Actemra (Tocilizumab (Intravenous))

Applies to tocilizumab: intravenous solution, subcutaneous solution

Respiratory

Very common (10% or more): Upper respiratory tract infection
Common (1% to 10%): Cough, dyspnea, nasopharyngitis, bronchitis[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, urticaria
Frequency not reported: Angioedema
Postmarketing reports: Stevens-Johnson Syndrome[Ref]

General

The most common serious adverse reactions were serious infections.[Ref]

Hypersensitivity

Of the 2876 patients tested for anti-tocilizumab antibodies in controlled clinical trials, 1.6% (46 patients) were positive; 5 patients experienced a hypersensitivity reaction that lead to treatment withdrawal. However, in 1.1% (30 patients) of those who developed antibodies there was no apparent correlation to clinical response.[Ref]

Common (1% to 10%): Hypersensitivity reaction
Postmarketing reports: Fatal anaphylaxis[Ref]

Oncologic

Frequency not reported: Malignancies[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, mouth ulceration, gastritis, diarrhea
Uncommon (0.1% to 1%): Stomatitis, gastric ulcer, diverticulitis
Rare (0.01% to 0.1%): Gastrointestinal perforation (most patients who developed GI perforations were taking concomitant nonsteroidal anti-inflammatory medications (NSAIDs), corticosteroids, or methotrexate)[Ref]

Hematologic

Very common (10% or more): Leukopenia, neutropenia, thrombocytopenia[Ref]

Hepatic

Common (1% to 10%): Transaminases increased, total bilirubin increased[Ref]

Immunologic

Common (1% to 10%): Cellulitis, pneumonia, oral herpes simplex, herpes zoster[Ref]

Local

Common (1% to 10%): Injection site reaction[Ref]

Metabolic

Very common (10% or more): Hypercholesterolemia
Common (1% to 10%): Weight increased, peripheral edema
Uncommon (0.1% to 1%): Hypertriglyceridemia[Ref]

Musculoskeletal

Common (1% to 10%): Back pain
Frequency not reported: Bacterial arthritis[Ref]

Ocular

Common (1% to 10%): Conjunctivitis[Ref]

Other

Common (1% to 10%): Peripheral edema[Ref]

Renal

Uncommon (0.1% to 1%): Nephrolithiasis[Ref]

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism[Ref]

Some side effects of tocilizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

-Mild renal impairment: No adjustment recommended
-Moderate to severe renal impairment: Data not available (renal function should be monitored closely in these patients)