NEW
Actemra IV

Actemra IV Special Precautions

tocilizumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
General: In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file.
All Indications: Infections: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents including tocilizumab (see Adverse Reactions). Tocilizumab treatment should not be initiated in patients with active infections. Administration of tocilizumab should be interrupted if a patient develops a serious infection until the infection is controlled. Healthcare professionals should exercise caution when considering the use of tocilizumab in patients with a history of recurring infection or with underlying conditions (e.g. diverticulitis, diabetes) which may predispose patients to infections.
In patients with COVID-19, tocilizumab should not be administered if patients also have any other concurrent serious active infection.
Vigilance for the timely detection of serious infection is recommended for patients receiving immunosuppressive agents, such as tocilizumab, as signs and symptoms of acute inflammation may be lessened, due to suppression of the acute phase reactants. Patients (which include younger children who may be less able to communicate their symptoms) and parents/guardians of minors should be instructed to contact a healthcare professional immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment.
Complications of diverticulitis: Events of diverticular perforation as complications of diverticulitis have been reported in patients treated with tocilizumab. Tocilizumab should be used with caution in patients with previous history of intestinal ulceration or diverticulitis. Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, should be evaluated promptly for early identification of gastrointestinal perforation.
Tuberculosis: As recommended for other biologic therapies, all patients should be screened for latent tuberculosis infection prior to starting tocilizumab therapy. Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before initiating tocilizumab.
Vaccinations: Live and live attenuated vaccines should not be given concurrently with tocilizumab as clinical safety has not been established.
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving tocilizumab.
In a randomized open-label study, adult RA patients treated with tocilizumab and MTX were able to mount an effective response to both the 23-valent pneumococcal polysaccharide and tetanus toxoid vaccines which was comparable to the response seen in patients on MTX only.
It is recommended that all patients, particularly paediatric or elderly patients, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating tocilizumab therapy. The interval between live vaccinations and initiation of tocilizumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with tocilizumab (see Clinical Trials under Adverse Reactions). In the post marketing setting, events of serious hypersensitivity and anaphylaxis have occurred in patients treated with a range of doses of tocilizumab, with or without concomitant therapies, premedication, and/or a previous hypersensitivity reaction. In the post marketing setting, cases with a fatal outcome have been reported with intravenous tocilizumab. These events have occurred as early as the first infusion of tocilizumab (see Contraindications, and Post Marketing Experience under Adverse Reactions). Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during infusion with tocilizumab. If an anaphylactic reaction or other serious hypersensitivity reaction occurs, administration of tocilizumab should be stopped immediately and tocilizumab should be permanently discontinued (see Dosage & Administration).
Active Hepatic Disease and Hepatic Impairment: Treatment with tocilizumab particularly when administered concomitantly with methotrexate, may be associated with elevations in hepatic transaminases, therefore caution should be exercised when considering treatment of patients with active hepatic disease or hepatic impairment (see Special Dosage Instructions under Dosage & Administration, and Clinical Trials under Adverse Reactions).
Hepatotoxicity: Mild and moderate elevations of hepatic transaminases have been observed with tocilizumab treatment (see Clinical Trials under Adverse Reactions). Increased frequency of these elevations was observed when drugs, which are known to cause hepatotoxicity (e.g. methotrexate (MTX)), were used in combination with tocilizumab.
Serious drug-induced liver injury, including acute liver failure, hepatitis and jaundice, have been observed with tocilizumab (see Post Marketing Experience under Adverse Reactions). Serious hepatic injury occurred between 2 weeks to more than 5 years after initiation of tocilizumab. Cases of liver failure resulting in liver transplantation have been reported.
Caution should be exercised when considering initiation of tocilizumab treatment in patients with elevated transaminases ALT or AST above 1.5x ULN. In patients with elevated ALT or AST above 5x ULN treatment is not recommended.
In RA, GCA, pJIA and sJIA, ALT/AST should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter. For recommended dose modifications, including tocilizumab discontinuation based on transaminases levels, see Dosage & Administration.
