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Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath [see WARNINGS AND PRECAUTIONS (5.1)].
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Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding [see WARNINGS AND PRECAUTIONS (5.2)].
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Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain [see WARNINGS AND PRECAUTIONS (5.3)].
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Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis or type 1 diabetes mellitus [see WARNINGS AND PRECAUTIONS (5.4)].
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Other Immune-Mediated Adverse Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of rash, nephritis, aseptic meningitis, thrombocytopenic purpura, myocarditis, hemolytic anemia, myositis, uveitis and keratitis [see WARNINGS AND PRECAUTIONS (5.5)].
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Infection: Advise patients to contact their healthcare provider immediately for infection [see WARNINGS AND PRECAUTIONS (5.6)].
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Infusion-Related Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see WARNINGS AND PRECAUTIONS (5.7)].
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Embryo-Fetal Toxicity: Advise females of reproductive potential that IMFINZI can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see WARNINGS AND PRECAUTIONS (5.8) and USE IN SPECIFIC POPULATIONS (8.1, 8.3)].
Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of IMFINZI [see USE IN SPECIFIC POPULATIONS (8.3)].
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Lactation: Advise female patients not to breastfeed while taking IMFINZI and for at least 3 months after the last dose [see WARNINGS AND PRECAUTIONS (5.8) and USE IN SPECIFIC POPULATIONS (8.2)].
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 trademark of AstraZeneca group of companies.
©AstraZeneca 2017
MEDICATION GUIDE
MEDICATION GUIDE
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
•
seve