Imfinzi

IMFINZI™
(durvalumab) Injection

What is the most important information I should know about IMFINZI?

IMFINZI is a medicine that may treat a type of cancer in the bladder and urinary tract by working with your immune system.

In some patients IMFINZI can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include:

• new or worsening cough
• shortness of breath
• chest pain

Liver problems (hepatitis). Signs and symptoms of hepatitis may include:

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• drowsiness
• dark urine (tea colored)
• bleeding or bruising more easily than normal
• feeling less hungry than usual

Intestinal problems (colitis). Signs and symptoms of colitis may include:

• diarrhea or more bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach area (abdomen) pain or tenderness

Hormone gland problems (especially the thyroid, adrenals, pituitary and pancreas). Signs and symptoms that your hormone glands are not working properly may include:

• headaches that will not go away or unusual headaches
• extreme tiredness
• weight gain or weight loss
• dizziness or fainting
• feeling more hungry or thirsty than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• urinating more often than usual
• nausea or vomiting
• stomach area (abdomen) pain
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include:

• decrease in the amount of urine
• blood in your urine
• swelling in your ankles
• loss of appetite

Skin problems. Signs of these problems may include:

• rash
• itching
• skin blistering

Problems in other organs. Signs and symptoms may include:

• neck stiffness
• headache
• confusion
• fever
• changes in mood or behavior
• blurry vision, double vision, or other vision problems
• eye pain or redness

Severe Infections. Signs and symptoms may include:

• fever
• cough
• frequent urination
• pain when urinating
• flu-like symptoms

Severe infusion reactions. Signs and symptoms of severe infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• fever
• feel like passing out
• back or neck pain
• facial swelling

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. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment with IMFINZI, if you have severe side effects.

What is IMFINZI?

IMFINZI is a prescription medicine used to treat a type of cancer in the bladder and urinary tract called urothelial carcinoma.

IMFINZI may be used when your urothelial carcinoma:

• has spread or cannot be removed by surgery and,
• you have tried chemotherapy that contains platinum, and it did not work or is no longer working.

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

Before you receive IMFINZI, 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 had an organ transplant
• have lung or breathing problems
• have liver problems
• are being treated for an infection
• are pregnant or plan to become pregnant. IMFINZI can harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI. 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 during treatment with IMFINZI.
• are breastfeeding or plan to breastfeed. It is not known if IMFINZI passes into your breast milk. Do not breastfeed during treatment and for at least 3 months after the last dose of IMFINZI.

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

How will I receive IMFINZI?

• Your healthcare provider will give you IMFINZI into your vein through an intravenous (IV) line over 60 minutes.
• IMFINZI is usually given every 2 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will test your blood to check you for certain side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of IMFINZI?

IMFINZI can cause serious side effects, including:

See “What is the most important information I should know about IMFINZI?”

The most common side effects of IMFINZI include:

• feeling tired
• muscle and/or bone pain
• constipation
• decreased appetite
• nausea
• swelling
• urinary tract infection

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. Ask your healthcare provider or pharmacist for more information.

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

General information about the safe and effective use of IMFINZI.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about IMFINZI, talk with your healthcare provider. You can ask your healthcare provider for information about IMFINZI that is written for health professionals.

What are the ingredients in IMFINZI?

Active ingredient: durvalumab

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, polysorbate 80, water for injection, USP.

• Astrazeneca

Durvalumab is injected into a vein through an IV. A healthcare provider will give you this injection.

This medicine must be given slowly and the IV infusion can take about 1 hour to complete.

Durvalumab is usually given once every 2 weeks. Follow your doctor's instructions.

You may need frequent medical tests to help your doctor determine how long to treat you with durvalumab.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Call your doctor for instructions if you miss an appointment for your durvalumab injection.

Durvalumab is injected into a vein through an IV. A healthcare provider will give you this injection.

This medicine must be given slowly and the IV infusion can take about 1 hour to complete.

Durvalumab is usually given once every 2 weeks. Follow your doctor's instructions.

You may need frequent medical tests to help your doctor determine how long to treat you with durvalumab.

