Patient Medication Information: uses, side effects, how to take - Bendamustine Hydrochloride for Injection (Eugia Pharma)
Serious Warnings and Precautions
Bendamustine Hydrochloride for Injection should not be used in patients with serious infections. Possible serious side effects with Bendamustine Hydrochloride for Injection include:
- serious infections, which can lead to death.
- other types of cancers.
- decreased production of blood cells. This is called myelosuppression. It may make you feel tired or bleed more easily. It may also you more likely to get an infection.
- serious heart problems, which can lead to death.
- serious skin reactions that can lead to death.
What is Bendamustine Hydrochloride for Injection used for?
Bendamustine Hydrochloride for Injection is used to treat adults with:
Relapsed indolent B-cell non-Hodgkin lymphoma (NHL), whose disease
- worsened after treatment with rituximab, or
- did not respond to previous treatment with rituximab.
- Chronic lymphocytic leukemia (CLL) that has not been previously treated.
How does Bendamustine Hydrochloride for Injection work?
Bendamustine Hydrochloride for Injection has been shown to cause cell death. The exact way in which Bendamustine Hydrochloride for Injection kills cells is not completely understood.
What are the ingredients in Bendamustine Hydrochloride for Injection?
Medicinal ingredients: Bendamustine hydrochloride
Non-medicinal ingredients: Mannitol
Bendamustine Hydrochloride for Injection comes in the following dosage forms:
Powder: 25 mg / vial and 100 mg / vial
Do not use Bendamustine Hydrochloride for Injection if:
you are allergic to bendamustine hydrochloride or to any of the other ingredients in
Bendamustine Hydrochloride for Injection including mannitol.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Bendamustine Hydrochloride for Injection. Talk about any health conditions or problems you may have, including if you:
- have any heart problems or high blood pressure
- have any infection including HIV or hepatitis B virus (HBV)
- have kidney or liver problems
- are planning to have a vaccine
- are under 18 years of age. Bendamustine Hydrochloride for Injection has not been shown to be effective in these patients.
Other warnings you should know about:
Bendamustine Hydrochloride for Injection may also cause:
- Extravasation. This happens when the drug leaks from the vein into the surrounding tissue. Your healthcare professional will monitor your infusion site for signs of extravasation after you have been given Bendamustine Hydrochloride for Injection.
Tumor lysis syndrome (TLS). This is caused by the sudden, rapid death of cancer cells.
You may be recommended to drink more fluids during your treatment and may need to have blood tests done.
- Liver problems, which can include the reactivation of a previous HBV infection.
- Infusion reactions and anaphylaxis. If you experience swelling of the face, lips or tongue, difficulty breathing, rash, or fainting, you may be having a reaction. If this happens, you may need to take other medications before your next Bendamustine Hydrochloride for Injection treatment. If the reaction is severe, your treatment may be discontinued.
- Other cancers including non-melanoma skin cancer.
- Changes in the rhythm of the heart. This is called QTc prolongation.
- Progressive multifocal leukoencephalopathy. This is a brain infection.
See the Serious Side Effects and What to do About them Table below, for information on these and other serious side effects.
Pregnancy and breastfeeding information for women:
- If you are pregnant or are planning to get pregnant, there are specific risks you should discuss with your healthcare professional.
- Taking Bendamustine Hydrochloride for Injection during pregnancy is not recommended. It can harm an unborn baby.
Avoid becoming pregnant while you are using Bendamustine Hydrochloride for
Injection. You should use an effective type of birth control before and during your treatment. Start using this birth control 2 weeks before receiving Bendamustine Hydrochloride for Injection. Continue using it until at least 4 weeks after your last dose.
- If you become pregnant or think you are pregnant during your treatment, tell your healthcare professional right away.
- It is not known if Bendamustine Hydrochloride for Injection passes into breastmilk. If you are breastfeeding or planning to breastfeed, you and your healthcare professional will talk about whether you should use Bendamustine Hydrochloride for Injection or breastfeed. You should not do both.
Fertility and pregnancy information for men:
- Bendamustine Hydrochloride for Injection may affect your ability to father a child.
Avoid fathering a child while you are using Bendamustine Hydrochloride for Injection.
You should use an effective type of birth control before and during your treatment. Start using this birth control 2 weeks before your first treatment and continue until at least 4 weeks after your last dose.
- If your sexual partner becomes pregnant, or thinks she is pregnant, during your treatment, contact your healthcare professional right away.
Tests and check-ups:
- You will need to have blood tests before and during your treatment. The results of these blood tests will help to tell your healthcare professional if you are experiencing some side effects. They will also show how Bendamustine Hydrochloride for Injection is affecting your blood, liver, kidneys and heart.
- If you have a history of heart problems, you may also need to have electrocardiograms during your treatment.
- Your healthcare professional will check your skin during your treatment.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Bendamustine Hydrochloride for Injection:
It is not known whether Bendamustine Hydrochloride for Injection interacts with other drugs as this has not been tested; however, the following may interact with Bendamustine Hydrochloride for Injection:
- A medicine used to treat bacterial infections called ciprofloxacin;
- A medicine used to treat depression called fluvoxamine;
- A medicine used to treat heartburn called omeprazole; and
- Smoking.
How to take Bendamustine Hydrochloride for Injection:
Bendamustine Hydrochloride for Injection will be given to you by a healthcare professional. The Bendamustine Hydrochloride for Injection powder is first mixed into a solution. This solution is then given to you through a vein in your arm. This is called an intravenous (IV) infusion.
