HULIO 40 mg Injection Uses, Dosage, Side Effects, Precautions & Warnings

what is HULIO  medication used for and indication
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Generic drug of the Therapeutic class: Immunology Medicines

Active ingredients: Adalimumab

what is HULIO  medication used for and indication?

Rheumatoid arthritis

Hulio in combination with methotrexate is indicated for:

  • the treatment of moderately to severely active rheumatoid arthritis in adults when the response to DMARDs, including methotrexate, is inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
  • Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is unsuitable.
  • Hulio has been shown to slow the progression of structural damage to joints measured by radiography and improve functional ability when given in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

  • Hulio in combination with methotrexate is indicated for the treatment of progressive polyarticular juvenile idiopathic arthritis in patients from 2 years of age with insufficient response to one or more DMARDs.
  • Hulio 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

  • Hulio 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 .

Axial spondylitis

Ankylosing spondylitis (AS)

  • Hulio is indicated for the treatment of severe and active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.

Axial spondyloarthritis without radiographic evidence of AS

  • Hulio is indicated for the treatment of severe axial spondyloarthritis without radiographic evidence of AS, but with objective evidence of inflammation on MRI and / or elevated CRP in adults who have had an inadequate response or intolerance to anti -nonsteroidal inflammatory drugs.

Psoriatic arthritis

  • Hulio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying therapy (DMARD) has been inadequate. Hulio has been shown to slow the progression of peripheral joint structural damage as measured by radiography, in patients with symmetrical polyarticular forms of the disease (see section 5.1) and improve functional ability.

Psoriasis

  • Hulio is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who require systemic therapy.

Plaque psoriasis in children and adolescents

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

Hidradenitis suppurativa (HS)

  • Hulio is indicated for the treatment of active, moderate to severe hidradenitis suppurativa (Verneuil’s disease) in adults and adolescents from 12 years of age in case of insufficient response to conventional systemic treatment of hidradenitis suppurativa (see sections Pharmacodynamic properties and Pharmacokinetic properties).

Crohn’s disease

  • Hulio is indicated for the treatment of moderate to severe active Crohn’s disease in adult patients who have not responded despite appropriate and well-managed treatment with a corticosteroid and / or immunosuppressant; or in whom this treatment is contraindicated or poorly tolerated.

Crohn’s disease in children and adolescents

  • Hulio is indicated for the treatment of moderate to severe active Crohn’s disease in children and adolescents from 6 years of age who have failed to respond to conventional therapy including first-line nutritional therapy and a corticosteroid and / or an immunomodulator, or in which these treatments are poorly tolerated or contraindicated.

Ulcerative colitis

  • Hulio is indicated for the treatment of active, moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or in whom this treatment is contraindicated or poorly tolerated.

Uveitis

  • Hulio is indicated for the treatment of non-infectious, intermediate, posterior uveitis and panuveitis in adult patients who have had an insufficient response to corticosteroid therapy, in patients requiring corticosteroid sparing, or in whom corticosteroid therapy is inappropriate.

Uveitis in children and adolescents

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

HULIO  Dosage

Treatment with Hulio should
be started and supervised by a specialist physician qualified in
the diagnosis and treatment of conditions for which
Hulio is indicated.

It is recommended that ophthalmologists consult
an appropriate specialist before initiating treatment with Hulio.

A surveillance card will be given to patients treated with Hulio.

After proper training
in the injection technique, patients can self-inject Hulio,
if their doctor considers it possible, and provided
appropriate medical supervision.

