Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 20mg/mL (4-, 10-, and 20-mL single-dose vials)
injection, single-use autoinjector (ACTPen) for SC
- 162mg/0.9mL
injection, single-use prefilled syringe for SC
- 162mg/0.9mL
Rheumatoid Arthritis
Indicated for adults with moderate-to-severe active rheumatoid arthritis with inadequate response to 1 or more disease modifying antirheumatic drugs (DMARDs)
May use alone or in combination with methotrexate or other DMARDs
Not recommended in patients with an ANC<1,000/mm3 , platelet count <50,000 mm3, or ALT/AST >10x ULN
IV infusion
4 mg/kg IV q4Weeks initially; may increase to 8 mg/kg q4Weeks based on clinical response
Not to exceed 800 mg/dose q4weeks
SC injection
- Weight <100 kg: 162 mg SC every other week, followed by an increase to weekly based on clinical response
- Weight ≥100 kg: 162 mg SC weekly
Giant Cell Arteritis
Indicated for treatment of giant cell arteritis (GCA)
Not recommended in patients with an ANC<1,000/mm3 , platelet count <50,000 mm3, or ALT/AST >10x ULN
IV
- 6 mg/kg IV q4Weeks in combination with tapering course of glucocorticoids
- May be used alone following glucocorticoid discontinuation; if necessary, interrupt dosing for management of dose-related laboratory abnormalities (eg, elevated liver enzymes, neutropenia, thrombocytopenia)
- Not to exceed 600 mg/infusion
SC
- 162 mg SC weekly in combination with a tapering course of glucocorticoids
- Based on clinical considerations, may consider 162 mg SC every other week in combination with tapering course of glucocorticoids
- May be used alone following glucocorticoid discontinuation; if necessary, interrupt dosing for management of dose-related laboratory abnormalities (eg, elevated liver enzymes, neutropenia, thrombocytopenia)
-
Transitioning from IV to SC
- Administer first SC dose instead of next scheduled IV dose
- Dose interruption or reduced administration frequency of SC dose from every week to every other week dosing may be needed for management of dose-related laboratory abnormalities
Systemic Sclerosis-Associated Interstitial Lung Disease
Indicated for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
162 mg SC qWeek
Dose interruption may be needed for managing dose-related laboratory abnormalities (eg, elevated liver enzymes, neutropenia, thrombocytopenia)
SC administration with prefilled ACTPen autoinjector not studied in SSc-ILD
IV administration not approved for SSc-ILD
Not recommended in patients with an ANC<1,000/mm3, platelet count <50,000 mm3, or ALT/AST >10x ULN
Cytokine Release Syndrome
Indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS)
8 mg/kg IV once; may be administered as alone or in combination with corticosteroids
If no clinical improvement in the signs and symptoms of CRS occurs after initial dose, may administer up to 3 additional doses; allow 8-hr interval between consecutive doses
Not approved for SC administration
COVID-19
Indicated for treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
Not recommended in patients with an ANC<1,000/mm3 , platelet count <50,000 mm3 , or ALT/AST >10x ULN
8 mg/kg IV; not to exceed 800 mg/dose
May administer 1 additional IV infusion 8 hr after first infusion if clinical signs or symptoms worsen or unimproved
SC administration not authorized for treatment of COVID-19
Additional Medscape COVID-19 references are available
- Coronavirus Disease 2019 (COVID-19) (link https://emedicine.medscape.com/article/2500114-overview)
- Novel Coronavirus Resource Center (link https://www.medscape.com/resource/coronavirus)
Dosage Modifications
Renal impairment
- Mild-to-moderate (eGFR ≥30 mL/min): No dosage adjustment required
- Severe (eGFR <30 mL/min): Not studied
Hepatic impairment
- Not recommended with active hepatic disease or hepatic impairment
Liver enzyme abnormalities for RA, GCA, or SSc-ILD
-
>1 to 3x ULN
- Modify dose concomitant DMARDs (RA, SSc-ILD) or immunomodulatory agents (GCA) if appropriate
- RA or SSc-ILD persistent increases (IV): Reduce tocilizumab dose to 4 mg/kg OR hold dose until ALT/AST normalize
- GCA persistent increases (IV): Hold dose until ALT/AST normalize
- RA, GCA, or SSc-ILD persistent increases (SC): Reduce injection frequency to every other week OR hold dose until ALT/AST normalize; resume at every other week and increase frequency to every week as clinically appropriate
