HYRIMOZ adalimumab 40 mg solution for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Adalimumab, Quantity: 40 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; mannitol; sodium hydroxide; citric acid monohydrate; water for injections; hydrochloric acid; polysorbate 80; adipic acid

Administration route:

Subcutaneous

Units in package:

6 pre-filled syringes containing 0.8mL solution, 1 pre-filled syringe containing 0.8mL solution, 2 pre-filled syringes containing 0.8mL solution

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rheumatoid Arthritis HYRIMOZ? is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,HYRIMOZ? can be used alone or in combination with methotrexate.,Juvenile Idiopathic Arthritis Polyarticular Juvenile Idiopathic Arthritis HYRIMOZ? in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). HYRIMOZ? can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,Enthesitis-Related Arthritis HYRIMOZ? is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,Psoriatic Arthritis HYRIMOZ? is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.,Ankylosing Spondylitis HYRIMOZ? is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,Crohn?s Disease in Adults and Children (?6 years) HYRIMOZ? is indicated for the treatment of moderate to severe Crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab.,Ulcerative colitis HYRIMOZ? is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see section 5.1 Clinical trials).,Psoriasis in Adults and Children HYRIMOZ? is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. HYRIMOZ? is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,Hidradenitis Suppurativa in Adults and Adolescents (from 12 years of age) HYRIMOZ? is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,Uveitis HYRIMOZ? is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Product summary:

Visual Identification: Colourless to slightly yellowish solution. Clear to slightly opalescent.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 30 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:

2019-03-01

Patient Information leaflet

HYRIMOZ
®
1
HYRIMOZ
®
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 HYRIMOZ?
Hyrimoz contains the active ingredient adalimumab. Hyrimoz is used to
treat various inflammatory conditions.
For more information, see Section 1. Why am I using Hyrimoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HYRIMOZ?
Do not use if you have ever had an allergic reaction to Hyrimoz or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE IF HE/SHE IS NOT
AWARE THAT 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
Hyrimoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Hyrimoz and affect how it works, or
Hyrimoz may interfere with other medicines and
affect how they work.
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 HYRIMOZ?
Hyrimoz is injected under the skin (subcutaneous).
More instructions can be found in Section 4. How do I use Hyrimoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING HYRIMOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Hyrimoz.
•
Keep all your appointments, including for blood tests.
•
Tell your doctor if you develop an infection or you notice new or
changed spots on your skin.
•
Tell your doctor if you are scheduled for any vaccines.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dose unless your doctor
tells you to.
DRIVING OR USING
MACHINES
•
BE careful before you drive or use any machines until you know how
Hyrimoz affects you. The effects
on your ability to drive or use machines whilst taking Hyrimoz is not
known.
DRINKING
ALCOHOL
•
There is no information on t

Summary of Product characteristics

Page 1 of 73
AUSTRALIAN PRODUCT INFORMATION – HYRIMOZ
® (ADALIMUMAB)
SOLUTION FOR SUBCUTANEOUS INJECTION
1
NAME OF THE MEDICINE
Adalimumab (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.8 mL single use pre-filled syringe contains 40 mg of adalimumab
Each 0.8 mL single use pre-filled pen contains 40 mg of adalimumab
HYRIMOZ (adalimumab) is a recombinant human immunoglobulin (IgG1)
monoclonal antibody
containing
only
human
peptide
sequences.
Adalimumab
is
produced
by
recombinant
DNA
technology in a mammalian cell expression system. It consists of 1330
amino acids and has a
molecular weight of approximately 148 kilodaltons.
HYRIMOZ (adalimumab) is a biosimilar medicine to HUMIRA
®
.
The
comparability
of
HYRIMOZ
with
HUMIRA
has
been
demonstrated
with
regard
to
physicochemical characteristics and efficacy and safety outcomes [see
Section 5 Pharmacological
Properties, 5.1 Pharmacodynamic properties - Clinical trials and 4.8
Adverse Effects]. The evidence
for comparability supports the use of HYRIMOZ for the listed
indications.
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Solution for injection.
HYRIMOZ is supplied as a sterile, preservative-free solution of
adalimumab for subcutaneous
administration. The solution of HYRIMOZ is colourless to slightly
yellowish as well as clear to
slightly opalescent and isotonic with a pH of 5.2. The drug product is
supplied as either a single-use
pre-filled glass syringe, or as a single use, pre-filled pen
(SensoReady
®
pen). Enclosed within the pen
is a single-use, pre-filled glass syringe.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS
HYRIMOZ is indicated for reducing signs and symptoms, as well as
inhibiting the progression of
structural damage in adult patients with moderate to severely active
rheumatoid arthritis. This includes
the treatment of patients with recently diagnosed moderate to severely
active disease who have not
received methotrexate.
HYRIMOZ can be used alone or in combination with