Actemra - IV Infusion Tocilizumab - 80mg/4ml 1 4ml vial(s) / 4ml vial Roche Bangladesh Pharmaceutical Introduction: Actemra is a medicine used to treat various inflammatory conditions of the joints (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), skin (psoriasis), and bowel (ulcerative colitis, Crohn’s disease). It reduces swelling in these conditions by blocking TNF alpha. Actemra is given by a healthcare professional and should not be self-administered. You should use it regularly and at the same time each day to get the maximum benefit from it. Continue using it as recommended by your doctor and complete the dose even if you feel better. The most common side effects seen with this medicine include headache, high blood pressure, upper... Uses of Actemra: Ankylosing spondylitisRheumatoid arthritisPsoriasisUlcerative ColitisCrohn’s disease Side effects of Actemra: HeadacheHigh blood pressureUpper respiratory tract infectionIncreased liver enzymesNasopharyngitis (inflammation of the throat and nasal passages) How to use Actemra: Your doctor or nurse will give you this medicine. Kindly do not self administer. How Actemra works: Actemra blocks the action of certain chemical messengers that are responsible for inflammation, swelling and redness associated with certain joint diseases. What if you forget to take Actemra?: If you miss a dose of Actemra, please consult your doctor. Indication: Juvenile idiopathic arthritis, Rheumatoid Arthritis (RA) Administration: IV Preparation Withdraw a volume of 0.9% NaCl from bag/bottle equal to volume of the solution required for the patient's dose Adults and children weighing >30 kg: Dilute to 100 mL in 0.9% NaCl Children <30 kg: Dilute to 50 mL in 0.9% NaCl Slowly add dose to infusion bag or bottle and gently invert to mix (prevent foaming) IV Administration Administer as single IV infusion over 1 hr Do NOT administer as bolus or push Do not infuse with any other drugs as no compatibility studies have been conducted SC Preparation Remove prefilled SC syringe from refrigerator 30 minutes... Adult Dose: Parenteral Adult: Rheumatoid Arthritis Indicated for adults with moderate-to-severe active rheumatoid arthritis with inadequate response to 1 or more DMARDs as an IV infusion or SC injection May use alone or in combination with methotrexate or other DMARDs IV infusion 4 mg/kg IV q4wk initially; may increase to 8 mg/kg q4wk based on clinical response Not to exceed 800 mg/dose q4wk SC injection Weight 100 kg: 162 mg SC every week Hepatic impairment Not recommended with active hepatic disease or hepatic impairment Child Dose: Systemic Juvenile Idiopathic Arthritis (SJIA, Still's Disease) 2 years or older (30 kg): 8 mg/kg IV q2weeks May be administered as monotherapy or with methotrexate Polyarticular Juvenile Idiopathic Arthritis (PJIA) 2 years or older (30 kg or more): 8 mg/kg IV q4weeks May be administered as monotherapy or with methotrexate Renal Dose: Renal impairment Mild: No dosage adjustment required Moderate-to-severe: Has not been studied Contraindication: Hypersensitivity Mode of Action: Interleukin-6 receptor antagonist; changes in clinical trials observed include decreased C-reactive protein level to within normal range, decreased values in other pharmacodynamic parameters (eg, rheumatoid factor, erythrocyte sedimentation rate, amyloid A), and increased hemoglobin value Precaution: Serious infections leading to hospitalization or death (ie, tuberculosis; bacterial, invasive fungal, viral, or other opportunistic infections) have occurred with use Stop therapy if serious infection occurs; can restart if infection is controlled Test for latent tuberculosis before initiating; if positive, initiate tuberculosis therapy before starting tocilizumab Continue to monitor all patients for active tuberculosis during therapy Lactation: unknown whether distributed in breast milk, do not breast feed Side Effect: >10% SC injection site reactions (7.1-10.1%) 1-10% Upper respiratory tract infections,Nasopharyngitis,Headache,Hypertension,Increased ALT,Infusion related skin reactions (eg, rash, pruritus, urticaria),Dose related adverse reactions including decreased neutrophil count <1000/cu.mm, decreased platelets <100,000/cu.mm,Lipid elevations,Mouth ulcerations,Gastritis,Upper abdominal pain Interaction: Interactions with Other Medications and Other Forms of Interaction: Population pharmacokinetic analyses did not detect any effect of MTX, nonsteroidal anti-inflammatory drugs or corticosteroids on tocilizumab clearance. Tocilizumab has not been studied in combination with other biological DMARDs. The expression of hepatic CYP450 enzymes is suppressed by cytokines, eg, IL-6, that stimulate chronic inflammation. Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, eg, tocilizumab is introduced. In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19, and CYP3A4 enzyme expression. Tocilizumab normalizes expression of these enzymes. The effect of tocilizumab...