Usual dose: The dose you will receive will depend on your disease and will be measured based
on your height and weight.
Relapsed indolent non-Hodgkin lymphoma: 120 mg/m2 by IV infusion over 60 minutes. Bendamustine Hydrochloride for Injection is given on days 1 and 2 of each 21-day cycle. For this condition, you will receive Bendamustine Hydrochloride for Injection for up to 8 cycles.
Chronic lymphocytic leukemia (CLL): 100 mg/m2 given by IV infusion over 30 minutes. Bendamustine Hydrochloride for Injection is given on days 1 and 2 of each 28-day cycle. For this condition, you will receive Bendamustine Hydrochloride for Injection for up to 6 cycles.
Your healthcare professional may lower your dose of Bendamustine Hydrochloride for Injection or stop your treatment for a short time. This can happen if you experience side effects. If you have CLL, your healthcare professional may also decide to increase your dose of Bendamustine Hydrochloride for Injection.
Overdose:
If you think you, or a person you are caring for, have taken too much Bendamustine Hydrochloride for Injection, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
Bendamustine Hydrochloride for Injection should be given on a fixed schedule. If you miss an appointment, call your doctor for instructions.
What are possible side effects from using Bendamustine Hydrochloride for Injection?
These are not all the possible side effects you may have when taking Bendamustine Hydrochloride for Injection. If you experience any side effects not listed here, tell your healthcare professional.
- fatigue
- constipation
Bendamustine Hydrochloride for Injection can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and | |
| Only if severe | In all cases | get | |
| immediate medical | |||
| help | |||
| COMMON | |||
| Dehydration (when body does not have enough fluids): feeling thirsty, dry mouth, headache, dark yellow urine | √ | ||
| Hypertension (high blood pressure): severe headache, | √ | ||
| fatigue or confusion | |||
| Hyperuricemia (high blood level of uric acid): Severe pain in your joints or redness and swelling in your joints | √ | ||
| Hypokalemia (low blood level of potassium): muscle twitches, cramps or weakness or muscles that will not move | √ | ||
| Infections: fever, chills, nausea, vomiting, diarrhea, generally feeling unwell | √ | ||
| Nausea and vomiting | √ | ||
| New fever or temperature higher than 38ºC | √ | ||
| Severe or worsening rash or itching | √ | √ | |
| Myelosuppression (low blood cell counts): Shortness of breath, significant fatigue, bleeding, fever or other signs of infection | √ | ||
| Pulmonary fibrosis (scarring of the lung): difficulty breathing, cough, fatigue | √ | ||
| Pneumonia (infection in the lungs): cough, shortness of breath | √ | ||
| Kidney failure (severe kidney problems): confusion; itchiness or rashes; puffiness in your face and hands; swelling in your feet or ankles; urinating less or not at all; weight gain | √ | ||
| Cancer (development of abnormal cells that divide uncontrollably). Symptoms may include but are not limited to: weight loss, fatigue, night sweats, loss of appetite, coughing up blood or a cough that does not go away, fever, frequent or severe infections, bone pain | √ | ||
| UNCOMMON | |||
| Allergic reaction including serious reactions (anaphylaxis) and infusion reactions: Skin reactions such as rash or itching, facial swelling, or difficulty breathing during or soon after infusion | √ | √ |
| QTc Prolongation (a heart rhythm condition): irregular heartbeat, fainting, loss of consciousness, seizure | √ | ||
| Tumor Lysis Syndrome (the sudden, rapid death of cancer cells): Lack of urination, severe muscle weakness, heart rhythm disturbances and seizures | √ | √ | |
| Diarrhea | √ | ||
| RARE | |||
| Extravasation (leakage of drug from the vein after administration): redness, swelling, pain, infection at the site of infusion | √ | ||
Severe Skin Reactions (including Stevens- Johnson Syndrome, Toxic epidermal necrolysis and drug reaction with eosinophilia): Severe or worsening itching, intense redness, formation of hives, blisters or ulcers with either fever, joint pain, or a general unwell feeling. Can lead to death. | √ | √ | |
| Heart Failure: Chest pain, dizziness, fatigue, rapid breathing, shortness of breath, swelling of the feet or legs. | √ | √ | |
Myocardial infarction (heart attack): Pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light headedness, clammy skin, sweating, indigestion, anxiety. | √ | √ | |
| Liver Injury: Pain in the right abdomen, fever, fatigue, weakness, loss of appetite, jaundice, yellow color in the eyes, dark urine. | √ | √ | |
| VERY RARE | |||
Progressive multifocal leukoencephalopathy (a rare brain infection): memory loss, trouble thinking, difficulty walking or sight loss. | √ | √ | |
| Non-melanoma skin cancer: lumps | √ | ||
| or discoloured patches on the skin | |||
Nephrogenic diabetes insipidus (disorder of water balance): Extreme thirst, frequent urination of pale urine, frequent urination during the night | √ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspectedside effects associatedwith the use of healthproducts to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health- canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manageyour side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Your healthcare professional will store Bendamustine Hydrochloride for Injection at 15-30°C. It will be kept in the original package until time of use to protect it from light.
Your healthcare professional will keep Bendamustine Hydrochloride for Injection out of reach and sight of children.
If you want more information about Bendamustine Hydrochloride for Injection:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-ca na da/services /drugs-health-products/drug- products/drug-product-data base.html ; the manufacturer’s website http://www.eugia.ca , or by calling 1-855-648-6681.