culate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration or other foreign particles are observed, the solution should not be used.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (MEDICATION GUIDE)
Patient Counseling
Advise patients and parents or guardians of minors with PJIA or SJIA of the potential benefits and risks of ACTEMRA. Physicians should instruct their patients to read the Medication Guide before starting ACTEMRA therapy.
Infections:
Inform patients that ACTEMRA may lower their resistance to infections. Instruct the patient of the importance of contacting their doctor immediately when symptoms suggesting infection appear in order to assure rapid eva luation and appropriate treatment.
Gastrointestinal Perforation:
Inform patients that some patients who have been treated with ACTEMRA have had serious side effects in the stomach and intestines. Instruct the patient of the importance of contacting their doctor immediately when symptoms of severe, persistent abdominal pain appear to assure rapid eva luation and appropriate treatment.
Hypersensitivity and Serious Allergic Reactions
Assess patient suitability for home use for SC injection. Inform patients that some patients who have been treated with ACTEMRA have developed serious allergic reactions, including anaphylaxis. Advise patients to seek immediate medical attention if they experience any symptom of serious allergic reactions.
Instruction on Injection Technique
Perform the first injection under the supervision of a qualified healthcare professional. If a patient or caregiver is to administer subcutaneous ACTEMRA, instruct him/her in injection techniques and assess his/her ability to inject subcutaneously to ensure proper administration of subcutaneous ACTEMRA and the suitability for home use [See Patient Instructions for Use].
Prior to use, remove the prefilled syringe from the refrigerator and allow to sit at room temperature outside of the carton for 30 minutes, out of the reach of children. Do not warm ACTEMRA in any other way.
Advise patients to consult their healthcare provider if the full dose is not received.
A puncture-resistant container for disposal of needles and syringes should be used and should be kept out of the reach of children. Instruct patients or caregivers in the technique as well as proper syringe and needle disposal, and caution against reuse of these items.
Pregnancy Exposure Registry
Inform patients that there is a pregnancy registry to monitor fetal outcomes of pregnant women exposed to ACTEMRA [see USE IN SPECIFIC POPULATIONS (8.1)].Pregnancy
Inform female patients of reproductive potential that ACTEMRA may cause fetal harm and to inform their prescriber of a known or suspected pregnancy [see USE IN SPECIFIC POPULATIONS (8.1)].
MEDICATION GUIDE
ACTEMRA® (AC-TEM-RA)
(tocilizumab)
Solution for Intravenous Infusion
ACTEMRA® (AC-TEM-RA)
(tocilizumab)
Injection, Solution for Subcutaneous Administration
Read this Medication Guide before you start ACTEMRA, before each infusion, or each time you get a prescription refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about ACTEMRA?
ACTE |
