Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Sanofi-aventis groupe, 54, rue La Boétie, 75008 Paris, France
Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see section 5.1).
Treatment should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of rheumatoid arthritis. Patients treated with Kevzara should be given the patient alert card.
The recommended dose of Kevzara is 200 mg once every 2 weeks administered as a subcutaneous injection.
Reduction of dose from 200 mg once every 2 weeks to 150 mg once every 2 weeks is recommended for management of neutropenia, thrombocytopenia, and liver enzyme elevations.
Treatment with Kevzara should be withheld in patients who develop a serious infection until the infection is controlled.
Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., absolute neutrophil count (ANC) less than 2 × 109/L.
Initiating treatment with Kevzara is not recommended in patients with a platelet count below 150 × 103/µL.
Recommended dose modifications in case of neutropenia, thrombocytopenia, or liver enzyme elevations (see sections 4.4 and 4.8):
Low Absolute Neutrophil Count (see section 5.1):
| Lab Value (cells x 109/L) | Recommendation |
|---|---|
| ANC greater than 1 | Current dose of Kevzara should be maintained. |
| ANC 0,5-1 | Treatment with Kevzara should be withheld until >1 × 109/L. Kevzara can then be resumed at 150 mg every 2 weeks and increased to 200 mg every 2 weeks as clinically appropriate. |
| ANC less than 0,5 | Treatment with Kevzara should be discontinued. |
Low Platelet Count:
| Lab Value (cells x 103/µL) | Recommendation |
|---|---|
| 50 έως 100 | Treatment with Kevzara should be withheld until >100 × 103/µL. Kevzara can then be resumed at 150 mg every 2 weeks and increased to 200 mg every 2 weeks as clinically appropriate. |
| Less than 50 | If confirmed by repeat testing, treatment with Kevzara should be discontinued. |
Liver Enzyme Abnormalities:
| Lab Value | Recommendation |
|---|---|
| ALT >1 to 3 x Upper Limit of Normal (ULN) | Clinically appropriate dose modification of concomitant DMARDs should be considered. |
| ALT >3 έως 5 x ULN | Treatment with Kevzara should be withheld until < 3 x ULN. Kevzara can then be resumed at 150 mg every 2 weeks and increased to 200 mg every 2 weeks as clinically appropriate. |
| ALT >5 x ULN | Treatment with Kevzara should be discontinued. |
If a dose of Kevzara is missed and it has been 3 days or less since the missed dose, the next dose should be administered as soon as possible. The subsequent dose should be administered at the regularly scheduled time. If it has been 4 days or more since the missed dose, the subsequent dose should be administered at the next regularly scheduled time, the dose should not be doubled.
No dose adjustment is required in patients with mild to moderate renal impairment. Kevzara has not been studied in patients with severe renal impairment (see section 5.2).
The safety and efficacy of Kevzara have not been studied in patients with hepatic impairment, including patients with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serology (see section 4.4). Elderly: No dose adjustment is required in patients over 65 years of age (see section 4.4).
The safety and efficacy of Kevzara in children up to 18 years of age have not been established. No data are available.
Subcutaneous use.
The total content (1.14 ml) of the pre-filled syringe/pre-filled pen should be administered as a subcutaneous injection. Injection sites (abdomen, thigh and upper arm) should be rotated with each injection. Kevzara should not be injected into skin that is tender, damaged, or has bruises or scars.
A patient may self-inject Kevzara or the patient’s caregiver may administer Kevzara if their healthcare professional determines that it is appropriate. Proper training should be provided to patients and/or caregivers on the preparation and administration of Kevzara prior to use.
For further details on administration of this medicinal product see section 6.6.
There are limited data available on overdose with Kevzara. There is no specific treatment for Kevzara overdose. In the event of an overdose, the patient should be closely monitored, treated symptomatically, and supportive measures instituted as required.
Shelf life: 2 years.
Once removed from the refrigerator, Kevzara should be administered within 14 days and should not be stored above 25°C.
Store in a refrigerator (2°C-8°C). Do not freeze.
Store pre-filled syringe/pre-filled pen in the original carton in order to protect from light.
All presentations contain a 1.14 ml solution in a syringe (type 1 glass) equipped with a stainless steel staked needle and an elastomer plunger stopper.
Pre-filled syringe 150 mg: The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a light-orange polypropylene finger flange.
Pre-filled syringe 200 mg: The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a dark-orange polypropylene finger flange.
Pre-filled pen 150 mg: The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and light-orange cap.
Pre-filled pen 200 mg: The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and dark-orange cap.
Pack sizes:
Not all pack sizes may be marketed.
The pre-filled syringe/pre-filled pen should be inspected before use. The solution should not be used if it is cloudy, discoloured, or contains particles, or if any part of the device appears to be damaged.
After removing the pre-filled syringe/pre-filled pen from the refrigerator, it should be allowed to reach room temperature (<25°C) before injecting Kevzara. Comprehensive instructions for the administration of Kevzara in a pre-filled syringe/pre-filled pen are given in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. After use, place the pre-filled syringe/pre-filled pen into a puncture-resistant container and discard as required by local regulations. Do not recycle the container. Keep the container out of sight and reach of children.
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