Medically reviewed on Sep 10, 2018
(toe si LIZ oo mab)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Actemra: 80 mg/4 mL (4 mL); 200 mg/10 mL (10 mL); 400 mg/20 mL (20 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Actemra: 162 mg/0.9 mL (0.9 mL) [contains polysorbate 80]
Brand Names: U.S.
- Antirheumatic, Disease Modifying
- Interleukin-6 Receptor Antagonist
Tocilizumab is an antagonist of the interleukin-6 (IL-6) receptor. Endogenous IL-6 is induced by inflammatory stimuli and mediates a variety of immunological responses. Inhibition of IL-6 receptors by tocilizumab leads to a reduction in cytokine and acute phase reactant production.
Vdss: Children and Adolescents: Systemic juvenile idiopathic arthritis (SJIA): 2.54 L; Polyarticular juvenile idiopathic arthritis (PJIA): 4.08 L; Adults: Rheumatoid arthritis (RA): 6.4 L; Giant cell arteritis (GCA): 7.46 L
Onset of Action
Cytokine release syndrome (CRS): Median time to defervescence: 4 hours (Fitzgerald 2017); Fever and hypotension typically resolve within a few hours (Lee 2014); Blood pressure stabilization: 1 to 3 days (Abboud 2016; Maude 2014b). A median of 1 dose (range: 1 to 4) was required for management of CRS due to chimeric antigen receptor T-cell therapy.
Time to Peak
SubQ: ~3 days (for every-week dosing); ~4.5 days (for every-2-week dosing)
IV: Concentration dependent: Steady state: Children and Adolescents: SJIA: Up to 23 days; PJIA: Up to 17 days; Adults: RA: Terminal, single dose: 6.3 days (concentration-dependent; may be increased up to 11 to 13 days at steady state)
SubQ: Concentration dependent: Children and Adolescents: PJIA: Up to 10 days; Adults: RA: Up to 5 days (every-other-week dosing) or up to 13 days (every-week dosing); GCA: 4.2 to 7.9 days (every other week dosing) or 18.3 to 18.9 days (every-week dosing)
Special Populations Note
RA: For IV administration, the body weight–based dose (8 mg/kg) resulted in ~86% higher exposure in patients who weighed >100 kg in comparison with patients who weighed <60 kg.
GCA: Higher exposure was observed in patients with lower body weight. For the 162 mg every week dosing regimen, the steady-state Cavg was 51% higher in patients with body weight <60 kg compared with patients weighing between 60 to 100 kg. For the 162 mg every-other-week regimen, the steady-state Cavg was 129% higher in patients with body weight <60 kg compared with patients weighing between 60 to 100 kg.
Use: Labeled Indications
Cytokine release syndrome, severe or life-threatening: Treatment of chimeric antigen receptor (CAR) T-cell induced severe or life-threatening cytokine release syndrome in patients ≥2 years of age
Giant cell arteritis: Treatment of giant cell arteritis (GCA) in adult patients
Polyarticular juvenile idiopathic arthritis: Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2 years of age
Rheumatoid arthritis: Treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs)
Systemic juvenile idiopathic arthritis: Treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients ≥2 years of age
Off Label Uses
Cytokine release syndrome (severe or life-threatening; due to BiTE therapy)
Clinical experience suggests that tocilizumab may be effective in adult and pediatric patients for the management of severe or life-threatening cytokine release syndrome associated with bi-specific T-cell engaging (BiTE) cancer treatment [Lee 2014], [Maude 2014a]. Additional data may be necessary to further define the role of tocilizumab in the treatment of this condition.
Known hypersensitivity to tocilizumab or any component of the formulation
Canadian labeling: Additional contraindications (not in the US labeling): Active infections
Note: In patients with giant cell arteritis (GCA) or rheumatoid arthritis (RA), do not initiate if ANC is <2,000/mm3, platelets are <100,000/mm3 or if ALT or AST are >1.5 times ULN. Patients with severe or life-threatening cytokine release syndrome frequently have cytopenias or elevated liver transaminases due to the underlying disease state and/or its treatment; evaluate risk versus benefit of tocilizumab treatment in patients with severe or life-threatening cytokine release syndrome.
Cytokine release syndrome (due to chimeric antigen receptor-T cell therapy), severe or life-threatening: Note: If clinical improvement does not occur after the first dose, up to 3 additional doses may be administered (with at least an 8 hour interval between consecutive doses). Tocilizumab may be administered as monotherapy or in combination with corticosteroids.
