| The SPC was revised due to two Type II variations (approval March 2010):
The scope of the variations was the addition of the indication Juvenile Arthritis and the further pack size 30 mg.
The following sections have been changed:
1
2
Addition
1 pre-filled syringe of 0.60 ml contains 30 mg methotrexate.
3
4.1
Metoject 50 mg/ml is indicated for the treatment of
- polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate,
4.2
Dosage in adult patients with rheumatoid arthritis:
The recommended initial dose is 7.5 mg of methotrexate once weekly, administered either subcutaneously, intramuscularly or intravenously. Depending on the individual activity of the disease and tolerability by the patient, the initial dose may be increased gradually by 2.5 mg per week. A weekly dose of 25 mg should in general not be exceeded. However, doses exceeding 20 mg/week are associated with significant increase in toxicity, especially bone marrow suppression. Response to treatment can be expected after approximately 4 – 8 weeks. Upon achieving the therapeutically desired result, the dose should be reduced gradually to the lowest possible effective maintenance dose.
Dosage in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic arthritis
The recommended dose is 10-15 mg/m² body surface area (BSA)/once weekly. In therapy-refractory cases the weekly dosage may be increased up to 20mg/m2 body surface area/once weekly. However, an increased monitoring frequency is indicated if the dose is increased.
Due to limited data availability about intravenous use in children and adolescents, parenteral administration is limited to subcutaneous and intramuscular injection.
Patients with JIA should always be referred to a rheumatology specialist in the treatment of children/adolescents.
Use in children < 3 years of age is not recommended as insufficient data on efficacy and safety are available for this population. (see section 4.4)
Patients with renal impairment:
Metoject 50 mg/ml should be used with caution in patients with impaired renal function. The dose should be adjusted as follows:
Creatinine clearance (ml/min) Dose
> 50 100 %
20 – 50 50 %
< 20 Metoject 50 mg/ml must not be used
See section 4.3
The dose should be increased as necessary but should in general not exceed the maximum recommended weekly dose of 25 mg. In a few exceptional cases a higher dose might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate as toxicity will markedly increase.
4.3
4.4
Use in children < 3 years of age is not recommended as insufficient data on efficacy and safety are available for this population (see section 4.2).
4.5
4.7
4.8
4.9
6.2
6.3
6.4
6.5 pack size 0.60 ml
6.6
|
