Adult Dosing
Moderate-severe rheumatoid arthritis
IV infusion
- Give once q4 wks as a 60-minute IV infusion
- Initially 4 mg/kg, may increase to 8mg/kg based on clinical response
- Do not start if ANC <2000/mm3, platelets < 100000/mm3, or ALT/AST >1.5x ULN
- Reduce dose to 4mg/kg if elevated liver enzymes, neutropenia, or thrombocytopenia occur
- Max: 800 mg/dose
SC injection
- <100 kg: 162 mg SC every other week, followed by an increase to every week based on clinical response
100 kg: 162 mg SC every week
Pediatric Dosing
Polyarticular Juvenile Idiopathic Arthritis
- 2years (<30 kg): 10 mg/kg IV q4weeks
- 2 years (>30 kg or more): 8 mg/kg IV q4weeks
Systemic Juvenile Idiopathic Arthritis
- 2 years (<30 kg): 12 mg/kg IV q2weeks
- 2 years (>30 kg): 8 mg/kg IV q2weeks
Note:
- May use alone or in combination with methotrexate
- Do not start if ANC <2000/mm3, platelets < 100000/mm3, or ALT/AST >1.5x ULN
- Reduce dose to 4mg/kg if elevated liver enzymes, neutropenia, or thrombocytopenia occur
[Outline]
Renal Dose Adjustment (Based on CrCl)
- 50-80 mL/min: No dose adjustment
- <50: Dose adjustments not defined
Hepatic Dose Adjustment
- Hepatic impairment: Use not recommended in active hepatic disease or baseline AST/ALT >1.5x ULN
See Supplemental Patient Information
- Anaphylaxis has been reported, discontinue immediately
- Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal)
- Interrupt therapy if a serious infection develops until the infection is controlled
- Test for and treat latent TB prior to starting therapy
- Use with caution in patients who may be at increased risk for gastrointestinal perforation as events of gastrointestinal perforation have been reported with the drug
- Monitor neutrophils, platelets, liver function tests every 4-8 weeks
- Monitor lipids 4-8 weeks after initiation, then every 6 months
- Manage patients according to clinical guidelines for the management of hyperlipidemia
- Treatment with immunosuppressant like tocilizumab may result in an increased risk of malignancies
- Institute appropriate medical treatment if serious hypersensitivity reactions, including anaphylaxis occur with infusion of tocilizumab
- Monitor closely if new infection develops; discontinue if serious or opportunistic infection or sepsis develop
- Closely monitor for signs and symptoms potentially indicative of demyelinating disorders as demyelinating disorders have been reported with the drug. Prescribe cautiously in patients with preexisting or recent onset demyelinating disorders
- Live vaccines should not be given with tocilizumab
Cautions: Use cautiously in
- Hepatic impairment
- Renal impairment
- History of recurring/chronic infection
- Tuberculosis
- Neutropenia
- Immunosuppression
- CNS demyelinating disorders
- Elderly patients
Supplemental Patient Information
- Instruct patient to read Medication Guide before starting therapy
- Advise patient to contact health care professional immediately when symptoms of severe, persistent abdominal pain appear
- Warn patient not to receive live vaccines while undergoing tocilizumab therapy
Pregnancy Category:C
Breastfeeding: Safety unknown; due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
