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Generic Name
Tocilizumab
Brand Names
Tocilizumab-anoh, Tyenne, Actemra ACTPen, Avtozma, Tofidence, Actemra
FDA approval date: January 08, 2010
Classification: Interleukin-6 Receptor Antagonist
Form: Injection
What is Tocilizumab-anoh (Tocilizumab)?
TYENNE ® is an interleukin-6 receptor antagonist indicated for treatment of: Rheumatoid Arthritis .
Approved To Treat
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Brand Information
Tocilizumab-anoh (tocilizumab)
WARNING: RISK OF SERIOUS INFECTIONS
Patients treated with tocilizumab products including Tocilizumab-anoh are at increased risk for developing serious infections that may lead to hospitalization or death
If a serious infection develops, interrupt Tocilizumab-anoh until the infection is controlled. Reported infections include:
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before Tocilizumab-anoh use and during therapy. Treatment for latent infection should be initiated prior to Tocilizumab-anoh 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 Tocilizumab-anoh 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 Tocilizumab-anoh, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy
1CONTRAINDICATIONS
Tocilizumab-anoh is contraindicated in patients with known hypersensitivity to tocilizumab products
2ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in labeling:
- Serious Infections
- Gastrointestinal Perforations
- Laboratory Parameters
- Immunosuppression
- Hypersensitivity Reactions, Including Anaphylaxis
- Demyelinating Disorders
- Active Hepatic Disease and Hepatic Impairment
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.
2.1Clinical Trials Experience in Rheumatoid Arthritis Patients Treated with Intravenous Tocilizumab (Tocilizumab-IV)
The tocilizumab-IV data in rheumatoid arthritis (RA) includes 5 double-blind, controlled, multicenter studies. In these studies, patients received doses of tocilizumab-IV 8 mg per kg monotherapy (288 patients), tocilizumab- IV 8 mg per kg in combination with DMARDs (including methotrexate) (1582 patients), or tocilizumab-IV 4 mg per kg in combination with methotrexate (774 patients).
The all exposure population includes all patients in registration studies who received at least one dose of tocilizumab-IV. Of the 4009 patients in this population, 3577 received treatment for at least 6 months, 3309 for at least one year; 2954 received treatment for at least 2 years and 2189 for 3 years.
All patients in these studies had moderately to severely active rheumatoid arthritis. The study population had a mean age of 52 years, 82% were female and 74% were Caucasian.
The most common serious adverse reactions were serious infections
The proportion of patients who discontinued treatment due to any adverse reactions during the double-blind, placebo-controlled studies was 5% for patients taking tocilizumab-IV and 3% for placebo-treated patients. The most common adverse reactions that required discontinuation of tocilizumab-IV were increased hepatic transaminase values (per protocol requirement) and serious infections.
2.2Clinical Trials Experience in Rheumatoid Arthritis Patients Treated with Subcutaneous Tocilizumab (Tocilizumab-SC)
The tocilizumab-SC data in rheumatoid arthritis (RA) includes 2 double-blind, controlled, multicenter studies. Study SC-I was a non-inferiority study that compared the efficacy and safety of tocilizumab 162 mg administered every week subcutaneously and 8 mg/kg intravenously every four weeks in 1262 adult subjects with rheumatoid arthritis. Study SC-II was a placebo controlled superiority study that evaluated the safety and efficacy of tocilizumab 162 mg administered every other week subcutaneously or placebo in 656 patients. All patients in both studies received background non-biologic DMARDs.
The safety observed for tocilizumab-SC administered subcutaneously was consistent with the known safety profile of intravenous tocilizumab, with the exception of injection site reactions (ISRs), which were more common with tocilizumab-SC compared with placebo SC injections (IV arm).
2.3Clinical Trials Experience in Giant Cell Arteritis Patients Treated with Subcutaneous Tocilizumab (Tocilizumab-SC)
The safety of subcutaneous tocilizumab has been studied in one Phase III study (WA28119) with 251 GCA patients. The total patient years duration in the tocilizumab-SC GCA all exposure population was 138.5 patient years during the 12-month double blind, placebo-controlled phase of the study. The overall safety profile observed in the tocilizumab-SC treatment groups was generally consistent with the known safety profile of tocilizumab. There was an overall higher incidence of infections in GCA patients relative to RA patients. The rate of infection/serious infection events was 200.2/9.7 events per 100 patient years in the tocilizumab-SC weekly group and 160.2/4.4 events per 100 patient years in the tocilizumab-SC every other week group as compared to 156.0/4.2 events per 100 patient years in the placebo + 26 week prednisone taper and 210.2/12.5 events per 100 patient years in the placebo + 52 week taper groups.
