Actemra 162Mg/0.9Ml Injection Infusion ( Refrigerator )

Product Description:

• Actemra 162mg SC Injection is used alone or with other medications to treat moderate to severe rheumatoid arthritis in adults.
• It is also used to treat rheumatoid arthritis in children (such as systemic juvenile idiopathic arthritis-SJIA, and polyarticular juvenile idiopathic arthritis-PJIA).

Indications:

• Actemra 162mg SC Injection (Tocilizumab) is an interleukin 6 (IL6) receptor blocker indicated for the treatment of:
• Rheumatoid Arthritis (RA): Adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more variable antirheumatic drugs (DMARDs).
• Giant cell arteritis (GCA): adult patient with giant cell arteritis.
• Systemic sclerosis-associated interstitial lung disease (SScILD): Slow rate of decline in lung function in adult patients with systemic sclerosis-associated interstitial lung disease (SScILD)
• Idiopathic arthritis Juvenile (PJIA): Patients 2 years of age and older with idiopathic arthritis.
• Systemic Juvenile Idiopathic Arthritis (JIA): Patients 2 years of age and older with systemic juvenile idiopathic arthritis.
• Cytokine release syndrome (CRS): Adults and pediatric patients 2 years of age and older with severe or life-threatening cytokine release syndrome caused by chimeric antigen receptor (CAR) T cells.

How to use:

• Rheumatoid Arthritis: Actemra 162mg SC Injection Recommended Adult Intravenous Dosage: When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.
• Patients less than 100 kg weight: 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
• Patients at or above 100 kg weight: 162 mg administered subcutaneously every week.
• Giant Cell Arteritis: Recommended Adult Subcutaneous Dosage: The recommended dose of tocilizumab for adult patients with GCA is 162 mg given once every week as a subcutaneous injection, in combination with a tapering course of glucocorticoids. A dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations. tocilizumab can be used alone following discontinuation of glucocorticoids. tocilizumab subcutaneous formulation is not intended for intravenous administration.
• Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Actemra 162mg SC Injection Recommended Adult Subcutaneous Dosage: The Actemra 162mg SC Injection recommended dose of tocilizumab for adult patients with SSc-ILD is 162 mg given once every week as a subcutaneous injection.
• Polyarticular Juvenile Idiopathic Arthritis
• Recommended Intravenous PJIA Dosage Every 4 Weeks
• Patients less than 30 kg weight: 10 mg per kg
• Patients at or above 30 kg weight: 8 mg per kg
• Recommended Subcutaneous PJIA Dosage-
• Patients less than 30 kg weight: 162 mg once every three weeks
• Patients at or above 30 kg weight: 162 mg once every two weeks
• Systemic Juvenile Idiopathic Arthritis
• Recommended Intravenous SJIA Dosage Every 2 Weeks-
• Patients less than 30 kg weight: 12 mg per kg
• Patients at or above 30 kg weight: 8 mg per kg
• Recommended Subcutaneous SJIA Dosage-
• Patients less than 30 kg weight 162 mg every two weeks
• Patients at or above 30 kg weight 162 mg every week
• Cytokine Release Syndrome
• Recommended Intravenous CRS Dosage-
• Patients less than 30 kg weight: 12 mg per kg
• Patients at or above 30 kg weight: 8 mg per kg
• Alone or in combination with corticosteroids.
• General Dosing Information:
• It is recommended that tocilizumab not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).
• tocilizumab doses exceeding 800 mg per infusion are not recommended in RA or CRS patients.

Caution & Warnings:

• Hypersensitivity to tocilizumab or to any of the excipients.
• Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.
• Serious infections Do not use tocilizumab during active infections, including localized infections. If a severe infection develops, stop tocilizumab until the infection is under control.
• Gastrointestinal (GI) perforation should be used with caution in potentially high-risk patients.
• Hepatotoxicity Monitor patients for signs and symptoms of liver injury. Change or discontinue tocilizumab if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
• Laboratory monitoring is recommended as a potential consequence of processing-related changes in tests of neutrophils, platelets, lipids, and liver function.
• Hypersensitivity reactions, including anaphylaxis and death, have occurred.
• Live vaccines Avoid use with tocilizumab.

Ingredients:

• tocilizumabum 162mg/0.9ml