-
>3 to 5x ULN
- For RA, GCA, or SSc-ILD
- Confirm by repeat dosing
- Hold dose until <3x ULN and follow recommendations above for >1x to ≤3x ULN
- Persistent increases >3x ULN: Discontinue tocilizumab
-
>5x ULN
- Discontinue therapy
Neutropenia for RA, GCA, or SSc-ILD
ANC >1000 cells/mm3: Maintain dose
-
ANC 500-1000 cells/mm3
- Hold dose, then resume when ANC >1000 cells/mm3
- RA or SSc-ILD (IV): Resume at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
- GCA (IV): Resume at 6 mg/kg
- RA, GCA, or SSc-ILD (SC): Resume at every other week and increase frequency to weekly as clinically appropriate
-
ANC <500 cell/mm3
- Discontinue therapy
Thrombocytopenia for RA, GCA, SSc-ILD
-
50,000-10,000 cells/mm3
- Hold dose, then resume when platelet count >100,000 cells/mm3
- RA or SSc-ILD (IV): Resume at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
- GCA (IV): Resume at 6 mg/kg
- RA, GCA, or SSc-ILD (SC): Resume at every other week and increase frequency to weekly as clinically appropriate
-
<50,000 cells/mm3
- Discontinue therapy
Systemic Sclerosis (Orphan)
Orphan designation for treatment of systemic sclerosis
Orphan sponsor
- Genentech, Inc.; 1 DNA Way; South San Francisco, CA 94080-4990
Dosage Forms & Strengths
injectable solution
- 20mg/mL (4-, 10-, and 20-mL single-dose vials)
injection, single-use prefilled syringe for SC
- 162mg/0.9mL
Systemic Juvenile Idiopathic Arthritis
Indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in in patients ≥2 years
IV or SC may be administered as monotherapy or with methotrexate
<2 years: Safety and efficacy not established
Not recommended in patients with an ANC<1,000/mm3, platelet count <50,000 mm3, or ALT/AST >10x ULN
IV infusion
SC injection
- ≥2 years (<30 kg): 162 mg SC q2weeks
- ≥2 years (≥30 kg): 162 mg SC weekly
Polyarticular Juvenile Idiopathic Arthritis
Indicated for active polyarticular juvenile idiopathic arthritis (PJIA) in patients ≥2 years
IV or SC may be administered as monotherapy or with methotrexate
<2 years: Safety and efficacy not established
Not recommended in patients with an ANC<1,000/mm3, platelet count <50,000 mm3, or ALT/AST >10x ULN
IV infusion
SC injection
- ≥2 years (<30 kg): 162 mg SC q3weeks
- ≥2 years (≥30 kg): 162 mg SC q2weeks
Cytokine Release Syndrome (CRS)
Indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients aged ≥2 years
SC is not approved for CRS
<2 years: Safety and efficacy not established
≥2 years
- <30 kg: 12 mg/kg IV once
- ≥30 kg: 8 mg/kg IV once
- May be administered as monotherapy or with corticosteroids
- If no clinical improvement in the signs and symptoms of CRS occurs after initial dose, may administer up to 3 additional doses; allow 8-hr interval between consecutive doses
- Not to exceed 800 mg/dose
- Not approved for SC administration
COVID-19 (EUA)
June 24, 2021: Emergency use authorization (EUA) issued by the FDA for treatment of coronavirus disease 2019 (COVID-19) in hospitalized pediatric patients (aged 2-18 years) who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or ECMO
<30 kg: 12 mg/kg IV
≥30 kg: 8 mg/kg IV; not to exceed 800 mg/dose
May administer 1 additional IV infusion 8 hr after first infusion if clinical signs or symptoms worsen or unimproved
SC administration not authorized for treatment of COVID-19
Dosage Modifications
Dose reduction has not been studied in PJIA and SJIA populations
PJIA or SJIA: Dose interruptions are recommended for liver enzyme abnormalities, low ANC, and low platelet counts in outlined for adults with RA and GCA
If appropriate, modify dose or stop concomitant methotrexate and/or other medications and hold tocilizumab until clinical situation has been evaluated
Discontinue tocilizumab should be based upon medical assessment of the patient
Renal impairment
- Mild-to-moderate (eGFR ≥30 mL/min): No dosage adjustment required
- Severe (eGFR <30 mL/min): Not studied
Hepatic impairment
- Not recommended with active hepatic disease or hepatic impairment
Increased risk of serious infections in patient ≥65 years; use caution when treating the elderly
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (71)
- abatacept
abatacept, tocilizumab. Mechanism: unspecified interaction mechanism. Contraindicated. Concomitant use not recommended (in mfr. info.).
