2 mg/ml injection solution doxorubicin hydrochloride 

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or nurse.

– If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Doxorubicin Teva is and what it is used for 
2. What you need to know before you take Doxorubicin Teva 
3. How to use Doxorubicin Teva 
4. Possible side effects 
5. How to store Doxorubicin Teva 
6. Packaging content and other information 

1. What Doxorubicin Teva is and what it is used for

Doxorubicin Teva, which contains the active substance doxorubicin, belongs to a group of medicines called anthracyclines and is an anti-cancer medicine. The drug works by slowing down or stopping the growth of cancer cells. Doxorubicin Teva is often used in combination with other anticancer medicines.

Doxorubicin Teva can be used in the treatment of the following cancers, among others:

  • breast cancer
  • cancer of connective tissue, ligaments, bones, and muscles ( sarcoma )
  • small cell lung cancer
  • lymph node cancer ( Hodgkin’s disease and malignant non-Hodgkin’s lymphoma)
  • cancer of the blood ( acute leukemia )
  • bone marrow cancer ( myeloma )
  • cancer of the prostate or testicles
  • thyroid cancer
  • cancer of the ovaries or uterus
  • bladder cancer
  • cancer of the head/neck
  • stomach cancer
  • tumors in children such as tumors in the nerve cells ( neuroblastoma ), tumors originating from the skeletal muscles ( rhabdomyosarcoma ), and kidney tumors (Wilms tumor )

Doxorubicin hydrochloride contained in Doxorubicin Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you receive Doxorubicin Teva

You should not receive Doxorubicin Teva:

  • if you are allergic to doxorubicin, similar substances ( anthracyclines ), or any of the other ingredients of this medicine (listed in section 6).
  • if you are breast-feeding.

You should not receive Doxorubicin Teva in a blood vessel ( intravenously ):

  • if after previous cancer treatment you were told that you had a persistent decrease in the production of blood cells (ie that the bone marrow is not working properly)
  • if after a previous cancer treatment you suffered from severe inflammation or sores in the mouth
  • if your liver is not working properly
  • if you have any type of heart problem
  • if you have previously received doxorubicin or other anthracyclines you are up to the maximum total dose
  • if you suffer from any type of general infection
  • if you start to bleed easily.

You should not get Doxorubicin Teva directly in your bladder if you have:

  • a cancerous tumor that has grown into the bladder
  • urinary tract infection
  • inflammation of the bladder
  • blood in the urine
  • problems inserting the catheter (eg blockage of the urethra).

Talk to your doctor if any of the above apply to you.

Warnings and cautions

Talk to your doctor or nurse before receiving Doxorubicin Teva:

  • if you are trying to conceive, are likely to become pregnant in the future, or if you want to become a father (see also “Pregnancy, breast-feeding and fertility”)  
  • if you have or have ever had any type of heart problem
  • if you have liver or kidney problems
  • have received doxorubicin or similar anticancer medicines ( anthracyclines ) before
  • if you have previously received any type of radiation therapy

Before starting treatment and/or during treatment with Doxorubicin Teva, your doctor will perform the following tests:

  • Blood values
  • X-ray of lungs and chest
  • Functional test of heart
  • Examination of the mouth and throat to see if there are changes in the mucous membranes

Doxorubicin Teva severely reduces blood cell production in the bone marrow. It can make you more prone to infection or bleeding. Tell your doctor if you get a fever or other signs of infection or if you have any type of bleeding.

Vaccination is not recommended. Avoid contact with people who have recently been vaccinated against polio.

Your doctor will monitor your heart function during treatment due to:

  • doxorubicin can damage the heart muscle
  • doxorubicin may lead to heart failure after reaching a certain dose (adding all individual doses )

Doxorubicin Teva may make your urine red. It is not a sign of illness or medical condition.

Other medicines and Doxorubicin Teva

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

Other medicines may affect the effect of doxorubicin or the effect of other medicines may be affected by doxorubicin.

