amgevita Uses, Dosage, Side Effects, Precautions & Warnings

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

Active ingredients: Adalimumab

what is amgevita  medication used for and indication?

Rheumatoid arthritis

AMGEVITA 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.
  • AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
  • AMGEVITA slows the progression of structural damage to the joints measured by radiography and improves functional capacity when administered in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

  • AMGEVITA 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. AMGEVITA can be administered as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is unsuitable (for efficacy as monotherapy, see section Pharmacodynamic properties). Adalimumab has not been studied in patients less than 2 years of age.

Enthesitis-related arthritis

AMGEVITA 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 (see section 5.1).

Axial spondyloarthritis

Ankylosing spondylitis (AS)

  • AMGEVITA 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

  • AMGEVITA 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

  • AMGEVITA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying therapy has been inadequate. AMGEVITA slows 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 improves functional capacity.

Psoriasis

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

Plaque psoriasis in children and adolescents

  • AMGEVITA 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 light therapy or when these treatments are inappropriate.

Hidradenitis suppurativa (HS)

  • AMGEVITA 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 therapy for HS (see section Properties). Pharmacodynamics and Pharmacokinetic Properties).

Crohn’s disease

  • AMGEVITA 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 which these treatments are contraindicated or poorly tolerated.

Crohn’s disease in children and adolescents

  • AMGEVITA 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 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

  • AMGEVITA 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 these treatments are contraindicated or poorly tolerated.

Uveitis

  • AMGEVITA 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

  • AMGEVITA 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.

amgevita  Dosage

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

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

While taking
AMGEVITA, other concomitant therapies (such
as corticosteroids and / or immunomodulators) should be optimized.

amgevita Dosage
amgevita Dosage

Dosage

Rheumatoid arthritis

  • In
    adult patients with rheumatoid arthritis, the
    recommended dose of AMGEVITA is a single dose of 40 mg adalimumab
    administered every two weeks, subcutaneously. Administration of methotrexate should be continued during treatment with AMGEVITA.
  • The
    glucocorticoids, salicylates, nonsteroidal anti-inflammatory
    drugs or analgesics may be continued during
    treatment with AMGEVITA. 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 with decreased
    response to AMGEVITA 40 mg every other week may
    benefit from an increase in dosage to adalimumab 40 mg
    every week or 80 mg every other week. .
  • The
    available data for adalimumab suggest that
    clinical response is usually achieved within 12 weeks of treatment. The
    Continued therapy should be reconsidered in patients who have
    not responded within this time.

Interruption of treatment

  • It
    may be necessary to stop treatment, eg before
    surgery or in patients with severe infection.
  • The
    re-introduction of AMGEVITA after a period of 70 days or more should
    lead to clinical response of the same magnitude and a profile
    similar to that observed tolerance before treatment interruption.

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

  • The
    recommended dosage of AMGEVITA for patients with
    ankylosing spondylitis, axial spondyloarthritis without
    radiographic evidence of AS and for patients with
    psoriatic arthritis is 40 mg adalimumab as a single dose every two
    weeks, by injection.

subcutaneous.

  • The
    available data suggest that the 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 AMGEVITA to start treatment in
    adults is 80 mg subcutaneously. The dosage will continue
    one week later with 40 mg subcutaneously every other week.
  • The
    continuing treatment beyond 16 weeks should be carefully
    reconsidered in a patient not responding within this time.
  • Beyond
    16 weeks, in case of insufficient response to AMGEVITA 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 two weeks should be
    carefully reconsidered in a patient with
    insufficient response after increasing the dose (see section 5.1).
    If sufficient response is obtained with 40 mg every week or
    80 mg every two weeks, the dosage may then be reduced
    to 40 mg every 2 weeks.

Hidradenitis suppurativa

  • The
    recommended dosage regimen of AMGEVITA in adult
    patients with hidradenitis suppurativa (HS) is an initial dose of 160
    mg on Day 1 (given as 4 injections of 40 mg in one
    day or 2 injections of 40 mg mg per day for two
    consecutive days ), followed by a dose of 80 mg two weeks after on Day 15
    (given as 2 injections of 40 mg 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 AMGEVITA. During
    during treatment with AMGEVITA, 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, AMGEVITA 40 mg every week or 80
    mg every other week may be reintroduced (see section 5.1).
  • The benefit and risk of continued long-term treatment should be assessed regularly.

