Consumer medicine information

1. Why am I given SUGAMMADEX VIATRIS?

SUGAMMADEX VIATRIS contains the active ingredient sugammadex (as sodium). SUGAMMADEX VIATRIS is used to speed up recovery of your muscles after an operation.
For more information, see Section 1. Why am I give SUGAMMADEX VIATRIS? in the full CMI.

2. What should I know before I am given SUGAMMADEX VIATRIS?

You may already have been given SUGAMMADEX VIATRIS Injection. Your doctor will have considered the situation carefully and decided to use it.
You must not be given SUGAMMADEX VIATRIS if you have ever had an allergic reaction to sugammadex or any of the ingredients listed at the end of the CMI.
For more information, see Section 2. What should I know before I am given SUGAMMADEX VIATRIS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SUGAMMADEX VIATRIS 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 is SUGAMMADEX VIATRIS given?

The doctor will work out the dose of SUGAMMADEX VIATRIS you need based on your weight and how much muscle relaxant is still affecting you

• The usual dose is 2 - 4 mg per kg body weight. A dose of 16 mg per kg can be used only in adults if urgent recovery from muscle relaxation is needed.

• The dose of SUGAMMADEX VIATRIS for children and adolescents between 2-17 years old is 2 mg per kg.

5. What should I know while given SUGAMMADEX VIATRIS?

6. Are there any side effects?

Like all medicines, SUGAMMADEX VIATRIS can cause side effects, but not everyone gets them.
If the side effects occur while you are under anaesthetic, they will be seen and treated by your anaesthetist.
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

Sugammadex (as sodium).

2 Qualitative and Quantitative Composition

Sugammadex Viatris 200 mg/2 mL solution for injection vial contains 200 mg sugammadex (as sodium) in 2 mL solution.
Sugammadex Viatris 500 mg/5 mL solution for injection vial contains 500 mg sugammadex (as sodium) in 5 mL solution.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sugammadex Viatris 200 mg/2 mL and 500 mg/5 mL are clear and colourless to slightly yellow solution for injection. The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg.

4 Clinical Particulars

4.9 Overdose

In clinical studies, 1 case of an accidental overdose with 40 mg/kg was reported without any significant side effects. In a human tolerance study sugammadex was well tolerated in doses up to 96 mg/kg. Sugammadex can be removed using haemodialysis with a high flux filter. Based upon clinical studies, sugammadex concentrations in plasma are reduced with a high flux filter by about 70% after a 3-6 hour dialysis session.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

Pharmacotherapeutic group: all other therapeutic products, ATC code: V03AB35.

5.3 Preclinical Safety Data

Genotoxicity. Sugammadex was not genotoxic in in vitro tests for bacterial reverse mutation and chromosomal aberrations in human lymphocytes, and in in vivo micronucleus tests for clastogenicity.
Carcinogenicity. Carcinogenicity studies were not done given the intended single-dose use of sugammadex and given the absence of genotoxic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Sugammadex sodium is a white to off-white powder. It is soluble at room temperature in water, normal saline and 5% mannitol in water.
Molecular formula: C₇₂H₁₀₄O₄₈S₈Na₈.
Molecular mass: 2178.01 g/mol.
Chemical name: octakis (6-S-(2-carboxyethyl)-6-thio) cyclomaltooctaose octasodium salt.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSUGAMM.gif CAS number. 343306-79-6.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

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