- adalimumab
adalimumab and tocilizumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- adenovirus types 4 and 7 live, oral
tocilizumab decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- alefacept
alefacept and tocilizumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anthrax vaccine
tocilizumab decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- antithymocyte globulin equine
tocilizumab and antithymocyte globulin equine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin rabbit
tocilizumab and antithymocyte globulin rabbit both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- axicabtagene ciloleucel
tocilizumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- azathioprine
tocilizumab and azathioprine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- baricitinib
baricitinib, tocilizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- basiliximab
tocilizumab and basiliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
tocilizumab decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- brexucabtagene autoleucel
tocilizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- canakinumab
tocilizumab and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- certolizumab pegol
tocilizumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.
- ciltacabtagene autoleucel
tocilizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- diphtheria & tetanus toxoids
tocilizumab decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- diphtheria & tetanus toxoids/ acellular pertussis vaccine
tocilizumab decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine
tocilizumab decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- etanercept
tocilizumab and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
tocilizumab, etanercept. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Additive immunosuppression; risk of serious infection. - everolimus
tocilizumab and everolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- glatiramer
tocilizumab and glatiramer both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- golimumab
tocilizumab and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hepatitis A vaccine inactivated
tocilizumab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis a/b vaccine
tocilizumab decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis a/typhoid vaccine
tocilizumab decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis b vaccine
tocilizumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- human papillomavirus vaccine, nonavalent
tocilizumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- human papillomavirus vaccine, quadrivalent
tocilizumab decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- hydroxychloroquine sulfate
tocilizumab and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
tocilizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- infliximab
tocilizumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent
tocilizumab decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine quadrivalent, adjuvanted
tocilizumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine quadrivalent, cell-cultured
tocilizumab decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine quadrivalent, intranasal
tocilizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine trivalent
tocilizumab decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine trivalent, adjuvanted
tocilizumab decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- Japanese encephalitis virus vaccine
tocilizumab decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- leflunomide
tocilizumab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
tocilizumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
tocilizumab decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- measles mumps and rubella vaccine, live
tocilizumab decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- measles, mumps, rubella and varicella vaccine, live
tocilizumab decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- meningococcal A C Y and W-135 polysaccharide vaccine combined
tocilizumab decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- mercaptopurine
tocilizumab and mercaptopurine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- methotrexate
tocilizumab and methotrexate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- muromonab CD3
tocilizumab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mycophenolate
tocilizumab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pneumococcal vaccine heptavalent
tocilizumab decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rabies vaccine
tocilizumab decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.
