Consumer medicine information

1. Why am I receiving ANDEXXA?

ANDEXXA contains the active ingredient andexanet alfa. ANDEXXA is used to reverse the effects of certain blood thinning medications called factor Xa inhibitors (apixaban or rivaroxaban) in case of a life-threatening or uncontrolled bleeding situation.
For more information, see Section 1. Why am I receiving ANDEXXA? in the full CMI.

2. What should I know before I am given ANDEXXA?

Do not use if you have ever had an allergic reaction to ANDEXXA 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 am given ANDEXXA? in the full CMI.

3. What if I am taking other medicines?

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given ANDEXXA?

• ANDEXXA will be given to you in a hospital or clinic by a doctor or nurse.

5. What should I know while receiving ANDEXXA?

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. The most common side effects are sweating or chills (fever) and feeling hot (flushing). The more serious side effects are sudden numbness or weakness in the face, arm, or leg, especially on one side of the body (stroke), pressure, tightness, pain, or a squeezing or aching sensation in your chest or arms that may spread to your neck, jaw or back (heart-attack), rapid or irregular heartbeat, loss of consciousness or unresponsiveness (cardiac arrest), swelling, change in skin colour, trouble breathing (blood clot in the leg, arm, or lung)
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

Andexanet alfa.

2 Qualitative and Quantitative Composition

Each 20 mL vial contains 200 mg of andexanet alfa.
After reconstitution, each 1 mL of solution contains 10 mg of andexanet alfa.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for solution for infusion.
Sterile, white to-off-white lyophilised powder.
After reconstitution of the lyophilised powder with sterile water for injection the product is a clear, colourless to slightly yellow solution.

4 Clinical Particulars

4.9 Overdose

There is no clinical experience with overdose of Andexxa. No dose-limiting toxicities have been observed during clinical trials.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No animal studies were performed to evaluate the effects of andexanet alfa on genotoxicity.
Carcinogenicity. No studies were performed to evaluate the effects of andexanet alfa on carcinogenesis.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Andexanet alfa is a recombinant modified version of a human FXa protein expressed in Chinese hamster ovary (CHO) cells. The protein is a two-chain molecule comprised of a 105 amino acid light chain (approximately 12 kDa) and a 254 amino acid heavy chain (approximately 28 kDa). The chains are connected by a single inter-chain disulphide bond. Andexanet alfa has a total of 359 amino acid residues and an approximate molecular weight of 41 kDa.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSANDALF.gif CAS number. 1262449-58-0.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

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