Tremelimumab

What is Tremelimumab?

• Tremelimumab (Imjudo), is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking human IgG2 monoclonal antibody, is produced by recombinant DNA technology in NS0 cell suspension culture.

Tremelimumab 5GGV

What are the uses of this medicine?

Tremelimumab (Imjudo) is a prescription medicine used in combination with durvalumab to treat adults with:

• a type of liver cancer called unresectable hepatocellular carcinoma (uHCC). Imjudo may be used in combination with durvalumab when your uHCC cannot be removed by surgery.
• a type of lung cancer called non-small cell lung cancer (NSCLC). Imjudo may be used in combination with durvalumab and chemotherapy that contains platinum when your NSCLC:
• has spread to other parts of your body (metastatic), and
• your tumor does not have an abnormal “EGFR” or “ALK” gene.

• Imjudo is a medicine that may treat certain cancers by working with your immune system.
• Imjudo in combination with durvalumab can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

How does this medicine work?

• Tremelimumab binds to a protein called CTLA-4, which is found on the surface of T cells (a type of white blood cell).
• It may block CTLA-4 and help the immune system kill cancer cells.
• Tremelimumab is a type of monoclonal antibody and a type of immunomodulatory agent.
• CTLA-4 is a negative regulator of T-cell activity.
• Tremelimumab--actl is a monoclonal antibody that binds to CTLA-4 and blocks the interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation.
• In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Tremelimumab was approved for medical use in the United States in October 2022.

How should this medicine be used?

Recommended dosage: In Unresectable hepatocellular carcinoma (uHCC):

• Weight 30 kg and more: Imjudo 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks.
• Weight less than 30 kg: Imjudo 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks.

In Metastatic NSCLC:

• Weight 30 kg and more: 75 mg every 3 weeks in combination with durvalumab 1,500 mg and platinum-based chemotherapy for 4 cycles, and then administer durvalumab 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 75 mg in combination with durvalumab dose 6 at week 16.
• Weight less than 30 kg: 1 mg/kg every 3 weeks in combination with durvalumab 20 mg/kg and platinum-based chemotherapy for 4 cycles, and then administer durvalumab 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 1 mg/kg in combination with durvalumab dose 6 at week 16.

Administration:

• Your healthcare provider will give you Imjudo into your vein through an intravenous (IV) line over 60 minutes.

For the treatment of uHCC:

• On the same day you receive Imjudo, you will receive durvalumab through an intravenous (IV) line over 60 minutes.
• Imjudo is given to you as a single dose.
• You will then receive durvalumab every 4 weeks.

For the treatment of NSCLC:

• On the same day you receive Imjudo, you will receive durvalumab followed by platinum-containing chemotherapy. You will receive combination chemotherapy every 3 weeks for four cycles (Cycle 1-4).
• You will receive Imjudo in combination with durvalumab for one cycle only (Cycle 6).
• You will then receive durvalumab every 4 weeks. You healthcare provider will decide if you will also receive chemotherapy every 4 weeks.
• Your healthcare provider will test your blood to check you for certain side effects.
• If you miss your appointment, call your healthcare provider as soon as possible to reschedule your appointment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 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.

This medicine is available in fallowing brand namesː

• Imjudo

What side effects can this medication cause?

The most common side effects of Imjudo when used in combination with durvalumab include:

• rash
• diarrhea
• feeling tired
• itchiness
• muscle or bone pain
• stomach (abdominal)pain

The most common side effects of Imjudo when used in combination with durvalumab and platinum-containing chemotherapy in adults with metastatic NSCLC include:

• nausea
• feeling tired or weak
• muscle or bone pain
• decreased apetite
• rash
• diarrhea

Less common, but serious side effects may include:

• Lung problems
• Intestinal problems
• Liver problems
• Hormone gland problems
• Kidney problems
• Skin problems
• Pancreas problems
• Infusion reactions that can sometimes be severe or life-threatening

What special precautions should I follow?

• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis with renal dysfunction and immune-mediated pancreatitis.
• Monitor for early identification and management. Evaluate liver enzymes, creatinine, adrenocorticotropic hormone level and thyroid function at baseline and before each dose.
• Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath.
• Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain.
• 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.
• Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis.
• Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis.
• Advise patients to contact their healthcare provider immediately for signs or symptoms of severe dermatological reactions.
• Advise patients to contact their healthcare provider immediately for signs or symptoms of pancreatitis.
• 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.
• Imjudo in combination with durvalumab can cause severe or life-threatening infusion-related reactions. Interrupt, slow the rate of infusion, or permanently discontinue treatment based on the severity of the reaction.
• Based on findings from animal studies and its mechanism of action, Imjudo can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential that Imjudo 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 Imjudo.
• There are no data on the presence of tremelimumab-actl in human milk, its effects on a breastfed child, or on milk production. Advise female patients not to breastfeed while taking Imjudo and for at least 3 months after the last dose.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, Imjudo can cause fetal harm when administered to a pregnant woman.
• Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Can this medicine be used in children?

• The safety and effectiveness of tremelimumab-actl have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tremelimumab-actl
• Inactive ingredients: edetate disodium, histidine, L-histidine hydrochloride monohydrate, polysorbate 80, trehalose, and Water for Injection, USP.

Who manufactures and distributes this medicine?

Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-15185

What should I know about storage and disposal of this medication?

• Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
• Do not freeze.
• Do not shake.

• Dailymed label info on Tremelimumab
• FDA Tremelimumab