Details for: HALAVEN
Company: EISAI LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02377438 | HALAVEN | ERIBULIN MESYLATE | 0.5 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
Regulatory Decision Summary
Summary Safety Review - Halaven (eribulin mesylate) - Assessing the potential Risk of severe skin side effects
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
HALAVEN 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.
HALAVEN is used to treat adult patients with a type of cancer that starts in fat cells called liposarcoma.
Halaven 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
HALAVEN is an anti-cancer agent which works by stopping the growth of cancer cells.
When it should not be used
Do not use HALAVEN 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
Alcohol, hydrochloric acid, sodium hydroxide, water for injection.
What dosage form it comes in
HALAVEN contains 1.0 mg eribulin mesylate per vial in 2 mL of solution.
Warnings and precautions
Serious Warnings and Precautions
HALAVEN should be prescribed and managed by a doctor experienced in the use of cancer drugs. Serious side effects with HALAVEN include:
- Neutropenia (decrease in the number of white blood cells)
- Abnormal electrical signal of the heart called “prolongation of the QT interval” (changes in heartbeat)
- HALAVEN has not been studied in patients with severe hepatic (liver) impairment or End Stage Renal Disease (ESRD, a disease of the kidney).
BEFORE you use HALAVEN 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 an abnormal electrical signal of the heart called “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 HALAVEN during pregnancy because it may harm your unborn baby. Talk with your health professional about how to prevent pregnancy while receiving HALAVEN, as you should use effective contraception during and for at least 3 months after receiving HALAVEN. Tell your health professional right away if you become pregnant or think you are pregnant while receiving HALAVEN
- are breast feeding. It is not known if HALAVEN passes into breast milk. Breast feeding must be avoided.
HALAVEN may cause drowsiness or tiredness. Do not drive or operate machinery until you know how the medication affects you.
The safety and effectiveness of HALAVEN in patients under 18 years of age have not been established.
Interactions with this medication
Tell your doctor before taking HALAVEN if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
HALAVEN may interact with the following medications;
- drugs know to prolong the QT/QTc interval and/or cause torsade de pointes
- drugs that decrease electrolyte levels
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
Side effects and what to do about them
Possible side effects with the use of HALAVEN include:
Very common side effects (≥ 10%)
- low white or red blood cell count
- general weakness
- fever
- muscle or joint pain, bone pain
- headache
- decreased appetite
- weight loss
- shortness of breath
- cough
- blisters or sores of the inside of the mouth
- back pain
Common side effects
- dizziness, vertigo
- skin rash, itchiness
- high or low blood pressure
- anxiety, depression, trouble sleeping
- watery eyes
- dry mouth
- stomach upset, heartburn
- chills
- upper respiratory tract infections (cough, sore throat, runny nose)
- weight gain
- changed sense of taste
- numbness
- sore throat
- fast heart rate
- hoarse voice
- pain when passing urine
- sleepiness
HALAVEN 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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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. | ✔ | ||
| 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. | ✔ | ||
| 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. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking HALAVEN, contact your doctor or pharmacist.
How to store
Store up to 25°C. Excursions permitted to 30°C.
Do not freeze.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Eisai Limited, at: 1-877-873-4724.
This leaflet was prepared by Eisai Limited, Mississauga, ON L5N 7K2.
Last revised: August 4, 2017
HALAVEN® is a trademark owned by Eisai R&D Management Co., Ltd.