Tremelimumab-actl Injection

(tre" me lim' ue mab)

Brand Name(s): Imjudo^®

WHY is this medicine prescribed?

Tremelimumab-actl injection is used in combination with durvalumab (Imfinzi) to treat hepatocellular carcinoma (HCC; a type of liver cancer) that cannot be treated with surgery. Tremelimumab-actl injection is also used in combination with durvalumab and platinum-containing chemotherapy to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Tremelimumab-actl is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Tremelimumab-actl injection comes as a liquid to be injected into a vein over 60 minutes by a doctor or nurse in a hospital or medical facility. For the treatment of HCC, it is usually given as a single dose. For the treatment of NSCLC, it is usually given once every 3 weeks for 4 doses (cycles 1 to 4), and then as a single dose at week 16 (cycle 6).

Tremelimumab-actl injection may cause serious or life-threatening reactions during an infusion. A doctor or nurse will watch you closely while you are receiving the infusion to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during the infusion: chills, flushing, shaking, dizziness, shortness of breath, wheezing, fever, itching, rash, back or neck pain, or feeling faint.

Your doctor may slow down your infusion, permanently or temporarily stop your tremelimumab-actl injection treatment, or treat you with additional medications depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tremelimumab-actl injection and each time you receive a dose. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before receiving tremelimumab-actl injection,

• tell your doctor and pharmacist if you are allergic to tremelimumab-actl, any other medications, or any of the ingredients in tremelimumab-actl injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); diabetes; thyroid problems; any type of lung disease or breathing problems; any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); or kidney or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving tremelimumab-actl injection. You should use effective birth control to prevent pregnancy during your treatment with tremelimumab-actl injection and for at least 3 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving tremelimumab-actl injection, call your doctor immediately. Tremelimumab-actl injection may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving tremelimumab-actl injection and for at least 3 months after your final dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a tremelimumab-actl injection, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Tremelimumab-actl injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint, back, or bone pain
• trouble falling asleep or staying asleep
• hair loss
• swelling of your arms or legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• new or worsening cough, chest pain, or shortness of breath
• diarrhea; bloody or black, tarry, sticky stools; or severe stomach pain or tenderness
• yellowing of your eyes or skin, bleeding or bruising easily, decreased appetite, dark (tea colored) urine, pain in the upper right part of the stomach, extreme tiredness, nausea or vomiting
• decreased urination; blood in urine; swelling of feet, ankles, or lower legs; or loss of appetite
• headaches that won't go away or unusual headaches; extreme tiredness; weight loss or gain; increased hunger or thirst; feeling dizzy or faint; feeling cold; deepening of voice; constipation; hair loss; changes in mood or behavior such as decreased sex drive, or feeling irritable, confused, or forgetful; increased urination; or increased sweating
• stiff neck
• numbness or tingling in the arms or legs
• persistent muscle pain, weakness, or muscle cramps
• chest pain, fast or irregular heartbeats, shortness of breath, or swelling of feet or ankles
• rash or itching, scaling or blistering skin
• sores in mouth, nose, throat, or genital area
• fever or flu-like symptoms
• swollen glands
• blurry or double vision, sensitivity to light, or other vision problems
• ongoing pain that begins in the upper left or middle of the stomach but may spread to the back, loss of appetite
• nausea
• vomiting

Tremelimumab-actl injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to tremelimumab-actl injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: December 15, 2022.