Patient Medication Information: uses, side effects, how to take - Eribulin Mesylate Injection (DR Reddy's Laboratories)
ABOUT THIS MEDICATION
What the medication is used for:
Eribulin Mesylate Injection is a cancer medicine. It is sold by prescription. It is used to treat:
- breast cancer that has spread to other parts of the body. It is used when you have had two or more cancer drug treatment plans to treat your breast cancer that has spread.
Eribulin Mesylate Injection is used to treat adult patients with a type of cancer that starts in fat cells called liposarcoma.
Eribulin Mesylate Injection is used if you:
- can't have an operation to take the cancer out and have liposarcoma that is advanced or has spread to other parts of the body. And,
- have had other drugs to treat this.
What it does:
Eribulin Mesylate Injection is an anti-cancer agent which works by stopping the growth of cancer cells.
When it should not be used:
Do not use Eribulin Mesylate Injection if you are allergic to eribulin mesylate, or halichondrin B, or any drug related to halichondrin B.
What the medicinal ingredient is:
Eribulin mesylate
What the non-medicinal ingredients are:
dehydrated alcohol, hydrochloric acid, sodium hydroxide, water for injection.
What dosage forms it comes in:
Eribulin Mesylate Injection contains 1 mg eribulin mesylate per vial in 2 mL of solution.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Eribulin Mesylate Injection should be prescribed and managed by a doctor experienced in the use of cancer drugs. Serious side effects with Eribulin Mesylate Injection include:
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BEFORE you use Eribulin Mesylate Injection talk to your doctor or pharmacist about all of your medical conditions, including if you:
- have low white blood cell counts or low platelet levels
- have a fever (temperature above 38.1°C) or an infection
- have heart problems including “prolongation of the QT interval” (changes in heartbeat)
- experience numbness, tingling or burning in your hands and feet
- have liver or kidney problems
are pregnant or plan to become pregnant. You should not receive Eribulin Mesylate Injection during pregnancy because it may harm your unborn baby. Talk with your health professional about how to prevent pregnancy while receiving Eribulin Mesylate Injection, as you should use effective contraception during and for at least 3 months after receiving Eribulin Mesylate Injection. Tell your health professional right away if you become pregnant or think you are pregnant while receiving Eribulin Mesylate Injection
- are breast feeding. It is not known if eribulin mesylate passes into breast milk. Breast feeding must be avoided.
Eribulin Mesylate Injection may cause drowsiness or tiredness. Do not drive or operate machinery until you know how the medication affects you.
The safety and effectiveness of eribulin mesylate in patients under 18 years of age have not been established.
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INTERACTIONS WITH THIS MEDICATION
Tell your doctor before taking Eribulin Mesylate Injection if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Eribulin mesylate may interact with the following medications;
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PROPER USE OF THIS MEDICATION
Usual dose: 1.4 mg/m2 body surface area given as an injection into the vein over 2 to 5 minutes on Days 1 and 8 of a 21-day treatment cycle. Overdose: |
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| If you think you, or a person you are caring for, have taken too much Eribulin Mesylate Injection, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include: Very common side effects
| Common side effects
Eribulin Mesylate Injection can cause abnormal blood test results. These include changes in bone marrow function tests (white blood cell count, red blood cell count and platelet count), salt levels in the blood (including potassium, calcium, magnesium, phosphorus and sodium), liver enzymes (called AST, ALT, and alkaline phosphatase), protein, bile pigment (bilirubin) and other blood tests such as blood sugar and lactate dehydrogenase (LDH). Your doctor will decide when to perform test and will interpret the results. |
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Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional |
| Stop taking drug and get immediate medical help |
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Tiredness | ✓ | ||
| Hair loss | ✓ | ||
| Nausea, vomiting, constipation | ✓ | ||
Peripheral neuropathy: Numbness, tingling, or burning in hands and feet | ✓ | ||
| Diarrhea | ✓ | ||
| Urinary tract infection: fever, chills, burning, pain or difficulty urinating | ✓ | ||
Peripheral edema: Swelling of hands, feet, or limbs | ✓ | ||
| Belly pain or bloating | ✓ | ||
COMMON Febrile neutropenia: Infection (fever, chills, cough) when your white blood cell count is low. | ✓ | ||
| Thrombocytopenia (low numbers of platelets that are in the blood. These cells help blood to clot): bruising or taking longer to stop bleeding. | ✓ | ||
| Muscle spasms or weakness | ✓ | ||
| Prolongation of the QT interval: Changed heart beat | ✓ | ||
| Dehydration: feeling thirsty, tired, lightheaded, dry mouth, dark coloured urine and passing urine less often than normal. | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and |
| get immediate medical help |
| Only if severe | In all cases | ||
| Hyperglycaemia (high blood sugar): passing urine a lot, thirst and hunger. | ✓ | ||
| Pulmonary embolism (blood clot on the lung): chest pain, shortness of breath, coughing up blood. | ✓ | ||
UNCOMMON Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing. | ✓ | ||
| Hepatotoxicity (liver damage): belly pain, yellowing of the skin or whites of the eyes, itching. Nausea, vomiting and loss of appetite. | ✓ | ||
| Renal failure (kidneys not working): causing tiredness, not passing urine, swelling in the legs, confusion. | ✓ | ||
| Deep vein thrombosis (blood clot in the leg): pain, swelling, redness in the leg. | ✓ | ||
RARE Pancreatitis (inflammation of the pancreas): severe pain in the upper part of the belly with nausea and vomiting. | ✓ | ||
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This is not a complete list of side effects. For any unexpected effects while taking Eribulin Mesylate Injection, contact your doctor or pharmacist.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional |
| Stop taking drug and get immediate medical help |
| Only if severe | In all cases | ||
| Disseminated intravascular coagulation (DIC): a serious disorder of blood clotting resulting in the widespread formation of blood clots and internal bleeding. | ✓ | ||
| Sudden death | |||
| Serious Skin Reactions (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis): any combination of red itchy rash with blisters and peeling of the skin and /or of the lips, eyes, mouth, nasal passages or genitals. It often goes with fever, chills, headache, cough, body aches or joint pain. You may have dark urine, yellow skin or eyes. | ✓ | ||
| Atrial fibrillation (irregular heart beat): dizziness, palpitations, racing heartbeat. | ✓ | ||
| Pneumonia: productive cough, chest pain, difficulty breathing, fever. | ✓ | ||
| Sepsis that can lead to death: fever with a racing heartbeat, rapid shallow breathing, cold, pale, clammy or mottled skin and / or confusion. | ✓ | ||
UNKNOWN FREQUENCY Interstitial lung disease: Breathing problems including persistent cough and / or shortness of breath. | ✓ | ||
HOW TO STORE IT
Store the vials in their original cartons. Store up to 25°C with excursions permitted to 30°C. Do not freeze.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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MORE INFORMATION
If you want more information about Eribulin Mesylate Injection:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.drreddys.com, or by calling 1-855-845-1739.