IMFINZI- durvalumab injection, solution
AstraZeneca Pharmaceuticals LP

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MEDICATION GUIDE
IMFINZI ® (im-FIN-zee)
(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 or a type of lung cancer by working with your immune system.

IMFINZI can cause your 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
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
feeling cold
constipation
your voice gets deeper
urinating more often than usual
nausea or vomiting
stomach area (abdomen) pain

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

decrease in the amount of urine
blood in your urine
swelling of 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
chest pain, shortness of breath, or irregular heartbeat (myocarditis)
changes in mood or behavior
low red blood cells (anemia)
excessive bleeding or bruising
muscle weakness or muscle pain
blurry vision, double vision, or other vision problem
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:
o
has spread or cannot be removed by surgery, and
o
you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC:
o
has not spread outside your chest
o
cannot be removed by surgery, and
o
has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.

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-the-counter 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 in people with urothelial carcinoma include:

feeling tired
muscle or bone pain
constipation
decreased appetite
nausea
swelling of your arms and legs
urinary tract infection

The most common side effects of IMFINZI in people with NSCLC include:

cough
feeling tired
inflammation in the lungs (pneumonitis)
upper respiratory tract infections
shortness of breath
rash

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.

Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

By: AstraZeneca UK Limited

1 Francis Crick Ave.

Cambridge, England CB2 0AA

US License No. 2043

IMFINZI is a registered trademark of AstraZeneca group of companies.

For more information, call 1-800-236-9933 or go to www.IMFINZI.com

© AstraZeneca 2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                Issued: 7/2019

Revised: 8/2019
AstraZeneca Pharmaceuticals LP