Other drugs may interact with durvalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Durvalumab has the following uses:

Durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1

General

Durvalumab is available in the following dosage form(s) and strength(s):

• Injection: 500 mg/10 mL (50 mg/mL) solution in a single-dose vial.1

• Injection: 120 mg/2.4 mL (50 mg/mL) solution in a single-dose vial.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

• Administer 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks.1

• Dilute prior to intravenous infusion.1

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:

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• depressed mood
• difficult, burning, or painful urination
• difficulty having a bowel movement (stool)
• dry skin and hair
• feeling cold
• fever
• frequent urge to urinate
• hair loss
• hoarseness or husky voice
• lower back or side pain
• muscle cramps and stiffness
• pain
• rapid weight gain
• slowed heartbeat
• stomach cramps
• tenderness
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss
• watery or bloody diarrhea

• Chest pain
• chills
• cough
• dark urine
• difficult breathing
• general feeling of discomfort or illness
• general tiredness and weakness
• light-colored stools
• nausea and vomiting
• nervousness
• sensitivity to heat
• sweating
• thickening of bronchial secretions
• trouble sleeping
• upper right abdominal or stomach pain
• weight loss
• yellow eyes and skin

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• bloody nose
• blurred vision or other change in vision
• chest tightness
• eye redness, irritation, or pain
• general body swelling
• headache
• heavier menstrual periods
• loss of appetite
• nosebleeds
• pale skin
• pinpoint red spots on the skin
• redness of the eye
• sensitivity of the eye to light
• skin rash
• sore throat
• stiff neck or back
• tearing
• unusual bleeding or bruising

• Dizziness
• drowsiness
• fainting

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:

• Decreased appetite
• muscle or joint pain

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.

• Tell all of your health care providers that you take Imfinzi. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Check your blood sugar as you have been told by your doctor.
• Very bad health problems like some organ problems can happen with this medicine. This includes lung, liver, thyroid gland, pituitary gland, adrenal gland, kidney, and muscle problems. A very bad rash may also happen. Sometimes, these problems can be life-threatening. These problems may happen anytime during treatment or after treatment has stopped. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
• Some patients have had side effects during the infusion. Tell your doctor if you have any of these side effects during the infusion: back or neck pain, chills or shaking, dizziness, feeling like passing out, fever, flushing, itching, rash, shortness of breath, swelling of the face, or wheezing.
• It is common to have loose stools (diarrhea) with Imfinzi. However, a very bad bowel problem (colitis) with diarrhea has happened with this medicine. This may lead to tears or holes in the bowels and may be life-threatening. Call your doctor right away if you have bloody stools; dark, tarry, or sticky stools; diarrhea; or very bad stomach pain.
• This medicine may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking Imfinzi and for 3 months after care ends.
• If you get pregnant while taking this medicine or within 3 months after your last dose, call your doctor right away.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Imfinzi, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Imfinzi (durvalumab). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Imfinzi.

Review Date: October 4, 2017

Injection: 120 mg/2.4mL (50 mg/mL) and 500 mg/10mL (50 mg/mL) clear to opalescent, colorless to slightly yellow solution in a single-dose vial.

Imfinzi (durvalumab) is a cancer medicine that works with your immune system to interfere with the growth and spread of cancer cells in the body.

Imfinzi is used to treat cancer of the bladder or urinary tract.

Imfinzi is usually given when the cancer cannot be removed with surgery and has not responded to chemotherapy with other medicines.

Imfinzi was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, tumors responded to this medicine. However, further studies are needed.

Imfinzi is injected into a vein through an IV. A healthcare provider will give you this injection.

This medicine must be given slowly and the IV infusion can take about 1 hour to complete.

Imfinzi is usually given once every 2 weeks. Follow your doctor's instructions.

You may need frequent medical tests to help your doctor determine how long to treat you with this medicine.

Usual Adult Dose for Bladder Cancer:

10 mg/kg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Uses: For the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
1) Have disease progression during or following platinum-containing chemotherapy
2) Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Call your doctor for instructions if you miss an appointment for your injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.