2.4Clinical Trials Experience in Giant Cell Arteritis Patients Treated with Intravenous Tocilizumab (Tocilizumab-IV)
The safety of tocilizumab-IV was studied in an open label PK-PD and safety study in 24 patients with GCA who were in remission on tocilizumab-IV at time of enrollment. Patients received tocilizumab 7 mg/kg every 4 weeks for 20 weeks, followed by 6 mg/kg every 4 weeks for 20 weeks. The total patient years exposure to treatment was 17.5 years. The overall safety profile observed for tocilizumab administered intravenously in GCA patients was consistent with the known safety profile of tocilizumab.
2.5Clinical Trials Experience in Polyarticular Juvenile Idiopathic Arthritis Patients Treated with Intravenous Tocilizumab (Tocilizumab-IV)
The safety of tocilizumab-IV was studied in 188 pediatric patients 2 to 17 years of age with PJIA who had an inadequate clinical response or were intolerant to methotrexate. The total patient exposure in the tocilizumab-IV all exposure population (defined as patients who received at least one dose of tocilizumab-IV) was 184.4 patient years. At baseline, approximately half of the patients were taking oral corticosteroids and almost 80% were taking methotrexate. In general, the types of adverse drug reactions in patients with PJIA were consistent with those seen in RA and SJIA patients
2.6Clinical Trials Experience in Polyarticular Juvenile Idiopathic Arthritis Patients Treated with Subcutaneous Tocilizumab (Tocilizumab-SC)
The safety of tocilizumab-SC was studied in 52 pediatric patients 1 to 17 years of age with PJIA who had an inadequate clinical response or were intolerant to methotrexate. The total patient exposure in the PJIA tocilizumab-SC population (defined as patients who received at least one dose of tocilizumab-SC and accounting for treatment discontinuation) was 49.5 patient years. In general, the safety observed for tocilizumab administered subcutaneously was consistent with the known safety profile of intravenous tocilizumab, with the exception of injection site reactions (ISRs), and neutropenia.
2.7Clinical Trials Experience in Systemic Juvenile Idiopathic Arthritis Patients Treated with Intravenous Tocilizumab (Tocilizumab-IV)
The data described below reflect exposure to tocilizumab-IV in one randomized, double-blind, placebo- controlled trial of 112 pediatric patients with SJIA 2 to 17 years of age who had an inadequate clinical response to nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids due to toxicity or lack of efficacy. At baseline, approximately half of the patients were taking 0.3 mg/kg/day corticosteroids or more, and almost 70% were taking methotrexate. The trial included a 12 week controlled phase followed by an open-label extension. In the 12 week double-blind, controlled portion of the clinical study 75 patients received treatment with tocilizumab- IV (8 or 12 mg per kg based upon body weight). After 12 weeks or at the time of escape, due to disease worsening, patients were treated with tocilizumab-IV in the open-label extension phase.
The most common adverse events (at least 5%) seen in tocilizumab-IV treated patients in the 12 week controlled portion of the study were: upper respiratory tract infection, headache, nasopharyngitis and diarrhea.
2.8Clinical Trials Experience in Systemic Juvenile Idiopathic Arthritis Patients Treated with Subcutaneous Tocilizumab (Tocilizumab-SC)
The safety profile of tocilizumab-SC was studied in 51 pediatric patients 1 to 17 years of age with SJIA who had an inadequate clinical response to NSAIDs and corticosteroids. In general, the safety observed for tocilizumab administered subcutaneously was consistent with the known safety profile of intravenous tocilizumab, with the exception of ISRs where a higher frequency was observed in tocilizumab-SC treated SJIA patients compared to PJIA patients and adult RA or GCA patients
2.9Clinical Trials Experience in Patients with Cytokine Release Syndrome Treated with Intravenous Tociliaumb (Tocilizumab-IV)
In a retrospective analysis of pooled outcome data from multiple clinical trials 45 patients were treated with tocilizumab 8 mg/kg (12 mg/kg for patients less than 30 kg) with or without additional high-dose corticosteroids for severe or life-threatening CAR T cell-induced CRS. A median of 1 dose of tocilizumab (range, 1-4 doses) was administered. No adverse reactions related to tocilizumab were reported [see
2.10Clinical Trials Experience in COVID-19 Patients Treated with Intravenous Tocilizumab (Tocilizumab-IV)
The safety of tocilizumab in hospitalized COVID-19 patients was evaluated in a pooled safety population that includes patients enrolled in EMPACTA, COVACTA, AND REMDACTA. The analysis of adverse reactions included a total of 974 patients exposed to tocilizumab. Patients received a single, 60-minute infusion of intravenous tocilizumab 8 mg/kg (maximum dose of 800 mg). If clinical signs or symptoms worsened or did not improve, one additional dose of tocilizumab 8 mg/kg could be administered between 8- 24 hours after the initial dose.
Adverse reactions summarized in
In the pooled safety population, the rates of infection/serious infection events were 30%/19% in patients receiving tocilizumab versus 32%/23% receiving placebo.
