17 PATIENT COUNSELING INFORMATION

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Infections

Inform patients that Adalimumab-adaz may lower the ability of their immune system to fight infections. Instruct patients of the importance of contacting their doctor 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 Adalimumab- adaz [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions

Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions.

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 health care professional. If a patient or caregiver is to administer Adalimumab-adaz, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of Adalimumab-adaz [see Instructions for Use].

For patients who will use the Adalimumab-adaz single-dose prefilled Sensoready Pen, tell them that they:

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will hear**2 loud clicks**. The**1****st**** click** indicates that the injection has**started**. Several seconds later a**2****nd**** click** will indicate that the injection is almost**finished**.

•

must keep holding the Adalimumab-adaz single-dose prefilled Sensoready Pen firmly against their skin until they see a green indicator fill the window and stop moving.

Instruct patients to dispose of their used syringes or used Sensoready Pens in an FDA-cleared sharps disposal container immediately after use.Instruct patients not to dispose of syringes or pens in their household trash. Instruct patients that if they do not have an 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.

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Sandoz Inc.

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US License No. 2003

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