a cytotoxic agent that works to decrease tumor growth.[rx] It binds to its target, human CTLA-4, with high selectivity [rx] and subnanomolar affinity.[rx] Tremelimumab caused increased IL-2 production in a dose-dependent manner in ex-vivo blood stimulation assays using peripheral blood mononuclear cells (PBMCs) from healthy volunteers and patients with cancer, indicating that tremelimumab stimulated T cell-mediated cytotoxicity. Tremelimumab also increased the proliferation of effector T cells.[rx] In vitro, there was no evidence of nonspecific cytokine release induced by tremelimumab or drug binding to Fc receptors.[rxrx]

Tremelimumab aims to stimulate an immune system attack on tumors. Cytotoxic T lymphocytes (CTLs) can recognize and destroy cancer cells. However, there is also an inhibitory mechanism (immune checkpoint) that interrupts this destruction. Tremelimumab turns off this inhibitory mechanism and allows CTLs to continue to destroy the cancer cells.[4]

Tremelimumab binds to the protein CTLA-4, which is expressed on the surface of activated T lymphocytes and inhibits the killing of cancer cells.[rx] Tremelimumab blocks the binding of the antigen-presenting cell ligands B7.1 and B7.2 to CTLA-4, resulting in inhibition of B7-CTLA-4-mediated downregulation of T-cell activation; subsequently, B7.1 or B7.2 may interact with another T-cell surface receptor protein, CD28, resulting in a B7-CD28-mediated T-cell activation unopposed by B7-CTLA-4-mediated inhibition.[rx]

Indications

  • Tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma in combination with durvalumab.[rx] It is also indicated in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.[rx]
  • Metastatic Non-Small Cell Lung Cancer
  • Unresectable Hepatocellular Carcinoma (HCC)

Contraindications

  • overactive thyroid gland
  • a condition with low thyroid hormone levels
  • insulin is low or not working well. সহজ বাংলা: রক্তে চিনি বেশি থাকার রোগ।" data-rx-term="diabetes" data-rx-definition="Diabetes is a condition where blood sugar stays too high because insulin is low or not working well. সহজ বাংলা: রক্তে চিনি বেশি থাকার রোগ।">diabetes
  • decreased function of the adrenal gland
  • infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation of the middle tissue heart muscle
  • a type of infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation of the lung called interstitial pneumonitis
  • infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation of the large intestine
  • a hole in the intestine
  • kidney infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation
  • high blood sugar
  • abnormal liver function tests
  • pregnancy
  • a patient who is producing milk and breastfeeding
  • pancreatitis
  • infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation of the pituitary gland

Dosage

Tremelimumab-act is available in the following dosage form(s) and strength(s):

  • Injection: 25 mg/1.25 mL (20 mg/mL) solution in a single-dose vial.
  • Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial.

Dosage

  • It is essential that the manufacturer’s labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Dosage and Administration

  • Administer tremelimumab-actl as an intravenous infusion over 60 minutes after dilution.
  • The recommended dosage of tremelimumab-actl for the treatment of uHCC in adults is based on body weight as follows:
  • Body weight 30 kg and more: tremelimumab-actl 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab 1,500 mg as a single agent every 4 weeks.
  • Body weight less than 30 kg: tremelimumab-actl 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1, followed by durvalumab 20 mg/kg as a single agent every 4 weeks.
  • After Cycle 1 of combination therapy, administer durvalumab as a single agent every 4 weeks until disease progression or unacceptable toxicity occurs.
  • See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions.