- rabies vaccine chick embryo cell derived
tocilizumab decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rilonacept
tocilizumab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rotavirus oral vaccine, live
tocilizumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rubella vaccine
tocilizumab decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- sirolimus
tocilizumab and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- smallpox (vaccinia) vaccine, live
tocilizumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tacrolimus
tocilizumab and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- temsirolimus
tocilizumab and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tetanus toxoid adsorbed or fluid
tocilizumab decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- thalidomide
tocilizumab, thalidomide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Additive immunosuppression; risk of serious infection.
- tick-borne encephalitis vaccine
tocilizumab decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tisagenlecleucel
tocilizumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tongkat ali
tocilizumab and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- travelers diarrhea and cholera vaccine inactivated
tocilizumab decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid polysaccharide vaccine
tocilizumab decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid vaccine live
tocilizumab decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- upadacitinib
tocilizumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
- ustekinumab
tocilizumab and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- varicella virus vaccine live
tocilizumab decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- yellow fever vaccine
tocilizumab decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
Monitor Closely (29)
- astragalus
tocilizumab increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor. .
- belatacept
belatacept and tocilizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cyclosporine
tocilizumab and cyclosporine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- denosumab
tocilizumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- echinacea
tocilizumab increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor. .
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of tocilizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- fingolimod
tocilizumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- haemophilus influenzae type b vaccine
tocilizumab decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .
- hydroxyurea
hydroxyurea, tocilizumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of infection.
- influenza virus vaccine quadrivalent, recombinant
tocilizumab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- influenza virus vaccine trivalent, recombinant
tocilizumab decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- isavuconazonium sulfate
tocilizumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- maitake
tocilizumab increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor. .
- maraviroc
tocilizumab decreases levels of maraviroc by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- mechlorethamine
mechlorethamine, tocilizumab. Either increases levels of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- meningococcal group B vaccine
tocilizumab decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ocrelizumab
tocilizumab and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- ofatumumab SC
ofatumumab SC, tocilizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
tocilizumab and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- oxaliplatin
oxaliplatin and tocilizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.
- poliovirus vaccine inactivated
tocilizumab decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .
- siponimod
siponimod and tocilizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
tocilizumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, tocilizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, tocilizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and tocilizumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- zidovudine
tocilizumab decreases levels of zidovudine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Interaction applies to inflammatory conditions, such as rheumatoid arthritis, associated with increased levels of IL-6.
- zoster vaccine live
tocilizumab decreases effects of zoster vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
- zoster vaccine recombinant
tocilizumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (2)
- cat's claw
