IDACIO 40 mg / 0.8 ml solution for injection Uses, Dosage, Side Effects

IDACIO 40 mg
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IDACIO 40 mg / 0.8 ml solution for injection >> Generic drug of the Therapeutic class: Immunology Medicines

Active ingredients: Adalimumab

what is IDACIO medication used for and indication?

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

  • Idacio in combination with methotrexate is indicated for the treatment of progressive polyarticular juvenile idiopathic arthritis in patients from 2 years of age in case of insufficient response to one or more DMARDs.
  • Idacio can be administered as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is unsuitable (for efficacy in monotherapy see section Pharmacodynamic properties). Adalimumab has not been studied in patients less than 2 years of age.

Enthesitis-related arthritis

  • Idacio is indicated for the treatment of active arthritis associated with enthesitis in patients from 6 years of age with insufficient response or intolerance to conventional therapy.

Plaque psoriasis in children and adolescents

  • Idacio is indicated for the treatment of severe chronic plaque psoriasis in children from 4 years of age and adolescents with insufficient response to topical treatment and phototherapy or when these treatments are inappropriate.

Crohn’s disease in children and adolescents

  • Idacio is indicated for the treatment of moderate to severe active Crohn’s disease in children and adolescents from 6 years of age who have not responded to conventional treatment including first-line nutritional therapy and a corticosteroid and / or an immunomodulator, or in which these treatments are poorly tolerated or contraindicated.

Adolescent hidradenitis suppurativa (HS)

  • Idacio is indicated for the treatment of active, moderate to severe hidradenitis suppurativa (Verneuil’s disease) in adolescents from 12 years of age in case of insufficient response to conventional systemic treatment of HS . pharmacokinetics).

Uveitis in children and adolescents

  • Idacio is indicated for the treatment of chronic non-infectious anterior uveitis in children and adolescents from 2 years of age in case of insufficient response or intolerance to conventional treatment or for whom conventional treatment is inappropriate.

IDACIO  Dosage

The treatment Idacio should be initiated and supervised by a physician qualified specialist in the diagnosis and treatment of pathologies in which Idacio indicated. It is recommended that
ophthalmologists consult an appropriate specialist before initiating treatment with Idacio (see section 4.4). A special surveillance card will be given to patients treated with Idacio.

After proper training in the injection technique, patients can self-inject Idacio, if their doctor considers it possible, under the guise of appropriate medical supervision.

During treatment with Idacio, other concomitant treatments (such as corticosteroids and / or immunomodulators) should be optimized.

Dosage

Pediatric population

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis from 2 years old

  • The recommended dosage of Idacio for patients with polyarticular juvenile idiopathic arthritis from the age of 2 years depends on body weight (Table 1). Idacio is given every two weeks by injection under the skin.
  • The available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continuation of treatment should be carefully reconsidered in a patient who has not responded within this time frame.
  • There is no relevant use of adalimumab in patients under 2 years of age in this indication.
  • Other presentations of Idacio may be available depending on the therapeutic needs of each patient.

Enthesitis-related arthritis

  • The recommended dosage of Idacio for patients with enthesitis-related arthritis from the age of 6 years depends on body weight (Table 2). Idacio is given every two weeks as a subcutaneous injection.
  • Adalimumab has not been studied in patients less than 6 years of age with arthritis related to enthesitis.
  • Other presentations of Idacio may be available depending on the therapeutic needs of each patient.

Plaque psoriasis in children and adolescents

  • The recommended dosage of Idacio for patients with plaque psoriasis aged 4 to 17 years depends on body weight (Table 3). Idacio is administered as a subcutaneous injection.
  • The continuing treatment beyond 16 weeks should be carefully reconsidered in a patient not responding within this time.
  • If retreatment with Idacio is indicated, the recommendations mentioned above for dosage and duration of treatment should be followed.
  • The safety of adalimumab in children and adolescents with plaque psoriasis has been evaluated over a mean duration of 13 months.
  • There is no relevant use of adalimumab in children aged less than 4 years in this indication.
  • Other presentations of Idacio may be available depending on the therapeutic needs of each patient.

Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg)

  • There is no clinical trial conducted with adalimumab in adolescents with HS.
  • The dosage of adalimumab in these patients was determined frompharmacokinetic modeling and simulation.
  • The recommended dosage of Idacio is 80 mg at week 0 followed by 40 mg every two weeks from week 1 by subcutaneous injection.
  • In adolescents with insufficient response to Idacio 40 mg every two weeks, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
  • If necessary, antibiotics can be continued during treatment with Idacio. During treatment with Idacio, it is recommended that the patient cleanse his lesions daily with a topical antiseptic.
  • The continuing treatment beyond 12 weeks should be carefully reconsidered in patients showing no improvement during this period.
  • If treatment is interrupted, Idacio could be reintroduced if necessary.
  • The benefit and risk of continued long-term treatment should be assessed regularly (see data in adults under Pharmacodynamic properties).
  • There is no relevant use of adalimumab in children aged less than 12 years in this indication.
  • Other presentations of Idacio may be available depending on the therapeutic needs of each patient.