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

Dosage

Rheumatoid arthritis

  • In adult patients
    with rheumatoid arthritis, the recommended dose of Hulio
    is a single dose of 40 mg adalimumab given every two
    weeks, subcutaneously. Administration of methotrexate should
    be continued during treatment with Hulio.
  • Glucocorticoids,
    salicylates, nonsteroidal anti-inflammatory drugs or pain
    relievers may be continued while taking Hulio. As
    regards the combination with other anti-rheumatic drugs
    other than methotrexate (see sections Warnings and precautions for use and Pharmacodynamic properties).
  • As monotherapy, some
    patients who experience a decrease in their response to Hulio
    40 mg every other week may benefit from an increase
    in the dosage to 40 mg adalimumab every week or 80 mg
    every other week. .
  • Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
  • Continuation of treatment should be reconsidered in a patient who has not responded within these time limits.
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Interruption of treatment

  • Treatment may need to be interrupted, for example before
    surgery or in case of severe infection.
  • The available data
    suggest that re-introduction of adalimumab after stopping 70
    days or more results in a clinical response of the same magnitude and a
    safety profile similar to that observed before stopping
    treatment.

Ankylosing spondylitis, axial spondylitis without radiographic evidence of AS, and psoriatic arthritis

  • The recommended dose
    of Hulio for patients with ankylosing spondylitis,
    axial spondylitis without radiographic evidence of AS, and for
    patients with psoriatic arthritis is 40 mg adalimumab
    as a single dose every two weeks, by subcutaneous injection. .
  • Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
    Continuation of treatment should be reconsidered in a patient
    who has not responded within these time limits.

Psoriasis

  • The recommended dose
    of Hulio to start treatment in adults is 80 mg
    subcutaneously. The dosage will continue one week later with 40 mg
    subcutaneously every other week.
  • Continuation of treatment
    beyond 16 weeks should be carefully reconsidered in a
    patient who has not responded within this time.
  • Beyond 16 weeks, in
    case of insufficient response to Hulio 40 mg every other week,
    patients may benefit from an increase in dosage to 40 mg
    every week or 80 mg every other week. The benefits and
    risks of continuous treatment of 40 mg weekly or 80
    mg every other week should be carefully reconsidered
    in a patient with insufficient response after increasing
    the dosage.
  • In
    case of sufficient response obtained with 40 mg weekly or 80
    mg every two weeks, the dosage may then be reduced to
    40 mg every 2 weeks.
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Hidradenitis suppurativa

  • The
    recommended dosage regimen of Hulio in adult patients with hidradenitis
    suppurativa (HS) is an initial dose of 160 mg on day 1 (given
    as 4 injections of 40 mg over one day or 2 injections of
    40 mg mg per day for two consecutive days), followed by an 80
    mg dose two weeks later, on day 15 (given as two
    40 mg injections over one day).
  • Two weeks later (Day 29),
    continue with a dose of 40 mg every week or 80 mg
    every two weeks (given as two
    40 mg injections per day).
  • If necessary, antibiotics can be
    continued during treatment with Hulio. During treatment with
    Hulio, it is recommended that the patient cleanse his
    lesions daily with a topical antiseptic.
  • Continuation of treatment
    beyond 12 weeks should be carefully reconsidered in
    patients who do not show improvement during this period.
  • If treatment is
    interrupted, Hulio 40 mg every week or 80 mg every other
    week may be reintroduced .
  • The benefit and risk of continued long-term treatment should be assessed regularly.
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Crohn’s disease

  • In adult patients
    with moderate to severe active Crohn’s disease, the
    recommended induction regimen of Hulio is 80 mg at week 0,
    followed by 40 mg at week 2.
  • If needed. get a
    faster response to treatment, schedule 160 mg at week 0
    (given as 4 injections of 40 mg per day or 2
    injections per day for two consecutive days), 80 mg at week
    2 (given as of two injections of 40 mg per day), can
    be used knowing that the risk of adverse events is then
    higher during this induction phase.
  • After
    induction therapy , the recommended dose is 40 mg administered every
    two weeks by subcutaneous injection. If a patient has stopped
    treatment with Hulio, and if signs and symptoms of disease
    return, Hulio may be re-administered. Experience with re-
    administration of treatment beyond 8 weeks after the
    previous dose is limited.
  • During
    maintenance treatment , corticosteroids may be gradually reduced in
    accordance with clinical practice recommendations.
  • Some patients in
    whom a decreased response to treatment with Hulio 40 mg every
    two weeks is observed may benefit from an increase in
    the dose to Hulio 40 mg every week or 80 mg every
    two weeks.
  • Some patients who have
    not responded to treatment at week 4 may continue
    maintenance therapy until week 12. Continuation of
    treatment should be carefully reconsidered in a patient
    who has not responded within this time.
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Ulcerative colitis