cat's claw, tocilizumab. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Possible additive immunosuppr'n.
- lenalidomide
tocilizumab, lenalidomide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Additive immunosuppression; risk of serious infection. (Theoretical interaction).
Adverse Effects
>10%
SC injection site reactions (7.1-10.1%)
COVID-19 EUA
- Constipation (13%)
1-10%
Upper respiratory tract infection (6-8%)
Nasopharyngitis (4-7%)
Headache (3-7%)
Hypertension (3-6%)
ALT increased (1-6%)
Bronchitis (2-4%)
Rash (1-4%)
Dizziness (1-3%)
Mouth ulceration (1-2%)
Upper abdominal pain (2-3%)
Gastritis (1-2%)
Oral herpes simplex (<2%)
Stomatitis (<2%)
Gastric ulcer (<2%)
Increased weight (<2%)
Total bilirubin increased (<2%)
Leukopenia (<2%)
Peripheral edema (<2%)
Dyspnea (<2%)
Cough (<2%)
Conjunctivitis (<2%)
COVID-19
- Increased AST/ALT (10%)
- Constipation (9%)
- Urinary tract infection (5%)
- Hypertension (4%)
- Hypokalemia (4%)
- Anxiety (4%)
- Diarrhea (4%)
- Insomnia (4%)
- Neutrophil counts <1,000 cell/m3 (3.4%)
- Platelets counts <50,000 cells/mcL (3.2%)
- Nausea (3%)
Postmarketing Reports
Stevens-Johnson syndrome
Pancreatitis
Fatal anaphylaxis
Drug-induced liver injury, hepatitis, hepatic failure, jaundice
Rheumatoid arthritis, giant cell arteritis, and systemic sclerosis-associated interstitial lung disease
Warnings
Black Box Warnings
Risk of serious infections
- Increased risk for developing serious infections that may lead to hospitalization or death
- Most patients who developed these infections were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
- If a serious infection develops, interrupt therapy until the infection is controlled
Reported infections include
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease
- Test for latent tuberculosis before tocilizumab use and during therapy; initiate treatment for latent infection prior to use Invasive fungal infections (eg, candidiasis, aspergillosis, pneumocystis); patients with invasive fungal infections may present with disseminated, rather than localized, disease
- Bacterial, viral and other infections due to opportunistic pathogens
- Carefully consider risks and benefits of treatment prior to initiating therapy in patients with chronic or recurrent infection
- Closely monitor signs and symptoms of infection during and after treatment, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy
Contraindications
Hypersensitivity
Cautions
May cause neutropenia, decreased platelets, elevated liver transaminases, and increased lipid parameters; monitor neutrophils, platelets, lipids, and liver function tests every 4-8 weeks
Impact of treatment is unknown regarding development of malignancies, but malignancies were observed in clinical studies; treatment with immunosuppressants may increase risk of malignancies
Anaphylaxis or serious hypersensitivity reactions have occurred, including fatalities, with or without concomitant arthritis therapies
Impact of treatment with tocilizumab on demyelinating disorders is unknown, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in RA clinical studies; monitor for signs and symptoms potentially indicative of demyelinating disorders
Caution if increased risk for GI perforation; gastrointestinal perforation reported, primarily as complications of diverticulitis; promptly evaluate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation
Serious infections
Do not administer in patients with an active infection, including localized infections
Consider risk versus benefits before initiating in patients with chronic or recurrent infection, exposure to tuberculosis, history of serious or an opportunistic infection, have resided or traveled in areas of endemic tuberculosis or endemic mycoses, or who have underlying conditions predisposing them to infection
In patients with COVID-19, testing for latent infection is not necessary prior to initiating treatment with this medication
Not studied in combination with biological DMARDs (eg, TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies, selective costimulation modulators); avoid coadministration with biological DMARDs
Viral reactivation reported; cases of herpes zoster exacerbation observed in clinical studies; unknown if associated with hepatitis B reactivation; not studied
COVID-19 patients
- Monitor for signs and symptoms of new infections during and after treatment
- Limited information available regarding use in patients with COVID-19 and concomitant active serious infections
- Consider risks and benefits of treatment in COVID-19 patients with other concurrent infections
Neutropenia or thrombocytopenia (RA, GCA, SSc-ILD, COVID-19)