You must tell your doctor if you are taking or have recently taken:

  • other anticancer medicines (such as fluorouracil, cyclophosphamide, cytarabine, cisplatin, paclitaxel, or trastuzumab)
  • medicines for heart disease (such as calcium channel blockers and digoxin )
  • drugs that can damage the liver (such as mercaptopurine, methotrexate, and streptozocin)
  • medicines that affect the activity of your immune system (such as cyclosporine)
  • drugs for the treatment of epilepsy ( phenytoin, carbamazepine, valproate, phenobarbital, and other barbiturates )
  • medicines for infection (chloramphenicol and sulfonamides )
  • drugs that lower uric acid levels in the blood
  • live vaccines (eg against polio)
  • drugs for the treatment of heartburn and stomach ulcers (cimetidine)
  • medicines for pain and inflammation (amidopyrine derivatives)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Doxorubicin should not be used if you are pregnant. Tell your doctor immediately if you are pregnant or think you may be pregnant. Doxorubicin can cause severe birth defects if given during pregnancy. If you are pregnant, your doctor will only give you doxorubicin if the benefits of the treatment outweigh the potential risks to the unborn baby.

Precautions for men and women

Sexually active men and women should use an effective method of contraception during and up to 6 months after treatment. Women treated with Doxorubicin Teva should not become pregnant during and up to 6 months after treatment. Men treated with doxorubicin should ensure that their partner does not become pregnant during and up to 6 months after treatment.

Breast-feeding

The medicine can be passed on to the baby via breast milk. Do not breast-feed while you are being treated with Doxorubicin Teva.

Fertility

Doxorubicin can cause permanent infertility and men should therefore seek advice on storing (or freezing) semen before treatment. If you are considering having children after treatment, you should discuss it with your doctor.

Driving and using machines

Due to frequent nausea and vomiting, you are advised not to drive or use machines while receiving Doxorubicin Teva.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor if you are unsure.

Doxorubicin Teva contains sodium

This medicine contains 18 mg sodium (the main ingredient in table salt/table salt) per 5 ml vial, 35 mg sodium per 10 ml vial, 89 mg sodium per 25 ml vial, and 354 mg sodium per 100 ml vial. This corresponds to 0.9%, 2%, 4%, and 18% respectively of the highest recommended daily intake of sodium for adults.

How to use Doxorubicin Teva

Doxorubicin will be given to you under the supervision of a doctor who has experience in cancer treatment.

Intravenous administration

Dose one is usually calculated based on body surface area. Doxorubicin Teva can be given e.g. once a week, every three weeks, or at longer intervals. Dosage one and how often the medicine should be given also depends on what other cancer medicines are used and on what disease you have and your general condition. Your doctor will decide what dose to take.

Injection ( instillation ) into the bladder

Dose one is 30-50 mg doxorubicin in 25-50 ml saline solution. The injection ( installation one) can be repeated at 1 week to 1-month intervals. Your doctor will determine how often installation is needed.

Use for children and adolescents

Dosage should be reduced in children. Doctors will advise you on how much you need.

If you take more Doxorubicin Teva then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Because you will be given the medicine in a hospital, it is unlikely that you will get an overdose. However, if you have any further questions, ask your doctor or nurse immediately.

In acute overdose, side effects such as sores in the mouth, reduced white blood cell counts, and platelets can worsen and can lead to heart problems. Your doctor will take appropriate action if you have an overdose. Heart problems can occur six months after an overdose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor or healthcare professional immediately if you notice any of the following side effects:

  • Dizziness, fever, shortness of breath with chest and throat pain, or itchy rash. This can be a type of allergic reaction that can be very serious (rare side effects).
  • A burning or burning sensation at the site of administration in connection with the drug leaking from the vein to the surrounding tissue. This can lead to the death of local tissue cells and this requires treatment, in some cases surgery (rare side effect ).
  • You have a fever or other symptoms of infection. This may be a sign of decreased white blood cell count (a very common side effect ).
  • You get lighter bruises or bleeding. This may be a sign that you have platelets(a very common side effect ).
  • You feel tired and powerless. This may be a sign of anemia ( anemia, low red blood cell count ) (a very common side effect ).

