SUMMARY CMI
Bendamustine Sandoz®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Bendamustine Sandoz?
Bendamustine Sandoz contains the active ingredient bendamustine hydrochloride (as monohydrate). Bendamustine Sandoz is used is used for the treatment of certain types of cancer.
For more information, see Section 1. Why am I using Bendamustine Sandoz? in the full CMI.
2. What should I know before I use Bendamustine Sandoz?
Do not use if you have ever had an allergic reaction to bendamustine hydrochloride 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 Bendamustine Sandoz? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Bendamustine Sandoz 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 Bendamustine Sandoz?
- Your treatment with Bendamustine Sandoz will take place in a specialised medical unit, under the supervision of a doctor experienced in the use of cytotoxic medicinal products.
- Your doctor will decide what dose you will receive. The dose will be calculated from your height and weight. It will also depend on factors such as kidney function, liver function and other medicines you are being given.
More instructions can be found in Section 4. How do I use Bendamustine Sandoz? in the full CMI.
5. What should I know while using Bendamustine Sandoz?
| Things you should do |
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| Driving or using machines |
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| Drinking alcohol |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while using Bendamustine Sandoz? in the full CMI.
6. Are there any side effects?
You may experience serious side effects when using Bendamustine Sandoz.
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
FULL CMI
Bendamustine Sandoz®
Active ingredient(s): bendamustine hydrochloride (as monohydrate)
Consumer Medicine Information (CMI)
This leaflet provides important information about using Bendamustine Sandoz. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Bendamustine Sandoz.
Where to find information in this leaflet:
1. Why am I using Bendamustine Sandoz?
2. What should I know before I use Bendamustine Sandoz?
3. What if I am taking other medicines?
4. How do I use Bendamustine Sandoz?
5. What should I know while using Bendamustine Sandoz?
6. Are there any side effects?
7. Product details
1. Why am I using Bendamustine Sandoz?
Bendamustine Sandoz contains the active ingredient bendamustine hydrochloride (as monohydrate). Bendamustine Sandoz belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. These medicines are used to kill cancer cells.
Bendamustine Sandoz is used for the treatment of certain types of cancer.
Bendamustine Sandoz is used alone (monotherapy) or in combination with other medicines for the treatment of the following forms of cancer:
- Chronic lymphocytic leukaemia;
- Indolent, Stage III-IV Non-Hodgkin's Lymphoma and Stage III-IV Mantle Cell Lymphoma. It is prescribed for patients who have not been previously treated.
- Indolent Non-Hodgkins Lymphoma. It is prescribed for patients who have received one or more prior treatment and whose cancer is still progressing.
2. What should I know before I use Bendamustine Sandoz?
Warnings
Do not use Bendamustine Sandoz if:
- you are allergic to bendamustine hydrochloride (as monohydrate), or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
- are breast-feeding;
- have severe liver dysfunction (damage to the functional cells of the liver);
- have yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice);
- have severely disturbed bone marrow function (bone marrow depression) and serious changes in your number of white blood cells and platelets in the blood;
- have had major surgical operations less than 30 days before starting treatment;
- have an infection, especially one accompanied by a reduction in white blood cells (leukocytopaenia);
- in combination with yellow fever vaccines.
Check with your doctor if you:
- have reduced capability of the bone marrow to replace blood cells
- have infections, including fever or lung symptoms
- Have skin reaction. The reaction may increase in severity
- have heart disease (e.g. heart attack, chest pain, severely disturbed heart rhythms)
- have hepatitis B infection
- Have severe allergic or hypersensitivity reactions. You should pay attention to infusion reactions after your first cycle of Bendamustine Sandoz therapy
- have any other medical conditions
- take any medicines for any other condition
Unintentional injection into the tissue outside blood vessels (extravasal injection) should be stopped immediately. The needle should be removed after a short aspiration.
Thereafter, the affected area of tissue should be cooled. The arm should be elevated. Additional treatments like the use of corticosteroids are not of clear benefit.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Do not take this medicine and check with your doctor if you are pregnant or intend to become pregnant.
Like most medicines used to treat cancer, Bendamustine Sandoz is not recommended for use during pregnancy.
Do not breast-feed if you are using this medicine.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Your doctor can discuss with you the risks and benefits involved.