Crohn’s disease in children and adolescents

  • The recommended dosage of Idacio for patients with Crohn’s disease aged 6 to 17 years depends on body weight (Table 4). Idacio is administered as a subcutaneous injection.
  • The patients with an inadequate response to treatment is observed may benefit from increasing the dosage:
    • <40 kg: 20 mg every week
    • ≥ 40 kg: 40 mg every week or 80 mg every two weeks
  • Continuation of treatment should be carefully reconsidered in a patient who has not responded by week 12.
  • There is no relevant use of adalimumab in children aged less than 6 years in this indication.
  • Other presentations of Idacio may be available depending on the therapeutic needs of each patient.

Uveitis in children and adolescents

  • The recommended dosage of Idacio for children and adolescents with uveitis from the age of 2 years depends on body weight (Table 5). Idacio is administered as a subcutaneous injection.
  • In uveitis  in children and adolescents, no clinical trials have been conducted with adalimumab without concomitant treatment with methotrexate.
  • When initiating treatment with Idacio, a loading dose of 40 mg for patients <30 kg or 80 mg for patients ≥ 30 kg may be administered one week before the start of maintenance therapy. No clinical data are available from the use of a loading dose of adalimumab in children less than 6 years of age.
  • There is no relevant use of Idacio in children aged less than 2 years in this indication.
  • An annual reassessment of the benefits and risks associated with long-term continuous therapy is recommended.
  • Other presentations of Idacio may be available depending on the therapeutic needs of each patient.

Renal and / or hepatic impairment

  • Adalimumab has not been studied in these patient populations. It is not possible to recommend dosages.

Administration mode

  • Idacio is administered as a subcutaneous injection. Full instructions for use are provided in the package leaflet.
  • Other Idacio presentations are available.

IDACIO Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in the Composition section.
  • Active tuberculosis or other severe infections such as sepsis and opportunistic infections .
  • Moderate to severe heart failure (NYHA classes III / IV) .

IDACIO Side Effects

Summary of the safety profile

  • Adalimumab has been studied in 9,506 patients in pivotal, controlled, open- label trials of 60 months and longer duration. These trials included patients with recent or old rheumatoid arthritis, juvenile idiopathic arthritis ( polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) or patients with axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS ), psoriatic arthritis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis. The Pivotal controlled studies included 6,089 patients who received adalimumab and 3,801 patients who received placebo or an active comparator during the controlled phase.
  • The percentage of patients who discontinued treatment due to adverse reactions during the double-blind, controlled phase of the pivotal studies was 5.9% in patients treated with adalimumab and 5.4% in patients in the group control.
  • The most commonly reported side effects are infections (such as nasopharyngitis, upper respiratory tract infections and sinusitis), injection site reactions (erythema, itching, bleeding, pain or swelling), headache and musculoskeletal pain.
  • Some serious side effects have been reported with adalimumab. The TNF antagonists, such as adalimumab affect the system immune and their use may affect the body’s defenses against infection and cancer.
  • Life-threatening and fatal infections (including sepsis, opportunistic infections and tuberculosis), hepatitis B reactivations and various cancers (including leukemia, lymphoma and hepatosplenic T-cell lymphoma) have also been reported with use of Idacio.
  • Of Severe hematological, neurological and autoimmune effects have also been reported. This includes rare cases of pancytopenia, bone marrow anemia, cases of central and peripheral demyelination, and cases of lupus, lupus-related events, and Stevens-Johnson syndrome.

Pediatric population

  • In general, the frequency and type of adverse events seen in children and adolescents were comparable to those seen in adult patients.

List of adverse reactions

  • The list of adverse reactions is based on clinical studies and post-marketing experience and is presented by class of organ systems (SOC) and by frequency in Table 6 below : very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1 / 1,000, <1/100); rare (≥  1 / 10,000, <1 / 1,000) and not known (cannot be estimated from the available data). Within each frequency grouping , undesirable effects are presented in order of decreasing seriousness. The highest frequency observed in the various indications was included. The presence of an asterisk (*) in the “System organ class” column indicates that more information is available under the Contraindications sections ,Special warnings and precautions for use and Adverse effects .

Table 6 Adverse reactions

System organ class

Frequency

Side effects

Infections and infestations *

Very common

Infections
of the respiratory tract (including respiratory infection
bass and upper respiratory tract infection, pneumonia,
sinusitis, pharyngitis, rhino pharyngitis and pneumonia herpes)

Frequent

Systemic infections (including sepsis, candidiasis and influenza),

intestinal infections (including viral gastroenteritis),

infections
skin and soft tissue (including superficial périunguéal paronychia,
cellulitis, impetigo, necrotizing fasciitis and herpes zoster),

ear infections,

oral infections (including herpes, oral herpes and dental infections),

infections of the reproductive organs (including vulvovaginal yeast infection),

urinary tract infections (including pyelonephritis),

fungal infections,

joint infections

Rare

Neurological infections (including viral meningitis),

opportunistic infections and tuberculosis (including coccidioidomycosis,
histoplasmosis and Mycobacterium avium complex infections),
bacterial infections ,

eye infections, diverticulitis1)