Patients hospitalized with COVID-19 may have elevated ALT or AST levels. Multi-organ failure with involvement of the liver is recognised as a complication of severe COVID-19. The decision to administer tocilizumab should balance the potential benefit against the risks of acute treatment with tocilizumab. In COVID-19 patients with elevated ALT or AST above 10 x ULN, administration of tocilizumab treatment is not recommended.
In COVID-19 patients, ALT/AST should be monitored according to current standard clinical practices.
Viral reactivation: Viral reactivation (e.g. hepatitis B virus) has been reported with biologic therapies for rheumatoid arthritis. In clinical studies with tocilizumab, patients who screened positive for hepatitis were excluded.
Demyelinating disorders: Physicians should be vigilant for symptoms potentially indicative of new onset central demyelinating disorders. The potential for central demyelination with tocilizumab is currently unknown.
Neutropenia: Treatment with tocilizumab was associated with a higher incidence of neutropenia. Treatment-related neutropenia was not associated with serious infection in clinical trials (see Clinical Trials under Adverse Reactions).
Caution should be exercised when considering initiation of tocilizumab treatment in patients with a low neutrophil count i.e. absolute neutrophil count (ANC) below 2 x 109/L. In RA, pJIA and sJIA patients with an absolute neutrophil count below 0.5 x 109/L treatment is not recommended. In COVID-19 patients with an ANC below 1 x 109/L, administration of treatment is not recommended.
In RA patients, the neutrophil count should be monitored 4 to 8 weeks after start of therapy and thereafter according to good clinical practice. For recommended dose modifications based on ANC results, see Dosage & Administration.
In pJIA and sJIA patients, the neutrophil count should be monitored at the time of the second administration and thereafter according to good clinical practice (see Dose modifications under Dosage & Administration).
In COVID-19 patients, the neutrophil count should be monitored according to current standard clinical practices.
Thrombocytopenia: Treatment with tocilizumab was associated with a reduction in platelet counts. Treatment-related reduction in platelets was not associated with serious bleeding events in clinical trials (see Clinical Trials under Adverse Reactions).
Caution should be exercised when considering initiation of tocilizumab treatment in patients with a platelet count below 100 x 103/μL. In all patients, including COVID-19, with a platelet count below 50 x 103/μL treatment is not recommended.
In RA patients, platelets should be monitored 4 to 8 weeks after start of therapy and thereafter according to good clinical practice.
For recommended dose modifications based on platelet counts, see Dosage & Administration.
In pJIA and sJIA patients, platelets should be monitored at the time of the second administration and thereafter according to good clinical practice (see Dose modifications under Dosage & Administration).
In COVID-19 patients, platelets should be monitored according to current standard clinical practices.
Lipids parameters: Elevations of lipid parameters such as total cholesterol, triglycerides and/or low density lipoprotein (LDL) cholesterol have been observed (see Clinical Trials under Adverse Reactions).
In patients treated with tocilizumab, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of tocilizumab therapy. Patients should be managed according to local clinical guidelines for management of hyperlipidaemia.
Systemic Juvenile Idiopathic Arthritis: Macrophage activation syndrome (MAS): MAS is a serious life-threatening disorder that may develop in patients with sJIA. In clinical trials, tocilizumab has not been studied in patients during an episode of active MAS.
COVID-19 Patients: The efficacy of Actemra has not been established in the treatment of COVID-19 patients who do not have elevated C-reactive protein (CRP) levels.
Drug Abuse and Dependence: No studies on the effects on the potential for tocilizumab to cause dependence have been performed. However, there is no evidence from the available data that tocilizumab treatment results in dependence.
Renal Impairment: (See Special Dosage Instructions under Dosage & Administration, and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.)
Hepatic Impairment: (See Special Dosage Instructions under Dosage & Administration, and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.)
Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machine have been performed. However, there is no evidence from the available data that tocilizumab treatment affects the ability to drive and use machines.
Use in Children: (See Special Dosage Instructions under Dosage & Administration.)
Use in the Elderly: (See Special Dosage Instructions under Dosage & Administration, and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.)
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