Consumer medicine information

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?

6. Are there any side effects?

Side effects that require urgent medical attention include: Signs of an allergic reaction, such as chest tightness, difficulty breathing, swelling of face lips and tongue, rash; signs of heart failure, such as shortness of breath on exertion or lying down, swelling of the feet; signs suggesting a blood disorder, such as persistent fever, bruising, bleeding, paleness.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Adalimumab (rch).

2 Qualitative and Quantitative Composition

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, Section 5.1 Pharmacodynamic Properties, Clinical trials; Section 4.8 Adverse Effects (Undesirable Effects)). The evidence for comparability supports the use of Hyrimoz for the listed indications.
Presentations contain 80 mg adalimumab per 0.8 mL (100 mg/mL), 40 mg adalimumab per 0.8 mL (50 mg/mL) or 40 mg adalimumab per 0.4 mL (100 mg/mL), and 20 mg adalimumab per 0.2 mL (100 mg/mL).
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 or 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

4.9 Overdose

The maximum tolerated dose of adalimumab has not been established in humans. No dose-limiting toxicities have been observed during clinical trials with adalimumab. Multiple doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No genotoxicity was observed in an in vitro test for bacterial gene mutation or in an in vivo mouse micronucleus test for clastogenicity.
Carcinogenicity. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of adalimumab.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

CAS number. 331731-18-1.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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