NEPEXTO etanercept 50 mg/1 mL solution for injection auto-injector

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Etanercept, Quantity: 50 mg

Available from:

Maxx Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; glycine; sucrose; sodium citrate dihydrate; monobasic sodium phosphate dihydrate

Administration route:

Subcutaneous

Units in package:

1 and 4

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Nepexto is indicated for the treatment of:,Adults,Rheumatoid Arthritis,Active, adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Nepexto can be used in combination with methotrexate.,Severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease.,Psoriatic Arthritis,The signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. Etanercept has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.,Plaque Psoriasis,Adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.,Ankylosing Spondylitis,The signs and symptoms of active ankylosing spondylitis in adults.,Non-Radiographic Axial Spondyloarthritis,Treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change who have had an inadequate response to NSAIDs.,* Active disease is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >= 4.,Children and Adolescents,Children and adolescents weighing less than 62.5 kg should not receive Nepexto. These patients should be accurately dosed on a mg/kg basis with other etanercept products.,Juvenile Idiopathic Arthritis,Active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more DMARDs.,Active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.,Active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy.,Active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.,Etanercept has not been studied in children aged less than 2 years.,Paediatric Plaque Psoriasis,Chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant Psoriasis Area and Severity Index (PASI) response is not achieved.

Product summary:

Visual Identification: Clear to opalescent, colourless to yellow solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-09-14

Patient Information leaflet

NEPEXTO
®
1
NEPEXTO®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NEPEXTO?
NEPEXTO contains the active ingredient etanercept. NEPEXTO is used to
treat specific types of joint inflammation and skin
conditions, namely rheumatoid arthritis, juvenile idiopathic
arthritis, ankylosing spondylitis, non-radiographic axial
spondyloarthritis (nr-AxSpA), psoriatic arthritis and plaque
psoriasis.
For more information, see Section 1. Why am I using NEPEXTO?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NEPEXTO?
Do not use if you have ever had an allergic reaction to etanercept or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
NEPEXTO?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NEPEXTO and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE NEPEXTO?
•
NEPEXTO is given in adults either once a week as a 50 mg dose, or as
two separate 25 mg doses 3-4 days apart.
•
NEPEXTO should only be administered in children and adolescents
weighing 62.5 kg or more. The dose and frequency
depend on weight and the disease.
•
NEPEXTO is injected under the skin and is for single use in one
patient only. Refer to Instructions for Use provided in the
pack.
More instructions can be found in Section 4. How do I use NEPEXTO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NEPEXTO?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using NEPEXTO.
•
Tell your doctor if you have latex allergies.
•
Ensure children are up to date with vaccinations prior to starting
NEPEXTO.
•
Tell your doctor if you are at risk o

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
NEPEXTO
®
_Etanercept solution for injection _
1
NAME OF THE MEDICINE
Etanercept
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NEPEXTO is a biosimilar medicine to Enbrel
®
. The evidence for comparability supports the use of NEPEXTO
for the listed indications.
Each NEPEXTO auto-injector contains 50 mg of etanercept.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SOLUTION FOR INJECTION
NEPEXTO solution for injection in the auto-injector is a clear to
opalescent, colourless to yellow solution
with a pH of 6.1-6.5. The osmolality of the solution is 310 ± 30
mOsm/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NEPEXTO is indicated for the treatment of:
_ADULTS _
Rheumatoid Arthritis
Active, adult rheumatoid arthritis (RA) in patients who have had
inadequate response to one or more disease-
modifying antirheumatic drugs (DMARDs). NEPEXTO can be used in
combination with methotrexate.
Severe, active rheumatoid arthritis in adults to slow progression of
disease-associated structural damage in
patients at high risk of erosive disease.
Psoriatic Arthritis
The signs and symptoms of active and progressive psoriatic arthritis
in adults, when the response to previous
disease-modifying antirheumatic therapy has been inadequate.
Etanercept has been shown to reduce the rate
of progression of joint damage as measured by X-ray and to improve
physical function.
Plaque Psoriasis
Adult patients with moderate to severe chronic plaque psoriasis, who
are candidates for phototherapy or
systemic therapy.
Ankylosing Spondylitis
The signs and symptoms of active ankylosing spondylitis in adults.
Non-Radiographic Axial Spondyloarthritis
Treatment of adults with active* non-radiographic axial
spondyloarthritis with objective signs of inflammation
as indicated by elevated C-reactive protein (CRP) and/or MRI change
who have had an inadequate response
to NSAIDs.
* Active disease is defined as a Bath Ankylosing Spondylitis Disease
Activity Index (BASDAI) score of ≥