Neoplasms benign, malignant and unspecified (incl cysts and polyps) *

Frequent

Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma),

benign tumor

Rare

Lymphoma **,

solid organ tumors (including breast, lung and thyroid cancer), melanoma **

Rare

Leukemia1)

Frequency not known

Hepatosplenic T1 lymphoma), Merkel cell carcinoma (cutaneous neuroendocrine carcinoma) 1)

Blood disorders

Very common

Leukopenia (including neutropenia and

 

System organ class

Frequency

Side effects

and the lymphatic system *

agranulocytosis), anemia

Frequent

Leukocytosis, thrombocytopenia

Rare

Idiopathic thrombocytopenic purpura

Rare

Pancytopenia

Immune system disorders *

Frequent

Hypersensitivity,

allergies (including seasonal allergy)

Rare

Sarcoidosis1), vasculitis

Rare

Anaphylaxis1)

Metabolism and nutrition disorders

Very common

Increased lipid level

Frequent

Hypokalaemia,

increased uric acid,

abnormal sodium level in the blood, hypocalcaemia,

hyperglycemia, hypophosphatemia, dehydration

Psychiatric disorders

Frequent

Mood disorders (including depression), anxiety,

insomnia

Nervous system disorders *

Very common

Headache

Frequent

Paresthesia (including hypoaesthesia), Migraine,

nerve root compression

Rare

Cerebrovascular accident1), Tremor,

neuropathy

Rare

Multiple sclerosis,

demyelinating conditions (e.g. optic neuritis, Guillain-Barré syndrome) 1)

Eye disorders

Frequent

Visual disturbances

 

System organ class

Frequency

Side effects

Conjunctivitis, Blepharitis, swelling of the eyes

Rare

Diplopia

Ear and labyrinth disorders

Frequent

Dizziness

Rare

Deafness, tinnitus

Cardiac disorders *

Frequent

Tachycardia

Rare

Myocardial infarction1), arrhythmias,

congestive heart failure

Rare

Cardiac arrest

Vascular disorders

Frequent

Hypertension, hot flashes. hematomas.

Rare

Aortic aneurysm, vascular occlusion, thrombophlebitis

Respiratory, thoracic and mediastinal disorders *

Frequent

Asthma, dyspnea, cough

Rare

Pulmonary embolism1) ,

interstitial lung disease,

chronic obstructive pulmonary disease, pneumonia,

pleural effusion1)

Rare

Pulmonary fibrosis1)

Gastrointestinal disorders

Very common

Abdominal pain, nausea and vomiting

Frequent

Gastrointestinal bleeding, dyspepsia,

gastroesophageal reflux disease, Gougerot-Sjögren syndrome

 

System organ class

Frequency

Side effects

Rare

Pancreatitis, dysphagia, facial edema

Rare

Intestinal perforation1)

Hepatobiliary disorders *

Very common

Elevation of liver enzymes

Rare

Cholecystitis and cholelithiasis, hepatic steatosis, hyperbilirubinemia

Rare

Hepatitis,

reactivation of hepatitis B1), autoimmune hepatitis1)

Frequency

indeterminate

Hepatic failure1)

Skin and subcutaneous tissue disorders

Very common

Rash (including exfoliative rash)

Frequent

Aggravation or onset of psoriasis (including palmoplantar pustular psoriasis) 1), urticaria,

bruising (including purpura), dermatitis (including eczema), onychoclasia,

hyperhidrosis, alopecia1), pruritus

Rare

Night sweats, scar

Rare

Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1),

cutaneous vasculitis1), lichenoid skin reaction 1).

Frequency

indeterminate

Worsening of symptoms of dermatomyositis1)

Musculoskeletal and connective tissue disorders

Very common

Musculoskeletal pain

Frequent

Muscle spasms (including increased serum creatine phosphokinase)

Rare

Rhabdomyolysis,

systemic lupus erythematosus

Rare

Lupus-like syndrome1).

 

System organ class

Frequency

Side effects

Kidney and urinary tract disorders

Frequent

Renal failure, hematuria

Rare

Nocturia

Reproductive system and breast disorders

Rare

Erectile function disorders

General disorders and administration site conditions *

Very common

Injection site reaction (including erythema at the injection site)

Frequent

Chest pain, edema,

Fever1)

Rare

Inflammation

Investigations *

Frequent

Coagulation and bleeding disorders (including prolongation of activated partial thromboplastin time),

positivity to autoantibodies (including anti-double-stranded DNA antibodies),

increased blood lactate dehydrogenase level

Injury, poisoning and procedural complications

Frequent

Poor healing

* more information is available under the sections Contraindications , Special warnings and precautions for use and Undesirable effects .

** including open label extension studies.

1) including data from spontaneous reports Hidradenitis suppurativa (HS)

  • The safety profile in patients with HS treated with adalimumab weekly corresponds to the known safety profile of adalimumab.

Uveitis

  • The safety profile in patients with uveitis treated with adalimumab every other week is consistent with the safety profile known to adalimumab.

Description of selected adverse

reactions Injection site reactions

  • In the pivotal controlled trials in adults and children, 12.9% of patients treated with adalimumab experienced injection site reactions (erythema and / or pruritus , bleeding, pain or swelling) compared to 7.2% of patients receiving placebo or the active comparator. Injection site reactions generally did not require stopping the drug.

