IMFINZI 500 MG / 10 ML ( DURVALUMAB 50 MG / ML ) CONCENTRATE FOR DILUTION FOR IV INFUSION 10 ML VIAL

Important Safety Information
What is the most important information I should know about IMFINZI® (durvalumab) and IMJUDO® (tremelimumab-actl)?
IMFINZI and IMJUDO are medicines that may treat certain cancers by working with your immune system. IMFINZI and IMJUDO 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.

What are IMFINZI and IMJUDO?
IMFINZI and IMJUDO are prescription medications that may treat certain cancers.

IMFINZI is used to treat adults with a type of lung cancer called NSCLC.

• IMFINZI may be used alone when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.
• IMFINZI may be used in combination with chemotherapy that contains platinum prior to surgery and alone after surgery when your NSCLC is able to be removed by surgery, and your tumor does not have an abnormal “EGFR” or “ALK” gene.
• IMFINZI may be used in combination with IMJUDO 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.

IMFINZI is used to treat adults with a type of lung cancer called SCLC.

• IMFINZI may be used alone when your LS-SCLC cannot be removed by surgery and has responded or stabilized after initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.
• IMFINZI may be used with the chemotherapy medicines etoposide and either carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC).

IMFINZI is used to treat adults with a type of cancer called BTC, including cancer of the bile ducts (cholangiocarcinoma) and gallbladder cancer. IMFINZI may be used in combination with chemotherapy medicines gemcitabine and cisplatin when your BTC has spread to nearby tissues (locally advanced), or has spread to other parts of the body (metastatic).

IMFINZI is used in combination with IMJUDO to treat adults with a type of liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma or uHCC).

IMFINZI is used in combination with the chemotherapy medicines carboplatin and paclitaxel followed by IMFINZI alone to treat adults with a type of uterine cancer called endometrial cancer that has spread (advanced) or has come back (recurred) and a laboratory test shows that your tumor is mismatch repair deficient (dMMR).

IMFINZI may be used in combination with the chemotherapy medicines gemcitabine and cisplatin prior to surgical removal of your bladder (neoadjuvant treatment) followed by IMFINZI alone after surgery (adjuvant treatment) to treat a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body.

It is not known if IMFINZI and IMJUDO are safe and effective in children.

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, and 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; and 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), and 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; increased 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; and 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, and 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; and swollen lymph nodes

Pancreas problems: pain in your upper stomach area (abdomen), severe nausea or vomiting, and 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 IMFINZI and 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, numbness or weakness 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, joint pain, joint stiffness or swelling; and low red blood cells and 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, and back or neck pain

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with IMFINZI. Your healthcare provider will monitor you for these complications

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 with IMFINZI and IMJUDO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with IMFINZI and IMJUDO if you have severe side effects

Before you receive IMFINZI and 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 received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. IMFINZI and IMJUDO can harm your unborn baby
• Females who are able to become pregnant:
  • Your healthcare provider will give you a pregnancy test before you start treatment with IMFINZI and IMJUDO.
  • You should use an effective method of birth control during your treatment and for 3 months after the last dose of IMFINZI and IMJUDO. 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 with IMFINZI and IMJUDO.
• are breastfeeding or plan to breastfeed. It is not known if IMFINZI and IMJUDO pass into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of IMFINZI and IMJUDO.

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

What are the possible side effects of IMFINZI and IMJUDO?
IMFINZI and IMJUDO can cause serious side effects (see above):

The most common side effects of IMFINZI when used alone in adults with NSCLC that cannot be removed by surgery include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash.

The most common side effects of IMFINZI when used with platinum-containing chemotherapy in adults with NSCLC that can be removed by surgery include low red blood cells (anemia), nausea, constipation, feeling tired, muscle or bone pain, and rash.

The most common side effects of IMFINZI when used in combination with IMJUDO and platinum-containing chemotherapy in adults with metastatic NSCLC include nausea, feeling tired or weak, muscle or bone pain, decreased appetite, rash, and diarrhea.

The most common side effects of IMFINZI when used alone in adults with limited-stage small cell lung cancer (LS-SCLC) include inflammation in the lungs and feeling tired or weak.

The most common side effects of IMFINZI when used with etoposide and either carboplatin or cisplatin in adults with extensive-stage small cell lung cancer (ES-SCLC) include nausea, hair loss, and feeling tired or weak.

The most common side effects of IMFINZI when used with gemcitabine and cisplatin in adults with biliary tract cancer (BTC) include feeling tired, nausea, constipation, decreased appetite, stomach (abdominal) pain, rash, and fever.

The most common side effects of IMFINZI and IMJUDO in adults with unresectable hepatocellular carcinoma (uHCC) include rash, diarrhea, feeling tired, itchiness, muscle or bone pain, and stomach (abdominal) pain.

The most common side effects of IMFINZI when used with carboplatin and paclitaxel in adults with endometrial cancer include inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs, muscle or bone pain, nausea, hair loss, feeling tired, stomach (abdominal) pain, constipation, rash, decreased level of magnesium in the blood, increased liver function tests, diarrhea, vomiting, cough, decreased level of potassium in the blood, shortness of breath, headache, and increased level of alkaline phosphate in the blood.

