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Roche anti (tocilizumab) instructions
Common name: tocilizumab
Trade name: Actemra
Full names: tocilizumab, tocilizumab, IL-6 receptor monoclonal antibody injection, tocilizu mab, Actemra
Indications:
For the treatment of rheumatoid arthritis: For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have not responded to one or more TNF antagonists.
Usage and dosage:
Rheumatoid arthritis, tocilizumab can be used alone or in combination with methotrexate or other DMARDs.
1. Recommended dose for adults every 4 weeks: Patients with inadequate response to one or more TNF antagonists: When used in combination with DMARDs or as monotherapy, the recommended starting dose is 4 mg/kg and then increased to 8 mg/kg based on clinical response. It is recommended not to start tocilizumab in patients with absolute neutrophil count (ANC) less than 2000/mm3, platelet count less than 100,000/mm3, or ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than 1.5 times the upper limit of normal (ULN).
2. It is recommended that the dose of tocilizumab per infusion should not exceed 800 mg.
3. Administration is intravenous infusion with 0.9% sodium chloride diluted to 100 mL using sterile technique. Give as a single intravenous infusion over a 1 hour period. Do not give bolus injections.
4. Dose Adjustment: Recommended management of certain dose-related laboratory changes including elevated liver enzymes, leukopenia, and thrombocytopenia.
Adverse reactions:
>10%:
Endocrine and metabolism: elevated serum cholesterol (19%-20%; children and adolescents: ≤2%)
Liver: elevated serum alanine aminotransferase (≤36%), serum aspartate Elevated transaminases (≤22%)
Local reactions: Injection site reactions (SubQ: Children and adolescents: 15%-44% [higher incidence when body weight ≥30kg]; Adults: 7%-10%)
Others: Infusion-related reactions (4%-20%)
1% - 10%:
Cardiovascular: hypertension (6%), peripheral edema (<2%)
Dermatology: rash (2%)
Endocrine and metabolic: hypothyroidism (<2%), elevated LDL cholesterol (9%-10%; children and adolescents :<2%)
Gastrointestinal tract: diarrhea (≥5% in children and adolescents), gastric ulcer (<2%), gastritis (1%), oral mucosal ulcer (2%), stomatitis (<2%), epigastric pain (2%), weight gain (<2%)
Hematology and tumors: leukopenia Few (<2%), neutropenia (children and adolescents <30kg, grade 3: 26%; children and adolescents ≥30kg, grade 3: 4%; adults, grade 3: 3%-4%), thrombocytopenia (1%)
Liver: elevated serum bilirubin (<2%)
Immunology: Antibody development (children and adolescents: ≤6%; adults: <2%; neutralizing, adults: ≤1%)
Infection: Herpes simplex infection (<2%)
Nervous system: dizziness (3%), headache (7%)
Ophthalmology: conjunctivitis (< 2%)
Kidney: Kidney stones (<2%)
Respiratory: Bronchitis (3%), cough (<2%), dyspnea (<2%), nasopharyngitis (7%), upper respiratory tract infection (7%)
Undefined frequency:
Cardiovascular: hypotension
Endocrinology and Metabolism: Increased HDL cholesterol
Gastrointestinal Tract: Nausea
Hematology and Neoplasms: Malignancy
Hypersensitivity: Angioedema
Ear: Otitis Media
Postmarketing Reports:
Dermatology: Cellulitis, History Stevens-Johnson Syndrome
Gastrointestinal Tract: Gastrointestinal diverticulitis, gastroenteritis, gastrointestinal perforation, pancreatitis
Genitourinary Tract: Urinary tract infections
Liver: Liver failure, liver injury, hepatitis, hepatotoxicity, jaundice
Anaphylaxis: Anaphylaxis, hypersensitivity reaction
br>Infections: Aspergillosis, candidiasis, cryptococcosis, sepsis, severe infections, varicella zoster infection, viral infections
Nervous system: chronic inflammatory demyelinating polyneuropathy
Neuromuscular and skeletal: multiple sclerosis, septic arthritis
Respiratory system: active pulmonary tuberculosis, bacterial infection of Pneumocystis spp., pneumonia
Contraindications:
Contraindicated for those who are allergic to tocilizumab or any component of the preparation.
Active infection.
Precautions:
Gastrointestinal perforation: Use with caution in patients at increased risk for gastrointestinal perforation; perforation has been reported in patients, often secondary to diverticulitis. Monitor for new abdominal symptoms; promptly evaluate if new symptoms develop.
Hematologic Effects: Neutropenia and thrombocytopenia may occur; treatment interruption, dose or interval adjustment, or interruption of therapy may be required. Monitor neutrophils and platelets. Do not initiate treatment in patients with giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis, rheumatoid arthritis (RA), or systemic juvenile idiopathic arthritis with ANC <2,000/mm³ or platelet count <100,000/mm³; discontinue treatment in patients with ANC <500/mm³ or platelet count <50,000/mm³.
Liver Effects: Liver damage has been reported leading to liver transplantation or death. Symptoms or signs of hepatic insufficiency may occur months to years after initiation of therapy, with significant elevations in hepatic transaminases (>5×ULN) or with mild elevations in transaminases. Treatment interruptions, dose or interval adjustments, or interruption of treatment may be necessary. Monitor LFT before starting and during treatment. It is not recommended to start treatment in patients with RA or GCA whose baseline ALT or AST is >1.5×ULN; to discontinue treatment if ALT or AST is >5×ULN. Patients who develop symptoms of liver injury during treatment should be evaluated for liver failure; treatment is interrupted if LFT is abnormal (eg, ALT > 3 × ULN, serum total bilirubin > 2 × ULN); do not restart treatment unless the abnormal liver function test is otherwise explained and liver failure has returned to normal. Patients taking concomitant hepatotoxic drugs, such as methotrexate, are at increased risk for elevated transaminases.
Herpes zoster reactivation: Herpes zoster reactivation has been reported.
Hyperlipidemia: Treatment is associated with increases in total cholesterol, triglycerides, low-density lipoprotein, or high-density lipoprotein; monitor for 4 to 8 weeks after initiation and then according to current guidelines.
Hypersensitivity: May cause hypersensitivity or anaphylaxis; allergic events, including death, have been reported with intravenous administration; hypersensitivity reactions have occurred in preoperative patients, in patients with or without a previous history of hypersensitivity reactions, and with the first infusion. Medications to treat allergic reactions should be available immediately. If symptoms of an allergic reaction occur while using SubQ, patients should seek medical attention. Patients who develop an allergic reaction to tocilizumab should discontinue treatment immediately and permanently. In clinical studies, reactions requiring discontinuation of treatment included generalized erythema, rash, and urticaria.
Malignancy: The use of tocilizumab may affect defense against malignancy; the impact on the development and course of malignancy is not fully understood; however, malignancy has been observed in clinical trials.
Demyelinating diseases of the central nervous system: Use with caution in patients with existing or recent onset demyelinating diseases of the central nervous system; rare demyelinating diseases of the central nervous system (multiple sclerosis and chronic inflammatory demyelinating polyneuropathy) have occurred. All patients should be monitored for signs and symptoms of demyelinating disease.
Liver Impairment: Not recommended for patients with active liver disease or liver damage. It is not recommended to initiate treatment in patients with RA (rheumatoid) and GCA (giant cell arteritis) with baseline ALT (alanine aminotransferase) or AST (aspartate aminotransferase) >1.5 × ULN.