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What HALAVEN is and what it is used for
HALAVEN is an anticancer agent that acts by stopping the growth and spread of cancer cells.
It is used for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the initial tumor) when at least two other treatments have been tried but have exhausted their effects.
2. What you need to know before you use HALAVEN
Do not use HALAVEN:
if you are allergic to eribulin mesylate or any of the other ingredients of this medicine (listed in section 6);
if you are breast-feeding.
Warnings and precautions
Talk to your doctor or nurse before using HALAVEN:
if you have liver problems;
if you have a fever or infection;
if you have a feeling of numbness, tingling, pricking, touching sensation or muscle weakness;
if you have heart problems.
If you get any of these conditions, tell your doctor who may wish to stop treatment or reduce the dose.
Other medicines and HALAVEN
Tell your doctor if you are using or have recently used or are likely to use other medicines.
Pregnancy, breastfeeding and fertility
HALAVEN can cause serious birth defects and should not be used if you are pregnant unless it is judged to be absolutely necessary after discussing all the risks for you and the baby. It can also cause persistent future male fertility problems if they accept it and they should discuss this with their doctor before starting treatment. Women of childbearing potential should use effective contraception during treatment with HALAVEN and up to 3 months thereafter.
HALAVEN should not be used during breast-feeding because of a possible risk to the child.
Driving and using machines
HALAVEN can cause side effects such as tiredness (very common) and dizziness (often). Do not drive or use machines if you feel tired or dizzy.
HALAVEN contains small amounts of ethanol (alcohol)
This medicine contains small amounts of ethanol (alcohol) less than 100 mg in one vial.
3. How to use HALAVEN
HALAVEN will be given by your doctor or nurse as an injection into a vein for 2 to 5 minutes. The dose you receive is based on your body surface area (expressed in square meters or m2), which is calculated by weight and height. The usual dose of HALAVEN is 1.23 mg / m 2 but it can be adjusted by your doctor based on your blood tests or other factors.
How often will you receive HALAVEN?
HALAVEN is usually given on Days 1 and 8 of each 21-day cycle. Your doctor will determine how many treatment cycles you should receive. Depending on the results of your blood tests, the doctor may delay the administration of the product until the blood tests are normalized. The doctor may also decide to lower the dose you receive.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Very common side effects (reported in at least 1 in 10 patients) are:
Reducing the number of white or red blood cells;
Fatigue and weakness;
Nausea, vomiting, constipation, diarrhea;
Feelings of numbness, tingling and bitching;
Elevated body temperature;
Loss of appetite;
Joint and muscle pain;
Common side effects (reported in at least 1 in 100 patients) are:
Decrease in platelet count (which may lead to bruising or prolonged bleeding);
Infection with fever, chills;
Accelerated heart rate, redness;
Increased tearing, conjunctivitis (redness and inflammation of the surface of the eye), bleeding from the nose;
Dehydration, dry mouth, mouth ulcers, oral candidiasis, indigestion, heartburn, aching or abdominal swelling;
Swelling of soft tissues, pain (especially in the chest, back and bone pain), muscle spasms or weakness;
Infections of the mouth, the airways and the urinary tract;
Sore throat, red, inflamed or runny nose, flu-like symptoms;
Deviations in functional liver function, altered sugar, phosphate, potassium or magnesium levels in the blood;
Inability to sleep, depression, changed taste;
Difficulty breathing, cough, sore throat;
Rash, itching, swelling and numbness of the hands and feet, nail problems, dry or red skin;
Enhanced sweating (including night sweats).
Uncommon side effects (reported in less than 1 in 100 patients) are:
Severe infections with blood poisoning (sepsis), herpes zoster, herpes zoster;
Noise in the ears;
High levels of bilirubin in the blood;
Local swelling of the skin;
Renal insufficiency, blood or protein in the urine, urinary pain.
Rare side effects (reported in less than 1 in 1000 patients) are:
Inflammation of the pancreas.
Reporting of side effects
If any of the side effects gets serious, tell your doctor or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How to store HALAVEN
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you are not using. These measures will help to protect the environment.
6. Package Contents and Additional Information
What HALAVEN contains
The active substance is eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg of eribulin.
The other ingredients are ethanol and water for injections, with very small amounts of hydrochloric acid and sodium hydroxide being present.
What HALAVEN looks like and contents of the pack
HALAVEN is a clear, colorless, aqueous solution for injection supplied in glass vials containing 2 ml of the solution.
Each carton contains either 1 or 6 vials.
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