Infections

  • In the pivotal controlled trials in adults and children, the frequency of infections was 1.51 per patient-year in the adalimumab and 1.46 per patient-year in the placebo and control groups. The infections mainly consisted of nasopharyngitis, upper respiratory tract infections and sinusitis. Most patients continued with adalimumab after the infection cleared.
  • The incidence of serious infections was 0.04 per patient-year in the adalimumab group and 0.03 per patient-year in the placebo group and the control group.
  • In controlled and open-label studies with adalimumab in adults and in the pediatric population, serious infections (including fatal infections, which have rarely occurred) have been observed. reported including reports of tuberculosis (including miliary and extra-pulmonary sites) and invasive opportunistic infections (eg disseminated histoplasmosis or extrapulmonary histoplasmosis , blastomycosis, coccidioidomycosis, pneumocystosis, candidiasis, aspergillosis and listeriosis). Most cases of tuberculosis have occurred within the first eight months after starting treatment and may reflect reactivation of latent disease .

Malignant tumors and lymphoproliferative disorders

  • No case of cancer was observed in 249 pediatric patients representing an exposure of 655.6 patient-years during the studies with adalimumab in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis). In addition, no cases of cancer were observed in 192 pediatric patients representing an exposure of 498.1 patient-years in studies with adalimumab in pediatric Crohn ‘s disease.
  • No cases of cancer were observed in 77 pediatric patients corresponding to an exposure of 80 patient-years in a study with adalimumab in pediatric chronic plaque psoriasis . No cases of cancer were observed in 60 pediatric patients representing an exposure of 58.4 patient-years in a study with adalimumab in pediatric uveitis .
  • During the controlled periods of the pivotal clinical trials in adults with adalimumab lasting at least 12 weeks in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis, a rate (95% confidence interval) of cancers other than lymphomas or non-melanoma skin cancers, of 6 , 8 (4.4 – 10.5) per 1,000 patient-years among 5,291 patients treated with adalimumab, was observed versus a rate of 6.3 (3.4 – 11.8) per 1,000 patient-years among the 3,444 patients in the control group (the mean duration of treatment was 4.0 months for patients treated with adalimumab and 3.8 months for patients in the control group). The rate (95% confidence interval) of non melanoma skin cancer was 8.8 (6.0 – 13.0) per 1,000 patient-years for patients treated with adalimumab and 3.2 (1 , 3 – 7.6) per 1000 patient-years among patients in the control group. In these skin cancers, squamous cell carcinomas occurred at rates of 2.7 (1.4 – 5.4) per 1000 patient years in patients treated with adalimumab and 0.6 (0.1 – 4.5) per 1000 patient years in patients in the control group ( 95% confidence interval ). The rate (95% confidence interval) of lymphomas was 0.7 (0.2 – 2.7) per 1000 patient years in patients treated with adalimumab and 0.6 (0.1 – 4.5 ) per 1000 patient-years in patients in the control group.
  • By combining controlled portions of these tests and the tests Expansion open ended or current with a mean duration of around 3.3 years including 6427 patients and more than 26,439 patient- years of treatment, the observed rate of cancers, other than lymphomas and non-melanoma skin cancers is approximately 8.5 per 1,000 patient-years. The observed rate of non-melanoma skin cancer is approximately 9.6 per 1,000 patient-years and the observed rate of lymphomas is approximately 1.3 per 1,000 patient-years.
  • In post-marketing period from January 2003 to December 2010, primarily in patients with rheumatoid arthritis, the reported rate of cancer is approximately 2.7 per 1,000 patient-years of treatment. The reported rates for non-melanoma skin cancer and lymphoma are approximately 0.2 and 0.3 per 1000 patient-years of treatment, respectively .
  • At During post-marketing surveillance, rare cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab.

Autoantibodies

The research repeated autoantibodies were performed on serum samples of patients from IV trials in arthritis rheumatoid. In these trials, initially negative antinuclear antibody titers were positive at week 24 in 11.9% of patients treated with adalimumab and 8.1% of patients on placebo and comparator. Two of the 3441 patients treated with adalimumab in all studies in rheumatoid arthritis and psoriatic arthritis showed clinical signs suggesting a new onset lupus-like syndrome . The condition of the patients improved after stopping treatment. No patient presented with lupus nephritis or central nervous symptoms.

