Mfd. by :- Regeneron Pharmaceuticals and Sanofi (Fulfilled By : Magicine Pharma)
Magicine Pharma is registered with the Government Of NCT, India, Ministry Of Health in Government of Delhi, India, registration number DL-RAJ-122372 and as a wholesale distributor, department file No. 44208.
Brand name - Kevzara
Generic name - Sarilumab
Manufacturer - Sanofi US and Regeneron
Salt composition - Sarilumab
Storage - Store in a refrigerator (2ºC - 8ºC)
Dosage form - Injection
Strength - 150mg/1.14mL and 200mg/1.14mL
Packaging - 2 single-dose pre-filled syringes
Gender - Unisex
Indication - Used in the treatment of adult patients with moderately to severely active rheumatoid arthritis
Kevzara (Sarilumab) is an interleukin-6 (IL-6) receptor antagonist used in the treatment of adult patients with moderately to severely active rheumatoid arthritis, who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). Sarilumab is usually used after other treatments have failed.
Sarilumab is a human monoclonal antibody (IgG1 subtype) that binds to both soluble and membrane-bound IL-6 receptors (IL-6Rα), and works to inhibit IL-6-mediated signalling which involves ubiquitous signal-transducing glycoprotein 130 (gp130) and the Signal Transducer and Activator of Transcription-3 (STAT-3). In functional human cell-based assays, Sarilumab was able to block the IL-6 signalling pathway, measured as STAT-3 inhibition, only in the presence of IL-6. IL-6 is a pleiotropic cytokine that stimulates diverse cellular responses such as proliferation, differentiation, survival, and apoptosis and can activate hepatocytes to release acute-phase proteins, including C-reactive protein (CRP) and serum amyloid A. Elevated levels of IL-6 are found in the synovial fluid of patients with rheumatoid arthritis. They play an important role in both the pathologic inflammation and joint destruction which are hallmarks of RA. IL-6 is involved in diverse physiological processes such as migration and activation of T-cells, B-cells, monocytes, and osteoclasts leading to systemic inflammation, synovial inflammation, and bone erosion in patients with RA. The activity of sarilumab in reducing inflammation is associated with laboratory changes such as decrease in ANC and elevation in lipids.
Following single-dose subcutaneous (SC) administration of sarilumab 200 mg and 150 mg in patients with RA rapid reduction of CRP levels was observed. Levels were reduced to normal as early as 4 days after treatment initiation. Following single-dose sarilumab administration, in patients with RA, ANC decreased to the nadir between 3 to 4 days and thereafter recovered towards baseline. Treatment with Sarilumab resulted in decreases in fibrinogen and serum amyloid A, and increases in haemoglobin and serum albumin.
The active ingredient in Kevzara is Sarilumab. The inactive ingredients are Histidine, Arginine, Polysorbate 20, Sucrose and Water for injections.
Kevzara (Sarilumab) is used in the treatment of adult patients with moderately to severely active rheumatoid arthritis.
Contraindicated in case of hypersensitivity to the active and inactive ingredients of the medicine.
Fever
Body ache
Sweating
Pain or burning when you urinate
Diarrhea
Stomach ache
Weight loss
Ongoing stomach ache
Change in bowel habits
Skin rash
Skin redness
Chills
Unusual tiredness
Painful urination
Shortness of breath
Coughing with red or pink mucus
Use Sarilumab exactly as directed by your healthcare provider. Do not increase or decrease the dose, unless your healthcare provider tells you.
Do not double the dose to compensate for the missed dose. Consult your healthcare provider for supportive guidance.
There is no specific treatment for Sarilumab overdose. Please consult your healthcare provider for proper supportive measures.
Make sure to tell your doctor if you have or ever had:
A chronic infection
HIV
A weak immune system
Liver disease
Kidney disease
Stomach or intestinal ulcers
Kidney disease
Cancer
Scheduled vaccine
Do not receive a "live" vaccine while using Kevzara. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).
Q1- What is Kevzara?
A- Kevzara (Sarilumab) is used in the treatment of adult patients with moderately to severely active rheumatoid arthritis.
Q2- How should I take Kevzara injection?
A- Take Kevzara (Sarilumab) exactly as your healthcare provider tells you.
Q3- What are the possible side effects of Sarilumab?
A- There can be side effects such as fever, body ache, sweating, skin rash, skin redness, diarrhea, weight loss, stomach ache, painful urination and shortness of breath. Please consult your healthcare provider if you experience these or any other side effects.
Q4- In what strength is Kevzara available?
A- Sarilumab is available in the strength of 150mg/1.14mL and 200mg/1.14mL.
Q5- What happens if I miss a dose?
A- Please consult your healthcare provider in such a case. Do not double the dose to catch up the missed dose.
Q6- What should I avoid while consuming this medicine?
A- Avoid consumption of alcohol.
Q7- What are self care tips?
A- Note all the side effects or changes you observe and tell your healthcare provider for proper assistance.
Q8 Can I take this medicine during pregnancy?
A- Kevzara should be used in pregnancy only if the potential benefit justifies the potential risk to the developing baby.
Q9- Can I drive after taking Sarilumab?
A- Sarilumab may cause drowsiness. Avoid driving and operating heavy machines if you experience such side effects.
Q10- What are the storage conditions?
A- Store in a refrigerator (2ºC - 8ºC). Do not freeze. Store in original cartons to protect from light. Keep out of the reach of children.
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