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
- diabetes
- decreased function of the adrenal gland
- inflammation of the middle tissue heart muscle
- a type of inflammation of the lung called interstitial pneumonitis
- inflammation of the large intestine
- a hole in the intestine
- kidney inflammation
- high blood sugar
- abnormal liver function tests
- pregnancy
- a patient who is producing milk and breastfeeding
- pancreatitis
- 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
| Abciximab | The risk or severity of adverse effects can be increased when Abciximab is combined with Tremelimumab. |
| Adalimumab | The risk or severity of adverse effects can be increased when Adalimumab is combined with Tremelimumab. |
| Aducanumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Aducanumab. |
| Alemtuzumab | The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Tremelimumab. |
| Alirocumab | The risk or severity of adverse effects can be increased when Alirocumab is combined with Tremelimumab. |
| Amivantamab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Amivantamab. |
| Anifrolumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Anifrolumab. |
| Ansuvimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Ansuvimab. |
| Anthrax immune | The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Tremelimumab. |
| Antilymphocyte | The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Tremelimumab. |
| Antithymocyte | The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Tremelimumab. |
| Articaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Articaine. |
| Asfotase alfa | The risk or severity of adverse effects can be increased when Asfotase alfa is combined with Tremelimumab. |
| Atezolizumab | The risk or severity of adverse effects can be increased when Atezolizumab is combined with Tremelimumab. |
| Atoltivimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Atoltivimab. |
| Avelumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Avelumab. |
| Bamlanivimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Bamlanivimab. |
| Basiliximab | The risk or severity of adverse effects can be increased when Basiliximab is combined with Tremelimumab. |
| Belantamab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Belantamab mafodotin. |
| Belimumab | The risk or severity of adverse effects can be increased when Belimumab is combined with Tremelimumab. |
| Benralizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Benralizumab. |
| Benzocaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Benzocaine. |
| Benzyl alcohol | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Benzyl alcohol. |
| Besilesomab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Besilesomab. |
| Bevacizumab | The risk or severity of adverse effects can be increased when Bevacizumab is combined with Tremelimumab. |
| Bezlotoxumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Bezlotoxumab. |
| Bimekizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Bimekizumab. |
| Blinatumomab | The risk or severity of adverse effects can be increased when Blinatumomab is combined with Tremelimumab. |
| Brentuximab | The risk or severity of adverse effects can be increased when Brentuximab vedotin is combined with Tremelimumab. |
| Brodalumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Brodalumab. |
| Brolucizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Brolucizumab. |
| Bupivacaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Bupivacaine. |
| Burosumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Burosumab. |
| Butacaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Butacaine. |
| Butamben | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Butamben. |
| Canakinumab | The risk or severity of adverse effects can be increased when Canakinumab is combined with Tremelimumab. |
| Caplacizumab | The risk or severity of adverse effects can be increased when Caplacizumab is combined with Tremelimumab. |
| Capromab | The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Tremelimumab. |
| Capsaicin | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Capsaicin. |
| Casirivimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Casirivimab. |
| Catumaxomab | The risk or severity of adverse effects can be increased when Catumaxomab is combined with Tremelimumab. |
| Cemiplimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Cemiplimab. |
| Certolizumab | The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Tremelimumab. |
| Cetuximab | The risk or severity of adverse effects can be increased when Cetuximab is combined with Tremelimumab. |
| Chloroprocaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Chloroprocaine. |
| Cilgavimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Cilgavimab. |
| Cinchocaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Cinchocaine. |
| Cocaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Cocaine. |
| Conjugated | Conjugated estrogens may increase the thrombogenic activities of Tremelimumab. |
| Daratumumab | The risk or severity of adverse effects can be increased when Daratumumab is combined with Tremelimumab. |
| Darbepoetin alfa | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tremelimumab. |
| Denosumab | The risk or severity of adverse effects can be increased when Denosumab is combined with Tremelimumab. |
| Dienestrol | Dienestrol may increase the thrombogenic activities of Tremelimumab. |
| Diethylstilbestrol | Diethylstilbestrol may increase the thrombogenic activities of Tremelimumab. |
| Digoxin Immune | The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Tremelimumab. |
| Dinutuximab | The risk or severity of adverse effects can be increased when Dinutuximab is combined with Tremelimumab. |
| Diphenhydramine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Diphenhydramine. |
| Dostarlimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Dostarlimab. |
| Dulaglutide | The risk or severity of adverse effects can be increased when Dulaglutide is combined with Tremelimumab. |
| Dupilumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Dupilumab. |
| Durvalumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Tremelimumab. |
| Dyclonine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Dyclonine. |
| Ebola vaccine | The therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Tremelimumab. |
| Eculizumab | The risk or severity of adverse effects can be increased when Eculizumab is combined with Tremelimumab. |
| Efalizumab | The risk or severity of adverse effects can be increased when Efalizumab is combined with Tremelimumab. |
| Eflapegrastim | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Eflapegrastim. |
| Eftrenonacog alfa | The risk or severity of adverse effects can be increased when Eftrenonacog alfa is combined with Tremelimumab. |
| Elotuzumab | The risk or severity of adverse effects can be increased when Elotuzumab is combined with Tremelimumab. |
| Emapalumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Emapalumab. |
| Emicizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Emicizumab. |
| Eptinezumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Eptinezumab. |
| Erenumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Erenumab. |
| Erythropoietin | The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Tremelimumab. |
| Es estrogens | Esterified estrogens may increase the thrombogenic activities of Tremelimumab. |
| Estetrol | Estetrol may increase the thrombogenic activities of Tremelimumab. |
| Estradiol | Estradiol may increase the thrombogenic activities of Tremelimumab. |
| Estradiol acetate | Estradiol acetate may increase the thrombogenic activities of Tremelimumab. |
| Estradiol benzoate | Estradiol benzoate may increase the thrombogenic activities of Tremelimumab. |
| Estradiol cypionate | Estradiol cypionate may increase the thrombogenic activities of Tremelimumab. |
| Estradiol valerate | Estradiol valerate may increase the thrombogenic activities of Tremelimumab. |
| Estriol | Estriol may increase the thrombogenic activities of Tremelimumab. |
| Estrone | Estrone may increase the thrombogenic activities of Tremelimumab. |
| Estrone sulfate | Estrone sulfate may increase the thrombogenic activities of Tremelimumab. |
| Ethinylestradiol | Ethinylestradiol may increase the thrombogenic activities of Tremelimumab. |
| Ethyl chloride | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Ethyl chloride. |
| Etidocaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Etidocaine. |
| Evolocumab | The risk or severity of adverse effects can be increased when Evolocumab is combined with Tremelimumab. |
| Fanolesomab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Fanolesomab. |
| Fremanezumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Fremanezumab. |
| Galcanezumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Galcanezumab. |
| Gemtuzumab | The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Tremelimumab. |
| Golimumab | The risk or severity of adverse effects can be increased when Golimumab is combined with Tremelimumab. |
| Guselkumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Guselkumab. |
| Hepatitis B | The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Tremelimumab. |
| Hcytomegalovirus | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Human cytomegalovirus immune globulin. |
| Himmunoglobulin | The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Tremelimumab. |
| Human globulin | The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Tremelimumab. |
| Human varicella | The risk or severity of adverse effects can be increased when Human varicella-zoster immune globulin is combined with Tremelimumab. |
| Ibalizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Ibalizumab. |
| Ibritumomab | The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Tremelimumab. |
| Idarucizumab | The risk or severity of adverse effects can be increased when Idarucizumab is combined with Tremelimumab. |
| Imdevimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Imdevimab. |
| Imlifidase | The therapeutic efficacy of Tremelimumab can be decreased when used in combination with Imlifidase. |
| Inebilizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Inebilizumab. |
| Infliximab | The risk or severity of adverse effects can be increased when Infliximab is combined with Tremelimumab. |
| Inotuzumab | The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Tremelimumab. |
| Ipilimumab | The risk or severity of adverse effects can be increased when Ipilimumab is combined with Tremelimumab. |
| Isatuximab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Isatuximab. |
| Ixekizumab | The risk or severity of adverse effects can be increased when Ixekizumab is combined with Tremelimumab. |
| Lanadelumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Lanadelumab. |
| Levobupivacaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Levobupivacaine. |
| Lidocaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Lidocaine. |
| Loncastuximab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Loncastuximab tesirine. |
| Maftivimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Maftivimab. |
| Margetuximab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Margetuximab. |
| Meloxicam | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Meloxicam. |
| Mepivacaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Mepivacaine. |
| Mepolizumab | The risk or severity of adverse effects can be increased when Mepolizumab is combined with Tremelimumab. |
| Mestranol | Mestranol may increase the thrombogenic activities of Tremelimumab. |
| Methoxy | The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Tremelimumab. |
| Mirvetuximab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Mirvetuximab Soravtansine. |
| Mogamulizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Mogamulizumab. |
| Mosunetuzumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Mosunetuzumab. |
| Muromonab | The risk or severity of adverse effects can be increased when Muromonab is combined with Tremelimumab. |
| Natalizumab | The risk or severity of adverse effects can be increased when Natalizumab is combined with Tremelimumab. |
