KEVZARA- sarilumab injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SARILUMAB (UNII: NU90V55F8I) (SARILUMAB - UNII:NU90V55F8I)

Available from:

sanofi-aventis U.S. LLC

INN (International Name):

sarilumab

Composition:

sarilumab 150 mg in 1.14 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KEVZARA® is indicated for 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). KEVZARA is indicated for treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. KEVZARA is contraindicated in patients with known hypersensitivity to sarilumab or any of the inactive ingredients [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)] . Risk Summary The limited human data with KEVZARA in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage. Monoclonal antibodies, such as sarilumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see Clinical Considerations) . From animal data, and consistent with the mechanism of ac

Product summary:

KEVZARA (sarilumab) injection is supplied as a colorless to pale yellow solution in a single-dose pre-filled syringes and single-dose pre-filled pens. Storage and Stability Refrigerate at 36°F to 46°F (2°C to 8°C) in original carton to protect from light. Do not freeze. Do not shake. If needed, patients/caregivers may store KEVZARA at room temperature up to 77°F (25°C) up to 14 days in the outer carton. Do not store above 77°F (25°C). After removal from the refrigerator, use KEVZARA within 14 days or discard.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

sanofi-aventis U.S. LLC
----------
MEDICATION GUIDE
KEVZARA® (KEV-ZA-RA)
(SARILUMAB)
INJECTION, FOR SUBCUTANEOUS USE
This Medication Guide has been approved by the
U.S. Food and Drug Administration
Revised: February 2023
What is the most important information I should know about KEVZARA?
KEVZARA can cause serious side effects including:
1.
Serious Infections. KEVZARA is a prescription medicine that affects
your immune system.
KEVZARA can lower the ability of your immune system to fight
infections. Some people have
serious infections while using KEVZARA, including tuberculosis (TB),
and infections caused by
bacteria, fungi, or viruses that can spread throughout the body. Some
people have died from these
infections.
Your healthcare provider should test you for TB before starting
KEVZARA.
•
Your healthcare provider should monitor you closely for signs and
symptoms of TB during
treatment with KEVZARA.
You should not start using KEVZARA if you have any kind of infection
unless your healthcare
provider says it is okay.
Before starting KEVZARA, tell your healthcare provider if you:
•
think you have an infection or have symptoms of an infection, with or
without a fever:
•
sweats or chills
•
muscle aches
•
cough
•
shortness of breath
•
blood in your phlegm
•
weight loss
•
warm, red or painful skin or sores on your
body
•
diarrhea or stomach pain
•
burning when you urinate or urinating more
often than normal
•
feeling very tired
•
are being treated for an infection.
•
get a lot of infections or have infections that keep coming back.
•
have diabetes, HIV, or a weak immune system. People with these
conditions have a higher
chance of getting infections.
•
have TB, or have been in close contact with someone with TB.
•
live or have lived, or have traveled to certain parts of the country
(such as the Ohio and
Mississippi River valleys and the Southwest) where there is an
increased chance of getting
certain fungal infections (histoplasmosis, coccidioidomycosis, or
blastomycosis). These
infection

Summary of Product characteristics

KEVZARA- SARILUMAB INJECTION, SOLUTION
SANOFI-AVENTIS U.S. LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KEVZARA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KEVZARA.
KEVZARA (SARILUMAB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2017
WARNING: RISK OF SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
SERIOUS INFECTIONS LEADING TO HOSPITALIZATION OR DEATH INCLUDING
BACTERIAL, VIRAL,
INVASIVE FUNGAL, AND OTHER OPPORTUNISTIC INFECTIONS HAVE OCCURRED IN
PATIENTS
RECEIVING KEVZARA. (5.1)
IF A SERIOUS INFECTION DEVELOPS, INTERRUPT KEVZARA UNTIL THE INFECTION
IS CONTROLLED.
(5.1)
CASES OF TUBERCULOSIS (TB) HAVE BEEN REPORTED. PRIOR TO STARTING
KEVZARA, TEST FOR
LATENT TB; IF POSITIVE, START TREATMENT FOR TB. (5.1)
CLOSELY MONITOR PATIENTS FOR SIGNS AND SYMPTOMS OF INFECTION DURING
TREATMENT WITH
KEVZARA. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1.2)
02/2023
Dosage and Administration (2.3, 2.5)
02/2023
INDICATIONS AND USAGE
KEVZARA is an interleukin-6 (IL-6) receptor antagonist indicated for
treatment of:
adult patients with moderately to severely active rheumatoid arthritis
(RA) who have had an inadequate
response or intolerance to one or more disease-modifying antirheumatic
drugs (DMARDs). (1.1)
adult patients with polymyalgia rheumatica (PMR) who have had an
inadequate response to
corticosteroids or who cannot tolerate corticosteroid taper. (1.2)
DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS FOR ADMINISTRATION
KEVZARA initiation is not recommended in patients with ANC less than
2,000/mm , platelets less than
150,000/mm or liver transaminases above 1.5 times ULN. See Full
Prescribing Information (FPI) for
complete information. (2.1)
RECOMMENDED DOSAGE IN RA
The recommended dosage is 200 mg subcutaneously, once every 2 weeks.
(2.2)
For RA, KEVZARA may be used as monotherapy or in combination with
methotrexate (MTX) or other
conventional DMARDs. (2.2)
RECOMMENDED DOSAGE IN PMR
T