HUMIRA 80mg Solution for injection in pre-filled syringe / pen Ref.[7463] Active ingredients: Adalimumab

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Therapeutic indications

Rheumatoid arthritis

Humira in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Psoriasis

Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Hidradenitis suppurativa (HS)

Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).

Crohn’s disease

Humira is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

Paediatric Crohn’s disease

Humira is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

Ulcerative colitis

Humira is indicated for treatment of moderately to severely active 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 who are intolerant to or have medical contraindications for such therapies.

Uveitis

Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

Paediatric Uveitis

Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Posology and method of administration

Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira (see section 4.4). Patients treated with Humira should be given the Patient Reminder Card.

After proper training in injection technique, patients may self-inject with Humira if their physician determines that it is appropriate and with medical follow-up as necessary.

During treatment with Humira, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.

Posology

Rheumatoid arthritis

The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Humira.

Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.

In monotherapy, some patients who experience a decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.

Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period.

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Psoriasis

The recommended dose of Humira for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose. Humira 40 mg solution for injection in pre-filled syringe and/or pre-filled pen is available for the maintenance dose.

Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.

Beyond 16 weeks, patients with inadequate response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week. The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1). If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Hidradenitis suppurativa

The recommended Humira dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days), followed by 80 mg two weeks later at Day 15. Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week. Antibiotics may be continued during treatment with Humira if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Humira.

Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.

Should treatment be interrupted, Humira 40 mg every week or 80 mg every other week may be re-introduced (see section 5.1).

The benefit and risk of continued long-term treatment should be periodically evaluated (see section 5.1).

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Crohn’s disease

The recommended Humira induction dose regimen for adult patients with moderately to severely active Crohn’s disease is 80 mg at Week 0 followed by 40 mg at Week 2. In case there is a need for a more rapid response to therapy, the regimen 160 mg at Week 0 (given as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days), 80 mg at Week 2, can be used with the awareness that the risk for adverse events is higher during induction.

After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection. Alternatively, if a patient has stopped Humira and signs and symptoms of disease recur, Humira may be re-administered. There is little experience from re-administration after more than 8 weeks since the previous dose.

During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.

Some patients who experience decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg Humira every week or 80 mg every other week.

Some patients who have not responded by Week 4 may benefit from continued maintenance therapy through Week 12. Continued therapy should be carefully reconsidered in a patient not responding within this time period.

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Ulcerative colitis

The recommended Humira induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (given as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days) and 80 mg at Week 2. After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.

During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.

Some patients who experience decrease in their response to 40 mg every other week may benefit from an increase in dosage to 40 mg Humira every week or 80 mg every other week.

Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment. Humira therapy should not be continued in patients failing to respond within this time period.

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Uveitis

The recommended dose of Humira for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. Humira 40 mg solution for injection in pre-filled syringe and/or pre-filled pen is available for the maintenance dose. There is limited experience in the initiation of treatment with Humira alone. Treatment with Humira can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Humira.

It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Special populations

Elderly

No dose adjustment is required.

Renal and/or hepatic impairment

Humira has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population

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

There are no clinical trials with Humira in adolescent patients with HS. The posology of Humira in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).

The recommended Humira dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection.

In adolescent patients with inadequate response to Humira 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.

Antibiotics may be continued during treatment with Humira if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Humira.

Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.

Should treatment be interrupted, Humira may be re-introduced as appropriate.

The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1)

There is no relevant use of Humira in children aged less than 12 years in this indication.

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Paediatric Crohn’s disease

The recommended dose of Humira for patients with Crohn’s disease from 6 to 17 years of age is based on body weight (Table 1). Humira is administered via subcutaneous injection.

Table 1. Humira Dose for Paediatric Patients with Crohn’s disease:

Patient WeightInduction DoseMaintenance Dose Starting at Week 4
<40 kg40 mg at Week 0 and 20 mg at Week 2. In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 80 mg at Week 0 and 40 mg at Week 2.20 mg every other week
≥40 kg80 mg at Week 0 and 40 mg at Week 2. In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 160 mg at Week 0 and 80 mg at Week 2.40 mg every other week

Patients who experience insufficient response may benefit from an increase in dosage:

  • <40 kg: 20 mg every week
  • ≥40 kg: 40 mg every week or 80 mg every other week

Continued therapy should be carefully considered in a subject not responding by Week 12.

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

There is no relevant use of Humira in children aged less than 6 years for this indication.

Paediatric Uveitis

The recommended dose of Humira for paediatric patients with uveitis from 2 years of age is based on body weight (Table 2). Humira is administered via subcutaneous injection.

In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate.

Table 2. Humira Dose for Paediatric Patients with Uveitis:

Patient WeightDosing Regimen
<30 kg20 mg every other week in combination with methotrexate
≥30 kg40 mg every other week in combination with methotrexate

When Humira therapy is initiated, a loading dose of 40 mg for patients <30 kg or 80 mg for patients ≥30 kg may be administered one week prior to the start of maintenance therapy. No clinical data are available on the use of a Humira loading dose in children <6 years of age (see section 5.2).

There is no relevant use of Humira in children aged less than 2 years in this indication.

It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).

Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Paediatric plaque psoriasis

The safety and efficacy of Humira in children aged 4-17 years have been established for plaque psoriasis.

The recommended Humira dose is up to a maximum of 40 mg per dose.

Paediatric ulcerative colitis

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

Method of administration

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

Humira is available in other strengths and presentations.

Overdose

No dose-limiting toxicity was observed during clinical trials. The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze. Keep the pre-filled syringe or pre-filled pen in its outer carton in order to protect from light.

A single Humira pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The syringe or pen must be protected from light, and discarded if not used within the 14-day period.

Nature and contents of container

Humira 80 mg solution for injection in pre-filled syringe: Humira 80 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of:

  • 1 pre-filled syringe (0.8 ml sterile solution) with 1 alcohol pad in a blister.

Humira 80 mg solution for injection in pre-filled syringe with automatic needle guard: Humira 80 mg solution for injection in single-use pre-filled syringe with automatic needle guard. The syringe is made from type I glass with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of:

  • 1 pre-filled syringe with automatic needle guard (0.8 ml sterile solution) with 1 alcohol pad in a blister.

Humira 80 mg solution for injection in pre-filled pen: Humira 80 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe. The syringe inside the pen is made from type 1 glass with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of:

  • 1 pre-filled pen (0.8 ml sterile solution), with 2 alcohol pads in a blister.
  • 3 pre-filled pens (0.8 ml sterile solution), with 4 alcohol pads in a blister.

Not all presentations or pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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