Why is this medication prescribed?

Hepatocellular carcinoma (HCC), a form of liver cancer that cannot be surgically removed, is treated with tremelimumab-actl injection in conjunction with durvalumab (Imfinzi). A specific kind of non-small cell lung cancer (NSCLC) that has spread to other parts of the body is also treated with tremelimumab-actl injection, durvalumab, and chemotherapy drugs that contain platinum. Tremelimumab-actl belongs to a group of drugs known as monoclonal antibodies. It functions by supporting your immune system’s ability to inhibit or stop the growth of cancer cells.

How should this medicine be used?

In a hospital or other healthcare setting, a doctor or nurse will administer tremelimumab-actl injection into a vein over the course of 60 minutes. It is typically administered as a single dose for the treatment of HCC. It is typically administered once every three weeks for four doses (cycles 1 to 4) before being administered all at once at week sixteen (cycle six) for the treatment of NSCLC.

During an infusion, tremelimumab-actl injection may result in significant or fatal side effects. While you are receiving the infusion, a doctor or nurse will keep a close eye on you to make sure you are not having a severe response to the medication. Tell your doctor or nurse right away if you have any of the symptoms listed below that could happen during the infusion: chills, flushing, shaking, disorientation, shortness of breath, wheezing, fever, itching, rash, back or neck discomfort, or feeling faint.

Depending on your reaction to the drug and any side effects you have, your doctor may reduce the rate of your infusion, halt your tremelimumab-actl injectable treatment permanently or temporarily, or administer additional medication. How you are feeling while undergoing therapy should be discussed with your doctor.

As soon as you start receiving tremelimumab-actl injectable from your healthcare provider, they will also offer you a copy of the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, thoroughly read the material, then consult your physician or pharmacist.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you think this drug may be recommended for other conditions.

What special precautions should I follow?

• If you have an allergy to tremelimumab-actl, any other drugs, or any of the chemicals in tremelimumab-actl injection, notify your doctor right away. For a list of the ingredients, consult your pharmacist or the Medication Guide.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter medications, vitamins, herbal items, nutritional supplements, and any drugs you are now taking or intend to take. Your doctor might need to adjust your medication doses or keep a close eye out for any negative 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 that causes swelling and sores in the lining of the colon [large intestine], and rectum), or lupus (condition in which the immune system attacks many different parts), diabetes, thyroid issues, any form of lung disease, breathing issues, any condition that affects your nervous system, like myasthenia gravis (a nervous system disorder that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and potentially paralysis due to sudden nerve damage), as well as kidney or liver disease.
• In case you are expecting a child, tell your doctor right away. While receiving tremelimumab-actl injection, it is best to avoid getting pregnant. You should use reliable birth control to avoid getting pregnant while receiving tremelimumab-actl injectable medication and for at least three months following your last dosage. The best birth control options for you can be discussed with your doctor. Call your doctor as soon as possible if you became pregnant while having tremelimumab-actl injectable. The fetus could suffer from the injection of tremelimumab-actl.
• In case you are nursing or intend to, let your doctor know. As well as for at least 3 months following your final dose of tremelimumab-actl injection, you should refrain from breastfeeding.

What special dietary instructions should I follow?

Maintain your regular diet unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Call your doctor as soon as you can if you are unable to keep a scheduled appointment to obtain a tremelimumab-actl injection.

What side effects can this medication cause?

Side effects from tremelimumab-actl injection are possible. If any of these symptoms are severe or do not go away, consult your doctor:

• Back, bone, or joint discomfort
• Having difficulty falling or staying asleep
• Losing hair
• Your arms or legs becoming swollen

Some adverse effects may be severe. Call your doctor right away or seek emergency medical attention if you have any of these symptoms:

• Chest pain or shortness of breath, with a new or worsening cough
• Bloody or dark, tarry, sticky feces, acute stomach discomfort, or soreness or diarrhea
• Reduced appetite, dark (tea-colored) urine, pain in the upper right part of the stomach, excessive fatigue, yellowing of the eyes or skin, bleeding or bruising easily, nausea or vomiting
• Reduced urination, blood in the urine, ankle or lower leg edema, decreased appetite, or decreased urination
• Excessive fatigue, weight loss or gain, increased hunger or thirst, feeling lightheaded or faint, feeling cold, and persistent or uncommon headaches; Increased urination, increased sweating, constipation, hair loss, changes in attitude or behavior including a decline in sex drive or a sense of being agitated, disoriented, or forgetful, as well as deepening of voice
• Rigid neck
• Arms or legs feeling numb or tingly
• Chronic muscle aches, fatigue, or cramping
• Chest pain, rapid or irregular heartbeats, breathlessness, or swelling in the ankles or feet
• Skin that is flaking, blistering, or rashy
• Mouth, throat, nose, or genital sores
• The flu-like symptoms such as temperature
• An enlarged gland
• Light sensitivity or other vision issues, double or hazy vision,
• Persistent stomach ache that starts in the upper left or middle but may move to the back, stomach aches
• Nausea
• Vomiting

Other negative effects from tremelimumab-actl injection are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone (1-800-332-1088) if you suffer a serious side event.

In case of emergency/overdose

Call 1-800-222-1222 to reach the poison control hotline in the event of an overdose. Call emergency services at 911 right away if the sufferer has fallen, experienced a seizure, is having problems breathing, or cannot be roused.

What other information should I know?

Do not miss any of your doctor’s or lab appointments. To assess your body’s reaction to the tremelimumab-actl injection, your doctor will request a few lab tests.

It’s crucial that you keep a written record of every medication you take, including any vitamins, minerals, or other dietary supplements. This list should also include any over-the-counter (OTC) medications you use. When you visit a doctor or are admitted to the hospital, you should always bring this list with you. In case of crises, it is also crucial to have this information on hand.