Imjudo

Generic name: Tremelimumab-actl
Dosage form: injection
Drug class: Anti-CTLA-4 monoclonal antibodies

Usage of Imjudo

Imjudo is a prescription medicine that may be used in combination with Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma or non-small cell lung cancer (NSCLC) that has spread (metastatic NSCLC).

Imjudo is a human monoclonal antibody that works by blocking the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).

Imjudo side effects

Imjudo can cause serious side effects, including:

See Important information

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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Imjudo

Before you receive Imjudo, tell your healthcare provider about all of your medical conditions, including if you:

have immune system problems such as Crohn's disease, ulcerative colitis, or lupus

have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome

are pregnant or plan to become pregnant. Imjudo can harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose.

Females who are able to become pregnant

Your healthcare provider should do a pregnancy test before you start treatment.

You should use an effective method of birth control during your treatment and for 3 months after your last dose. Talk to your healthcare provider about birth control methods that you can use during this time.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment.

Relate drugs

How to use Imjudo

Usual Adult Dose for Unresectable Hepatocellular Carcinoma

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

Comment: - Administer Imjudo as an intravenous infusion over 60 minutes after dilution.

Use: - indicated in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma

Usual Adult Dose for Metastatic NSCLC

Greater than or equal to 30 kg: 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.

30 kg or less: 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.

Use: - the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mUTAtions or anaplastic lymphoma kinase (ALK) genomic tumor aberrations in combination with durvalumab and platinum-based chemotherapy.

Warnings

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.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems.

cough

shortness of breath

chest pain

Intestinal problems.

diarrhea (loose stools) or more frequent bowel movements than usual

stools that are black, tarry, sticky, or have blood or mucus

severe stomach-area (abdomen) pain or tenderness

Liver problems.

yellowing of your skin or the whites of your eyes

severe nausea or vomiting

pain on the right side of your stomach-area (abdomen)

dark urine (tea colored)

bleeding or bruising more easily than normal

Hormone gland problems.

headaches that will not go away or unusual headaches

eye sensitivity to light

eye problems

rapid heartbeat

increase sweating

extreme tiredness

weight gain or weight loss

feeling more hungry or thirsty than usual

urinating more often than usual

hair loss

feeling cold

constipation

your voice gets deeper

dizziness or fainting

changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems.

decrease in your amount of urine

blood in your urine

swelling of your ankles

loss of appetite

Skin problems.

rash

itching

skin blistering or peeling

painful sores or ulcers in mouth or nose, throat, or genital area

fever or flu-like symptoms

swollen lymph nodes

Pancreas problems.

Pain in your upper stomach-area (abdomen)

severe nausea or vomiting

loss of appetite

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Imjudo. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

chest pain, irregular heartbeats, shortness of breath or swelling of ankles

confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs

double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight

persistent or severe muscle pain or weakness, muscle cramps

low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking

itching or rash

flushing

shortness of breath or wheezing

dizziness

feel like passing out

fever

back or neck pain

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment if you have severe side effects.

What other drugs will affect Imjudo

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.