Fertility
Women of childbearing potential must use effective methods of contraception both before and during Bendamustine Sandoz therapy.
Men receiving treatment with Bendamustine Sandoz are advised not to conceive a child during treatment for up to 6 months afterwards. Before starting treatment, you should seek advice on storing sperm because of the possibility of permanent infertility.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Bendamustine Sandoz and affect how it works.
In particular, tell your doctor if you are taking any of the following:
- medicines that may result in excessive immunosuppression, such as cyclosporine or tacrolimus.
- fluvoxamine, medicines used to treat depression.
- ciprofloxacin and aciclovir, medicines use to treat infections.
- cimetidine, a medicine used to treat duodenal, gastric ulcers.
- viral vaccination.
- medicines that inhibit the formation of blood in the bone marrow.
These medicines may be affected by Bendamustine Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Bendamustine Sandoz.
4. How do I use Bendamustine Sandoz?
Your treatment with Bendamustine Sandoz will take place in a specialised medical unit, under the supervision of a doctor experienced in the use of cytotoxic medicinal products.
Treatment should not be started if your white blood cells (leukocytes) have fallen to counts below 3,000 cells/µL and/or your blood platelets have fallen to counts below 75,000 cells/µL. Your doctor will determine these values at regular intervals.
How much is given
Your doctor will decide what dose you will receive. The dose will be calculated from your height and weight. It will also depend on factors such as kidney function, liver function and other medicines you are being given.
Dose for Chronic Lymphocytic Leukaemia:
- 100 mg per square metre of your body surface area
- Cycle should be repeated after 4 weeks up to 6 times.
Dose for progressing Non-Hodgkin's Lymphoma:
- 120 mg per square metre of your body surface area on days 1 and 2
- Cycle should be repeated after 3 weeks up to 6 times
Dose for previously not treated indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma:
- 90 mg per square metre on days 1 and 2
- Cycle should be repeated after 4 weeks up to 6 cycles.
Your doctor may change the dose during treatment depending on your response.
Ask your doctor if you want to know more about the dose of Bendamustine Sandoz you receive.
How it is given
Bendamustine Sandoz will be dissolved in sterile normal sodium chloride (salt) solution for injection.
Bendamustine Sandoz is administered into a vein over 30-60 minutes in various dosages, either alone (monotherapy) or in combination with other medicines.
How long to take it
There is no time limit laid down as a general rule for treatment with Bendamustine Sandoz. Duration of treatment depends on disease and response to treatment.
If you use too much Bendamustine Sandoz
As Bendamustine Sandoz is given to you under supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience side effects after being given Bendamustine Sandoz, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Bendamustine Sandoz?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some blood, urine or other tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Keep follow-up appointments with your doctor. It is important to have your follow-up doses of Bendamustine Sandoz at the appropriate times to get the best effects from your treatment.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
Bendamustine Sandoz can lower the number of white blood cells and platelets in your blood. This means that you have an increased chance of getting an infection or bleeding. The following precautions should be taken to reduce your risk of infection or bleeding:
- Avoid people who have infections. Check with your doctor immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, lower back or side pain.
- Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist, nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work.
- Be careful not to cut yourself when you are using sharp objects such as a razor or nail cutter.
Remind any doctor, dentist or pharmacist you visit that you are using Bendamustine Sandoz.
Things to be careful of
- If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Bendamustine Sandoz affects you.
Bendamustine Sandoz may cause sleepiness, dizziness, lack of coordination or fatigue in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
- Bendamustine Sandoz will be stored in the pharmacy or on the ward.
- The injection is kept in a cool, dry place, protected from light, where the temperature stays below 25°C.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Bendamustine Sandoz will be disposed of appropriately at the pharmacy or the ward, which it is stored.
Do not use this medicine after the expiry date.
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. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
| Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
| Serious side effects | What to do |
| Tell your doctor as soon as possible if you notice any of these side effects. |
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Bendamustine Sandoz contains
| Active ingredient (main ingredient) | Bendamustine Sandoz 25 mg vial contains 25 mg of bendamustine hydrochloride equivalent to 26.1 mg bendamustine hydrochloride (as monohydrate). Bendamustine Sandoz 100 mg vial contains 100 mg of bendamustine hydrochloride equivalent to 104.6 mg bendamustine hydrochloride (as monohydrate). |
| Other ingredients (inactive ingredients) | Mannitol |
Do not take this medicine if you are allergic to any of these ingredients.
