TocilizumabSnapshot

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:

• 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)

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

• 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

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/