IV: Maximum dose: 800 mg per dose
<30 kg: 12 mg/kg
≥30 kg: 8 mg/kg
Giant cell arteritis: SubQ: 162 mg once every week (in combination with a tapering course of glucocorticoids); based on clinical considerations, may consider 162 mg once every other week (with a tapering course of glucocorticoids). Tocilizumab may be administered as monotherapy following discontinuation of glucocorticoids.
Rheumatoid arthritis: Note: Methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs) may be continued for the treatment of rheumatoid arthritis. Tocilizumab should not be used in combination with biologic DMARDs.
IV: Initial: 4 mg/kg once every 4 weeks; may be increased to 8 mg/kg once every 4 weeks based on clinical response (maximum dose: 800 mg).
<100 kg: 162 mg once every other week; increase to 162 mg once every week based on clinical response
≥100 kg: 162 mg once every week
Transitioning from IV therapy to SubQ therapy: Administer the first SubQ dose instead of the next scheduled IV dose.
Cytokine release syndrome (due to bi-specific T-cell engaging therapy), severe or life-threatening (off-label use): IV: 4 mg/kg once; may repeat the dose if clinical improvement does not occur within 24 to 48 hours (Lee 2014). Additional data may be necessary to further define the role of tocilizumab in the treatment of this condition.
Note: In patients with polyarticular juvenile idiopathic arthritis (pJIA) or systemic juvenile idiopathic arthritis (SJIA), do not initiate if ANC is <2,000/mm3, platelets are <100,000/mm3 or if ALT or AST are >1.5 times ULN. Patients with severe or life-threatening cytokine release syndrome frequently have cytopenias or elevated liver transaminases due to the underlying disease state and/or its treatment; evaluate risk versus benefit of tocilizumab treatment in patients with severe or life-threatening cytokine release syndrome.
Cytokine release syndrome (due to chimeric antigen receptor-T cell therapy), severe or life-threatening: Children ≥2 years of age and Adolescents: Note: If clinical improvement does not occur after the first dose, up to 3 additional doses may be administered (with at least an 8 hour interval between consecutive doses). Tocilizumab may be administered as monotherapy or in combination with corticosteroids.
IV: Maximum dose: 800 mg per dose
<30 kg: 12 mg/kg
≥30 kg: 8 mg/kg
Polyarticular juvenile idiopathic arthritis: Children ≥2 years of age and Adolescents: Note: Dose adjustment should not be made based solely on a single-visit body weight measurement due to fluctuations in body weight. May be used as monotherapy or in combination with methotrexate.
<30 kg: 10 mg/kg once every 4 weeks
≥30 kg: 8 mg/kg once every 4 weeks
<30 kg: 162 mg once every 3 weeks
≥30 kg: 162 mg once every 2 weeks
Transitioning from IV therapy to SubQ therapy: Administer the first SubQ dose instead of the next scheduled IV dose.
Systemic juvenile idiopathic arthritis: Children ≥2 years of age and Adolescents: IV: Note: Dose adjustment should not be made based solely on a single-visit body weight measurement due to fluctuations in body weight. May be used as monotherapy or in combination with methotrexate.
<30 kg: 12 mg/kg once every 2 weeks
≥30 kg: 8 mg/kg once every 2 weeks
Cytokine release syndrome (due to bi-specific T-cell engaging therapy), severe or life-threatening (off-label use): IV: 8 mg/kg once; may repeat the dose if clinical improvement does not occur within 24 to 48 hours (Lee 2014). Additional data may be necessary to further define the role of tocilizumab in the treatment of this condition.
Dosing: Renal Impairment
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Not recommended for use in patients with active hepatic disease or hepatic impairment.
Hepatotoxicity during treatment: Rheumatoid arthritis (RA) and giant cell arteritis (GCA):
>1 to 3 x ULN: Adjust concomitant disease-modifying antirheumatic drugs (for RA) or immunomodulatory agents (for GCA) as appropriate. For patients receiving IV therapy with persistent increases >1 to 3 x ULN, reduce dose to 4 mg/kg or interrupt until ALT/AST have normalized. For patients receiving SubQ therapy with persistent increases >1 to 3 x ULN, reduce injection frequency to every other week or interrupt until ALT/AST have normalized; increase frequency to every week as clinically appropriate.
>3 to 5 x ULN (confirmed with repeat testing): Interrupt until ALT/AST <3 x ULN and follow dosage adjustments recommended for liver enzyme abnormalities >1 to 3 x ULN. For persistent increases >3 x ULN, discontinue.
>5 x ULN: Discontinue.
Dosing: Adjustment for Toxicity
Hypersensitivity (anaphylaxis or other clinically significant hypersensitivity reaction): Stop immediately and discontinue permanently.