Crohn’s disease

  • In
    adult patients with moderate to
    severe active Crohn’s disease , the recommended induction regimen of AMGEVITA is
    80 mg at week 0, followed by 40 mg at week 2. If it is
    necessary to obtain faster response to treatment, schedule
    160 mg at week 0 (given as 4 injections of 40 mg
    per day or 2 injections of 40 mg per day for two
    consecutive days ), 80 mg at week 2 (given in the form 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 .
  • Following
    induction therapy, the recommended dose is 40
    mg administered every two weeks by subcutaneous injection. If
    a patient has stopped treatment with AMGEVITA and the signs and
    symptoms of disease return, AMGEVITA 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
    AMGEVITA 40 mg every other week is observed may benefit
    from an increase in the dose to AMGEVITA 40 mg every
    week or 80 mg every other week.
  • 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.

Ulcerative colitis

  • In
    adult patients with moderate to
    severe ulcerative colitis , the recommended induction regimen of AMGEVITA 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 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
    AMGEVITA 40 mg every two weeks is observed may
    benefit from an increase in the dose to AMGEVITA 40 mg every
    week or 80 mg every two weeks.
  • The
    clinical response is usually achieved within 2 to 8 weeks of
    treatment. Treatment with AMGEVITA should not be continued in
    patients who have not responded within this time frame .

Uveitis

  • In
    adult patients with uveitis, the recommended dose
    of AMGEVITA 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. The
    treatment can be started AMGEVITA in combination with
    corticosteroids and / or other immunomodulatory therapies not
    organic. The combined corticosteroid dose may be gradually
    reduced in accordance with clinical practice, starting two weeks
    after initiation of treatment with AMGEVITA.
  • An
    annual reassessment of the benefits and risks associated
    with long-term continuous therapy is recommended (see section 5.1).

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 AMGEVITA for patients with
    polyarticular juvenile idiopathic arthritis from the age of 2 years depends
    on body weight (Table 1). AMGEVITA is administered every two
    weeks as a subcutaneous injection.

Table 1. Amgevita dosage in patients with polyarticular juvenile idiopathic arthritis

  • 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.

Enthesitis-related arthritis

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

Table 2. Dosage of AMGEVITA in Patients with Enthesitis-Related Arthritis

  • Adalimumab has not been studied in patients less than 6 years of age with arthritis related to enthesitis.

Plaque psoriasis in children and adolescents

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

Table 3. Amgevita dosage in children and adolescents with plaque psoriasis

  • The
    continuing treatment beyond 16 weeks should be carefully
    reconsidered in a patient not responding within this time.
  • If
    retreatment with AMGEVITA is indicated, the above recommendations
    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 AMGEVITA in children aged less than 4 years in this indication.

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 AMGEVITA in these patients
    was determined from pharmacokinetic modeling and
    simulation.
  • The
    recommended dose of AMGEVITA 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 AMGEVITA 40 mg every
    two weeks, an increase in the dosage to 40 mg every
    week or 80 mg every other week may be considered.
  • If
    necessary, antibiotics can be continued during
    treatment with AMGEVITA. During treatment with AMGEVITA, 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, AMGEVITA 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 AMGEVITA in children aged less than 12 years in this indication.

Crohn’s disease in children and adolescents

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

Table 4. Dosage of AMGEVITA in Children and Adolescents with Crohn’s Disease

  • 40 mg in week 0 and 20 mg in week 2
  • 80 mg in week 0 and 40 mg in week 2
  • 80 mg in week 0 and 40 mg in week 2
  • 160 mg in week 0 and 80 mg in week 2

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.

Uveitis in children and adolescents

  • The
    recommended dose of AMGEVITA for children and adolescents
    with uveitis from the age of 2 years depends on body weight
    (Table 5). AMGEVITA is administered by subcutaneous injection.
  • In
    uveitis in children and adolescents, no clinical trials have been
    conducted with AMGEVITA without concomitant treatment with methotrexate.
  • Table 5. Dosage of AMGEVITA in Children and Adolescents with Uveitis
  • When initiating treatment with AMGEVITA, 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
    AMGEVITA in children less than 6 years of age .
  • There is no relevant use of AMGEVITA 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.

Pediatric ulcerative colitis

  • The
    safety and efficacy of adalimumab in children 4 to 17 years of age
    have not 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 spondyloarthritis including ankylosing spondylitis

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

Administration mode

  • AMGEVITA is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet.

