Consumer medicine information

Angiomax 250 mg Powder for injection

Bivalirudin

BRAND INFORMATION

Brand name

Angiomax

Active ingredient

Bivalirudin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Angiomax 250 mg Powder for injection.

1. Why am I using ANGIOMAX®?


ANGIOMAX® contains the active ingredient bivalirudin. ANGIOMAX® is is a medicine that stops blood clotting. It helps prevent unwanted blood clotting during an “angioplasty”.
For more information, see Section 1. Why am I using ANGIOMAX®? in the full CMI.

2. What should I know before I use ANGIOMAX®?


Do not use if you have ever had an allergic reaction to bivalirudin 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 use ANGIOMAX®? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with ANGIOMAX® 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 do I use ANGIOMAX®?

  • Your doctor will give you ANGIOMAX® into a vein as an injection and/or as a continuous infusion.

More instructions can be found in Section 4. How do I use ANGIOMAX®? in the full CMI.

5. What should I know while using ANGIOMAX®?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using ANGIOMAX®.
  • If you are taking warfarin, your doctor may do some blood clotting tests after your treatment with ANGIOMAX®.
Things you should not do
  • Do not give ANGIOMAX® to anyone else, even if they appear to have the same condition as you.
Looking after your medicine
  • ANGIOMAX® is usually stored in the clinic.
  • ANGIOMAX® will be stored below 25°C.
  • After ANGIOMAX® powder has been dissolved, the doctor will use the solution as soon as possible.
  • DO NOT FREEZE. Do not place in a freezer or freezing compartment of a refrigerator.

For more information, see Section 5. What should I know while using ANGIOMAX®? in the full CMI.

6. Are there any side effects?


ANGIOMAX® (like other anticoagulants), may have unwanted or excessive bleeding as a side effect.
If any of the following happen, tell your medical or nursing staff immediately. (If you have been discharged from hospital, go to accident and emergency at your nearest hospital)

  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • tightness of the chest, wheezing
  • itchiness or hives

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.

BRAND INFORMATION

Brand name

Angiomax

Active ingredient

Bivalirudin

Schedule

S4

 

1 Name of Medicine

Bivalirudin.

2 Qualitative and Quantitative Composition

Each vial contains: 250 mg bivalirudin present as bivalirudin trifluoroacetate (salt) hydrate, 125 mg mannitol, and sodium hydroxide (lyophilised product) as a powder for injection.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Angiomax (bivalirudin) is available as a sterile, lyophilised product in single-use, glass vials.
250 mg Angiomax powder for injection when reconstituted with 5 mL WFI yields a 50 mg/mL solution.

4 Clinical Particulars

4.9 Overdose

Symptoms. Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of bivalirudin have been reported in clinical trials and in postmarketing reports. A number of reported overdoses were due to failure to adjust the infusion dose of bivalirudin in patients with renal dysfunction including persons on haemodialysis (see Section 4.2 Dose and Method of Administration).
Bleeding as well as deaths due to haemorrhage, have been observed in some reports of overdose.
Treatment. Contact the Poisons Information Centre on 131 126 for advice on overdosage management.
In case of overdosage, Angiomax should be discontinued and the patient should be closely monitored for signs of bleeding.
Discontinuation of Angiomax leads to a gradual reduction in anticoagulant effects due to metabolism of the drug.
There is no known antidote to Angiomax.
Angiomax is haemodialysable.
Approximately 25% bivalirudin is cleared by haemodialysis.
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. In vitro, bivalirudin displayed no genotoxic potential in the bacterial cell reverse mutation assay (Ames test), the Chinese hamster ovary cell forward gene mutation test (CHO/HGPRT), the human lymphocyte chromosomal aberration assay, and the rat hepatocyte unscheduled DNA synthesis (UDS) assay. Bivalirudin displayed no genotoxic potential in the in vivo rat micronucleus assay.
Carcinogenicity. No long-term studies in animals have been performed to evaluate the carcinogenic potential of Angiomax.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Angiomax (bivalirudin) is a specific and reversible direct thrombin inhibitor. Bivalirudin is a synthetic, 20 amino acid residue peptide. Its chemical name is D-phenylalanyl- L-prolyl- L-arginyl- L-prolyl -glycyl-glycyl -glycyl-glycyl-L- asparagyl-glycyl -L-aspartyl-L -phenylalanyl-L-glutamyl -L-glutamyl-L -isoleucyl-L-prolyl -L-glutamyl-L-glutamyl-L-tyrosyl -L-leucine. Its molecular weight is 2,180 daltons. The substance isolated from the synthesis and used in the manufacture of Angiomax is bivalirudin trifluoroacetate (salt) hydrate.
Chemical structure.
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7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.