Consumer medicine information

Vegzelma 100 mg/4 mL Concentrate for intravenous infusion

Bevacizumab

BRAND INFORMATION

Brand name

Vegzelma

Active ingredient

Bevacizumab

Schedule

S4

1. Why am I using VEGZELMA?


VEGZELMA contains the active ingredient bevacizumab. VEGZELMA is used to treat:

  • brain tumours resistant to previous treatments
  • metastatic (spreading) cancer of the large bowel (i.e. in the colon or rectum), breast or cervix in combination with chemotherapy agents
  • lung cancer and cancer of the ovaries and fallopian tubes (which can extend to the lining of surrounding organs such as stomach, liver) in combination with chemotherapy agents
  • kidney cancer (renal cell cancer) in combination with interferon therapy (Roferon-A®).

For more information, see Section 1. Why am I using VEGZELMA? in the full CMI.

2. What should I know before I use VEGZELMA?


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

3. What if I am taking other medicines?


Some medicines may interfere with VEGZELMA 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 VEGZELMA?

  • Dose depends on your body weight and the type of cancer to be treated.
  • VEGZELMA solution is prepared by a health care professional.
  • VEGZELMA is given by infusion into a vein (intravenous infusion) by a health care professional.

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

5. What should I know while using VEGZELMA?

Things you should do
  • Tell all doctors, dentists and pharmacists who are treating you that you are being treated with VEGZELMA.
  • Tell your doctor immediately if you become pregnant during treatment with VEGZELMA, or plan to start a family in the near future.
  • Tell your doctor immediately if you are breast-feeding while being treated with VEGZELMA.
  • Tell your doctor if you are planning to have surgery or you have a wound that is not healing properly.
  • Tell your doctor if you need to undergo an invasive dental treatment or dental surgery, in particular when you are also receiving or have received a bisphosphonate (for example medicines containing ibandronate sodium, zoledronic acid or disodium pamidronate)
  • Tell your doctor if you feel VEGZELMA is not helping your condition.
  • Be sure to keep all of your appointments with your doctor so that your progress can be checked.
Things you should not do
  • Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.
Driving or using machines
  • Be careful driving or operating machinery until you know how VEGZELMA affects you.
Looking after your medicine
  • VEGZELMA will be stored in the pharmacy or on the hospital ward in a refrigerator at a temperature between 2° to 8°C.

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

6. Are there any side effects?


Side effects that require urgent medical attention include: stomach cramps or pains, severe or bloody diarrhoea, bleeding from stomach or intestines which may look like coffee grounds or black sticky bowel motions (stools), nausea and vomiting; including vomiting blood or material that looks like coffee grounds, coughing or spitting blood, pain, redness, swelling and warmth over a vein which may suggest deep vein thrombosis (blood clots in the veins of legs), severe body pain including headaches, loss of control of your bladder or bowels; passage of wind or bowel motions through the vagina, severe bleeding, problems with your wounds healing after surgery, confusion, seizures (fits), feeling of numbness or tingling in hands or feet, dry mouth in combination with thirst and/or reduced or darkened urine, abscesses (pus-filled sores), falling asleep or fainting, problems with the heart with breathing difficulties, chest pain, increase in heart rate (pulse), shortness of breath.
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

Vegzelma

Active ingredient

Bevacizumab

Schedule

S4

1 Name of Medicine

Vegzelma is a biosimilar medicine to Avastin (bevacizumab). The evidence for comparability supports the use of Vegzelma for the listed indications.

2 Qualitative and Quantitative Composition

Vegzelma is available in 100 mg and 400 mg single dose vials containing 4 mL and 16 mL, respectively, of bevacizumab (25 mg/mL).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrate for solution for infusion.
Vegzelma is a clear to slightly opalescent, colourless to pale brown, sterile solution for intravenous (IV) infusion. Vegzelma is not formulated for intravitreal use (see Section 4.4, Severe eye infections following compounding for unapproved intravitreal use).

4 Clinical Particulars

4.9 Overdose

The highest dose tested in humans (20 mg/kg body weight, IV) was associated with severe migraine in several patients.
Treatment of overdose should consist of general supportive measures.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

In a 26 week pre-clinical study in cynomolgus monkeys, physeal dysplasia was observed in young animals with open growth plates, at bevacizumab average serum concentrations below the expected human therapeutic average serum concentrations.
No specific studies in animals have been performed to evaluate the effect of bevacizumab on fertility. No adverse effect on the male reproductive organ was observed in repeat dose toxicity studies in cynomolgus monkeys, but inhibition of ovarian function was observed in females. This was characterised by decreases in ovarian and/or uterine weight and the number of corpora lutea, a reduction in endometrial proliferation and an inhibition of follicular maturation in cynomolgus monkeys treated with bevacizumab. The lowest dose tested in the 26 week study (2 mg/kg weekly which corresponds to 0.6-fold the human therapeutic dose based on AUC) caused a reduction in uterine weight, however the reduction was not statistically significant. In rabbits, administration of 50 mg/kg of bevacizumab IV for 3 or 4 doses every 4 days resulted in decreases in ovarian and/or uterine weight and number of corpora lutea. The changes in both monkeys and rabbits were reversible upon cessation of treatment.
Bevacizumab has been shown to be embryotoxic and teratogenic when administered to rabbits. Observed effects included decreases in foetal body weights, an increased number of foetal resorptions and an increased incidence of specific gross and skeletal foetal alterations. Adverse foetal outcomes were observed at all tested doses. At the lowest dose tested, maternal serum AUC values were about 0.7-fold those observed in humans at the recommended clinical dose.
Carcinogenesis and mutagenesis. Studies to evaluate the carcinogenic and mutagenic potential of Vegzelma have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Bevacizumab is an immunoglobulin G (IgG) composed of two identical light chains, consisting of 214 amino acid residues and two 453 residue heavy chains containing an N-linked oligosaccharide and has a molecular weight of approximately 149,000 daltons.
CAS number. CAS 216974-75-3.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

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