Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany
Libmyris in combination with methotrexate, is indicated for:
Libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Adalimumab 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.
Libmyris 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 DMARD. Libmyris 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). Adalimumab has not been studied in patients aged less than 2 years.
Libmyris 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).
Libmyris is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy.
Libmyris 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 (NSAIDs).
Libmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Adalimumab 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.
Libmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Libmyris 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.
Libmyris is indicated for the treatment of active moderate to severe HS (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).
Libmyris 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.
Libmyris 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.
Libmyris 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.
Libmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Libmyris 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 corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Libmyris 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.
Libmyris treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Libmyris is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Libmyris (see section 4.4). Patients treated with Libmyris should be given the Patient Reminder Card.
After proper training in injection technique, patients may self-inject with Libmyris if their physician determines that it is appropriate and with medical follow-up as necessary.
During treatment with Libmyris, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Libmyris is only available as 40 mg pre-filled syringe, 40 mg pre-filled pen and 80 mg pre-filled syringe. Thus, it is not possible to administer Libmyris to patients that require less than a full 40 mg dose. If an alternate dose is required, other adalimumab products offering such an option should be used.
The recommended dose of Libmyris 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 Libmyris.
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Libmyris. 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 Libmyris 40 mg every other week may benefit from an increase in dose 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.
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 adalimumab 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 Libmyris for patients with AS, 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 Libmyris 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 Libmyris 40 mg every other week may benefit from an increase in dose 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 dose (see section 5.1). If adequate response is achieved with 40 mg every week or 80 mg every other week, the dose may subsequently be reduced to 40 mg every other week.
The recommended Libmyris dose regimen for adult patients with 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 Libmyris 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 Libmyris.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Should treatment be interrupted, Libmyris 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 periodically evaluated (see section 5.1).
The recommended Libmyris 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), followed by 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 Libmyris and signs and symptoms of disease recur, Libmyris 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 Libmyris 40 mg every other week may benefit from an increase in dose to 40 mg Libmyris 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.
The recommended Libmyris 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 40 mg every other week may benefit from an increase in dose to 40 mg Libmyris every week or 80 mg every other week.
Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment. Libmyris therapy should not be continued in patients failing to respond within this time period.
The recommended dose of Libmyris 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 adalimumab alone. Treatment with Libmyris 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 Libmyris.
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
No dose adjustment is required.
Adalimumab has not been studied in these patient populations. No dose recommendations can be made.
Libmyris is only available as 40 mg pre-filled syringe, 40 mg pre-filled pen and 80 mg pre-filled syringe. Thus, it is not possible to administer Libmyris to paediatric patients that require less than a full 40 mg dose. If an alternate dose is required, other adalimumab products offering such an option should be used.
The recommended dose of Libmyris for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1). Libmyris is administered every other week via subcutaneous injection.
Table 1. Libmyris dose for patients with polyarticular juvenile idiopathic arthritis:
| Patient weight | Dosing regimen |
|---|---|
| 10 kg to <30 kg | - |
| ≥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 adalimumab in patients aged less than 2 years for this indication.
The recommended dose of Libmyris for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2). Libmyris is administered every other week via subcutaneous injection.
Table 2. Libmyris dose for patients with enthesitis-related arthritis:
| Patient weight | Dosing regimen |
|---|---|
| 15 kg to <30 kg | - |
| ≥30 kg | 40 mg every other week |
Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
There is no relevant use of adalimumab in the paediatric population for the indications of AS and psoriatic arthritis.
The recommended Libmyris dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3). Libmyris is administered via subcutaneous injection.
Table 3. Adalimumab dose for paediatric patients with plaque psoriasis:
| Patient weight | Dosing regimen |
|---|---|
| 15 kg to <30 kg | - |
| ≥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 adalimumab is indicated, the above guidance on dose and treatment duration should be followed.
The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
There is no relevant use of adalimumab in children aged less than 4 years for this indication.
There are no clinical trials with adalimumab in adolescent patients with HS. The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
The recommended Libmyris 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 Libmyris 40 mg every other week, an increase in dose to 40 mg every week or 80 mg every other week may be considered.
Antibiotics may be continued during treatment with Libmyris 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 Libmyris.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Should treatment be interrupted, Libmyris 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 adalimumab in children aged less than 12 years in this indication.
The recommended dose of Libmyris for patients with Crohn’s disease from 6 to 17 years of age is based on body weight (Table 4). Libmyris is administered via subcutaneous injection.
Table 4. Adalimumab 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 | - |
| ≥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 |
* Libmyris is only available as 40 mg pre-filled syringe, 40 mg pre-filled pen and 80 mg pre-filled syringe. Thus, it is not possible to administer Libmyris to patients that require less than a full 40 mg dose.
Patients who experience insufficient response may benefit from an increase in dose:
Continued therapy should be carefully considered in a subject not responding by Week 12.
There is no relevant use of adalimumab in children aged less than 6 years for this indication.
The recommended dose of Libmyris for patients from 6 to 17 years of age with ulcerative colitis is based on body weight (Table 5). Libmyris is administered via subcutaneous injection.
Table 5. Adalimumab dose for paediatric patients with ulcerative colitis:
| Patient weight | Induction dose | Maintenance dose starting at Week 4* |
|---|---|---|
| <40 kg | • 80 mg at Week 0 (given as two 40 mg injections in one day) and • 40 mg at Week 2 (given as one 40 mg injection) | • 40 mg every other week |
| ≥40 kg | • 160 mg at Week 0 (given as four 40 mg injections in one day or 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) | • 80 mg every other week |
* Paediatric patients who turn 18 years of age while on Libmyris should continue their prescribed maintenance dose.
Continued therapy beyond 8 weeks should be carefully considered in patients not showing signs of response within this time period.
There is no relevant use of Libmyris in children aged less than 6 years in this indication.
The recommended dose of Libmyris for paediatric patients with uveitis from 2 years of age is based on body weight (Table 6). Libmyris is administered via subcutaneous injection.
In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate.
Table 6. Adalimumab dose for paediatric patients with uveitis:
| Patient weight | Dosing regimen |
|---|---|
| <30 kg | - |
| ≥30 kg | 40 mg every other week in combination with methotrexate |
When Libmyris 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 an adalimumab loading dose in children <6 years of age (see section 5.2).
There is no relevant use of adalimumab 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).
Libmyris is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet.
Libmyris is only available as 40 mg pre-filled syringe, 40 mg pre-filled pen and as 80 mg pre-filled syringe. Thus, it is not possible to administer Libmyris to patients that require less than a full 40 mg dose. If an alternate dose is required, other adalimumab products offering such an option should be used.
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.
2 years.
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light.
A single 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 pre-filled syringe or the pre-filled pen must be discarded if not used within the 14-day period.
0.4 ml preservative-free solution for injection in a pre-filled type I glass syringe with a fixed 29-gauge needle, extended finger flanges and needle guard, and a plunger stopper (bromobutyl rubber, latexfree).
Pack sizes: 1, 2 or 6 pre-filled syringe(s) packed in a PVC/PE blister, with 1, 2 or 6 alcohol pad(s).
0.4 ml preservative-free solution for injection in pre-filled needle-based injection system (autoinjector) containing a pre-filled type I glass syringe with a fixed 29-gauge needle and a plunger stopper (bromobutyl rubber, latex-free). The pen is a single use, disposable, handheld, mechanical injection device.
Pack sizes: 1, 2 or 6 pre-filled pens packed in a PVC/PE blister, with 1, 2 or 6 alcohol pad(s).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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