- Associated with higher incidence of neutropenia and thrombocytopenia
- Treatment-related reduction in platelets was not associated with serious bleeding events
- Not recommended to initiate treatment for RA, GCA and SSc-ILD in patients with a platelet count <100,000/mm3
- Not recommended for COVID-19 in patients with an ANC <1,000/mm3 or platelets count <50,000/mm3 counts
- If platelet count <50,000/mm3, treatment not recommended
- Monitor neutrophils or platelets 4-8 weeks after initiating therapy and q3months thereafter
Hepatic injury
-
RA or GCA
- Serious cases of hepatic injury with IV or SC therapy; some cases have resulted in liver transplant or death; onset for cases ranged from months to years after initiating tocilizumab
- For RA and GCA patients, obtain a liver test panel (ALT, AST, alkaline phosphatase, and total bilirubin) before initiating therapy, every 4-8 weeks after start of therapy for the first 6 months of treatment and every 3 months thereafter
- Not recommended to initiate in RA or GCA 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 therapy; for recommended modifications based upon increase in transaminases
- Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice; if patient is found to have abnormal liver tests (eg, ALT >3x ULN, total bilirubin >2x ULN)
- Interrupt treatment and establish probable cause; once liver tests normalize, restart in patients with another explanation for liver test abnormalities
-
PJIA or SJIA
- A similar pattern of liver enzyme elevation is noted with in the PJIA and SJIA populations
- Monitor liver test panel at the time of the second administration and thereafter every 4-8 weeks for PJIA and every 2-4 weeks for SJIA
-
COVID-19
- Patients hospitalized with COVID-19 may have elevated ALT or AST levels
- Multiorgan failure with liver involvement has been recognized as a complication of severe COVID-19
- During randomized, controlled studies, tocilizumab was associated with increased incidence of transaminase elevations
- When deciding to administer tocilizumab, balance potential benefit against risks of acute treatment
- Not recommended in patients with COVID-19 who have elevated ALT or AST >10x ULN
- Monitor ALT/AST when used for COVID-19 according to current standard clinical practice
Drug interactions overview
-
Vaccines
- Do not coadminister with live vaccines (eg, MMR, intranasal influenza)
- IL-6 inhibition may interfere with the normal immune response to new antigens
- All patients, particularly those with PJIA and SJIA, should be current with their immunizations before initiating therapy
-
CYP450
- Inhibition of IL-6 signaling in RA patients treated with tocilizumab may restore CYP450 activities to higher levels than those in the absence of tocilizumab, and thereby increases metabolism of drugs that are CYP450 substrates
- Exercise caution when coadministering tocilizumab with drugs that are substrates of CYP3A4 where decrease in effectiveness is undesirable, (eg, oral contraceptives, lovastatin, atorvastatin)
- Effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy
Pregnancy & Lactation
Pregnancy
Insufficient data available in pregnant women to determine whether there is a drug-associated risk for major birth defects and miscarriage
Pregnancy registry
- Monitors pregnancy outcomes in women exposed to tocilizumab during pregnancy
- Register or encourage patients and pregnant women to register themselves by calling 1-877-311-8972
Fetal/neonatal adverse reactions
- Monoclonal antibodies (eg, tocilizumab) are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant
- Consider risks and benefits before administering live or live-attenuated vaccines to infants exposed in utero
Lactation
No data available on the presence of tocilizumab in human milk, effects of the drug on the breastfed infant, or effects of the drug on milk production
Maternal immunoglobulin G (IgG) is present in human milk
If tocilizumab is transferred into human milk, effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to tocilizumab are unknown
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Interleukin-6 receptor antagonist; IL-6 is a pleiotropic proinflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts
IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation
IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes
Absorption
Peak plasma concentration
- RA (4 mg/kg IV q4Weeks): 86.1 mcg/mL
- RA (8 mg/kg IV q4Weeks): 176 mcg/mL
- RA (162 mg SC every other week): 12.1 mcg/mL
- RA (162 mg SC weekly): 49.8 mcg/mL
- GCA (162 SC every other week): 17.2 mcg/mL
- GCA (162 SC weekly): 72.1 mcg/mL
- PJIA (8 mg/kg IV q4Weeks): 181 mcg/mL
- PJIA (10 mg/kg IV q4Weeks): 167 mcg/mL
