Infections

Inform patients that ABRILADA may lower the ability of their immune system to fight infections. Instruct patients of the importance of contacting their healthcare provider if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Warnings and Precautions (5.1, 5.2, 5.4)].

Malignancies

Counsel patients about the risk of malignancies while receiving ABRILADA [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions

Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions [see Warnings and Precautions (5.3)].

Other Medical Conditions

Advise patients to report any signs of new or worsening medical conditions such as congestive heart failure, neurological disease, autoimmune disorders, or cytopenias. Advise patients to report any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever [see Warnings and Precautions (5.5, 5.6, 5.8, 5.9)].

Instructions on Injection Technique

Inform patients that the first injection is to be performed under the supervision of a qualified healthcare professional. If a patient or caregiver is to administer ABRILADA, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of ABRILADA [see Instructions for Use].

For patients who will use ABRILADA pen, tell them that they:

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Will only be able to press down the injection button when they are pushing the pen down firmly enough at the injection site.

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Will hear a click when the injection button is pressed all the way down. The click means the start of the injection.

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Will know the injection has finished and have received a full dose of medicine when they see the orange bar in the window, 5 seconds after hearing the 2nd click.

Instruct patients to dispose of their used needles and syringes or used pen in a FDA-cleared sharps disposal container immediately after use. Instruct patients not to dispose of loose needles and syringes or pen in their household trash. Instruct patients that if they do not have a FDA-cleared sharps disposal container, they may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting and puncture-resistant lid without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container.

Instruct patients that when their sharps disposal container is almost full, they will need to follow their community guidelines for the correct way to dispose of their sharps disposal container. Instruct patients that there may be state or local laws regarding disposal of used needles and syringes. Refer patients to the FDA's website at http://www.fda.gov/safesharpsdisposal for more information about safe sharps disposal, and for specific information about sharps disposal in the state that they live in.

Instruct patients not to dispose of their used sharps disposal container in their household trash unless their community guidelines permit this. Instruct patients not to recycle their used sharps disposal container.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com. For Medical Information about ABRILADA, please visit www.pfizermedinfo.com or call 1-800-438-1985.