Hepatobiliary events

  • In controlled phase III clinical trials in rheumatoid arthritis and psoriatic arthritis with a follow-up period of 4 to 104 weeks, elevations of ALT ≥ 3 x ULN occurred in 3.7% of patients treated with adalimumab and in 1.6% of patients in the control group.
  • In adalimumab phase III controlled clinical trials in patients with juvenile idiopathic polyarticular arthritis aged 4 to 17 years and patients with enthesitis-related arthritis aged 6 to 17 years, elevations of ALT ≥ 3 x ULN occurred in 6.1% of patients treated with adalimumab and in 1.3% of patients in the control group. Most of the elevations in ALT have occurred with concomitant use of methotrexate. No elevation of ALT ≥ 3 x ULN occurred in the phase III trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis aged 2 to <4 years.
  • In phase III controlled clinical trials of adalimumab in patients with Crohn’s disease and ulcerative colitis with a control period of 4 to 52 weeks, elevations of ALT ≥ 3 x ULN occurred in 0.9% of patients treated with adalimumab and in 0.9% of patients in the control group.
  • In the phase III clinical trial of adalimumab in children and adolescents with Crohn’s disease which evaluated the efficacy and safety profile of two weight-based maintenance regimens following adjusted induction therapy by weight up to 52 weeks of treatment, elevations of ALT ≥ 3 x ULN are occurred in 2.6% of patients (5/192), of whom 4 were treated in combination with immunosuppressants at the start of the study.
  • In phase III controlled clinical trials in plaque psoriasis with a control period of 12 to 24 weeks, elevations of ALT ≥ 3 x ULN occurred in 1.8% of patients treated with adalimumab and in 1.8% % of patients in the control group.
  • It has not been observed ALT elevations ≥ 3 x ULN in the study phase III adalimumab in pediatric patients with plaque psoriasis .
  • In controlled clinical trials of adalimumab (starting doses of 160 mg at Week 0 and 80 mg at Week 2 followed by 40 mg every week from week 4), in patients with hidradenitis suppurativa with a control period of 12 to 16 weeks, elevations of ALT ≥ 3 x ULN occurred in 0.3% of patients treated with adalimumab and 0.6% of patients in the control group.
  • In controlled clinical trials of adalimumab (starting dose 80 mg at week 0 followed by 40 mg every two weeks from week 1) in adult patients with uveitis for up to 80 weeks , with a median duration of exposure of 166.5 days and 105.0 days, respectively, for patients treated with adalimumab and patients in the control group, elevations of ALT ≥ 3 x ULN occurred in 2.4% of patients treated with adalimumab and 2.4% of patients in the control group. In clinical trials across all indications, patients with elevated ALT were asymptomatic and in most cases the elevations were transient and reversible upon continued treatment. However, during post-marketing surveillance, hepatic insufficiency as well as less severe hepatic disorders , which may precede hepatic insufficiency, such as hepatitis including autoimmune hepatitis, have been reported. in patients receiving adalimumab.

Co-administration of azathioprine / 6-mercaptopurine

  • In studies in Crohn’s disease in adults, a higher incidence of severe tumors and infections was observed with the combination of adalimumab and azathioprine / 6-mercaptopurine compared to adalimumab used alone. Reporting of

suspected adverse reactions

  • The reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals report any suspected adverse reactions via the national reporting system –see Annex V.

IDACIO Interactions

Adalimumab has been studied in patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis taking adalimumab as monotherapy and in those taking methotrexate concomitantly. Antibody formation was lower when adalimumab was co-administered with methotrexate compared to its use as monotherapy. Administration of adalimumab without methotrexate resulted in increased antibody formation, increased clearance and reduced efficacy of adalimumab.

The combination of Idacio and anakinra is not recommended (see section Warnings and precautions for use “Simultaneous administration of biological DMARDs or anti-TNFs”).

The combination of Idacio and abatacept is not recommended (see section Warnings and precautions for use “Simultaneous administration of biological or anti-TNF DMARDs”).

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Warnings and Precautions

Traceability

  • In order to improve the traceability of biological medicinal products, the name of the medicinal product  and the batch number of the administered product must be clearly recorded.

Infections

  • The patients receiving TNF-antagonists are more susceptible to serious infections. Impaired lung function can increase the risk of developing infections. Patients should therefore be closely monitored for infections (including tuberculosis) before, during and after treatment with Idacio. As the duration of elimination of adalimumab may be up to four months, monitoring should be continued throughout this period.
  • The treatment Idacio should not be initiated in patients with infections scalable, including chronic or localized infections until infections are not controlled. In patients who have been exposed to tuberculosis or who have traveled to areas at high risk of tuberculosis or endemic mycoses, for example histoplasmosis, coccidioidomycosis or blastomycosis, the risks and benefits of treatment with Idacio should be considered before initiation. treatment (see Other opportunistic infections).
  • The Patients who develop a new infection during treatment with Idacio must be monitored
    carefully and complete diagnostic workup should be practiced. If a serious new infection or sepsis develops, the administration of Idacio should be discontinued and appropriate antimicrobial or antifungal therapy should be started until the infection is controlled. The physician should exercise caution before using Idacio in patients with a history of recurrent infection or with underlying conditions that may predispose them to infections, including concomitant treatment with immunosuppressive drugs.

Serious infections

  • Of serious infections, including sepsis due to infectionsbacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients treated with adalimumab.
  • The other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicemia. There have been reports of infections requiring hospitalization or with fatal outcome.