What Bendamustine Sandoz looks like
Bendamustine Sandoz is a white to off-white, freeze-dried powder in an amber glass vial with rubber stopper and an aluminium cap with flip-top.
Each pack contains one single-use vial.
Bendamustine Sandoz 25 mg vial (AUST R 337201
Bendamustine Sandoz 100 mg vial (AUST R 337202)
Who distributes Bendamustine Sandoz
Bendamustine Sandoz is supplied in Australia by:
Sandoz Pty Ltd
54 Waterloo Rd
Macquarie Park, NSW 2113
Tel: 1800 726 369
This leaflet was prepared in October 2023.
Published by MIMS November 2023
A total of 50 patients had 60 serious adverse events. Most frequently occurring serious adverse events in the bendamustine group were hypersensitivity and pneumonia (each with 3 patients) and anaemia, vomiting, pyrexia and tumour lysis syndrome (each with 2 patients). Most frequent documented serious adverse event in the chlorambucil group was herpes zoster (with 2 patients). All other events were documented only once by patient. See Table 2.
Number of adverse events possible, probable or definite related to the study medication (including missing relationship) was higher in the bendamustine arm than in the chlorambucil arm. Especially blood and lymphatic system disorders, gastrointestinal disorders and pyrexia occurred more frequently under bendamustine than under chlorambucil. See Table 3.
The most frequent adverse reactions leading to study withdrawal for patients receiving bendamustine were hypersensitivity (2%) and pyrexia (1%).
The data described below reflect exposure to bendamustine in 176 patients with indolent B-cell NHL treated in two single-arm studies (SDX-105-03 and SDX-105-01).
Haematologic toxicities, based on laboratory values and CTC grade, in NHL patients treated in both single arm studies combined are described in Table 8. Clinically important chemistry laboratory values that were new or worsened from baseline and occurred in > 1% of patients at Grade 3 or 4, in NHL patients treated in both single arm studies combined were hyperglycaemia (3%), elevated creatinine (2%), hyponatraemia (2%), and hypocalcaemia (2%).
In both studies, serious adverse reactions, regardless of causality, were reported in 37% of patients receiving bendamustine. The most common serious adverse reactions occurring in 5% of patients were febrile neutropaenia and pneumonia. Other important serious adverse reactions reported in clinical trials and/or postmarketing experience were acute renal failure, cardiac failure, hypersensitivity, skin reactions, pulmonary fibrosis, pneumonitis, pulmonary alveolar haemorrhage, and myelodysplastic syndrome.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylaxis; and injection or infusion site reactions including phlebitis, pruritus, irritation, pain, and swelling. Increases in alanine aminotransferase; aspartate aminotransferase; blood bilirubin and blood urea levels have been reported. Somnolence, atrial fibrillations and palpitations have also been reported.
Complete response is lower than noted in Table 10 - for both bendamustine and chlorambucil - if there is a requirement for imaging to confirm lymph nodes ≤ 1.5 cm.
At median follow-up of 45 months (IQR 25-57), median progression-free survival was significantly longer in the bendamustine plus rituximab group than in the R-CHOP group (69.5 months [26.1 to not yet reached] vs. 31.2 months [15.2-65.7]; hazard ratio 0.58, 95% CI 0.44-0.74; p < 0.0001).
The improvement in progression-free survival with B-R was independent of age, concentration of lactate dehydrogenase (LDH), and FLIPI score (see Table 12). Overall survival did not differ between the two treatment groups.
Progression-free survival (PFS), a secondary endpoint in this study, was comparable across all patient groups defined by baseline characteristics (see Table 14). The median PFS was 72 weeks in patients without previous alkylator therapy, and 51 weeks in patients who were sensitive to the previous alkylator therapy or chemotherapy. In the patients who had received previous radio-immunotherapy, the PFS was 53 weeks. Disease characteristics at baseline (FLIPI risk category, number of lymph nodal sites, or bulky disease) did not markedly affect duration of PFS.
Chemical formula: 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, monohydrochloride, monohydrate.