Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Humira in combination with methotrexate, is indicated for:
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.
Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Humira has not been studied in patients aged less than 2 years.
Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function.
Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
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).
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.
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.
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.
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.
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.
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.
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.
There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.
Available data suggest that re-introduction of Humira after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
The recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
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.
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.
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.
The recommended Humira dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day). Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day). 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.
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 four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at Week 2 (given as two 40 mg injections in one day), 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.
The recommended Humira induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at Week 2 (given as two 40 mg injections in one day). 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 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.
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.
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. 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.
No dose adjustment is required.
Humira has not been studied in these patient populations. No dose recommendations can be made.
Polyarticular juvenile idiopathic arthritis from 2 years of age:
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1). Humira is administered every other week via subcutaneous injection.
Table 1. Humira Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis:
| Patient Weight | Dosing Regimen |
|---|---|
| 10 kg to <30 kg | 20 mg every other week |
| ≥30 kg | 40 mg every other week |
Available data suggest that clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.
There is no relevant use of Humira in patients aged less than 2 years for this indication.
Humira may be available in other strengths and/or presentations depending on the individual treatment needs.
Enthesitis-related arthritis:
The recommended dose of Humira for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2). Humira is administered every other week via subcutaneous injection.
Table 2. Humira Dose for Patients with Enthesitis-Related Arthritis:
| Patient Weight | Dosing Regimen |
|---|---|
| 15 kg to <30 kg | 20 mg every other week |
| ≥30 kg | 40 mg every other week |
Humira has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Humira may be available in other strengths and/or presentations depending on the individual treatment needs.
The recommended Humira dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3). Humira is administered via subcutaneous injection.
Table 3. Humira Dose for Paediatric Patients with Plaque Psoriasis:
| Patient Weight | Dosing Regimen |
|---|---|
| 15 kg to <30 kg | Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose |
| ≥30 kg | Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose |
Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
If retreatment with Humira is indicated, the above guidance on dose and treatment duration should be followed.
The safety of Humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
There is no relevant use of Humira in children aged less than 4 years for this indication.
Humira may be available in other strengths and/or presentations depending on the individual treatment needs.
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.
The recommended dose of Humira for patients with Crohn’s disease from 6 to 17 years of age is based on body weight (Table 4). Humira is administered via subcutaneous injection.
Table 4. Humira Dose for Paediatric Patients with Crohn’s disease:
| Patient Weight | Induction Dose | Maintenance Dose Starting at Week 4 |
|---|---|---|
| <40 kg | 40 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 kg | 80 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:
Continued therapy should be carefully considered in a subject not responding by week 12.
There is no relevant use of Humira in children aged less than 6 years for this indication.
Humira may be available in other strengths and/or presentations depending on the individual treatment needs.
The recommended dose of Humira for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5). Humira is administered via subcutaneous injection.
In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate.
Table 5. Humira Dose for Paediatric Patients with Uveitis:
| Patient Weight | Dosing Regimen |
|---|---|
| <30 kg | 20 mg every other week in combination with methotrexate |
| ≥30 kg | 40 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.
Humira has not been studied in these patient populations. No dose recommendations can be made.
Humira is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet.
Humira is available in other strengths and presentations.
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: 2 years.
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.
Humira 40 mg solution for injection in pre-filled syringe: Humira 40 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:
Humira 40 mg solution for injection in pre-filled syringe with needle guard: Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) with needle guard for hospital and caregiver use. The syringe 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 syringe with needle guard (0.8 ml sterile solution) in a blister, and 1 alcohol pad.
Humira 40 mg solution for injection in pre-filled pen: Humira 40 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:
Not all presentations or pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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