How does it work?
Pharmorubicin injection solution contains the active ingredient epirubicin, which is a type of anticancer chemotherapy medicine used to treat cancer. (NB. Epirubicin is also available without a brand name, ie as the generic medicine.) Epirubicin is a type of chemotherapy medicine called a cytotoxic anthracycline antibiotic.
Cancers form when cells within the body multiply abnormally and uncontrollably. These cells spread, destroying nearby tissues. Epirubicin works by stopping the cancer cells from multiplying. Its exact mechanism of action is unknown but it seems to work by inhibiting cell growth.
Epirubicin inserts itself into the strands of genetic material (DNA) inside the cancerous cells and binds them together. This prevents the cells from making genetic material (DNA and RNA) and proteins. This prevents the cells from growing and they therefore die.
Unfortunately, epirubicin can also affect normal, healthy cells, particularly those that multiply quickly, such as blood cells and hair cells. The most important side effect is on the bone marrow, where blood cells are made. Epirubicin decreases the production of normal healthy blood cells, which can leave people susceptible to infection. Regular blood tests are needed to monitor the levels of blood cells.
In most chemotherapy regimens, doses are administered in courses at various intervals to allow normal cells to recover from the adverse effects of the anticancer medicines between doses. However, during this period, cancer cells will also recover and start to replicate again. Successful treatment depends on the administration of the next course of therapy before the cancer has re-grown to its previous size and the net effect is to decrease the amount of cancer with each successive course.
Epirubicin is used principally in combination with other anticancer medicines. It is usually administered by injection or drip (infusion) into a vein. It is also sometimes given intravesically (into the bladder) for bladder cancer.
What is it used for?
- Cancer of the lymph nodes (lymphoma).
- Cancer of the blood (leukaemia).
- Cancer of the bone marrow (multiple myeloma).
- Various other types of cancers, including lung, breast, ovarian, stomach and colorectal cancers.
- The medicine can also be administered directly into the bladder to treat superficial bladder cancer, and to prevent its recurrence in people who have had surgery for bladder cancer.
- Chemotherapy medicines can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
- This medicine may be harmful to an unborn baby, and for this reason you should use effective contraception to avoid becoming pregnant or fathering a child during treatment. You should continue to use contraception to prevent pregnancy for at least a few months after stopping treatment with this medicine. Discuss this with your doctor. Women should consult their doctor immediately if they get pregnant during treatment.
- Your ability to get pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.
- Your heart, liver and kidney function should be monitored before and during treatment with this medicine.
- This medicine can cause severe reactions such as blistering and ulceration of the skin if it leaks out of the vein while it is being administered (extravasation). It is important to tell the person administering your medicine if you notice any leakage of fluid from your cannula site, or any burning or stinging around the vein while the medicine is being given.
Use with caution in
- People who are having or have recently had radiotherapy treatment in the area of the chest cavity.
- People who have had treatment with other medicines that may have side effects on the heart, eg other anthracycline chemotherapy medicines.
- Heart disease.
- Decreased liver function.
Not to be used in
When given into a vein, this medicine should not be used in:
- People with acute infections.
- People with a severe reduction in blood cell production in the bone marrow, resulting in low levels of white blood cells or platelets in the blood (for example due to radiotherapy or previous courses of chemotherapy).
- People with severely decreased liver function.
- People with severe heart failure or disorders of the heart muscle.
- People who have recently had a heart attack.
- People with unstable angina or severe irregular heartbeats (arrhythmias).
When administered directly into the bladder for bladder cancer this medicine should not be used in:
- People with urinary tract infections.
- People with inflammation of the bladder (cystitis).
- People with invasive tumours that are penetrating into the bladder.
- People with blood in their urine.
- People in whom there are problems inserting a catheter.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine should not be used in pregnancy, unless considered essential by your doctor due to life-threatening disease, because it is likely to be harmful to a developing baby.
- Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment and for at least a few months after treatment is finished. Seek further medical advice from your doctor.
- It is not known if this medicine passes into breast milk, however if it does, it is likely to be harmful to a nursing infant. Mothers who need treatment with this medicine should not breastfeed. Seek medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Very common (affect more than 1 in 10 people)
- Decrease in the number of white blood cells in the blood (leukopenia and neutropenia).
- Decrease in the number of red bloods cell in the blood (anaemia).
- Hair loss (alopecia).
- Red discoloration of urine (this is due to the colour of the medicine and is normal - it should lats for one or two days only).
Common (affect between 1 in 10 and 1 in 100 people)
- Loss of appetite.
- Hot flushes.
- Nausea and vomiting.
- Inflammation of the lining of the mouth (stomatitis).
- Inflammation of the mucous membranes in the intestinal tract (mucositis).
- Reaction at site of injection such as redness.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Decrease in the number of platelets in the blood (thrombocytopenia).
- Inflammation of the wall of a vein (phlebitis).
Rare (affect between 1 in 1000 and 1 in 10,000 people)
- Elevated uric acid levels in the blood.
- Nettle-type rash (urticaria).
- Stopping of menstrual bleeding.
- Decreased sperm production.
- Feeling weak or tired.
- Alteration in results of liver function tests.
- Problems with your heart, such as heart failure, irregular heartbeats, fast or slow heartbeat.
- Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).
- Formation of blood clots in the blood vessels (thromboembolism).
- Blood clot in the lung (pulmonary embolus).
- Problems with the eyes such as conjunctivitis.
- Change in the colour of nails
- Skin reactions such as rash, itching, redness, photosensitivity and changes in pigmentation.
Only a small amount of epirubicin is absorbed into the blood after administration into the bladder. The side effects listed above are rare with bladder treatment.
Burning sensations and a frequent need to pass urine are commonly reported when the medicine is used in the bladder. Occasionally, it may also cause inflammation of the bladder (cystitis), sometimes with bleeding. Tell your doctor straight away if you notice any blood in your urine after having this treatment for bladder cancer.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines during treatment this one, to ensure that the combination is safe.
There may be an increased risk of side effects if this medicine is used in combination with other anticancer medicines.
There is a higher risk of side effects on the heart if this medicine is used in combination with other medicines that can affect the heart, in particular the anti-cancer medicine trastuzumab. Your doctor will want to monitor your heart function more frequently if this is the case.
Cimetidine increases the blood levels of epirubicin and should not be taken while having treatment with this medicine.
Chemotherapy decreases the body's immune response. This means that vaccines may be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. If live vaccines are needed they should be postponed until at least six months after finishing chemotherapy.
Other medicines containing the same active ingredient
Epirubicin injection is also available without a brand name, ie as the generic medicine.