Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
RoActemra, in combination with methotrexate (MTX), is indicated for
In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
RoActemra 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.
RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Tocilizumab SC formulation is administered with a single-use PFS+NSD. Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA and /or GCA. The first injection should be performed under the supervision of a qualified health care professional. A patient or parent/guardian can self-inject RoActemra only if the physician determines that it is appropriate and the patient or parent/guardian agrees to medical follow-up as necessary and has been trained in proper injection technique.
Patients who transition from tocilizumab IV therapy to SC administration should administer the first SC dose at the time of the next scheduled IV dose under the supervision of a qualified health care professional.
All patients treated with RoActemra should be given the Patient Alert Card.
Suitability of the patient or parent/guardian for subcutaneous home use should be assessed and patients or parent/guardian instructed to inform a healthcare professional before administering the next dose if they experience symptoms of an allergic reaction. Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4).
The recommended posology is subcutaneous 162 mg once every week.
Limited information is available regarding switching patients from RoActemra intravenous formulation to RoActemra subcutaneous fixed dose formulation. The once every week dosing interval should be followed.
Patients transitioning from intravenous to subcutaneous formulation should administer their first subcutaneous dose instead of the next scheduled intravenous dose under the supervision of a qualified healthcare professional.
The recommended posology is subcutaneous 162 mg once every week in combination with a tapering course of glucocorticoids. RoActemra can be used alone following discontinuation of glucocorticoids. RoActemra monotherapy should not be used for the treatment of acute relapses (see 4.4).
Based upon the chronic nature of GCA, treatment beyond 52 weeks should be guided by disease activity, physician discretion, and patient choice.
Liver enzyme abnormalities:
| Laboratory Value | Action |
|---|---|
| >1 to 3 x Upper Limit of Normal (ULN) | Modify the dose of the concomitant MTX if appropriate. For persistent increases in this range, reduce RoActemra dose to 4 mg/kg or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised. Restart with 4 mg/kg or 8 mg/kg, as clinically appropriate. |
| >3 to 5 x ULN (confirmed by repeat testing, see section 4.4). | Interrupt RoActemra dosing until <3 x ULN and follow recommendations above for >1 to 3 x ULN. For persistent increases >3 x ULN, discontinue RoActemra |
| >5 x ULN | Discontinue RoActemra. |
Low absolute neutrophil count (ANC):
In patients not previously treated with RoActemra, initiation is not recommended in patients with an absolute neutrophil count (ANC) below 2 × 109/l.
| Laboratory Value (cells x 109/l) | Action |
|---|---|
| ANC >1 | Maintain dose |
| ANC 0.5 to 1 | Interrupt RoActemra dosing. hen ANC increases >1 × 109/l resume RoActemra at 4 mg/kg and increase to 8 mg/kg as clinically appropriate |
| ANC <0.5 | Discontinue RoActemra |
Low platelet count:
| Laboratory Value (cells x 103/μL) | Action |
|---|---|
| 50 to 100 | Interrupt RoActemra dosing. When platelet count >100 × 103/μ resume RoActemra at 4 mg/kg and increase to 8 mg/kg as clinically appropriate |
| <50 | Discontinue RoActemra |
Missed dose
If a patient misses a subcutaneous weekly injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose on the next scheduled day. If a patient misses a subcutaneous once every other week injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose immediately and the next dose on the next scheduled day.
No dose adjustment is required in elderly patients > 65 years of age.
No dose adjustment is required in patients with mild or moderate renal impairment. RoActemra has not been studied in patients with severe renal impairment (see section 5.2). Renal function should be monitored closely in these patients.
RoActemra has not been studied in patients with hepatic impairment. Therefore, no dose recommendations can be made.
The safety and efficacy of RoActemra subcutaneous formulation in children from birth to less than 1 year have not been established. There is no data.
A change in dose should only be based on a consistent change in the patient’s body weight over time. RoActemra can be used alone or in combination with MTX.
The recommended posology in patients above 1 year of age is subcutaneous 162 mg once every week in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 2 weeks in patients weighing less than 30 kg. Patients must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously.
The recommended posology in patients above 2 years of age is subcutaneous 162 mg once every 2 weeks in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 3 weeks in patients weighing less than 30 kg.