  • In adult patients
    with moderate to severe ulcerative colitis, the
    recommended induction regimen of Hulio is 160 mg at week 0
    (given as 4 injections of 40 mg per day or 2
    injections of 40 mg per day. day for two consecutive days) and 80
    mg at week 2 (given as two 40 mg injections
    per day). After induction therapy, the recommended dose is
    40 mg administered every two weeks by subcutaneous injection.
  • During
    maintenance treatment , corticosteroids may be gradually reduced in
    accordance with clinical practice recommendations.
  • Some patients in
    whom a decreased response to treatment with Hulio 40 mg every
    two weeks is observed may benefit from an increase in
    the dose to Hulio 40 mg every week or 80 mg every
    two weeks.
  • Available data
    suggest that clinical response is usually achieved within
    2 to 8 weeks of treatment. Treatment with Hulio should not be
    continued in patients who have not responded within this time frame .
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Uveitis

  • In adult
    patients with uveitis, the recommended dose of Hulio is an
    initial dose of 80 mg followed by a dose of 40 mg every two weeks
    starting one week after the first dose.
  • There
    is limited experience with initiating treatment with adalimumab monotherapy. Treatment with Hulio can be started in combination with corticosteroid therapy and / or with other
    non-biological immunomodulatory treatments .
  • The combined corticosteroid dose may
    be gradually reduced in accordance with clinical practice,
    starting two weeks after initiation of treatment with Hulio.
  • An annual reassessment
    of the benefits and risks associated with long-
    term continuous therapy is recommended (see section 5.1).
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Special populations

Older subjects

  • No dosage adjustment is necessary.

Renal and / or hepatic impairment

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

Pediatric population

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis from 2 years old

  • The recommended dosage of Hulio for patients with polyarticular juvenile idiopathic arthritis from the age of 2 years depends on body weight
    (Table 1).
  • Hulio is given every two weeks as a subcutaneous injection.

Table 1: Dosage of Hulio in Patients with Polyarticular Juvenile Idiopathic Arthritis

  • Available data suggest that 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 Hulio may be available depending on the therapeutic needs of each patient.

Enthesitis-related arthritis

  • The recommended dosage of Hulio for patients with enthesitis-related arthritis from the age of 6 years depends on body weight (Table 2).
  • Hulio is given every two weeks as a subcutaneous injection.

Table 2: Dosage of Hulio in Patients with Enthesitis-Related Arthritis

  • Adalimumab has not been studied in patients less than 6 years of age with arthritis related to enthesitis.
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Plaque psoriasis in children and adolescents

  • The recommended dosage of Hulio for patients with plaque psoriasis aged 4 to
    17 years depends on body weight (Table 3).
  • Hulio is administered as a subcutaneous injection.

Table 3: Dosage of Hulio in Children and Adolescents with Plaque Psoriasis

  • Continuation of treatment beyond 16 weeks should be carefully reconsidered in a
    patient who has not responded within this time.
  • If retreatment with Hulio 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 Hulio 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
    hidradenitis suppurativa. The dosage of adalimumab in these patients was determined from pharmacokinetic modeling and simulation.
  • The recommended dose of Hulio 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 Hulio 40 mg every two weeks, an increase in the dosage to 40 mg every week or 80 mg every two weeks may be considered.
  • If necessary, antibiotics can be continued during treatment with Hulio.
  • During treatment with Hulio, it is recommended that the patient
    cleanse his lesions daily with a topical antiseptic.
  • Continuation of treatment beyond 12 weeks should be carefully reconsidered in patients who do not show improvement during this period.
  • If treatment is interrupted, Hulio can 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 under 12 years of age in this indication.
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Crohn’s disease in children and adolescents

  • The recommended dosage of Hulio for patients with Crohn’s disease aged 6 to 17 years depends on body weight (Table 4).
  •  Hulio is administered as a subcutaneous injection.