Contraindications

  • Hypersensitivity adalimumab
  • Hamster protein hypersensitivity
  • Active tuberculosis
  • Severe infection
  • Stage III or IV heart failure
  • Pregnancy
  • Lack of effective female contraception

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) .

amgevita  Side Effects

  • 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 spondyloarthritis (ankylosing spondylitis and
    axial spondyloarthritis without radiographic evidence of AS ),
    psoriatic arthritis, Crohn’s disease, ulcerative
    colitis, psoriasis and 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 qu’AMGEVITA affect the immune system
    and their use may affect the defenses of the
    body against infections 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 undesirable effects is based on clinical studies and
    post-marketing experience and is presented by
    system organ and frequency in Table 6 below: very
    common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥
    1 / 1,000 to <1/100); rare (≥ 1 / 10,000 to <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 (HS)

  • The
    safety profile in patients with HS treated with
    weekly adalimumab 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 group and 0.03 per patient-year in the placebo group and the
    control group.
  • 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 extrapulmonary 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 of
    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
    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 psoriasis in
    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 pivotal adult clinical trials 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,
    6.8 (4.4 – 10.5) per 1,000 patient-years among the 5,291 patients
    treated with adalimumab, was observed versus a rate of 6.3
    (3.4 – 11.8) per 1000 patient-years among the 3444 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 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 lymphoma 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 the controlled periods of these trials
    with the completed or ongoing open-label extension trials of adalimumab with an
    average duration of approximately 3.3 years including 6,427 patients and more than 26,439
    patient-years of treatment, the 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 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).
  • In
    post-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.

Hepato-biliary 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 x N 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 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 N 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 N 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 N 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 adjusted induction therapy by weight
    up to 52 weeks of treatment, elevations of ALT ≥ 3 x N
    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 of adalimumab in
    plaque psoriasis with a control period of 12 to 24 weeks,
    elevations of ALT ≥ 3 x N 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 N 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 each week
    from week 4), in patients with
    HS with a period of control from 12 to 16 weeks,
    elevations of ALT ≥ 3 x N 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 for patients treated with
    adalimumab and patients in the control group, respectively, elevations of ALT
    ≥ 3 x N 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 l.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.

Reporting of suspected adverse reactions

  • The
    declaration of suspected adverse reactions after authorization of the
    drug 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.

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

Drive and use machines

Amgevita may have a minor effect on the ability to drive and use machines. Dizziness and visual disturbances may occur after administration of Amgevita ( see Undesirable effects ).

Warnings and Precautions

Traceability

  • In order
    to improve the traceability of biological medicinal products, the name
    of the medicinal product (see section 1) 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
    carefully monitored for infections (including
    tuberculosis) before, during and after treatment with AMGEVITA. As the
    duration of elimination of adalimumab may be up to four months,
    monitoring should be continued throughout this period.
  • The
    treatment AMGEVITA should not be initiated in patients with
    active infections, including chronic infections or
    localized, are not controlled. In patients who have been exposed
    to tuberculosis or who have traveled to areas at high risk for
    tuberculosis or endemic mycoses, for example histoplasmosis,
    coccidioidomycosis or blastomycosis, the risks and benefits of
    treatment with AMGEVITA should be considered before
    initiation. treatment (see Opportunistic infections).
  • The
    Patients who develop a new infection during
    treatment with AMGEVITA must be monitored
    carefully and complete diagnostic workup should be practiced.
  • If
    a serious new infection or sepsis
    develops, administration of AMGEVITA should be discontinued and
    appropriate antimicrobial or antifungal therapy should be started until
    the infection is controlled.
  • Caution should be exercised by the physician before using AMGEVITA in patients with a
    history of recurrent infection or with
    underlying conditions which may predispose them to infections, including
    concomitant treatment with immunosuppressive drugs.

Serious infections

  • Of
    serious infections, including sepsis due to infections
    bacterial, 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 AMGEVITA, all patients should
    be tested for active or non-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 AMGEVITA should not be initiated.
  • In
    all 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 AMGEVITA.
  • A
    TB prophylaxis should also be considered before
    introducing AMGEVITA in patients with factors
    multiple risk or tuberculosis despite a significant test
    screening for tuberculosis negative 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 AMGEVITA.

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 AMGEVITA 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 surface antigen positive – Ag
    positive HBs) . Some cases have had a fatal outcome. Patients
    should be screened for HBV infection before
    initiating treatment with AMGEVITA. 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 AMGEVITA,
    careful monitoring of signs and symptoms of active
    HBV infection should be observed 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, AMGEVITA
    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 AMGEVITA ; Discontinuation of
    treatment with AMGEVITA should be considered in the event of any
    of these troubles. The association between intermediate uveitis and
    demyelinating diseases of the central nervous system is known.
  • Aneurological assessment should be performed in patients with
    non-infectious intermediate uveitis before initiating
    treatment with AMGEVITA, and repeated regularly during
    treatment to look for any system demyelinating disease of
    preexisting or progressive CNS.