2.11Postmarketing Experience
The following adverse reactions have been identified during post-approval use of tocilizumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Hypersensitivity Reactions: Fatal anaphylaxis, Stevens-Johnson Syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Pancreatitis
- Drug-induced liver injury, Hepatitis, Hepatic failure, Jaundice
- Hypofibrinogenemia
3DRUG ABUSE AND DEPENDENCE
No studies on the potential for tocilizumab products to cause dependence have been performed. However, there is no evidence from the available data that tocilizumab products treatment results in dependence.
4OVERDOSAGE
There are limited data available on overdoses with tocilizumab products. One case of accidental overdose was reported with intravenous tocilizumab in which a patient with multiple myeloma received a dose of 40 mg per kg. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received single doses of up to 28 mg per kg, although all 5 patients at the highest dose of 28 mg per kg developed dose-limiting neutropenia.
In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate symptomatic treatment.
5DESCRIPTION
Tocilizumab-anoh is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. Tocilizumab-anoh has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
7Instructions for Use
Tocilizumab-anoh (toe si liz' ue mab-anoh)
Read and follow the Instructions for Use that come with your Tocilizumab-anoh Prefilled Syringe before you start using it and each time you get a refill. There may be new information. Before you use Tocilizumab-anoh, make sure your healthcare provider shows you the right way to use it.
Important Information
- Do not remove the prefilled syringe cap until you are ready to inject Tocilizumab-anoh.
- Do not try to take apart the prefilled syringe at any time.
- Do not reuse the same syringe.
- Do not shake the prefilled syringe.
- Do not use the prefilled syringe if it has been dropped or damaged.
Storing Tocilizumab-anoh
- Store the unused prefilled syringe in the original carton in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
- When removed from the refrigerator, Tocilizumab-anoh can be stored up to 3 weeks at or below 77°F (25°C). If not used within the 3 weeks, Tocilizumab-anoh should be thrown away (discarded).
- Keep the prefilled syringe out of direct sunlight.
- Do not remove the prefilled syringe from its original carton during storage.
- Do not leave the prefilled syringe unattended.
- Keep the prefilled syringe out of the reach of children.
Parts of your Prefilled Syringe (See
Preparing for the Injection
Giving the Injection
After the Injection
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by: CELLTRION, Inc., 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea
Distributed by: CELLTRION USA, Inc., One Evertrust Plaza Suite 1207, Jersey City, NJ 07302
8Instructions for Use
Tocilizumab-anoh (toe si liz' ue mab-anoh)
Read and follow the Instructions for Use that come with your Tocilizumab-anoh prefilled autoinjector before you start using it and each time you get a refill. There may be new information. Before you use Tocilizumab-anoh, make sure your healthcare provider shows you the right way to use it.
Important Information
- Do not remove the prefilled autoinjector cap until you are ready to inject Tocilizumab-anoh.
- Do not try to take apart the prefilled autoinjector at any time.
- Do not reuse the same prefilled autoinjector.
- Do not inject through clothing.
- Do not use the prefilled autoinjector if it has been dropped or damaged.
Storing Tocilizumab-anoh
- Store the unused prefilled autoinjector in the original carton in a refrigerator between 36°F to 46ºF (2°C to 8ºC).
- When removed from the refrigerator, Tocilizumab-anoh can be stored up to 3 weeks at or below 77°F (25°C). If not used within the 3 weeks, Tocilizumab-anoh should be thrown away (discarded).
- Keep the prefilled autoinejctor out of direct sunlight.
- Do not remove the prefilled autoinjector from its original carton during storage.
- Do not leave the prefilled autoinjector unattended.
- Keep the prefilled autoinjector out of the reach of children.
Parts of your Tocilizumab-anoh prefilled autoinjector (See
Preparing for the Injection
Giving the Injection
After the Injection
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by: CELLTRION, Inc., 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea
Distributed by: CELLTRION USA, Inc., One Evertrust Plaza Suite 1207, Jersey City, NJ 07302
9PRINCIPAL DISPLAY PANEL - 80 mg/4 mL Vial Carton
NDC 72606-048-01
Tocilizumab-anoh
80 mg/4 mL
For Intravenous Infusion
1 vial
CELLTRION USA
10PRINCIPAL DISPLAY PANEL - 200 mg/10 mL Vial Carton
NDC 72606-049-01
Tocilizumab-anoh
200 mg/10 mL
For Intravenous Infusion
1 vial
CELLTRION USA
11PRINCIPAL DISPLAY PANEL - 400 mg/20 mL Vial Carton
NDC 72606-050-01
Tocilizumab-anoh
400 mg/20 mL
For Intravenous Infusion
1 vial
CELLTRION USA
12PRINCIPAL DISPLAY PANEL - 162 mg/0.9 mL Autoinjector Carton
Tocilizumab-anoh
162 mg/0.9 mL
FOR SUBCUTANEOUS USE ONLY
NDC 72606-051-04
Rx only
Each carton contains 1 single-dose Autoinjector,
x 1
1
CELLTRION USA
