•Institutional Use Vial Carton – 40 mg
Humira is supplied for institutional use only in a carton containing a single-use, glass vial, providing 40 mg (0.8 mL) of Humira. The NDC number is 0074-3797-01.
Storage and Stability
Do not use beyond the expiration date on the container. Humira must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. Do not use if frozen even if it has been thawed. When traveling, store Humira in a cool carrier with an ice pack. Protect the prefilled syringe from exposure to light. Store in original carton until time of administration.
Patient Counseling Information
See FDA-approved patient labeling (Medication Guide and Instructions for Use).
Patient Counseling
Provide the Humira “Medication Guide” to patients or their caregivers, and provide them an opportunity to read it and ask questions prior to initiation of therapy and prior to each time the prescription is renewed. If patients develop signs and symptoms of infection, instruct them to seek medical eva luation immediately.
Advise patients of the potential benefits and risks of Humira.
•Infections
Inform patients that Humira 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.
•Malignancies
Counsel patients about the risk of malignancies while receiving Humira.
•Allergic Reactions
Advise patients to seek immediate medical attention if they experience any symptoms of severe allergic reactions. Advise latex-sensitive patients that the needle cap of the prefilled syringe contains latex.
•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.
Instruction 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 Humira, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of Humira [see Instructions for Use].
For patients who will use the Humira Pen, tell them that they:
•Will hear a loud ‘click’ when the plum-colored activator button is pressed. The loud click means the start of the injection.
•Must keep holding the Humira Pen against their squeezed, raised skin until all of the medicine is injected. This can take up to 10 seconds.
•Will know that the injection has finished when the yellow marker fully appears in the window view and stop