Actemra400mg/20ml

Tocilizumab 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. Tocilizumab 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 respiratory tract infection, increased liver enzymes, and nasopharyngitis (pain or irritation in the throat). Consult your doctor if any of the side effects persist or bother you. Your doctor may be able to help with ways to reduce or prevent these symptoms. You may also be more prone to infections when you are being treated with this medicine. Tell your doctor right away if you develop any symptoms of an infection like fever, cough, rash, loose stools, or flu-like symptoms. To make sure the medicine is safe for you, before taking it, let your doctor know if you have any problems with your heart, kidneys, or liver. You should also tell your doctor about all the other medicines you are taking. While on treatment with this medicine, your doctor may monitor your blood counts by taking regular blood tests to make sure the medicine is not affecting your blood counts. It is important for pregnant and breastfeeding women to ask the advice of their doctors before taking this medicine. Tocilizumab blocks the action of certain chemical messengers that are responsible for inflammation, swelling and redness associated with certain joint diseases.

• Ankylosing spondylitis • Rheumatoid arthritis • Psoriasis • Ulcerative Colitis • Crohn’s disease

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

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

Your doctor or nurse will give you this medicine. Kindly do not self administer.

If you miss a dose of Tocilizumab, please consult your doctor.

Common: • Headache • High blood pressure • Upper respiratory tract infection • Increased liver enzymes • Nasopharyngitis (inflammation of the throat and nasal passages)

[UNSAFE] Tocilizumab may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur. ACTEMRA 400 MG INJECTION is given as a drip (intravenous infusion) or as an injection directly into a vein. You may be asked for regular blood tests to check blood counts, cholesterol level and liver functioning during the treatment. It might make you feel dizzy. If this happens, avoid driving or operating on machinery. It makes it hard to fight with an infection. Inform your doctor if you notice fever, cough or stomach pain. Inform your doctor if you are pregnant, planning to become pregnant or are breastfeeding. Do not stop taking medicine without talking to your doctor first.

Hypersensitivity

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 on CYP enzymes (except CYP2C19 and CYP2D6) is clinically relevant for CYP450 substrates with a narrow therapeutic index, and/or where the dose is individually adjusted. In a study in RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of tocilizumab, to the level similar or slightly higher than those observed in healthy subjects. When starting or stopping therapy with tocilizumab, patients taking medications, which are individually dose-adjusted and are metabolised via CYP450 3A4, 1A2, or 2C9 (eg, atorvastatin, calcium channel blockers, theophylline, warfarin, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses of these products may need to be adjusted to maintain their therapeutic effect. Given its long elimination t½, the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.

[SAFE] Consuming alcohol with Tocilizumab does not cause any harmful side effects.

[CONSULT YOUR DOCTOR] Tocilizumab may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[SAFE IF PRESCRIBED] Tocilizumab is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.

[CAUTION] Tocilizumab should be used with caution in patients with kidney disease. Dose adjustment of Tocilizumab may be needed. Please consult your doctor. Limited information is available on the use of Tocilizumab in patients with moderate to severe kidney disease. No dose adjustment is required in patients with mild kidney disease. [CAUTION] Tocilizumab should be used with caution in patients with liver disease. Dose adjustment of Tocilizumab may be needed. Please consult your doctor. Use of Tocilizumab is not recommended in patients with active liver disease.

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