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 anaphylactic reactions
    have been reported after administration of adalimumab. If
    an anaphylactic or other
    severe allergic reaction occurs, administration of AMGEVITA should be
    stopped immediately and appropriate treatment initiated.

Dry natural rubber

  • The
    needle cap of the pre-filled pen contains
    dry natural rubber (a derivative of latex), which may cause
    allergic reactions .

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 the adalimumab clinical trials with anti-TNF drugs,
    more cases of cancer including lymphomas were observed in
    patients treated with an anti-TNF agent than in patients in the
    control 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 who were concomitantly treated
    with azathioprine or 6-mercaptopurine used in
    inflammatory bowel disease. The potential risk of combining
    azathioprine or 6-mercaptopurine with AMGEVITA should be
    carefully considered. A risk of developing
    hepatosplenic T-cell lymphoma in patients treated with
    AMGEVITA cannot be excluded.
  • 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, additional caution
    should be observed when considering treatment of these patients
    with AMGEVITA.
  • All
    patients, especially those with a history of
    intense immunosuppressive therapy or with psoriasis and a
    history of puvatherapy, should be screened for
    non-melanoma skin cancer before and during treatment with
    AMGEVITA. 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 AMGEVITA. Discontinuation of treatment with AMGEVITA
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 guidelines before initiating treatment with AMGEVITA.
  • The
    patients AMGEVITA may receive multiple vaccines
    simultaneously, except in respect of live vaccines.
    Administration of live vaccines (eg, BCG vaccine) to
    infants who have been exposed to AMGEVITA in utero is not
    recommended for 5 months after the last injection of AMGEVITA
    in the mother 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 have also been
reported in patients receiving adalimumab. AMGEVITA should be
used with caution in patients with
mild heart failure (NYHA classes I / II). AMGEVITA is contraindicated in
moderate to severe heart failure (see section 4.3). Treatment with AMGEVITA should be stopped in patients who experience new symptoms or worsening of their symptoms of congestive heart failure.

Autoimmune processes

  • The
    treatment AMGEVITA may cause antibody formation
    autoimmune. The impact of long-term treatment with AMGEVITA on the
    development of autoimmune diseases is unknown. If a patient
    develops lupus-like symptoms following
    treatment with AMGEVITA and exhibits a positive anti-
    double-stranded DNA reaction , treatment with AMGEVITA 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 AMGEVITA and anakinra is not recommended (see section Interactions with other medicinal products and other forms of interactions).
  • Co- administration of AMGEVITA with other biologic DMARDs
    (e.g. 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 AMGEVITA requiring
    surgery should be carefully monitored for
    infections and appropriate actions should be taken.
    There
    is limited experience with the safety of adalimumab in patients undergoing 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. Particular attention should be paid to the risk of infection when treating the elderly.

Pediatric population

  • See Vaccinations above.

Excipients with known effect

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

PREGNANCY & BREAST-FEEDING & FERTILITY

Women of childbearing age

  • Women of childbearing potential should consider using effective contraception during treatment with Amgevita and continue to use it for at least five months after the last administration of Amgevita.

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 course to term, including more than 1,500 pregnancies exposed to adalimumab in the first trimester , does not reveal any increase in the rate of malformations in newborns.
  • 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, 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 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. 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 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. 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 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. 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. 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. birth size 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. birth size 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. There are no preclinical data on the postnatal toxicity of adalimumab ( see Preclinical Safety ).
  • Due to its inhibitory effect on TNFα, adalimumab administered during pregnancy may affect the normal immune responses of the newborn. Amgevita 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 being 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, Amgevita 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 amgevita  ?

  • 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 ?

SHAPES and PRESENTATIONS

20 mg solution for injection (SC injection) (clear, colorless to slightly yellow) : 

  • 0.4 mL pre-filled single-dose syringe, with needle and needle protective cap, pack of 1.

Solution for injection (SC injection) (clear, colorless to slightly yellow) 40 mg: 

  • 0.8 mL single-dose pre-filled syringe, with needle and needle shield, packs of 1, 2 and 6 (3 x 2). 0.8 mL pre-filled single-dose pen*(SureClick), with protectiveneedlecap**, packs of 1, 2 and 6 (3 x 2).
    *  The pen is a disposable, portable, single-use mechanical injection device.
  • **  The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex) ( see Warnings and Precautions for use ).
COMPOSITION
  p ser 0.4 mL p ser or pen 0.8 mL
Adalimumab * 20 mg 40 mg
  • Excipients: glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide (to adjust pH), water for injections.
  • Each mL contains 50 mg of adalimumab.
  • *  Adalimumab is a recombinant human monoclonal antibody produced in Chinese hamster ovary cells.

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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