Information and resources for patients considering an autoinjector to manage the symptoms of rheumatoid arthritis (RA)
Information and resources for patients considering an autoinjector to manage the symptoms of rheumatoid arthritis (RA)
Giving appropriate patients the option to self-administer *1
ACTEMRA® (tocilizumab) is available in different routes of administration to meet patients’ needs. Some patients may prefer the ACTEMRA ACTPen® autoinjector, which is self-administered once a week or once every two weeks.
The ACTEMRA autoinjector is a prefilled, single-dose, pen-like device that shields the needle prior to injection and allows patients to self-administer the dose.
If you have a patient starting ACTEMRA, you can direct them here to learn more about the ACTPen. On the website, they’ll be able to access the Instructions for Use and find Quick Tips videos on its preparation and use.
Finding the right dose *1
Depending on the route of administration, the dose or frequency of ACTEMRA can be increased if symptoms indicate that RA is not sufficiently under control. Encourage patients to talk to you about their symptoms over the course of treatment.
Increased frequency for patients on subcutaneous (SC) injection:
• Patients receiving ACTEMRA every other week can be shifted to weekly dosing if symptoms and clinical response suggest the potential for greater suppression of RA
Increased dose for patients on intravenous (IV) infusion:
• The recommended starting dose is 4 mg/kg every 4 weeks, but that can be increased to 8 mg/kg every 4 weeks according to treatment response Download and share the Discussion Guide to help patients track their symptoms and prepare for conversations about their treatment.
Showing Support
• The Patient Brochure is an excellent resource for patients on or considering ACTEMRA. It contains information about how ACTEMRA is administered, instructions for how to use the ACTPen autoinjector, and information about potential side effects of ACTEMRA
• The Medication Guide and Instructions for Use are important resources for patients that describe what ACTEMRA is, what they can expect while on treatment, and how to prepare and administer a dose for self-administration
• When traveling, patients can register to receive a travel pack and sharps container. The Travel Pack will help you travel with your ACTEMRA. It includes an ice pack and a TSA card to help you bring your ACTEMRA through the airport. The sharps container will allow you to safely dispose of your ACTEMRA injection devices
• The ACTEMRA Patient Support line is available to help answer any questions patients may have about ACTEMRA or the ACTPen at 1-800-228-3672
Resources
• Quick Tips Video on Preparing Your ACTPen® for Use
• Quick Tips Video on Using Your ACTPen®
• Patient information about ACTEMRA SC injections
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 Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
IMPORTANT SAFETY INFORMATION
RISK OF SERIOUS INFECTIONS:
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
Reported infections include:
• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use.
• Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral and other infections due to opportunistic pathogens.
The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
CONTRAINDICATION
ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.
WARNINGS AND PRECAUTIONS
Gastrointestinal Perforations
Events of gastrointestinal (GI) perforation have been reported in clinical trials, primarily as complications of diverticulitis in RA patients. Use ACTEMRA with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with new-onset abdominal symptoms for early identification of GI perforation.
Hepatotoxicity
Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous ACTEMRA. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation. Most cases presented with marked elevations of transaminases (> 5 times ULN), and some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases. Treatment with ACTEMRA was associated with a higher incidence of transaminase elevations; increased frequency and magnitude of these elevations were observed when ACTEMRA was used in combination with potentially hepatotoxic drugs (e.g., methotrexate). It is not recommended to initiate ACTEMRA treatment in RA patients with elevated transaminases ALT or AST greater than 1.5x ULN. In patients who develop elevated ALT or AST greater than 5x ULN discontinue ACTEMRA. Measure liver tests promptly in patients who report symptoms that may indicate liver injury. If the patient is found to have abnormal liver tests, ACTEMRA treatment should be interrupted. ACTEMRA should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests.
Laboratory Parameters
Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests. Dosage modifications may be required.
Neutropenia
Treatment with ACTEMRA was associated with a higher incidence of neutropenia. It is not recommended to initiate ACTEMRA treatment in RA patients with a low neutrophil count i.e., absolute neutrophil count (ANC) less than 2000 per mm3. In patients who develop an ANC less than 500 per mm3 treatment is not recommended.
Thrombocytopenia
Treatment with ACTEMRA was associated with a reduction in platelet counts. It is not recommended to initiate ACTEMRA in RA patients with a platelet count below 100,000 per mm3. In patients who develop a platelet count less than 50,000 per mm3, treatment is not recommended.
Elevated Liver Enzymes
It is not recommended to initiate ACTEMRA treatment in patients with elevated transaminases ALT or AST >1.5x ULN. In patients who develop elevated ALT or AST >5x ULN, treatment is not recommended.
Lipid Abnormalities
Treatment with ACTEMRA was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterols, and/or HDL cholesterol.
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, have been reported in association with ACTEMRA and anaphylactic events with a fatal outcome have been reported with intravenous infusion of ACTEMRA. ACTEMRA for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. For ACTEMRA subcutaneous injection, advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If anaphylaxis or other hypersensitivity reaction occurs, stop administration of ACTEMRA immediately and discontinue ACTEMRA permanently. Do not administer ACTEMRA to patients with known hypersensitivity to ACTEMRA.
Anaphylaxis and other hypersensitivity reactions that required treatment discontinuation were reported in 0.1% (3 out of 2644) of patients in the 6-month controlled trials of intravenous ACTEMRA, 0.2% (8 out of 4009) of patients in the intravenous all-exposure RA population, 0.7% (8 out of 1068) in the subcutaneous 6-month controlled RA trials, and in 0.7% (10 out of 1465) of patients in the subcutaneous all-exposure population.
Demyelinating Disorders
The impact of treatment with ACTEMRA on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in clinical studies. Monitor patients 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
Avoid use of live vaccines concurrently with ACTEMRA. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving ACTEMRA or on the effectiveness of vaccination in patients receiving ACTEMRA. Patients should be brought up to date on all recommended vaccinations prior to initiation of ACTEMRA therapy, if possible.
ADVERSE REACTIONS
RHEUMATOID ARTHRITIS (RA)
The most common serious adverse reactions were serious infections. The most common serious infections included pneumonia, urinary tract infection, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis. In the ACTEMRA-IV 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-IV) through 6 months were:
DRUG INTERACTIONS
Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with ACTEMRA may restore CYP450 activities to higher levels than those in the absence of ACTEMRA leading to increased metabolism of drugs that are CYP450 substrates.
Exercise caution when coadministering ACTEMRA with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc.
USE IN PREGNANCY
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ACTEMRA during pregnancy. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.
The limited available data with ACTEMRA in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see additional Important Safety Information in full Prescribing Information, including BOXED WARNING.
Reference: 1. ACTEMRA [package insert]. South San Francisco, CA: Genentech, Inc.
ACTEMRA and ACTPen are registered trademarks of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
©2024 Genentech USA, Inc. All rights reserved.
M-US-00024463(v1.0) 08/24
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