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DailyMed – JIVI (antihemophilic factor


FDA-Approved Patient Labeling

Patient Information

Jivi (JIHV-ee)

antihemophilic factor (recombinant), PEGylated-aucl

This leaflet summarizes important information about Jivi with vial adapter. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Jivi. If you have any questions after reading this, ask your healthcare provider.

Do not attempt to self-infuse, unless your healthcare provider or hemophilia center has taught you how to self-infuse.

What is Jivi?

Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A (congenital Factor VIII deficiency).

Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older ) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).

Jivi is not for use in children < 12 years of age or in previously untreated patients.

Jivi is not used to treat von Willebrand disease.

Who should not use Jivi?

You should not use Jivi if you

are allergic to rodents (like mice and hamsters).
are allergic to any ingredients in Jivi.

What should I tell my healthcare provider before I use Jivi?

Tell your healthcare provider about:

All of your medical conditions that you have or had.
All of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies.
Pregnancy or planning to become pregnant. It is not known if Jivi may harm your unborn baby.
Breastfeeding. It is not known if Jivi passes into the milk.
Whether you have been told that you have inhibitors to Factor VIII.

What are the possible side effects of Jivi?

The common side effects of Jivi are headache, cough, nausea and fever.

Allergic reactions may occur with Jivi. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, or nausea. Allergic reactions to polyethylene glycol (PEG), a component of Jivi, are possible.

Your body can also make antibodies, called “inhibitors”, against Jivi, which may stop Jivi from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

If your bleeding is not being controlled with your usual dose of Jivi, consult your doctor immediately. You may have developed Factor VIII inhibitors or antibodies to PEG and your doctor may carry out tests to confirm this.

These are not all the possible side effects with Jivi. You can ask your healthcare provider for information that is written for healthcare professionals.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

What are the Jivi dosage strengths?

Jivi with 2.5 mL Sterile Water for Injection (SWFI) comes in four different dosage strengths labeled as International Units (IU): 500 IU, 1000 IU, 2000 IU, and 3000 IU. The four different strengths are color-coded as follows:

How do I store Jivi?

Do not freeze Jivi .

Store Jivi at +2°C to +8°C (36°F to 46°F) for up to 24 months from the date of manufacture. Within this period, Jivi may be stored for a period of up to 6 months at temperatures up to +25°C or 77°F.

Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature for 6 months, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light.

Administer reconstituted Jivi as soon as possible. If not, store at room temperature for no longer than 3 hours.

Throw away any unused Jivi after the expiration date.

Do not use reconstituted Jivi if it is not clear.

What else should I know about Jivi and hemophilia A?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use Jivi for a condition for which it is not prescribed. Do not share Jivi with other people, even if they have the same symptoms that you have.

This leaflet summarizes the most important information about Jivi that was written for healthcare professionals.

Instructions for Use

Jivi-antihemophilic factor (recombinant), PEGylated-aucl

Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.

You should always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using Jivi. If you are unsure of the procedures, please call your healthcare provider before using.

If bleeding is not controlled after using Jivi, then call your healthcare provider right away.

Your healthcare provider will prescribe the dose that you should take.

Your healthcare provider may need to take blood tests from time to time.

Talk to your healthcare provider before traveling. You should plan to bring enough Jivi for your treatment during this time.

See the step-by-step instructions below for reconstituting (mixing) Jivi with vial adapter. Follow the specific infusion instruction leaflet included with the infusion set provided.

Carefully handle Jivi. Dispose of all materials, including any leftover reconstituted Jivi product, in an appropriate container.

Use only the components for reconstitution and administration that are provided with each package of Jivi. If a package is opened or damaged, do not use this component. If these components cannot be used, please contact your healthcare provider. Gather all the materials needed for the infusion.

Reconstitution

Always work on a clean flat surface and wash your hands before performing the following procedures.

Rate of Administration

The entire dose of Jivi can usually be infused within 1 to 15 minutes. The maximum rate is 2.5 mL per minute. Your healthcare provider will determine the rate of administration that is best for you.

Resources at Bayer available to the patient:

For Adverse Reaction Reporting, contact Bayer Medical Communications 1-888-84-BAYER (1-888-842-2937)

To receive more product information, contact Jivi Customer Service 1-888-606-3780

Bayer Reimbursement HELPline 1-800-288-8374

For more information, visit http://www.Jivi.com

Bayer HealthCare LLC
Whippany, NJ 07981 USA

U.S. License No. 0008



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