Table 4: Dosage of Hulio in Children and Adolescents with Crohn’s Disease

  • Patients in whom an insufficient response to treatment is observed may benefit from an increase in the dosage:
    • <40 kg: 20 mg per week
    • ≥ 40 kg: 40 mg per 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 for this indication.
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Uveitis in children and adolescents

  • The recommended dosage of Hulio for children and adolescents with uveitis fromthe age of 2 years depends on body weight (Table 5).
  • Hulio is administered as a subcutaneous injection.
  • In uveitis in children and adolescents, no clinical trials have been conducted with Hulio without concomitant treatment with methotrexate.

Table 5: Hulio Dosage for Pediatric Patients with Uveitis

  • When initiating treatment with Hulio, 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 Hulio in children under 6 years of age.
  • There is no relevant use of adalimumab in children under 2 years of age in this indication.
  • An annual reassessment of the benefits and risks associated with long-term continuous therapy is recommended.
  • Other presentations of Hulio may be available depending on the therapeutic needs of each patient.

Pediatric ulcerative colitis

  • The safety and efficacy of adalimumab in children aged 4 to 17 years have not yet been established.
  • No data is available.
  • There is no relevant use of adalimumab in children aged less than 4 years in this indication.

Psoriatic arthritis and axial spondylitis including ankylosing spondylitis

  • There is no relevant use of adalimumab in the pediatric population in the indications, ankylosing spondylitis and psoriatic arthritis.

Administration mode

  • Hulio is administered as a subcutaneous injection. Full instructions for use are provided in the package leaflet.
  • A 40 mg vial for children and adolescents is available for patients requiring a dose lower than the full 40 mg dose.

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).

HULIO  Side Effects

Summary of the safety profile

  • Adalimumab has been studied in 9,506 patients in pivotal, open- label, controlled 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 spondylitis (ankylosing spondylitis and axial spondylitis without radiographic evidence of AS ), psoriatic arthritis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis.
  • The pivotal controlled studies involved 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 of the control group.
  • The most frequently 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 adalimumab.
  • Severe haematological, 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 side effects

  • The list of adverse reactions is based on clinical studies and post-marketing experience and is presented by system organ class (SOC) and 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 column “Class of organ systems ”indicates that more information is available under the sections Contraindications, Warnings and precautions for use and Undesirable effects.

Table 6: Adverse reactions

  • * Further information is available under the sections Contraindications, Warnings and precautions for use and Adverse reactions.
  • ** including open label extension studies.

1) including data from spontaneous notifications

Hidradenitis suppurativa

The safety profile in patients with hidradenitis suppurativa treated with adalimumab weekly is consistent with the known safety profile of adalimumab.

Uveitis

  • The safety profile in patients with uveitis treated with adalimumab every two weeks is consistent with the known safety profile of adalimumab.

Description of selected adverse reactions

Injection site reactions

  • In 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) versus 7 , 2% of patients receiving placebo or 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 group and 1.46 per patient-year in the placebo group. and the control group.
  • 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-treated group , and 0.03 per patient-year in the placebo and control groups.
  • In open-label, controlled studies with adalimumab in adults and in the pediatric population, serious infections (including fatal infections, which have rarely occurred) have been reported including reports of tuberculosis (including miliary and extra-pulmonary localizations) 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 cases of cancer were observed in 249 pediatric patients representing an exposure of 655.6 patient-years in studies with adalimumab in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and arthritis related to enthesitis). 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 Crohn’s disease in children and adolescents. No cases of cancer were observed in 77 pediatric patients corresponding to an exposure of 80 patient-years in a study with adalimumab in psoriasis chronic pediatric plaques. 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 withadalimumab of at least 12 weeks duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondylitis 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 1000 patient-years among the 5291 patients treated with adalimumab, was observed compared to a rate 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 1000 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 (95% confidence interval) of 2.7 (1.4 – 5.4) per 1,000
    patient years in patients treated with adalimumab and 0.6 (0.1 –
    4.5) per 1000 patient years in patients in the control group. 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 (see section 4.4).
  • Inpost-marketing surveillance, rare cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab.