Infection (serious infection, opportunistic infection, or sepsis): Interrupt treatment until the infection is controlled.
Polyarticular and systemic juvenile idiopathic arthritis: Dose reductions have not been studied; however, dose interruptions are recommended for liver enzyme abnormalities, low neutrophil counts, and low platelets similar to recommendations provided for rheumatoid arthritis. In addition, consider interrupting or discontinuing concomitant methotrexate and/or other medications and hold tocilizumab dosing until the clinical situation has been assessed.
Rheumatoid arthritis and giant cell arteritis:
ANC >1,000/mm3: Maintain dose.
ANC 500 to 1,000/mm3: Interrupt therapy; when ANC >1,000/mm3, resume IV tocilizumab at 4 mg/kg (may increase to 8 mg/kg as clinically appropriate) or resume SubQ tocilizumab at every other week dosing (increase frequency to every week as clinically appropriate).
ANC <500/mm3: Discontinue.
Platelets 50,000 to 100,000/mm3: Interrupt therapy; when platelet count is >100,000/mm3, resume IV tocilizumab at 4 mg/kg (may increase to 8 mg/kg as clinically appropriate) or resume SubQ tocilizumab at every other week dosing (increase frequency to every week as clinically appropriate).
Platelets <50,000/mm3: Discontinue.
IV: Prior to administration, dilute to 50 mL (children <30 kg) or 100 mL (children ≥30 kg and adults) by slowly adding to NS or 1/2NS. Use only the vials to prepare IV infusion solutions; do not use prefilled SubQ syringes to prepare IV solutions. Withdraw equal volume of NS or 1/2NS to the volume of tocilizumab required for dose; slowly add tocilizumab dose into infusion bag or bottle. Gently invert to mix (avoid foaming). Diluted solutions are compatible with polypropylene, polyethylene (PE), polyvinyl chloride (PVC), and glass infusion containers. Allow diluted solution to reach room temperature prior to infusion.
IV: Allow diluted solution for infusion to reach room temperature prior to administration; infuse over 60 minutes using a dedicated IV line. Do not infuse other agents through same IV line. Do not administer IV push or IV bolus. If additional doses are necessary for the management of cytokine release syndrome, the interval between doses should be at least 8 hours. Do not use if opaque particles or discoloration is visible.
SubQ: Administer the full amount in the prefilled syringe. Allow to reach room temperature prior to use. Do not use if particulate matter or discoloration is visible; solution should be clear and colorless to pale yellow. Rotate injection sites; avoid injecting into moles, scars, or tender, bruised, red, or hard skin. After proper training, patients may self-inject, or the patient's caregiver may administer tocilizumab; prefilled syringe is available for use by patients (self-administration). Do not administer subcutaneously for the treatment of systemic juvenile idiopathic arthritis.
Rheumatoid arthritis: When transitioning from IV administration to SubQ administration, give the first SubQ dose instead of the next scheduled IV dose.
Giant cell arteritis: Should only be administered subQ (IV administration is not approved for giant cell arteritis).
Store intact vials/syringes at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect vials and syringes from light (store in the original package until time of use); keep syringes dry. Solutions diluted for IV infusion in NS may be stored at 2°C to 8°C (36°F to 46°F) or room temperature for up to 24 hours; solutions diluted for IV infusion in 1/2NS may be stored at 2°C to 8°C (36°F to 46°F) for up to 24 hours or at room temperature for up to 4 hours; protect from light. Discard unused product remaining in the vials.
Abatacept: Tocilizumab may enhance the adverse/toxic effect of Abatacept. Avoid combination
Anti-TNF Agents: Tocilizumab may enhance the immunosuppressive effect of Anti-TNF Agents. Avoid combination
Baricitinib: May enhance the adverse/toxic effect of Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Avoid combination
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
CYP3A4 Substrates (High risk with Inducers): Tocilizumab may decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification
Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy
Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy
Tofacitinib: Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) may enhance the adverse/toxic effect of Tofacitinib. Avoid combination
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination
Incidence as reported for adults unless otherwise noted. Incidence as reported for monotherapy and combination therapy. Combination therapy refers to use in rheumatoid arthritis with nonbiological disease-modifying antirheumatic drugs or use in systemic juvenile idiopathic arthritis or polyarticular juvenile idiopathic arthritis in trials where most patients (~70% to 80%) were taking methotrexate at baseline.