If appropriate, the dose of concomitant MTX and/or other medications should be modified or dosing stopped and tocilizumab dosing interrupted until the clinical situation has been evaluated. As there are many co-morbid conditions that may effect laboratory values in sJIA or pJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Liver enzyme abnormalities:
| Laboratory Value | Action |
|---|---|
| >1 to 3 x ULN | Modify the dose of the concomitant MTX if appropriate. For persistent increases in this range, interrupt RoActemra until ALT/AST have normalized. |
| >3 x ULN to 5 x ULN | Modify the dose of the concomitant MTX if appropriate. Interrupt RoActemra dosing until <3x ULN and follow recommendations above for >1 to 3 x ULN |
| >5 x ULN | Discontinue RoActemra. The decision to discontinue RoActemra in sJIA or pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient. |
Low absolute neutrophil count (ANC):
| Laboratory Value (cells x 109/l) | Action |
|---|---|
| ANC >1 | Maintain dose |
| ANC 0.5 to 1 | Interrupt RoActemra dosing. When ANC increases to >1 × 109/l resume RoActemra |
| ANC <0.5 | Discontinue RoActemra. The decision to discontinue RoActemra in sJIA or pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient. |
Low platelet count:
| Laboratory Value (cells x 103/µl) | Action |
|---|---|
| 50 to 100 | Modify the dose of the concomitant MTX if appropriate. Interrupt RoActemra dosing. When platelet count is >100 × 103/µl resume RoActemra |
| <50 | Discontinue RoActemra. The decision to discontinue RoActemra in sJIA or pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient. |
Reduction of tocilizumab dose due to laboratory abnormalities has not been studied in sJIA patients.
The safety and efficacy of RoActemra subcutaneous formulation in children with conditions other than sJIA or pJIA have not been established.
Available data with the IV formulation suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra. Continued therapy should be carefully reconsidered in a patient exhibiting no improvement within this timeframe.
If a sJIA patient misses a subcutaneous weekly injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose on the next scheduled day. If a patient misses a subcutaneous once every 2 week injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose immediately and the next dose on the next scheduled day.
If a pJIA patient misses a subcutaneous injection of RoActemra within 7 days of the scheduled dose, he/she should take the missed dose as soon as they remember and take the next dose at the regular scheduled time. If a patient misses a subcutaneous injection of RoActemra by more than 7 days of the scheduled dose or is unsure when to inject RoActemra, call the doctor or pharmacist.
RoActemra is for subcutaneous use.
After proper training in injection technique, patients may self-inject with RoActemra if their physician determines that it is appropriate. The total content (0.9 mL) of the pre-filled syringe should be administered as a subcutaneous injection. The recommended injection sites (abdomen, thigh and upper arm) should be rotated and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
The pre-filled syringe should not be shaken.
Comprehensive instructions for the administration of RoActemra in a pre-filled syringe are given in the package leaflet, see section 6.6.
There are limited data available on overdose with RoActemra. One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg administered intravenously. No adverse reactions were observed.
No serious adverse reactions were observed in healthy volunteers who received a single dose up to 28 mg/kg, although dose limiting neutropenia was observed.
24 months.
Once removed from the refrigerator, RoActemra must be administered within 8 hours and should not be kept above 30°C.
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light and moisture.
0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle. The syringe is closed by a rigid needle shield (elastomer seal with a polypropylene shell) and a plunger stopper (butyl rubber with a fluororesin coating).
Pack sizes of 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes. Not all pack sizes may be marketed.
RoActemra is supplied in a single use pre-filled syringe fitted into a needle safety device. After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach room temperature (18°C to 28°C) by waiting for 25 to 30 minutes, before injecting RoActemra . The syringe should not be shaken. After removing the cap the injection must be started within 5 minutes, to prevent the medicine from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of removing the cap, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.
If following insertion of the needle you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.
Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to slightly yellowish, or any part of the pre-filled syringe appears to be damaged.
Comprehensive instructions for the administration of RoActemra in a pre-filled syringe are given in the package leaflet.
Any unused product or waste material should be disposed of in accordance with local requirements.
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