Side Effects

Most common

  • Bleeding gums
  • body aches or pain
  • bone pain
  • chest pain or tightness
  • chills
  • constipation
  • coughing up blood
  • depressed mood
  • difficulty swallowing
  • dry skin and hair
  • diarrhea
  • dizziness
  • ear congestion
  • feeling cold
  • hoarseness or husky voice
  • headache
  • increased menstrual flow or vaginal bleeding
  • loss of voice
  • muscle cramps, spasms, pain, stiffness, tenderness, or weakness
  • nervousness
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • red or dark brown urine
  • red or black, tarry stools
  • sensitivity to heat
  • sleeplessness
  • slow heartbeat
  • sneezing
  • sore throat
  • stomach cramps, tenderness, or pain
  • stuffy or runny nose
  • swollen glands in the neck
  • trouble breathing
  • trouble sleeping
  • unusual tiredness or weakness
  • weight gain or loss

More Common

  • Agitation
  • bloating
  • blood in the urine or stools
  • bloody or cloudy urine
  • coma
  • confusion
  • darkened urine
  • darkening of the skin
  • decreased urine output
  • drowsiness
  • hostility
  • irritability
  • lethargy
  • lightheadedness
  • muscle twitching
  • fainting
  • fast heartbeat
  • fever
  • a general feeling of discomfort or illness
  • indigestion
  • loss of appetite
  • mental depression
  • nausea
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • rapid, shallow breathing
  • rapid weight gain
  • seizures
  • skin rash
  • stupor
  • sweating
  • swelling of the face, ankles, or hands
  • swelling of the face, feet, or lower legs
  • thickening of bronchial secretions
  • unusual bleeding or bruising
  • vomiting
  • yellow eyes or skin

Rare

  • Light-colored stools
  • sudden severe weakness
  • upper right abdominal or stomach pain
  • Anxiety
  • back, leg, or stomach pain
  • blistering, peeling, or loosening of the skin
  • blue or pale skin
  • blurred vision or other change in vision
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • burning feeling in the chest or stomach
  • chest discomfort
  • difficulty in chewing or talking
  • difficulty in moving
  • double vision
  • drooping eyelids
  • eye pain, tearing
  • facial swelling
  • inability to move the arms and legs
  • joint pain
  • numbness or tingling in the fingers, face, or feet
  • pain, swelling, or redness in the joints
  • painful or difficult urination
  • red irritated eyes
  • red skin lesions, often with a purple center
  • redness, soreness, or itching skin
  • redness of the eye
  • seeing flashes or sparks of light
  • seeing floating spots before the eyes
  • the sensation of pins and needles
  • sensitivity of the eye to light
  • severe headache
  • sores, ulcers, or white spots on the lips or in the mouth
  • stabbing pain
  • stiff neck or back
  • stomach upset or discomfort
  • sudden numbness and weakness in the arms and legs
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • swollen or painful glands
  • veil or curtain appearing across part of the vision
  • Lack or loss of strength
  • loss or thinning of the hair

Drug Interactions

Pregnancy and Lactation

FDA pregnancy category – Not assigned 

Pregnancy

Based on findings from animal studies and its mechanism of action, tremelimumab-act can cause fetal harm when administered to a pregnant woman. There are no available data on the use of tremelimumab-act in pregnant women. In animal studies, CTLA-4 blockade is associated with an increased risk of immune-mediated rejection of the developing fetus and fetal death.

Lactation

There are no data on the presence of tremelimumab-act in human milk, its effects on a breastfed child, or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to tremelimumab-act are unknown. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with tremelimumab-actual and for 3 months after the last dose. Refer to the prescribing information for agents administered in combination with tremelimumab-act for breastfeeding recommendations, as appropriate.

Advice to Patients

  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Inform patients of the risk of immune-mediated adverse reactions that may require corticosteroid treatment and interruption or discontinuation of tremelimumab-actl in combination with durvalumab.
  • Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath.
  • Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain.
  • Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding.
  • Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis.
  • Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis.
  • Dermatological reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of severe dermatological reactions.
  • Pancreatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of pancreatitis.
  • Other immune-mediated adverse reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of aseptic meningitis, immune thrombocytopenia, myocarditis, hemolytic anemia, myositis, uveitis, keratitis, and myasthenia gravis.
  • Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions.
  • Advise females of reproductive potential that tremelimumab-actl can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy.
  • Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of tremelimumab-actl.
  • Advise female patients not to breastfeed while taking tremelimumab-actl and for at least 3 months after the last dose.
Doctor visit helper

Prepare before seeing a doctor

A simple rural-patient checklist to help you explain symptoms clearly, ask better questions, and avoid unsafe self-treatment.