- PJIA (162 mg SC q2Weeks): 29.7 mcg/mL
- PJIA (162 mg SC q3Weeks): 62.4 mcg/mL
- SJIA (8 mg/kg IV q2Weeks): 253 mcg/mL
- SJIA (12 mg/kg IV q2Weeks): 274 mcg/mL
- SJIA (162 mg SC weekly): 89.8 mcg/mL
- SJIA (162 mg SC q2Weeks): 127 mcg/mL
Plasma trough concentration
- RA (4 mg/kg IV q4Weeks): 0.1 mcg/mL
- RA (8 mg/kg IV q4Weeks): 13.4 mcg/mL
- RA (162 mg SC every other week): 4.1 mcg/mL
- RA (162 mg SC weekly): 42.9 mcg/mL
- GCA (162 SC every other week): 7.7 mcg/mL
- GCA (162 SC weekly): 9.6 mcg/mL
- PJIA (8 mg/kg IV q4Weeks): 3.28 mcg/mL
- PJIA (10 mg/kg IV q4Weeks): 0.35 mcg/mL
- PJIA (162 mg SC q2Weeks): 12.7 mcg/mL
- PJIA (162 mg SC q3Weeks): 13.4 mcg/mL
- SJIA (8 mg/kg IV q2Weeks): 70.7 mcg/mL
- SJIA (12 mg/kg IV q2Weeks): 65.9 mcg/mL
- SJIA (162 mg SC weekly): 72.4 mcg/mL
- SJIA (162 mg SC q2Weeks): 64.2 mcg/mL
Peak plasma time
- RA (weekly): 2.8 days
- RA (every other week): 4.7 days
- GCA (weekly): 3 days
- GCA (every other week): 4.5 days
Distribution
Vd: 6.4L (RA); 7.46 L (GCA); 4.08 L (PJIA); 2.54 L (SJIA)
Elimination
Half-life: up to 11 days (4 mg/kg); up to 13 days (8 mg/kg)
Half-life in RA patients: 13 days (162 mg every week); 5 days (162 mg every other week)
Half-life in GCA patients: 18.3-18.9 days (162 mg SC every week); 4.2-7.9 days (162 mg SC every other week)
Clearance: 0.0125 L/hr
Administration
IV Compatibility
0.9% or 0.45% NaCl
IV Preparation
Withdraw a volume of 0.9% or 0.45% NaCl from bag/bottle equal to volume of the solution required for patient's dose
Adults and children weighing ≥30 kg: Dilute to 100 mL in 0.9% or 0.45% NaCl
Children <30 kg: Dilute to 50 mL in 0.9% or 0.45% NaCl
Slowly add dose to infusion bag or bottle and gently invert to mix (prevent foaming)
Fully diluted solutions are compatible with polypropylene, polyethylene and polyvinyl chloride infusion bags and polypropylene, polyethylene, and glass infusion bottles
Recommended volume per kg of body weight
- 4 mg/kg-dose (RA): 0.2 mL/kg
- 6 mg/kg-dose (GCA): 0.3 mL/kg
- 8 mg/kg-dose (RA, SJIA, PJIA, and CRS ≥30 kg): 0.4 mL/kg
- 10 mg/kg-dose (PJIA <30 kg): 0.5 mL/kg
- 12 mg/kg-dose (SJIA and CRS <30 kg): 0.6 mL/kg
IV Administration
Infuse over 1 hr with an infusion set
Do NOT administer as bolus or push
Do not infuse with any other drugs as no compatibility studies have been conducted
SC Preparation
Remove prefilled SC syringe/autoinjector from refrigerator 30 minutes before administration
SC injection is not intended for IV drip infusion
Do not use prefilled syringes or autoinjectors exhibiting particulate matter, cloudiness, or discoloration; solution for SC administration should appear clear and colorless to pale yellow
SC Administration
Rotate SC injection sites (ie, thighs, abdomen, outer area of upper arm [caregiver only]) and inject full amount of the syringe (0.9 mL)
Transition from IV to SC (adult or pediatric arthritis indications): Administer first SC dose instead of next scheduled IV dose
Storage
Undiluted vials and prefilled SC syringes/autoinjectors: Refrigerate at 2-8ºC (36-46ºF) in original container and protect from light
Diluted IV solutions
- Using 0.45% NaCl: Refrigerate at 2-8ºC (36-46ºF) for up to 24 hr or store at room temperature for up to 4 hr
- Using 0.9% NaCl: Refrigerate at 2-8ºC (36-46ºF) or store at room temperature for up to 24 hr
- Protect from light
- Do not freeze
- Do not save unused, reconstituted drug in vials because product contains no preservatives
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Actemra intravenous - | 400 mg/20 mL (20 mg/mL) vial |  | |
| Actemra intravenous - | 200 mg/10 mL (20 mg/mL) vial |  | |
| Actemra intravenous - | 80 mg/4 mL (20 mg/mL) vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
tocilizumab subcutaneous
TOCILIZUMAB - SUBCUTANEOUS INJECTION
(TOE-si-LIZ-ue-mab)
COMMON BRAND NAME(S): Actemra
WARNING: This medication may lower your ability to fight an infection. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Your risk may be increased if you are also taking other drugs that can lower your ability to fight an infection (such as methotrexate or corticosteroids). Before using tocilizumab, tell your doctor your medical history, especially of any kind of infection. During treatment, tell your doctor right away if you develop any signs of infection (such as cough, sore throat, fever, chills, pain when urinating).Before and during treatment with this medication, your doctor will test you for tuberculosis (TB). Your doctor should also monitor you for symptoms of TB during and after treatment with this drug. If needed, treatment for tuberculosis or other infections should be given before receiving this medication.