Tuberculosis

  • Of TB cases, including cases of TB reactivation and primary infection tuberculosis have been reported for patients receiving adalimumab. Cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis have been reported.
  • Before initiating treatment with Idacio, all patients should be tested for active or not active (“latent”) tuberculosis infection . This assessment should include a detailed medical evaluation in patients with a history of tuberculosis or possible previous exposure to patients with active tuberculosis and / or current or past immunosuppressive therapy. Appropriate screening tests (eg tuberculin skin test and chest x-ray) should be performed in all patients (according to local recommendations). It is advisable to note the performance and the results of these tests in the patient monitoring. Prescribers are reminded that the tuberculin skin test can give false negatives, especially in seriously ill or immunosuppressed patients.
  • If active tuberculosis is diagnosed, treatment with Idacio should not be initiated.
  • In all of the situations described below, the benefit / risk ratio of the treatment should be assessed very carefully.
  • In case of suspicion of latent tuberculosis, consulting a specialist, qualified in the treatment of tuberculosis should be considered.
  • In case of diagnosis of latent tuberculosis, prophylactic tuberculosis appropriate and in accordance with local recommendations must be implemented before the start of treatment with Idacio.
  • A TB prophylaxis should also be considered before introducing Idacio in patients with risk factors or multiple TB significant despite testing of negative tuberculosis and in patients with a history of latent or active tuberculosis in that the administration of an appropriate anti-tuberculosis treatment cannot be confirmed.
  • The case of reactivation of tuberculosis despite treatment prophylactic occurred in patients treated with adalimumab. Some patients who had been successfully treated for active tuberculosis developed the disease again during treatment with adalimumab.
  • The patients should be advised that they will need their doctor in case of occurrence of symptoms suggestive signs or infection tuberculosis (eg persistent cough, wasting / loss of weight, low grade fever, listlessness), during or after treatment Idacio.

Other opportunistic infections

  • Of opportunistic infections, including invasive fungal infections, have been observed in patients treated with adalimumab. These infections were not always detected in patients receiving TNF antagonists, resulting in delayed initiation of appropriate therapy, sometimes with fatal outcome.
  • In patients who present with signs and symptoms such as fever, malaise, weight loss, sweating, cough, dyspnea and / or pulmonary infiltrates or other serious systemic disease with or without concomitant shock , an invasive fungal infection should be suspected; in this case, the administration of Idacio should be stopped immediately.Diagnosis and initiation of empiric antifungal therapy in these patients should be made in consultation with a physician experienced in the management of patients with invasive fungal infections.

Reactivation of hepatitis B

  • A reactivation of hepatitis B occurred in patients who received a TNF antagonist including adalimumab and who were carriers chronic of this virus (that is to say antigen-positive area HBsAg positive) . Some cases have had a fatal outcome. Patients should be screened for HBV infection before initiating treatment with Idacio. For patients who test positive for hepatitis B, it is recommended to consult a doctor specializing in the treatment of hepatitis B.
  • In HBV carriers who require treatment with Idacio, watch carefully for signs and symptoms of active HBV infection throughout treatment and for several months after discontinuation. There are insufficient data available regarding the treatment of patients with HBV treated with antiviral drugs to prevent HBV reactivation and treated with a TNF antagonist. In patients who develop HBV reactivation, Idacio should be discontinued and effective antiviral therapy and appropriate additional therapy should be initiated.

Neurological events

  • The TNF blockers, including adalimumab, have been associated in rare circumstances the onset or exacerbation of symptoms clinical and / or radiographic evidence of demyelinating disease of the
    central nervous system including multiple sclerosis, Optic neuritis and peripheral demyelinating disease, including Guillain-Barré syndrome. Prescribers are advised with caution before treating patients with pre-existing or recently-occurring central or peripheral nervous system demyelinating disease with   ; Discontinuation of treatment should be considered if any of these disorders develop. The association between uveitis intermediate and demyelinating diseases of the central nervous system is known. Neurologic assessment should be performed in patients with non-infectious intermediate uveitis before initiating therapy with Idacio, and repeated regularly during therapy to check for pre-existing or active central nervous system demyelinating disease .

Allergic reactions

  • In clinical trials, serious allergic reactions associated with adalimumab were rarely reported and non-serious allergic reactions associated with adalimumab were uncommon. Cases of severe allergic reactions, including anaphylaxis, have been reported after administration of adalimumab.
  • If an anaphylactic or other serious allergic reaction occurs, the administration of Idacio should be stopped immediately and appropriate treatment initiated.

Immunosuppression

  • In a study of 64 patients with rheumatoid arthritis treated with adalimumab, there was no evidence
    of delayed-type hypersensitivity depression, decreased immunoglobulin levels or a change in the count of effector T and B lymphocytes, NK lymphocytes, monocytes / macrophages and neutrophilic granulocytes.

