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TocilizumabSnapshot

Indication and Dosage

NOTE: This information is based on international data. Refer to local guidance for specific approved regimens.

Indication (1)
  • Ministry of Health suggests off-label use to treat COVID-19 when ALL of the below criteria are met:

    • No improvement in oxygen requirements after 24 to 48 hours of treatment with corticosteroids

    • Significantly elevated inflammatory markets (C-Reactive Protein 75 mg/L or higher)

    • No evidence of infection (bacterial, fungal, or tubercular)

Dosage

  • 8 mg/kg as a single intravenous infusion (1)

  • Do not exceed a total dose of 800 mg (1)(2)

Administration

Administration:

  • Dilution:

    • From a 100 mL 0.9% Sodium Chloride for Injection infusion bag, withdraw a volume of solution that is equal to the volume of tocilizumab solution required for the patient’s dose

    • Withdraw the required volume of tocilizumab from the vial and add to the infusion bag

    • Gently invert the bag to mix and to avoid foaming

    • Use immediately. If not used immediately, the diluted solution may be stored at 2 to 8 degrees C (36 to 46 degrees F) for up to 24 hours and should be protected from light (2)

  • Administration: Administer via intravenous infusion over 1 hour (1)(2)

Precautions

Infections (Black Box Warning):

  • Treatment has been associated with serious and sometimes fatal infections (e.g., active tuberculosis, invasive fungal infections, opportunistic bacterial and viral infections)

  • Avoid use in patients with active infection that is not due to SARS-CoV-2

  • Screen for latent tuberculosis infection before giving tocilizumab. Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before receiving tocilizumab (2)

  • Cases of severe and disseminated strongyloidiasis have been reported in patients with COVID-19 who received tocilizumab plus a corticosteroid. For patients from strongyloidiasis endemic areas, consider giving prophylactic ivermectin before treatment with tocilizumab plus a corticosteroid (3) Gastrointestinal Perforation: (2)

  • Treatment has been associated with gastrointestinal perforation, primarily as complications of diverticulitis

  • Use with caution in patients with a history of intestinal ulceration or diverticulitis

  • Promptly evaluate patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain

Hepatotoxicity: (2)

  • Caution if administering to patients with active hepatic disease or elevated ALT/AST > 1.5-time ULN; avoid use in patients with ALT/AST > 5-times ULN

  • Serious drug-induced hepatotoxicity (e.g., acute liver failure, hepatitis, jaundice) have been associated with treatment

Demyelinating disorders: (2) Caution may be warranted by patients with neurological disease such as preexisting or recent onset demyelinating disorders

Neutropenia: (2) Caution may be warranted by patients with neurological disease such as preexisting or recent onset demyelinating disorders

Thrombocytopenia: (2) Caution in patients with platelet count < 100 x 10 3/mm3; avoid use in patients with platelet count < 50 x 103/mm3

Pregnancy: (2)

  • Only use during pregnancy if clearly needed

  • No adequate data regarding treatment of pregnant women

Adverse Reactions

  • Hypersensitivity and Serious Allergic Reactions: anaphylaxis, infusion-related reactions

  • Infections: Upper respiratory, cellulitis, herpes simplex/zoster, diverticulitis, sepsis

  • Hematologic: thrombocytopenia, neutropenia, leukopenia

  • Gastrointestinal: gastrointestinal perforation, abdominal pain, oral ulcers, gastritis, stomatitis, gastric ulcers

  • Hepatic: elevated hepatic enzymes, hyperbilirubinemia

  • Metabolic: hypercholesterolemia, hypertriglyceridemia

  • Dermatologic: rash, pruritus, urticaria

  • Neurologic: dizziness, headache

  • Respiratory: dyspnea, cough

  • Other: weight gain, peripheral edema, hypertension, conjunctivitis, nephrolithiasis, hypothyroidism

Drug Interactions (2)

Vaccinations:

  • Avoid concurrent use with live and live-attenuated vaccines

  • No data are available on secondary transmission of infection from persons receiving live vaccines to patients receiving tocilizumab

  • No data are available on the effectiveness of vaccination in patients receiving tocilizumab

References:

  1. Directorate General of Health Services, MoHFW, GOI. Comprehensive Guidelines for Management of COVID-19 patients. Retrieved June 7, 2021. Available on the World Wide Web at: https://dghs.gov.in/WriteReadData/News/202105270436027770348ComprehensiveGuidelinesforManagementofCOVID-1927May2021DteGHS.pdf

  2. Actemra (tocilizumab for injection) prescribing information. Mumbai India: Cipla Ltd.; 2020 Jul. Available on the World Wide Web at: https://www.ciplamed.com/content/actemra-iv-injection

  3. COVID-19 Treatment Guidelines Panel. Coronavirus Diseases 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Accessed April 21, 2021. Available at on the World Wide Web at: https://covid19treatmentguidelines.nih.gov/