Safety note: This is not a prescription or diagnosis. For severe symptoms, pregnancy danger signs, children with serious illness, chest pain, breathing difficulty, stroke-like weakness, or major injury, seek urgent care.

Which doctor may help?

Start with a registered doctor or the nearest qualified health center.

What to tell the doctor

  • Write when the problem started and how it changed.
  • Bring old prescriptions, investigation reports, and current medicines.
  • Write allergies, pregnancy status, diabetes, kidney/liver disease, and major past illnesses.
  • Bring one family member if the patient is weak, elderly, confused, or a child.

Questions to ask

  • What is the most likely cause of my symptoms?
  • Which danger signs mean I should go to hospital quickly?
  • Which tests are necessary now, and which can wait?
  • How should I take medicines safely and what side effects should I watch for?
  • When should I come for follow-up?

Tests to discuss

  • Vital signs: temperature, pulse, blood pressure, oxygen saturation
  • Basic physical examination by a clinician
  • CBC, urine test, blood sugar, or imaging only when clinically needed

Avoid these mistakes

  • Do not use antibiotics, steroid tablets/injections, or strong painkillers without proper medical advice.
  • Do not hide pregnancy, kidney disease, ulcer, allergy, or blood thinner use.
  • Do not delay emergency care when danger signs are present.

Medicine safety and first-aid guide

This section is for patient education only. It does not replace a doctor, pharmacist, or emergency care.

Safe first steps

  • Avoid heavy lifting, sudden bending, and prolonged bed rest.
  • Use comfortable posture and gentle movement as tolerated.
  • Discuss physiotherapy, X-ray, or MRI only when clinically needed.

OTC medicine safety

  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

  • Do not start antibiotics without a proper medical decision.
  • Do not use steroid tablets or injections casually for quick relief.
  • Do not delay emergency care because of home remedies.

Get urgent help if

  • Back pain with leg weakness, numbness around private area, loss of urine/stool control, fever, cancer history, or major injury needs urgent care.
Medicine names, dose, and timing must be decided by a qualified clinician or pharmacist after checking age, pregnancy, allergy, other diseases, and current medicines.

For rural patients and family caregivers

Patient health record and symptom diary

Write your symptoms, medicines already taken, test results, and questions before visiting a doctor. This note stays on your device unless you print or copy it.

Doctor to discuss: Medicine doctor / pediatrician for children / qualified clinician
Tests to discuss with doctor
  • Temperature chart and hydration assessment
  • CBC with platelet count if fever persists or dengue/other infection is possible
  • Urine test, malaria/dengue tests, chest evaluation, or blood culture only when clinically indicated
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Do I need antibiotics, or is this more likely viral?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Tremelimumab – Uses, Dosage, Side Effects, Interaction

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

RX Patient Help

Ask a health question safely

Write your symptom story. A health professional or site editor can review it before any answer is prepared. This box is not for emergency care.

Emergency first: Severe chest pain, breathing trouble, unconsciousness, stroke signs, severe injury, heavy bleeding, or rapidly worsening symptoms need urgent local medical care now.

Frequently Asked Questions

Is this article a replacement for a doctor?

No. It is educational content only. Patients should consult a qualified clinician for diagnosis and treatment.

When should I seek urgent care?

Seek urgent care for severe symptoms, rapidly worsening condition, breathing difficulty, severe pain, neurological changes, or any emergency warning sign.

References

Add references, clinical guidelines, textbooks, journal articles, or trusted medical sources here. You can edit this area from the RX Article Professional Blocks panel.

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  10. Mirogabalin – Uses, Dosage, Side Effects, Interactions

    DefinitionMirogabalin has been used in trials studying the treatment of Post-herpetic Neuralgia, Pain? Associated With Fibromyalgia, and Diabetic peripheral neuropathic pain. Mirogabalin is a medication designed...

    August 12, 2023 • Drugs (A - Z)