• Medication Guide
• Prescribing Information
• Important Safety Information

INDICATION

ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

CONTRAINDICATION

ACTEMRA should not be administered to patients with known hypersensitivity to ACTEMRA.

WARNINGS AND PRECAUTIONS

Gastrointestinal Perforations
ACTEMRA should be used with caution in patients who may be at increased risk for gastrointestinal (GI) perforation. Patients presenting with new-onset abdominal symptoms should be evaluated promptly for early identification of GI perforation

Laboratory Monitoring
Neutrophils, platelets, lipids and hepatic transaminases should be monitored as changes in these parameters were associated with treatment with ACTEMRA. Dosage modifications or interruptions may be required. Please see full prescribing information for more information.

Immunosuppression
The impact of treatment with ACTEMRA on the development of malignancies is not known, but malignancies were observed in clinical studies with ACTEMRA. ACTEMRA is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies.

Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis and death, have occurred with infusion of ACTEMRA. ACTEMRA should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis. If anaphylaxis or other clinically significant hypersensitivity reaction occurs, administration of ACTEMRA should be stopped immediately and ACTEMRA should be permanently discontinued. Do not administer ACTEMRA to patients with known hypersensitivity to ACTEMRA.

Clinically significant hypersensitivity reactions, including anaphylaxis associated with ACTEMRA and requiring treatment discontinuation were reported in 0.1% (3 out of 2644) in the rheumatoid arthritis 24 week, controlled trials and in 0.2% (8 out of 4009) in the all-exposure population. These reactions were generally observed during the second to fourth infusion of ACTEMRA. Appropriate medical treatment should be available for immediate use in the event of a serious hypersensitivity reaction.

Anaphylaxis was reported in 1 out of 112 patients (less than 1%) treated with ACTEMRA during the SJIA controlled and open label extension study.

Demyelinating Disorders
Patients should be closely monitored for signs and symptoms of demyelinating disorders. Prescribers should exercise caution in considering the use of ACTEMRA in patients with preexisting or recent-onset demyelinating disorders.

Active Hepatic Disease and Hepatic Impairment
Treatment with ACTEMRA is not recommended in patients with active hepatic disease or hepatic impairment.

Vaccinations
Live vaccines should not be given with ACTEMRA. Patients should be brought up to date on all recommended vaccinations, except for live vaccines, prior to initiation of ACTEMRA therapy.

ADVERSE REACTIONS
RHEUMATOID ARTHRITIS (RA)

The most common serious adverse reactions were serious infections. In the ACTEMRA monotherapy clinical study, the rate of serious infections was 3.6 per 100 patient-years in the ACTEMRA group and 1.5 per 100 patient-years in the methotrexate group. The rate of serious infections in the 4 mg/kg and 8 mg/kg ACTEMRA plus DMARD groups was 4.4 and 5.3 events per 100 patient-years, respectively, compared to 3.9 events per 100 patient-years in the placebo plus DMARD group.

In the 5 Phase III clinical trials the most common adverse reactions (≥5% of patients treated with ACTEMRA) through 6 months were:

ADVERSE REACTIONS
SYSTEMIC JUVENILE IDIOPATHIS ARTHRITIS (SJIA)

The most common adverse events (at least 5%) seen in ACTEMRA treated patients in the 12 week controlled portion of the study were: upper respiratory tract infection, headache, nasopharyngitis and diarrhea.

Infections
In the 12 week controlled phase, the rate of all infections in the ACTEMRA group was 345 per 100 patient-years and 287 per 100 patient-years in the placebo group. In the ongoing open label extension (Part II), the overall rate of infections was 304 per 100 patient-years.

In the 12 week controlled phase, the rate of serious infections in the ACTEMRA group was 11.5 per 100 patient years. In the ongoing open label extension, the overall rate of serious infections was 11.4 per 100 patient years. The most commonly reported serious infections included pneumonia, gastroenteritis, varicella, and otitis media.

Macrophage Activation Syndrome
In the 12 week controlled study, no patient in any treatment group experienced macrophage activation syndrome (MAS) while on assigned treatment; 3 per 112 (3%) developed MAS during open-label treatment with ACTEMRA. One patient in the placebo group escaped to ACTEMRA 12 mg per kg at Week 2 due to severe disease activity, and ultimately developed MAS at Day 70. Two additional patients developed MAS during the long-term extension. All 3 patients had ACTEMRA dose interrupted (2 patients) or discontinued (1 patient) for the MAS event, received treatment, and the MAS resolved without sequelae. Based on a limited number of cases, the incidence of MAS does not appear to be elevated in the ACTEMRA SJIA clinical development experience; however no definitive conclusions can be made.

Infusion Reactions
Infusion related reactions were defined as all events occurring during or within 24 hours after an infusion. In the 12 week controlled phase, 4% of ACTEMRA and 0% of placebo treated patients experienced events occurring during infusion.

Within 24 hours after infusion, 16% of patients in the ACTEMRA treatment group and 5% of patients in the placebo group experienced an event. In the ACTEMRA group the events included rash, urticaria, diarrhea, epigastric discomfort, arthralgia and headache. One of these events, urticaria, was considered serious.

Anaphylaxis
Anaphylaxis was reported in 1 out of 112 patients (less than 1%) treated with ACTEMRA during the controlled and open label extension study.

USE IN PREGNANCY

There are no adequate and well-controlled studies in pregnant women. ACTEMRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. To monitor the outcomes of pregnant women exposed to ACTEMRA, pregnancy registry has been established. Physicians are encouraged to register patients by calling 1-877-311-8972 or register online at https://www.otispregnancy.org/forms/otis_referral-f115.

PATIENT COUNSELING INFORMATION

Patients should be advised of the potential benefits and risks of ACTEMRA. Physicians should instruct their patients to read the Medication Guide before starting ACTEMRA therapy. Inform patients that ACTEMRA may lower their resistance to infections and instruct patients of the importance of contacting their doctor immediately when symptoms of an infection appear. Inform patients that some patients receiving ACTEMRA have had serious side effects in the stomach and intestines and instruct patients of the importance of contacting their doctor immediately when symptoms of severe, persistent abdominal pain appear.

Please see full Prescribing Information including Boxed Warning for additional important safety information.

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