Advixa 40 SC Injection

Advixa 40 SC Injection is used for: Rheumatoid arthritis, Ankylosing spondylitis; Psoriatic arthritis, Crohn's disease; Ulcerative colitis, Plaque psoriasis, Juvenile Rheumatoid Arthritis, Hidradenitis Suppurativa Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS Adult Crohn’s Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab Pediatric Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of Adalimumab has not been established in patients who have lost response to or were intolerant to TNF blockers Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate Hidradenitis Suppurative (HS): The treatment of moderate to severe hidradenitis suppurativa

Subcutaneous Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis Adult: 40 mg as a single dose every other week. Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week. Crohn's disease, Ulcerative colitis Adult: Moderate to severely active disease: Initially, (Day 1) 160 mg (given as four 40-mg inj in 1 day or as two 40-mg inj for 2 consecutive days), then Second dose two weeks later (Day 15): 80 mg. Two weeks later (Day 29): Maintenance: 40 mg every other week, may increase to 40 mg weekly if needed. Review treatment if no response w/in 8 (ulcerative colitis) or 12 (Crohn's disease) wk of therapy. For patients with Ulcerative Colitis only: Adalimumab should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy. Plaque psoriasis Adult: Initially, 80 mg, followed by 40 mg every other week starting one week after initial dose. Hidradenitis Suppurativa: Initial dose (Day 1): 160 mg (given as four 40 mg injection on Day 1 or as two 40 mg injections per day on Days 1 and 2 Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day) Third (Day 29) and subsequent doses: 40 mg every week.

Subcutaneous Juvenile idiopathic arthritis Child: <2 years or <10 kg: Safety and efficacy not established >2 years 10 to <15 kg: 10 mg SC every other wk 15 to <30 kg: 20 mg SC every other wk >30 kg: 40 mg SC every other wk >4 yr 15 to <30 kg: 20 mg every other wk; >30 kg: 40 mg every other wk. Pediatric Crohn Disease Indicated to reduce signs and symptoms, and achieve and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators (eg, azathioprine, 6-mercaptopurine, methotrexate) <6 years: Safety and efficacy not established >6 years (17 to <40 kg) Initial dose (Day 1): 80 mg (two 40 mg injections in one day) Second dose two weeks later (Day 15): 40 mg Two weeks later (Day 29): Maintenance dose of 20 mg every other week. > 40 kg: Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day) Two weeks later (Day 29): Maintenance dose of 40 mg every other week. Induction: 80 mg SC on Day 1 (administer as two 40-mg injections in 1 day); THEN 2 weeks later (Day 15) give 40 mg Maintenance (beginning Week 4 [Day 29]): 20 mg SC every other week.

Instruct patients using the pen or prefilled syringe to inject the full amount in the syringe, according to the directions provided Injections should occur at separate sites in the thigh or abdomen; rotate injection sites and do not give injections into areas where the skin is tender, bruised, red, or hard

SERIOUS INFECTIONS: Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue Adalimumab if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting Adalimumab. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products. Serious Infections: Do not start Adalimumab during an active infection. If an infection develops, monitor carefully, and stop Adalimumab if infection becomes serious. Invasive Fungal Infections: For patients who develop a systemic illness on Adalimumab, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls. Anaphylaxis or Serious Allergic Reactions may occur. Hepatitis B Virus Reactivation: Monitor hepatitis B virus (HBV) carriers during and several months after therapy. If reactivation occurs, stop Adalimumab and begin anti-viral therapy. Demyelinating Disease: Exacerbation or new onset, may occur. Cytopenias, Pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping Adalimumab. Heart Failure: Worsening or new onset, may occur. Lupus-Like Syndrome: Stop Adalimumab if syndrome develops. Monitoring Parameters: Patients should be evaluated for active and latent tuberculosis before treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting Adalimumab. Monitor all patients for active TB during treatment, even if the initial latent TB test is negative. Monitor for infection before, during, and for 4 months after treatment. Monitor closely for infection in patients undergoing surgical procedures while on therapy; not studied; consider long half-life. Monitor for non-melanoma skin cancer before and during treatment, especially in patients with a history of PUVA treatment for psoriasis or extensive immunosuppressant therapy.