Malignant tumors and lymphoproliferative disorders

  • In the controlled part of clinical trials with anti-TNFs, more cases of cancer including lymphomas were observed in patients treated with an anti-TNF than in patients in thecontrol group . However, the incidence has been rare. During post-marketing surveillance, cases of leukemia have been reported in patients treated with anti-TNF. In addition, there is a background of increased risk of lymphoma and leukemia in patients with old, inflammatory and highly active rheumatoid arthritis , which complicates the estimation of risk. In the current state of knowledge, the possibility of a risk of developing lymphomas, leukemia or other malignant diseases in patients treated with anti-TNF cannot be excluded.
  • Of malignancies, some fatal, have been reported postmarketing in children, adolescents and
    young adults (up to age 22 years) treated with TNF antagonists (initiation of therapy before age 18), including adalimumab. About half of these cases were lymphomas. The other cases corresponded to other types of malignant tumors among which rare cancers generally associated with a context of immunosuppression. The risk of developing malignant tumors can not be excluded in children and adolescents treated with anti-TNF.
  • In the course of the post-marketing surveillance, rare cases of lymphoma  hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab. This rare form of T-cell lymphoma has a very aggressive course and is often fatal. Some of these hepatosplenic T-cell lymphomas seen with adalimumab
    have occurred in young adults having concomitant treatment with azathioprine or 6-mercaptopurine used in inflammatory bowel disease. The potential risk of combining azathioprine or 6-mercaptopurine with adalimumab should be carefully considered. A risk of developing  hepatosplenic T-cell lymphoma in patients treated with Idacio cannot be ruled out.
  • There are no studies in patients with a history of malignancies or in whom treatment with adalimumab is continued after the development of cancer. Therefore, increased caution should be observed when considering treatment of these patients with Idacio (see section 4.8).
  • All patients, especially those with a history of intense immunosuppressive therapy or with psoriasis and a
    history of puvatherapy, should be screened for skin cancer other than melanoma before and during treatment with Idacio. Cases of melanoma and Merkel cell carcinoma have also been reported in patients treated with anti-TNF inhibitors including adalimumab.
  • In a prospective clinical study evaluating the use of another anti-TNF agent , infliximab, in patients with
    moderate to severe chronic obstructive pulmonary disease (COPD), more cancers, especially of the lung, were reported. head and neck,
    among patients treated with infliximab compared to patients in the control group. All patients had a history of  heavy smoking. For this reason, care should be taken in the use of an anti-TNF in patients with COPD, and also in patients at risk for cancer due to heavy smoking.
  • Based on current data, it is not known whether treatment with adalimumab influences the risk of developing dysplasia or colon cancer. All patients with ulcerative colitis who are at high risk of dysplasia or colon cancer (for example, patients with old ulcerative colitis or primary sclerosing cholangitis) or who have a history of dysplasia or colon cancer should do regularly screened for dysplasia before treatment and throughout the course of their disease. This assessment should include colonoscopy and biopsies according to local recommendations.

Haematological reactions

  • From Rare reports of pancytopenia including aplastic anemia have been reported with TNF antagonists. Adverse effects of the blood system including medically significant cytopenias (eg , thrombocytopenia, leukopenia) have been observed with adalimumab. It should be recommended for all patients seek immediate medical advice if they have signs or symptoms suggestive of blood disorders (eg, persistent fever, bruising, bleeding, pallor) while Idacio.
  • Discontinuation of treatment with Idacio should be considered for patients in whom significant blood abnormalities are confirmed.

Vaccinations

  • Similar antibody responses to the standard 23-valence pneumococcal vaccine and to the trivalent influenza vaccine were observed in a study in 226 adults with rheumatoid  arthritis treated with adalimumab or placebo. There are no data available on the secondary transmission of infection from live vaccines in patients receiving adalimumab.
  • In children and adolescents, it is recommended, if possible, that all immunizations be up to date according to current immunization recommendations before initiating treatment with adalimumab.
  • The adalimumab in patients may receive multiple vaccines simultaneously, except in respect of livevaccines. Administration of live vaccines (eg, BCG vaccine) to infants who have been exposed to adalimumab in utero is not recommended for 5 months after the mother’s last injection of adalimumab during pregnancy.

Congestive heart failure

  • In a clinical trial with another TNF antagonist, worsening congestive heart failure and increased mortality from congestive heart failure were observed . Of cases of congestive heart failure worsening also been reported in patients receiving adalimumab. Idacio should be used with caution in patients with mild heart failure (NYHA classes I / II). Idacio is contraindicated in moderate to severe heart failure (see section Contraindications). Treatment with Idacio should be stopped in patients with new or worsening symptoms. congestive heart failure.

Autoimmune processes

  • The treatment Idacio may cause antibody formation autoimmune. The impact of long-term treatment with adalimumab on the development of autoimmune diseases is unknown. If a patient develops symptoms of a lupus-like syndrome following treatment with Idacio and exhibits a positive anti- double-stranded DNA reaction , treatment with Idacio should not be continued.

Simultaneous administration of biological DMARDs or anti-TNF

  • Some serious infections were seen in clinical studies in the concurrent use of anakinra and another TNF antagonist, etanercept, with no added clinical benefit compared to etanercept alone. Due to the nature of the side effects seen with treatment with etanercept and anakinra, similar side effects may also result from the combination of anakinra and other TNF blockers. Therefore, the combination of adalimumab and anakinra is not recommended (see section Interactions with other medicinal products and other forms of interactions).
  • Concomitant administration of adalimumab with other biologic DMARDs (eg anakinra and abatacept) or with other TNF blockers is not recommended due to the possible increased risk of infections, including serious infections, and other potential pharmacological interactions (see section Interactions with other medicinal products and other forms of interactions).

Surgery

  • There is limited experience with safety during surgical procedures in patients treated with adalimumab. The long half-life of adalimumab should be taken into account if surgery is planned. A patient treated with Idacio requiring surgery should be carefully monitored for infections and appropriate action should be taken. There is limited experience with the safety of adalimumab in patients operated on for arthroplasty.