USES: This medication is used to treat rheumatoid arthritis in adults and in children (such as polyarticular juvenile idiopathic arthritis-PJIA, systemic juvenile idiopathic arthritis-SJIA). It helps to reduce pain and swelling due to rheumatoid arthritis. Tocilizumab is used to treat giant cell arteritis. It helps to reduce swelling in your blood vessels so blood can flow more easily. This medication is also used to slow down the decrease in lung function in people with a certain type of lung disease (systemic sclerosis-associated interstitial lung disease - SSc-ILD). Tocilizumab belongs to a class of drugs known as Interleukin-6 (IL-6) blockers. It works by blocking IL-6, a substance made by the body that causes swelling (inflammation).
HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using tocilizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.Before use, take this medication out of the refrigerator. If you are using the prefilled syringe, let it warm up to room temperature for at least 30 minutes. If you are using the autoinjector, let it warm up to room temperature for at least 45 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not leave in direct sunlight. Check this product visually for particles or discoloration. If either is present, do not use the liquid.If you are using this medication to treat rheumatoid arthritis in adults, inject this medication under the skin as directed by your doctor, usually starting with once every 2 weeks, then increasing to once a week.If you are using this medication to treat PJIA in children, give this medication by injection under the skin as directed by the doctor, usually once every 2 or 3 weeks, based on your child's weight.If you are using this medication to treat SJIA in children, give this medication by injection under the skin as directed by the doctor, usually once every 1 or 2 weeks, based on your child's weight.If you are using this medication to treat giant cell arteritis or for SSc-ILD, inject this medication under the skin as directed by your doctor, usually once a week.Recommended injection sites include the abdomen or the front of your thigh. The outer area of the upper arms may also be used if another person is giving you the injection. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or broken.Learn how to store and discard medical supplies safely.The dosage is based on your weight, laboratory tests, and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, mark the days you need to inject the medication on a calendar.Tell your doctor if your condition does not get better or if it gets worse.
SIDE EFFECTS: See also Warning section.Headache or irritation/redness/pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: stomach/abdominal pain.Tocilizumab has rarely caused very serious (possibly fatal) liver disease. This effect may occur months to years after starting this medication. Tell your doctor right away if you develop symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using tocilizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, infections (including past/current/returning), liver problems, low blood cell count, nervous system problems (such as multiple sclerosis), stomach/abdominal problems (such as ulcers, diverticulitis).Tocilizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, tuberculosis, flu). Tell your doctor if you live in, have lived in, or have traveled to certain areas where there is an increased chance of getting certain kinds of fungal infections (blastomycosis, coccidioidomycosis, histoplasmosis). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using tocilizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Drugs that affect the immune system (such as tocilizumab) may increase your risk of certain cancers. Tell your doctor if you have ever had any type of cancer.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that can affect the immune system (such as certolizumab, corticosteroids including prednisone).This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include omeprazole, warfarin, and some cholesterol drugs such as atorvastatin/lovastatin/simvastatin, among others.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood counts, liver function, cholesterol tests) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Store in the original package in the refrigerator away from moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
