ease, ulcerative colitis, or lupus
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have had an organ transplant
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have lung or breathing problems
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have liver problems
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are being treated for an infection
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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.
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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?
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Your healthcare provider will give you IMFINZI into your vein through an intravenous (IV) line over 60 minutes.
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IMFINZI is usually given every 2 weeks.
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Your healthcare provider will decide how many treatments you need.
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Your healthcare provider will test your blood to check you for certain side effects.
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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
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muscle and/or bone pain
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constipation
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decreased appetite
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nausea
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swelling
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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.
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.
For more information, call 1-800-236-9933 or go to WWW.IMFINZI.COM
©AstraZeneca 2017
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 5/2017
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0310-4500-12
Rx only
IMFINZI™
(durvalumab)
Injection
120 mg/2.4 mL
(