| Necitumumab | The risk or severity of adverse effects can be increased when Necitumumab is combined with Tremelimumab. |
| Nivolumab | The risk or severity of adverse effects can be increased when Nivolumab is combined with Tremelimumab. |
| Obiltoxaximab | The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Tremelimumab. |
| Obinutuzumab | The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Tremelimumab. |
| Ocrelizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Ocrelizumab. |
| Odesivimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Odesivimab. |
| Ofatumumab | The risk or severity of adverse effects can be increased when Ofatumumab is combined with Tremelimumab. |
| Olaratumab | The risk or severity of adverse effects can be increased when Olaratumab is combined with Tremelimumab. |
| Omalizumab | The risk or severity of adverse effects can be increased when Omalizumab is combined with Tremelimumab. |
| Oxetacaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Oxetacaine. |
| Oxybuprocaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Oxybuprocaine. |
| Palivizumab | The risk or severity of adverse effects can be increased when Palivizumab is combined with Tremelimumab. |
| Panitumumab | The risk or severity of adverse effects can be increased when Panitumumab is combined with Tremelimumab. |
| Peginesatide | The risk or severity of Thrombosis can be increased when Peginesatide is combined with Tremelimumab. |
| Pembrolizumab | The risk or severity of adverse effects can be increased when Pembrolizumab is combined with Tremelimumab. |
| Pertuzumab | The risk or severity of adverse effects can be increased when Pertuzumab is combined with Tremelimumab. |
| Phenol | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Phenol. |
| Polatuzumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Polatuzumab vedotin. |
| Polyestradiol | Polyestradiol phosphate may increase the thrombogenic activities of Tremelimumab. |
| Pramocaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Pramocaine. |
| Prilocaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Prilocaine. |
| Procaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Procaine. |
| Proparacaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Proparacaine. |
| Propoxycaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Propoxycaine. |
| Quinestrol | Quinestrol may increase the thrombogenic activities of Tremelimumab. |
| Ramucirumab | The risk or severity of adverse effects can be increased when Ramucirumab is combined with Tremelimumab. |
| Ranibizumab | The risk or severity of adverse effects can be increased when Ranibizumab is combined with Tremelimumab. |
| Ravulizumab | The risk or severity of adverse effects can be increased when Ravulizumab is combined with Tremelimumab. |
| Raxibacumab | The risk or severity of adverse effects can be increased when Raxibacumab is combined with Tremelimumab. |
| Reslizumab | The risk or severity of adverse effects can be increased when Reslizumab is combined with Tremelimumab. |
| Risankizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Risankizumab. |
| Rituximab | The risk or severity of adverse effects can be increased when Rituximab is combined with Tremelimumab. |
| Romosozumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Romosozumab. |
| Ropivacaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Ropivacaine. |
| Sacituzumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Sacituzumab govitecan. |
| Sarilumab | The risk or severity of adverse effects can be increased when Sarilumab is combined with Tremelimumab. |
| Secukinumab | The risk or severity of adverse effects can be increased when Secukinumab is combined with Tremelimumab. |
| Siltuximab | The risk or severity of adverse effects can be increased when Siltuximab is combined with Tremelimumab. |
| Sotrovimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Sotrovimab. |
| Spesolimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Spesolimab. |
| Sulesomab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Sulesomab. |
| Sutimlimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Sutimlimab. |
| S Estrogens, A | Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Tremelimumab. |
| Sy Estrogens, B | Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Tremelimumab. |
| Tafasitamab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Tafasitamab. |
| Teplizumab | The risk or severity of adverse effects can be increased when Teplizumab is combined with Tremelimumab. |
| Tet globulin | The risk or severity of adverse effects can be increased when Tetanus immune globulin, human is combined with Tremelimumab. |
| Tetracaine | The risk or severity of methemoglobinemia can be increased when Tremelimumab is combined with Tetracaine. |
| Tezepelumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Tezepelumab. |
| Tibolone | Tibolone may increase the thrombogenic activities of Tremelimumab. |
| Tildrakizumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Tildrakizumab. |
| Tisotumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Tisotumab vedotin. |
| Tixagevimab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Tixagevimab. |
| Tocilizumab | The risk or severity of adverse effects can be increased when Tocilizumab is combined with Tremelimumab. |
| Tositumomab | The risk or severity of adverse effects can be increased when Tositumomab is combined with Tremelimumab. |
| Tralokinumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Tralokinumab. |
| Trastuzumab | The risk or severity of adverse effects can be increased when Trastuzumab is combined with Tremelimumab. |
| Trastuzumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Trastuzumab deruxtecan. |
| Trastuzumab | The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Tremelimumab. |
| Ustekinumab | The risk or severity of adverse effects can be increased when Ustekinumab is combined with Tremelimumab. |
| Vedolizumab | The risk or severity of adverse effects can be increased when Vedolizumab is combined with Tremelimumab. |
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.
References