Hail Occlusion

  • In Crohn’s disease, treatment failure may indicate the presence of fixed fibrous strictures that may require surgical treatment. The available data suggest that adalimumab does not worsen or cause strictures.

Older subjects

  • The frequency of serious infections in subjects treated with adalimumab over 65 years of age (3.7%) is higher than in patients under 65 years of age (1.5%). Some cases have had a fatal outcome. A special attention regarding the risk of infection should be given when treating elderly patients.

Pediatric population

  • See Vaccinations above.

Excipients with known effect

  • This medicine contains less than 1 mmol (23 mg) sodium per 0.8 ml dose , that is to say essentially ‘sodium-free’.

PREGNANCY & BREAST-FEEDING & FERTILITY

Women of childbearing age

  • The women of childbearing age should consider the use of a method of effective contraception during treatment with Idacio and continue for at least five months after the last administration of Idacio.

Pregnancy

  • A large number (approximately 2,100) of pregnancies exposed to adalimumab for which data were collected prospectively, resulting in a live birth with a known term outcome , including more than 1,500 pregnancies exposed to adalimumab during the first trimester, does not reveal any increase in the rate of malformations in the newborn.
  • In a prospective cohort study, 257 women with rheumatoid arthritis (RA) or Crohn’s disease (CD) treated
    with adalimumab at least during the first trimester and 120 women with untreated RA or CD by adalimumab were included. The prevalence at birth of major congenital anomalies was the primary endpoint. The rate of pregnancies resulting in at least one living newborn with a major congenital defect was 6/69 (8.7%) in women treated with adalimumab with RA and 5/74 (6.8 %) in untreated women with RA (unadjusted OR 1.31, 95% CI  0.38-4.52), and 16/152 (10.5%) in women treated with adalimumab with CD and 3/32 (9.4%) in untreated women with CD (Unadjusted OR 1.14, 95% CI 0.31-4.16). The adjusted OR (considering baseline differences) was 1.10 ( 95% CI 0.45-2.73) for RA and CD combined. No notable difference was reported between women treated with adalimumab and women not treated with adalimumab for secondary endpoints of spontaneous abortion, minor birth defects, preterm delivery, height. at birth and serious or opportunistic infections , and stillbirth or malignancy. Interpretation of the data may be affected due to methodological limitations of the study, including the small sample size and the non-randomized study design.
  • In a developmental toxicity study performed in monkeys, there were no signs of possible maternal toxicity, embryotoxicity or teratogenic potential.
  • Preclinical data on the postnatal toxicity of adalimumab are not available (see section Preclinical safety data).
  • Due to its inhibition of TNF- α , adalimumab administered during pregnancy could affect normal immune responses in the newborn. Adalimumab should be used during pregnancy only if needed.
  • In women treated with adalimumab during pregnancy, adalimumab can cross the placenta and pass into the blood of their child. As a result, these children may have an increased risk of infections. The administration of live vaccines (eg, BCG vaccine ) to children who have been exposed to adalimumab in utero is not recommended for 5 months after the mother’s last injection during pregnancy.

Feeding with milk

  • Limited data from the published literature indicate that adalimumab is excreted in breast milk at very low concentrations, with adalimumab being present in breast milk at concentrations equivalent to 0.1% -1% of maternal serum levels. .
  • When administered orally, immunoglobulin G proteins undergo intestinal proteolysis and exhibit low bioavailability.
  • No effects on breastfed newborns / infants are expected. As a result, Idacio can be used during breastfeeding.

Fertility

Preclinical data on the effects of adalimumab on fertility are not available.

What happens if I overdose from IDACIO?

No dose related toxicity was observed in clinical trials. The highest dose evaluated consisted of repeated doses of 10 mg / kg IV, which is approximately 15 times the recommended dose.

What is  Forms and Composition ?

Appearance and shape

  • Solution for injection (for injection).
  • Clear, colorless solution.
  •  Idacio 40 mg / 0.8 mL, solution for injection for pediatric use in a single use vial 0.8 mL of solution in a vial (type I glass) with a rubber stopper (synthetic rubber) sealed with an aluminum crimp.
  • Each pack contains 1 vial, 1 sterile injection syringe, 1 sterile needle, 1 vial adapter and 2 alcohol swabs.

Other shapes

  • IDACIO 40 mg, solution for injection in pre-filled syringe, box of 2 pre-filled syringes (+ alcohol swabs) of 0.80 mL
  • IDACIO 40 mg, solution for injection in pre-filled pen, box of 2 pre-filled pens (+ alcohol swabs) of 0.80 mL

Composition

Active ingredient Solution injectable SC
Adalimumab 40 mg *

* per unit dose

  • Active ingredients: Adalimumab
  • Excipients: Monosodium phosphate dihydrate , Disodium disodium phosphate dihydrate , Mannitol , Sodium chloride , Citric acid monohydrate , Sodium citrate , Polysorbate 80 , Sodium hydroxide (for pH adjustment) , Water for injections , Original substrates: Hamster protein No excipient with known effect is not present in the composition of this drug

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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