Pregnancy Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/Mother-To-Baby HUMIRA Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn disease (CD) Registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with RA or CD and a rate of 7.5% for major birth defects in the disease matched comparison cohort The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant Clinical consideration Disease-associated maternal and embryo/fetal risk Published data suggest that the risk of adverse pregnancy outcomes in women with RA or inflammatory bowel disease (IBD) is associated with increased disease activity Adverse pregnancy outcomes include preterm delivery (ie, <37 weeks gestation), low birth weight (ie, <2500 g) infants, and small for gestational age at birth Fetal/neonatal adverse reaction Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab in utero owing to possible effect on infant immune system Lactation Limited data from case reports in published literature describe presence of adalimumab in human milk at infant doses of 0.1-1% of maternal serum level; there are no reports of adverse effects of adalimumab on breastfed infant and no effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

Abatacept: Increased risk of serious infection Anakinra: Increased risk of serious infection Live vaccines: Avoid use with Adalimumab Increased risk of serious infections w/ other biologic disease-modifying antirheumatic drugs (e.g. abatacept, anakinra), rituximab. May increase immunosuppressant effect w/ tocilizumab, live vaccines. Concomitant administration with other biologic DMARDs (eg, anakinra and abatacept) or other TNF blockers is not recommended based upon possible increased risk for infections and other potential pharmacological interactions. Contraindicated (1) upadacitinib Serious - Use Alternative (73) abatacept alefacept anakinra anthrax vaccine antithymocyte globulin equine antithymocyte globulin rabbit axicabtagene ciloleucel azathioprine baricitinib basiliximab BCG vaccine live brexucabtagene autoleucel canakinumab certolizumab pegol ciltacabtagene autoleucel cyclosporine diphtheria & tetanus toxoids diphtheria & tetanus toxoids/ acellular pertussis vaccine diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine etanercept everolimus glatiramer golimumab hepatitis A vaccine inactivated hepatitis a/b vaccine hepatitis a/typhoid vaccine hepatitis b vaccine human papillomavirus vaccine, nonavalent human papillomavirus vaccine, quadrivalent hydroxychloroquine sulfate idecabtagene vicleucel infliximab influenza virus vaccine quadrivalent influenza virus vaccine quadrivalent, adjuvanted influenza virus vaccine quadrivalent, cell-cultured influenza virus vaccine quadrivalent, intranasal influenza virus vaccine trivalent influenza virus vaccine trivalent, adjuvanted Japanese encephalitis virus vaccine leflunomide lisocabtagene maraleucel measles (rubeola) vaccine measles mumps and rubella vaccine, live measles, mumps, rubella and varicella vaccine, live meningococcal A C Y and W-135 polysaccharide vaccine combined muromonab CD3 mycophenolate pneumococcal vaccine 13-valent pneumococcal vaccine heptavalent pneumococcal vaccine polyvalent rabies vaccine rabies vaccine chick embryo cell derived rilonacept rotavirus oral vaccine, live rubella vaccine selinexor sirolimus smallpox (vaccinia) vaccine, live tacrolimus temsirolimus tetanus toxoid adsorbed or fluid tick-borne encephalitis vaccine tisagenlecleucel tocilizumab tongkat ali travelers diarrhea and cholera vaccine inactivated typhoid polysaccharide vaccine typhoid vaccine live ustekinumab varicella virus vaccine live vedolizumab yellow fever vaccine zoster vaccine live

Side effects of Adalimumab : >10% Injection site pain (12-20%),Upper respiratory tract infection (URTI) (17%),Increased creatine phosphokinase (15%),Headache (12%),Rash (12%),Sinusitis (11%) 1-10% Nausea (9%),Urinary tract infection (UTI) (8%),Abdominal pain (7%),Flulike syndrome (7%),Hyperlipidemia (7%),Back pain (6%),Hypercholesterolemia (6%),Hematuria (5%),Hypertension (5%),Increased alkaline phosphatase (5%) <1% Allergic reactions,Hematologic disorder (leukopenia, thrombocytopenia, pancytopenia, aplastic anemia) Potentially Fatal: Sepsis, opportunistic infections, TB, HBV reactivation, other malignancies (e.g. leukaemia, lymphoma, hepatosplenic T-cell lymphoma), haematological, neurological and autoimmune reactions, anaphylaxis, angioneurotic oedema.

Adalimumab is a recombinant DNA-derived human Ig G1 monoclonal antibody. It binds to human tumour necrosis factor alfa (TNF-alpha), thus interfering w/ cytokine-driven inflammatory processes.

Advixa 40 40mg/ 0.4 ml SC Injection manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Adalimumab. Advixa 40 is availble in Bangladesh. Farmaco BD drug index information on Advixa 40 SC Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.