Endocrine & metabolic: Increased serum cholesterol (19% to 20%; children and adolescents: ≤2%)
Hepatic: Increased serum alanine aminotransferase (≤36%), increased serum aspartate aminotransferase (≤22%)
Local: Injection site reaction (SubQ: Including erythema, pruritus, pain, and hematoma; children and adolescents <30 kg: 44%; children and adolescents ≥30 kg 15%; adults: 4% to 10%)
Miscellaneous: Infusion-related reaction (4% to 20%)
1% to 10%:
Cardiovascular: Hypertension (1% to 6%), peripheral edema (<2%)
Central nervous system: Headache (1% to 7%), dizziness (3%)
Dermatologic: Skin rash (2%), dermatological reaction (1% [includes pruritus, urticaria])
Endocrine & metabolic: Increased LDL cholesterol (9% to 10%; children and adolescents ≤2%), hypothyroidism (<2%)
Gastrointestinal: Diarrhea (children and adolescents: ≤5%), abdominal pain (2%), oral mucosa ulcer (2%), gastric ulcer (<2%), stomatitis (<2%), weight gain (<2%), gastritis (1%)
Hematologic & oncologic: Neutropenia (children and adolescents <30 kg: 26%; adults, grade 3: 2% to 7%; children and adolescents ≥30 kg: 4%; adults, grade 4: <1%), thrombocytopenia (1% to 2%), leukopenia (<2%)
Hepatic: Increased serum bilirubin (<2%)
Immunologic: Antibody development (children and adolescents: ≤6%; adults: <2%, neutralizing, adults: ≤1%)
Infection: Herpes simplex infection (<2%)
Ophthalmic: Conjunctivitis (<2%)
Renal: Nephrolithiasis (<2%)
Respiratory: Upper respiratory tract infection (7%), nasopharyngitis (7%), bronchitis (3%), cough (<2%), dyspnea (<2%)
Frequency not defined:
Infection: Infection, serious infection, varicella zoster infection
Otic: Otitis media
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, aspergillosis, candidiasis, cellulitis, chronic inflammatory demyelinating polyneuropathy, cryptococcosis, diverticulitis of the gastrointestinal tract, gastroenteritis, gastrointestinal perforation, hypersensitivity reaction, hypertriglyceridemia, hypotension, increased HDL cholesterol, malignant neoplasm, multiple sclerosis, nausea, opportunistic infection, pancreatitis, pneumonia, pneumonia due to Pneumocystis jirovecii, septic arthritis, sepsis, Stevens-Johnson syndrome, tuberculosis, urinary tract infection, viral infection (reactivation)
Concerns related to adverse effects:
• Elevated liver enzymes: Tocilizumab is associated with transaminase elevations. Monitor transaminases. Treatment should be discontinued in patients who develop elevated ALT or AST >5 x ULN. Patients receiving concomitant hepatotoxic drugs (eg, methotrexate) are at an increased risk of developing elevated transaminases; elevations are typically reversible and do not result in clinically evident hepatic injury.
• GI perforation: Use with caution in patients at increased risk for GI perforation; perforation has been reported, typically secondary to diverticulitis. Monitor for new-onset abdominal symptoms; promptly evaluate if new symptoms occur.
• Hematologic effects: Neutropenia and thrombocytopenia may occur; may require treatment interruption, dose or interval modification, or discontinuation. Monitor neutrophils and platelets. Do not initiate treatment in patients with giant cell arteritis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, or systemic juvenile idiopathic arthritis with an ANC <2,000/mm3 or platelet count <100,000/mm3; discontinue treatment for ANC <500/mm3 or platelet count <50,000/mm3.
• Herpes zoster reactivation: Herpes zoster reactivation has been reported.
• Hyperlipidemia: Therapy is associated with increases in total cholesterol, triglycerides, LDL, and/or HDL; monitor ~4 to 8 weeks after initiation, then approximately every 6 months. Hyperlipidemia should be managed according to current guidelines.
• Hypersensitivity: May cause hypersensitivity or anaphylaxis; anaphylactic events including fatalities have been reported with IV administration; hypersensitivity reactions have occurred in patients who were premedicated, in patients with and without a prior history of hypersensitivity, and as early as the first infusion. Medications for the treatment of hypersensitivity reactions should be available for immediate use. Patients should seek medical attention if symptoms of hypersensitivity reaction occur with SubQ use. Stop immediately and permanently discontinue treatment in patients who develop a hypersensitivity reaction to tocilizumab. In clinical studies, reactions requiring treatment discontinuation included generalized erythema, rash, and urticaria.