Autoantibodies

  • Repeated autoantibody tests were performed on serum samples from patients in the IV trials in rheumatoid
    arthritis.
  • 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 3,441 patients treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies exhibited clinical signs suggestive of a new onset lupus-like syndrome . The condition of the patients
    improved after stopping treatment.
  • No patient presented lupus nephritis or central nervous symptoms.

Hepatobiliary events

  • In phase III controlled clinical trials of adalimumab in rheumatoid arthritis and psoriatic arthritis with a control period of 4 to 104 weeks, elevations of ALT ≥ 3 × ULN occurred in 3.7% of patients treated with adalimumab and in 1.6% of patients in the control group.
  • In phase III controlled clinical trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis aged 4 to 17 years and patients with enthesitis-related arthritis aged 6 to 17 years, elevations of ALT ≥ 3 × 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 × ULN occurred in the phase III trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis aged 2 to less than 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 × 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 that evaluated
    the efficacy and safety profile of two weight-based maintenance regimens following treatment of ‘ weight- adjusted induction up to 52 weeks of treatment, elevations of ALT ≥ 3 × ULN occurred in 2.6% of patients (5/192), of whom 4 were treated in combination with immunosuppressants at the start of
    study.
  • In phase III controlled clinical trials of adalimumab in plaque psoriasis with a control period of 12 to 24 weeks, elevations of ALT ≥ 3 × ULN occurred in 1.8% of patients treated with l 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 on adalimumab in pediatric patients with plaque psoriasis.
  • In controlled clinical trials of adalimumab (starting doses 160 mg at week 0 and 80 mg at week 2, followed by 40 mg weekly from week 4), in patients with HS With a control period of 12 to 16 weeks, elevations of ALT ≥ 3 × 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 other week 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 × 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 Hepatitis. ‘adalimumab.

Concomitant administration of azathioprine / 6-mercaptopurine

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

HULIO  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 Hulio and anakinra is not recommended (see section Warnings and precautions for use “Simultaneous administration of biological DMARDs and anti-TNF drugs”).
  • The combination of Hulio and abatacept is not recommended (see section Warnings and precautions for use “Simultaneous administration of biological DMARDs and anti-TNF drugs”)
  • In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

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Warnings and Precautions

PREGNANCY & BREAST-FEEDING & FERTILITY

Women of childbearing age

  • Women of childbearing potential should consider using effective contraception to prevent pregnancy and continue for at least five months after the last administration of Hulio.

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 birth 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,
  • 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 congenital anomalies, 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 inhibitory effect on TNFα, adalimumab administered during pregnancy may affect the normal immune responses of 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 human milk at very low concentrations, with adalimumab present in human 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. Therefore, adalimumab can be used during breast-feeding.

Fertility

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

What happens if I overdose from HULIO  ?

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 ?

Solution for injection (injection).

Clear or slightly opalescent, colorless to pale yellow-brownish solution.

Hulio 40 mg solution for injection in single-use pre-filled syringe with automatic needle guard.

The syringe is made of cycloolefin polymer with a stopper (chlorobutyl rubber) and a needle (stainless steel) with cap (butyl / diene polymer and polypropylene).

Package size:

  • 2 pre-filled syringes (with 2 alcohol swabs)

* per unit dose

  • Active ingredients: Adalimumab
  • Excipients with known effects Sorbitol
  • Other excipients: Monosodium glutamate , Methionine, Polysorbate 80, Hydrochloric acid (for pH adjustment), Water for injections, Original substrates: Hamster protein

NOT’s

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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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