Other reported side effects are:

Very common (may affect more than 1 user in 10)

  • nausea, vomiting, stomach pain, digestive problems, diarrhea
  • inflammation of the mucous membranes, e.g. in the mouth or esophagus
  • hair loss (normally transient), reddening of the skin, the skin becomes sensitive to artificial or natural light (light hypersensitivity)
  • red urine for one or two days after administration. This is normal and nothing to worry about
  • severe cardiac complications (cardiac toxicity), e.g. damage to the heart muscle or fast, slow, or irregular heartbeat. Effects may occur shortly after starting a treatment or several years later
  • fever

Common ( may  affect up to 1 in 10 people):

  • bleeding
  • cardiac arrhythmias (irregular heartbeat, faster heartbeat, slower heartbeat), decreased amount of blood pumped through the heart, impaired cardiac muscle function ( cardiomyopathy ) which can be life-threatening 
  • eating disorders ( anorexia )
  • local allergic reaction in areas treated with radiation, itching
  • difficulty urinating or pain when urinating, inflammation of the bladder after instillation into the bladder, sometimes with irritation of the bladder, blood in the urine, painful urination, more frequent urination or decreased amount of urine, cramps in the bladder

Uncommon (may affect up to 1 in 100 people):

  • acute blood cancer (certain types of leukemia )
  • bleeding in the stomach or intestines, abdominal pain, necrosis (tissue death in the colon), a severe infection of the gastrointestinal tract
  • dehydration
  • bacterial infection, including bacterial infection in the blood (blood poisoning)

Rare ( may  affect up to 1 in 1,000 people):

  • skin rash, hives
  • dark areas of skin and nails; loss of nails ( onycholysis )
  • frostbite
  • dizziness
  • injection site reactions, including redness, rash, and pain, inflammation of the vein ( phlebitis ), thickening or hardening of the vein wall (phlebosclerosis), infection and inflammation of the subcutaneous tissue, such as connective tissue

Very rare (may affect up to 1 in 10,000 people)

  • flushing
  • altered heart function (non-specific ECG changes), isolated cases of life-threatening irregular heartbeat ( arrhythmia ), heart failure, inflammation of the pericardium/heart muscle, sometimes fatal, lost nerve impulses in the heart
  • formation of blood clots in a blood vessel
  • discoloration ( pigmentation ) of the oral mucosa
  • swelling and numbness in the hands and feet (acrylic erythema ), blistering, tissue damage, especially in the hands and feet, which cause redness, swelling, blisters, stinging or burning sensation where the drug leaks into the tissue (palmar-plantar erythrodysesthesia syndrome)
  • acute renal failure
  • abnormally high levels of uric acid or urate in the blood
  • missed periods, hot flashes
  • fertility problems in men (few or no sperm in semen)
  • elevated levels of uric acid in the blood
  • ulcers of the mucous membranes of the mouth, pharynx, esophagus, stomach, or intestines
  • gastric ulcer

Has been reported (occurs in an unknown number of users)

  • oily, hairless, or scaly skin spots ( actinic keratosis )
  • temporarily elevated liver values
  • liver toxicity that can sometimes lead to chronic liver tissue damage ( cirrhosis )
  • severe pain and swelling in the joints
  • increased tear flow
  • inflammation of the conjunctiva of the eye, inflammation of the cornea of ​​the eye (the outermost membrane of the eye)
  • difficulty breathing due to sudden narrowing of the airways
  • radiation damage (to the skin, lungs, pharynx, esophagus, gastrointestinal mucosa, heart) that may recur after administration of doxorubicin
  • pneumonia
  • feeling weak

5. How to store Doxorubicin Teva

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C-8 ° C).

Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

6. Contents of the packaging and other information

Content declaration

  • The active substance is doxorubicin hydrochloride 2 mg/ml
  • The other ingredients are sodium chloride, hydrochloric acid, and water for injections

What the medicine looks like and the contents of the pack

Doxorubicin Teva solution for injection is a clear, red, particle-free liquid.

Pack size: 5 ml, 10 x 5 ml, 10 ml, 10 x 10 ml, 25 ml, 10 x 25 ml, 100 ml and 5 x 100 ml vials.

Not all pack sizes may be marketed.

Muhammad Nadeem

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