Kevzara Injection
Sarilumab
200mg/Pen
Sanofi Aventis Groupe
| Pack size | 2 Pre-Filled Pens |
|---|---|
| Dispensing mode | POM |
| Source | FRANCE |
| Agent | AL ITTIHAD DRUG STORE |
| Retail Price | 4211.00 AED |
Available as:
Indications
Kevzara Injection is used for:
Rheumatoid Arthritis
Adult Dose
Rheumatoid Arthritis
Indicated for adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to ?1 disease-modifying antirheumatic drugs (DMARDs)
200 mg SC q2wk
May be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate: No dose adjustment required
Severe: Not studied
Administration
SC Preparation
Remove from refrigerator and allow to sit at room temperature for 30 minutes (prefilled syringes) or 60 minutes (prefilled pen) y
Visually inspect syringe for particulate matter and discoloration prior to administration
Solution should be clear and colorless to pale yellow; do not use if the solution is cloudy, discolored, or contains particles, or if any part of the prefilled syringe appears to be damaged
SC Administration
Patient may self-inject or the patient's caregiver may administer after properly instructed
Instruct patients to inject the full amount in the syringe (1.14 mL), which provides 200 mg or 150 mg
Rotate injection sites with each injection; do not inject into skin that is tender, damaged, or has bruises or scars
Do not rub the injection site
Contra Indications
Documented hypersensitivity to drug or inactive ingredients
Precautions
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported
GI perforations reported in clinical studies, primarily as complications of diverticulitis; GI perforation risk may be increased with concurrent diverticulitis or concomitant use of NSAIDs or corticosteroids
Immunosuppression may result in an increased risk of malignancies
Hypersensitivity reactions reported
Not recommended with active hepatic disease or hepatic impairment
Pregnancy-Lactation
Pregnancy
Limited human data in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage
Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester
Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed in utero
From the animal data, and consistent with the mechanism of action, levels of IgG, in response to antigen challenge, may be reduced in the fetus/infant of treated mothers
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Avoid coadministering with biological DMARDs (eg, TNF antagonists, IL-1R antagonists, antiCD20 monoclonal antibodies, JAK inhibitors, selective costimulation modulators) because of increased risk for immunosuppression and infection
Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections
Adverse Effects
Side effects of Sarilumab :
>10%
ALT >ULN to ≤3 x ULN (38-43%)
AST >ULN to ≤3 x ULN (27-30%)
1-10%
Neutropenia (7-10%)
ANC <1000/mm³ (4-6%)
Injection site erythema (4-5%)
Injection site pruritics (4-5%)
Upper respiratory tract infection (3-4%)
ALT >3x to 5x ULN (3-4%)
Urinary tract infection (3%)
Hypertriglyceridemia (1-3%)
Leukopenia (0.9-2%)
AST >3x to 5x ULN (1%)
ALT>5x ULN (0.7-1%)
Decreased platelet counts (0.7-1%)
<1%
ANC <500 /mm³ (0.7%)
AST>5x ULN (0.2-0.7%)
Mechanism of Action
Human monoclonal antibody that binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors
IL-6 is produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes (eg, rheumatoid arthritis)
IL-6 is a pleiotropic proinflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts
IL-6 has been shown to be involved in diverse physiological processes (eg, T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute-phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation
Note
Kevzara 200mg/Pen Injection manufactured by Sanofi Aventis Groupe. Its generic name is Sarilumab. Kevzara is availble in United Arab Emirates.
Farmaco UAE drug index information on Kevzara Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.