RoActemra,

Tocilizumab is a recombinant humanized anti-human interleukin 6 (IL 6) receptor monoclonal antibody of the immunoglobulin (Ig) IgG1 subclass. Tocilizumab binds specifically to both soluble and membrane-bound IL 6 receptors (sIL 6R and mIL 6R), and has been shown to inhibit sIL 6R and mIL 6R-mediated signaling. Interleukin-6 is a multi-functional cytokine, produced by a variety of cell types involved in local paracrine function as well as regulation of systemic physiological and pathological processes eg, induction of immunoglobulin secretion, T-cell activation, induction of hepatic acute phase proteins and stimulation of haematopoiesis. Interleukin-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia. The possibility exists for tocilizumab to affect host defences against infections and malignancies. The role of IL-6 receptor inhibition in the development of malignancies is not known.

ব্যবহার

রিউমাটয়েড আর্থ্রাইটিস (আরএ): RoActemra, এমন এক বা একাধিক রোগ-সংশোধনকারী অ্যান্টি-রিউম্যাটিক ড্রাগস (ডিএমআরডি) -এর অপর্যাপ্ত প্রতিক্রিয়া ব্যক্ত করে এমন মারাত্মক সক্রিয় বাতজনিত মধ্যস্থ থেকে মাঝারি থেকে প্রাপ্ত বয়স্ক রোগীদের চিকিৎসার জন্য নির্দেশিত হয়। জায়ান্ট সেল আর্টেরাইটিস (জিসিএ): RoActemra, প্রাপ্তবয়স্ক রোগীদের মধ্যে দৈত্য কোষ ধমনী (জিসিএ) এর চিকিৎসার জন্য নির্দেশিত হয়। পলিআর্টিকুলার জুভেনাইল আইডিওপ্যাথিক আর্থ্রাইটিস (পিজেআইএ): টোকিলিজুমাব 2 বছর বা তার বেশি বয়সী রোগীদের সক্রিয় পলিয়ার্টিকুলার কিশোর ইডিয়োপ্যাথিক আর্থ্রাইটিসের চিকিৎসার জন্য ইঙ্গিতযুক্ত। সিস্টেমিক জুভেনাইল আইডিওপ্যাথিক আর্থ্রাইটিস (এসজেআইএ): RoActemra, 2 বছর বা তার বেশি বয়সী রোগীদের সক্রিয় পদ্ধতিগত কিশোর ইডিয়োপ্যাথিক আর্থ্রাইটিসের চিকিৎসার জন্য চিহ্নিত হয়। সাইটোকাইন রিলিজ সিন্ড্রোম (সিআরএস): RoActemra, বয়স্ক এবং পেডিয়াট্রিক রোগীদের 2 বছর বা তার বেশি বয়সীদের মধ্যে চিমেরিক অ্যান্টিজেন রিসেপ্টর (সিএআর) টি সেল-প্ররোচিত গুরুতর বা জীবন-হুমকী সাইটোকাইন রিলিজ সিন্ড্রোমের চিকিৎসার জন্য নির্দেশিত হয়।

RoActemra, এর দাম কত? RoActemra, এর দাম

সুচিপত্র

• RoActemra,
• কাজ
• খাওয়ার নিয়ম
• পার্শ্বপ্রতিক্রিয়া
• সতর্কতা
• মিথস্ক্রিয়া
• গর্ভাবস্থাকালীন ব্যবহার
• তীব্র ওভারডোজ
• অন্যান্য ওষুধের সাথে প্রতিক্রিয়া
• বৈপরীত্য
• সংরক্ষণ

খাওয়ার নিয়ম / ব্যবহারের নিয়ম

RoActemra, খাওয়ার নিয়ম / ব্যবহারের নিয়ম

General (IV or SC Injection): Substitution by any other biological medicinal product requires the consent of the prescribing physician.

For adult patients with RA, tocilizumab may be administered as an IV infusion or a SC injection. For patients with pJIA and sJIA, tocilizumab is administered as an IV infusion.

Tocilizumab IV formulation should be diluted by a healthcare professional with sterile 0.9% w/v sodium chloride solution using aseptic technique (see Caution for Usage).

Tocilizumab is recommended for IV infusion over 1 hr.

Tocilizumab SC formulation is administered with a single-use PFS+NSD or pre-filled pen. The 1st injection should be performed under the supervision of a qualified healthcare professional. The recommended injection sites (abdomen, thigh and upper arm) should be rotated and injections should never be given into moles, scars or areas where the skin is tender, bruised, red, hard or not intact.

SC Injection: Adults: Rheumatoid Arthritis (RA): Recommended Dose: 162 mg given once every week as a SC injection. Tocilizumab can be used alone or in combination with MTX and/or other DMARDs.

Patients transitioning from tocilizumab IV therapy to SC administration should administer the 1st SC dose at the time of the next scheduled IV dose under the supervision of a qualified healthcare professional.

Tocilizumab SC formulation is not intended for IV administration. Assess suitability of patient for SC home use and instruct patients to inform a healthcare professional if they experience symptoms of allergic reaction before administering the next dose. Patients should seek immediate medical attention if developing symptoms of serious allergic reactions

পার্শ্বপ্রতিক্রিয়া

Rheumatoid Arthritis: Patients Treated with Subcutaneous Tocilizumab: The safety of SC tocilizumab in RA was study in SC-I. The study compared the efficacy and safety of tocilizumab 162 mg administered every week SC versus 8 mg/kg IV in 1,262 subjects with adult RA. All patients in the study received background non-biologic DMARD(s). The safety and immunogenicity observed for tocilizumab administered SC was consistent with the known safety profile of tocilizumab IV and no new or unexpected adverse drug reactions were observed (see Table 7). A higher frequency of injection site reactions was observed in the SC arms compared with placebo SC injections in the IV arms

সতর্কতা

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

মিথস্ক্রিয়া

Interactions with Other Medicinal Products and Other Forms of Interaction: Population pharmacokinetic analyses did not detect any effect of MTX, nonsteroidal anti-inflammatory drugs or corticosteroids on tocilizumab clearance.

Concomitant administration of a single dose of 10 mg/kg tocilizumab with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.

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 medicinal products, 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 half-life (t½), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.

গর্ভাবস্থাকালীন ব্যবহার

Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Lactation: Unknown whether distributed in breast milk, do not breast feed

বৈপরীত্য

Hypersensitivity to tocilizumab or to any of the excipients.

অতিরিক্ত সতর্কতা

Children: The safety and efficacy of tocilizumab in children with conditions other than pJIA or sJIA have not been established.

Children Elderly: No dose adjustment is required in elderly patients ≥65 years.

Renal Impairment: No dose adjustment is required in patients with mild renal impairment (see Pharmacology: Pharmacokinetics under Actions). Tocilizumab has not been studied in patients with moderate to severe renal impairment.

Hepatic Impairment: The safety and efficacy of tocilizumab has not been studied in patients with hepatic impairment (see Precautions).

তীব্র ওভারডোজ

There are limited data available on overdosage with tocilizumab. One (1) case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg IV. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received a single dose up to 28 mg/kg IV, although dose-limiting neutropenia was observed.

অন্যান্য ওষুধের সাথে প্রতিক্রিয়া

সংরক্ষণ

২-৮ ডিগ্রী সেলসিয়াস তাপমাত্রায় সংরক্ষন করুন । জমতে দেওয়া যাবে না । আল থেকে দূরে এবং শুঁকনো জায়গায় সংরক্ষণ করুন ।