Consumer medicine information

Bavencio 200 mg/10 mL Concentrate for infusion

Avelumab

BRAND INFORMATION

Brand name

Bavencio

Active ingredient

Avelumab

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Bavencio 200 mg/10 mL Concentrate for infusion.

1. Why am I using BAVENCIO?


BAVENCIO contains the active ingredient, avelumab. BAVENCIO is used to treat certain types of cancer.
For more information, see Section 1. Why am I using BAVENCIO? in the full CMI.

2. What should I know before I use BAVENCIO?


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

3. What if I am taking other medicines?


Some medicines may interfere with BAVENCIO 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 BAVENCIO?

  • Prior to the first four infusions of BAVENCIO, you will be given paracetamol and an antihistamine. For subsequent infusions, these medicines will only be given if your doctor believe this is necessary.
  • You will receive BAVENCIO as an infusion (a drip) into a vein (intravenously) over a period of 60 minutes, once every 2 weeks.

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

5. What should I know while using BAVENCIO?

Things you should do
  • Remind any doctor, nurse, dentist or pharmacist you visit that you are using BAVENCIO.
Driving or using machines
  • Treatment-related symptoms can affect your concentration and ability to react.

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

6. Are there any side effects?


Common side effects include feeling tired or weak; muscle, back, stomach area or joint pain; loose stools, vomiting, nausea, constipation; swelling in the arms, feet or legs; feeling less hungry, weight loss; cough; rash, itching, redness of the skin; fever, chills; shortness of breath; dizziness, headache; high blood pressure; low blood pressure; flushing; difficulty in speaking or breathing, hoarseness; urinary tract infection such as burning sensation when urinating, strong or frequent urge to urinate.
Serious side effects include infusion-related reactions; problems due to inflammation of your lungs (pneumonitis); problems with your liver (hepatitis or liver toxicity when used in combination with axitinib); problems with your intestines (colitis) or diarrhoea; problems with your hormone producing glands (including the thyroid, pituitary, and adrenal glands); problems with your pancreas (pancreatitis); Type 1 diabetes, including a serious, sometimes life-threatening problem due to increased acid in the blood produced from diabetes (diabetic ketoacidosis); problems with your kidneys; problems with your muscles (myositis, myasthenia gravis/myasthenic syndrome, polymyalgia rheumatica); problems with your bile ducts (sclerosing cholangitis); problems with your joints (arthritis); problems with your glands that make moisture for the body (Sjögren's syndrome); problems with your heart (myocarditis or major adverse cardiovascular events when used in combination with axitinib); problems with your eyes (uveitis); an immune system disorder that can cause nerve inflammation (Guillain-Barré Syndrome); low number of neutrophils (neutropenia).
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

Bavencio

Active ingredient

Avelumab

Schedule

S4

 

1 Name of Medicine

Avelumab.

2 Qualitative and Quantitative Composition

Each 10 mL vial contains 200 mg of avelumab.
Each mL of concentrate contains 20 mg of avelumab.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).
Clear, colourless to slightly yellow solution.

4 Clinical Particulars

4.9 Overdose

There are limited experiences with overdose with avelumab in clinical studies.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions. The treatment is directed to the management of symptoms.
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 avelumab. As a large protein molecule, avelumab is not expected to interact directly with DNA or other chromosomal material.
Carcinogenicity. No studies have been conducted to assess the carcinogenic potential of avelumab.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The solution pH is in the range of 5.0 - 5.6 and the osmolality is between 285 and 350 mOsm/kg.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAVELUM.gif Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
CAS number. 1537032-82-8.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

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