The most common side effects of IMFINZI when used with gemcitabine and cisplatin in adults with muscle-invasive bladder cancer (MIBC) include low red blood cells (anemia), low white blood cells, increased level of creatinine in the blood, decreased level of sodium in the blood, nausea, increased liver function tests, decreased level of calcium in the blood, decreased blood platelet counts, feeling tired, increase level of potassium in the blood, decreased lymphocyte counts, constipation, decreased level of magnesium in the blood, decreased appetite, increased level of alkaline phosphatase in the blood, rash, fever, diarrhea, vomiting and 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 of IMFINZI and IMJUDO. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca productsReport side effects related to AstraZeneca products .
If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

--Brand Name--
US Brand Name: Imfinzi

--Description--
Durvalumab injection is used in combination with platinum-containing chemotherapy before surgery and then used alone after surgery in patients with non-small cell lung cancer (NSCLC) which can be removed by surgery and do not have an abnormal EGFR or ALK gene. It is also used alone to treat NSCLC that has not spread and cannot be removed by surgery in patients who have received other cancer medicines (eg, platinum) and radiation treatment for their NSCLC. It is also used in combination with tremelimumab-actl and platinum-containing chemotherapy to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body in patients whose tumors do not have an abnormal EGFR or ALK gene. This medicine is also used alone to treat limited-stage small cell lung cancer (LS-SCLC) that cannot be removed by surgery in patients who have received other cancer medicines (eg, platinum) and radiation treatment for their LS-SCLC. This medicine is also used in combination with etoposide and either carboplatin or cisplatin as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).

Durvalumab injection is also used in combination with other cancer medicines (eg, gemcitabine and cisplatin) to treat biliary tract cancer (BTC) that has spread to nearby tissues or to other parts of the body.

Durvalumab injection is also used in combination with tremelimumab-actl to treat liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma or uHCC).

Durvalumab injection is also used in combination with other cancer medicines (eg, carboplatin and paclitaxel) and then used alone to treat mismatch repair deficient (dMMR) advanced endometrial cancer (cancer of the lining of the uterus or womb) that has spread or has come back.

Durvalumab injection is also used in combination with other cancer medicines (eg, gemcitabine and cisplatin) before surgery and then used alone after surgery to treat muscle invasive bladder cancer (MIBC).

This medicine is to be given only by or under the supervision of your doctor.

This product is available in the following dosage forms: Solution

--Before Using--
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of durvalumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of durvalumab injection in the elderly.

Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal gland problems or
• Diabetes or
• Immune system problems or
• Infection or
• Kidney problems or
• Liver problems or
• Lung or breathing problems or
• Thyroid problems—Use with caution. May make these conditions worse.
• Organ transplant or tissue transplant (eg, cornea transplant), recent—Use with caution. May increase risk for organ or tissue transplant rejection.
• Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.

--Proper Use--
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 60 minutes every 2, 3, or 4 weeks.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

--Precautions--
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem (eg, pneumonitis).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Colitis (inflammation of the colon) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.

Adrenal, pituitary, or thyroid gland problems may occur while you are receiving this medicine. Tell your doctor if you have changes in mood or behavior, constipation, dry skin or hair, feeling cold, sensitivity to heat, sweating, trouble sleeping, or weight changes.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), or toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or a skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

Check with your doctor right away if you have severe headache, drowsiness, confusion, general feeling of illness, or stiff neck or back while you are receiving this medicine. These may be symptoms of meningitis.

Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, painful or difficult urination, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

This medicine may cause inflammation of the heart muscle (myocardium) called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.

This medicine may cause thrombocytopenic purpura. Check with your doctor right away if you have black, tarry stools, blood in the urine, bloody nose, fever, heavier menstrual periods, pinpoint red spots on the skin, skin rash, unusual bleeding or bruising or unusual tiredness or weakness.

Call your doctor right away if you have difficulty with breathing, swallowing, or talking, muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.

This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a skin rash, dizziness, trouble breathing, chest tightness, swelling in your face or hands, or fever or chills while you are receiving this medicine.

This medicine may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.

--Side Effects--
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• body aches or pain
• burning, numbness, tingling, or painful sensations
• chest pain or tightness
• chills
• constipation
• cough
• coughing up blood
• depressed mood
• diarrhea
• difficult, burning, or painful urination
• difficulty having a bowel movement
• dry skin and hair
• ear congestion
• feeling cold
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• hair loss
• headache
• hoarseness, husky, or loss of voice
• increased menstrual flow or vaginal bleeding
• loss of taste or smell
• lower back or side pain
• muscle cramps and stiffness
• nausea or vomiting
• nervousness
• nosebleeds
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• runny or stuffy nose
• sensitivity to heat
• slow or fast heartbeat
• sneezing
• sore throat
• stomach cramps
• sweating
• tenderness
• thickening of bronchial secretions
• tingling of the hands or feet
• trouble breathing
• trouble sleeping
• unsteadiness or awkwardness
• unusual tiredness or weakness
• unusual weight gain or loss
• watery or bloody diarrhea
• weakness in arms, hands, legs, or feet
• weight gain

Less common

• Back, leg, or stomach pains
• black, tarry stools
• bloody nose
• changes in vision
• dark urine
• eye redness, irritation, or pain
• general body swelling
• heavier menstrual periods
• light-colored stools
• loss of appetite
• pale skin
• pinpoint red spots on the skin
• sensitivity of the eye to light
• skin rash
• stiff neck or back
• tearing
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• yellow eyes and skin

Rare

• Blistering, peeling, or loosening of the skin
• dizziness
• drowsiness
• fainting
• joint or muscle pain
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decrease appetite
• lack or loss of strength
• muscle or bone pain
• thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Write a review