• Infections: [US Boxed Warning]: Serious and potentially fatal infections (including active tuberculosis, invasive fungal, bacterial, viral, protozoal, and other opportunistic infections) have been reported in patients receiving tocilizumab; infection may lead to hospitalization or death. Most of the serious infections have occurred in patients on concomitant immunosuppressive therapy. Patients should be closely monitored for signs and symptoms of infection during and after treatment. If serious infection occurs during treatment, withhold tocilizumab until infection is controlled. Prior to treatment initiation, carefully consider risk versus benefit in patients with chronic or recurrent infections, tuberculosis exposure, history of or current opportunistic infection, underlying conditions predisposing to infection, or patients residing in or with travel to areas of endemic tuberculosis or endemic mycosis. The most common serious infections occurring have included pneumonia, UTI, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis, and bacterial arthritis. Do not administer tocilizumab to a patient with an active infection, including localized infection. Interrupt treatment for serious infection, opportunistic infection, or sepsis.
• Malignancy: Use of tocilizumab may affect defenses against malignancies; impact on the development and course of malignancies is not fully defined; however, malignancies were observed in clinical trials.
• Tuberculosis: [US Boxed Warning]: Tuberculosis (pulmonary or extrapulmonary) has been reported in patients receiving tocilizumab; both reactivation of latent infection and new infections have been reported. Patients should be tested for latent tuberculosis infection before and during therapy; consider treatment of latent tuberculosis used prior to tocilizumab treatment. Some patients who test negative prior to therapy may develop active infection; monitor for signs and symptoms of tuberculosis during and after treatment in all patients. Patients should be evaluated for tuberculosis risk factors with a tuberculin skin test prior to starting therapy. Consider antituberculosis treatment in patients with a history of latent or active tuberculosis if adequate treatment course cannot be confirmed, and for patients with risk factors for tuberculosis despite a negative test.
• Demyelinating CNS disease: Use with caution in patients with preexisting or recent onset CNS demyelinating disorders; rare cases of CNS demyelinating disorders (multiple sclerosis and chronic inflammatory demyelinating polyneuropathy) have occurred. All patients should be monitored for signs and symptoms of demyelinating disorders.
• Hepatic impairment: Use is not recommended in patients with active hepatic disease or hepatic impairment. Monitor ALT and AST. Do not initiate treatment if ALT or AST is >1.5 times ULN.
Concurrent drug therapy issues:
• Biological disease-modifying antirheumatic drugs (DMARDs): Concomitant use with other biological DMARDs (eg, TNF blockers, IL-1 receptor blockers, anti-CD20 monoclonal antibodies, selective costimulation modulators) has not been studied and should be avoided due to the increased risk of infection.
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Elderly: Infection has been reported at a higher incidence in elderly patients compared with younger adults; use with caution in elderly patients.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
• Appropriate use: SubQ administration is only indicated for adult patients with rheumatoid arthritis and giant cell arteritis (GCA) and pediatric patients with polyarticular juvenile idiopathic arthritis. Do not use SubQ injection for IV infusion. Do not administer IV for the treatment of GCA.
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there is no data available concerning secondary transmission of infection from live vaccines in patients receiving therapy.
Latent TB screening prior to therapy initiation (all patients); neutrophils, platelets, ALT/AST (prior to therapy, 4 to 8 weeks after start of therapy, and every 3 months thereafter [rheumatoid arthritis]); neutrophils, platelets, ALT/AST (prior to therapy, at second administration, and every 2 to 4 weeks [systemic juvenile idiopathic arthritis] or 4 to 8 weeks [polyarticular juvenile idiopathic arthritis] thereafter); additional liver function tests (eg, bilirubin) as clinically indicated; lipid panel (prior to, at 4 to 8 weeks following initiation, and approximately every 6 months during therapy); monitor all patients for signs and symptoms of infection (prior to, during, and after therapy); signs and symptoms of CNS demyelinating disorders
Adverse events have been observed in some animal reproduction studies. As pregnancy progresses, monoclonal antibodies are increasingly transported across the placenta, with the largest amount transferred during the third trimester. Immune response in infants exposed to tocilizumab in utero may be affected. Consider risks/benefits prior to administering live or live-attenuated vaccines to infants exposed to tocilizumab during pregnancy.
A pregnancy registry has been established to monitor outcomes of women exposed to tocilizumab during pregnancy. Health care providers or pregnant patients are encouraged to register (877-311-8972).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience injection site irritation, common cold symptoms, rhinitis, or pharyngitis. Have patient report immediately to prescriber signs of infection, signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), behavioral changes, mood changes, confusion, neck rigidity, sensitivity to lights, severe muscle weakness, severe headache, severe dizziness, passing out, vision changes, mole changes, shortness of breath, angina, severe nausea, vomiting, severe abdominal pain, severe abdominal edema, skin growths, burning or numbness feeling, or bowel changes (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about tocilizumab
- Tocilizumab Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 24 Reviews
- Drug class: interleukin inhibitors
Other brands: Actemra