IMFINZI- durvalumab injection, solution 
AstraZeneca Pharmaceuticals LP


IMFINZI® (im-FIN-zee)

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

IMFINZI is a medicine that may treat certain cancers by working with your immune system.

IMFINZI 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.

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
fast and deep breathing
sweet smell to your breath
sweet or metallic taste in your mouth
different odor to your urine or sweat
urinating more often than usual
hair loss
feeling cold
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.

skin blistering or peeling
painful sores or ulcers in mouth or nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes

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. 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
shortness of breath or wheezing
feel like passing out
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. 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, if you have severe side effects.

What is IMFINZI?

IMFINZI is a prescription medicine used to treat adults with:

a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used 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.
a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and 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).

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 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 can harm your unborn baby.
Females who 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 or think you may be 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, 3 or 4 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 NSCLC include:

feeling tired
inflammation in the lungs
upper respiratory tract infections
shortness of breath

The most common side effects of IMFINZI when used with other anticancer medicines in people with ES-SCLC include:

hair loss
feeling tired or weak

Tell your doctor 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 doctor 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

© AstraZeneca 2021

This Medication Guide has been approved by the U.S. Food and Drug Administration.                         Revised: 07/2021

Revised: 5/2022
AstraZeneca Pharmaceuticals LP