Consumer medicine information

Boxed Warnings

Warning: serious meningococcal infections. Ultomiris increases the risk of meningococcal infections.
Life-threatening meningococcal infections/sepsis have occurred in patients treated with Ultomiris. Meningococcal infection may become rapidly life-threatening or fatal if not recognised and treated early (see Section 4.4 Special Warnings and Precautions for Use).
Immunise patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Ultomiris, unless the risks of delaying Ultomiris therapy outweigh the risk of developing a meningococcal infection (see Section 4.4 Special Warnings and Precautions for Use for additional guidance on the management of the risk of meningococcal infection).
Refer to the most current edition of the Australian Immunisation Handbook for meningococcal vaccination guidelines.
Patients who initiate Ultomiris treatment less than 2 weeks after receiving meningococcal vaccination must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. Patients should be advised about the signs and symptoms of meningococcal infection and to seek medical care immediately if they occur.

1 Name of Medicine

Ravulizumab rch.

2 Qualitative and Quantitative Composition

Ultomiris is a formulation of ravulizumab rch which is a long acting humanised monoclonal IgG2/4K antibody produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology.
Ultomiris is supplied as a single use vial containing 100 mg/mL (300 mg in 3 mL or 1100 mg in 11 mL) of ravulizumab rch.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrated solution for intravenous infusion.
Ultomiris 100 mg/mL is a translucent, clear to yellowish colour, pH 7.4 solution.

4 Clinical Particulars

4.9 Overdose

No case of overdose has been reported to date.
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 studies have been conducted to assess the genotoxic potential of ravulizumab rch.
Carcinogenicity. No studies have been conducted to assess the carcinogenic potential of ravulizumab rch.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSRAVULI.gif CAS number. CAS registry number: 1803171-55-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ULTMIRST.gif