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Doxorubicin Hydrochloride

Doxorubicin Hydrochloride 10 mg and 50 mg Powder for Injection

Doxorubicin Hydrochloride1. What Doxorubicin Hydrochloride Powder for Injection is and what it is used for

Doxorubicin Hydrochloride Powder for Injection is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Doxorubicin is used in the treatment of certain types of cancer, for example, cancers of the blood (leukaemia), breast, soft tissue, bone, lung and bladder. It is also used in the treatment of some cancers in children. Doxorubicin is often given with other anti-cancer medicines.

2. Before you use Doxorubicin Hydrochloride Powder for Injection

Do not use Doxorubicin Hydrochloride Powder for Injection

•    if you have shown signs of hypersensitivity (severe allergy) to doxorubicin or any of the other ingredients mentioned in section 6, in the past

•    if your bone marrow is not making enough blood cells (your doctor will check for this using blood tests)

•    if after your last dose you had a burning sensation in your mouth or mouth ulcers

Tell your doctor if any of the above applies to you before this medicine is used.

Take special care with Doxorubicin Hydrochloride Powder for Injection

•    if you have any heart problems

•    if you have liver problems

•    if the levels of cells in your blood become low (your doctor will check this)

•    if you have received or are going to have radiation therapy

Tell your doctor if any of the above applies to you before this medicine is used.

Taking/using other medicines

Special care is needed if you are taking/using other medicines as some could interact with doxorubicin; for example:

•    the toxicity of other anti-cancer medicines may be increased by the use of doxorubicin e.g. blood in the urine with cyclophosphamide and liver damage with 6-mercaptopurine

•    the combination of ciclosporin (a medicine used to reduce the activity of the body’s immune system) and doxorubicin may increase the risk of nervous system side effects

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

  • Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine.

Due to the risk of birth defects, women of childbearing potential should use appropriate contraception methods during treatment with doxorubicin.

Ask your doctor or pharmacist for advice before taking any medicine.

  • Driving and using machines

Do not drive or use machines if you experience any side effect (e.g. drowsiness) which may lessen your ability to do so.

3. How to Use Doxorubicin Hydrochloride Powder for Inject

This medicine is given by injection into a vein, by infusion (drip) into an artery or by instillation (using a catheter) into the bladder.

  • Dose

Your doctor will work out the correct dose of Doxorubicin Hydrochloride Powder for Injection for you and how often it must be given.

The dose of medicine given to you will depend upon your medical condition, your age, size, blood cell levels, how well your liver is working and whether you are receiving any other anti-cancer medicines. Your doctor will check your blood cell levels and tell how well your liver is working using blood tests.

If you are to be given an instillation of this medicine directly into the bladder, you may be told by your doctor not to drink any fluids for 12 hours before treatment. After the installation you may be asked to change your position frequently to ensure that the medicine comes into contact with all areas of the bladder.

If you are given too much or too little Doxorubidn Hydrochloride Powder for Injection

This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

4. Possible Side Effects

Like all medicines, Doxorubicin Hydrochloride Powder for Injection can have side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:

•    severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

•    chest pain

•    pain at the injection site during or immediately after the injection

These are serious side effects. You may need urgent medical attention.

If any of the following happen, tell your doctor as soon as possible:

The following side effects are more common:

•    unexpected bruises or bleeding, or symptoms of an infection e.g. fever, chills or achiness (these problems may occur up to 3 weeks after your last treatment)

•    painful burning sensation in the mouth, throat or oesophagus (food-pipe). It often develops 5 to 10 days after treatment. The vagina and back passage may also be affected. Ulcers may form which can become infected. It normally gets better after 10 days. It is often worse if you have had radiation treatment to these areas before.

•    abnormally fast heart beat

•    skin problems (possibly a skin infection affecting the face, neck or legs; the affected area may be hot, tender and red)

•    pain or redness of the blood vessels

•    inflammation of a vein or red streaking along a vein near the injection site

•    reddening of the face (if the injection has been given too quickly)

•    hair loss

•    dehydration (feeling thirsty)

•   feeling or being sick

•    diarrhoea

•    red coloured urine

The following side effects are less common:

•    itchy skin rash (hives)

•    paleness due to anaemia

•    conjunctivitis (red, sore and itchy eyes)

•    drowsiness

•    loss of appetite

•    unusual colouration of the nail beds and skin creases (seen in children)

As doxorubicin may affect your heart, your doctor may do tests to monitor your heart function before starting treatment and during or after treatment. Problems with your heart may occur even years after stopping doxorubicin treatment.

Doxorubicin may lead to changes in your blood cells. Your doctor will take blood samples to monitor for these and also to check how well your liver and kidneys are working. Leukaemia (abnormalities of the white blood cells) has been reported when doxorubicin has been given together with some other cancer treatments.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

  • Effects on fertility

Men and women taking this medicine may become infertile. In women, ovulation and menstruation (periods) should return once treatment is stopped. If you have any questions about the effects of this medicine on the chances of you having a baby, ask your doctor.

5. How to store Doxorubicin Hydrochloride Powder for Injection

Keep out of the reach and sight of children

  • Expiry

This medicine must not be used after the expiry date which is stated on the vial label and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month.

  • Storage

Keep the vial in the outer carton, in order to protect from light, and store at or below 25°C.

Unused portions of opened vials must not be stored for later use.

Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 21 days provided they have been prepared in a way to exclude microbial contamination.

6. Further Information

What Doxorubicin Hydrochloride Powder for Injection contains

The active ingredient is doxorubicin hydrochloride. After reconstitution, each millilitre (ml) of solution contains 2 milligrams (mg) of doxorubicin hydrochloride.

The other ingredient is lactose monohydrate.

What Doxorubicin Hydrochloride Powder for Injection looks like and contents of the pack

Doxorubicin Hydrochloride Powder for Injection is an orange-red powder for solution for injection (a powder which is made into a solution before being injected). It comes in glass containers called vials.

It may be supplied in packs containing:

•    1 x 10 mg vial

•    1 x 50 mg vial

Doxorubicin Hydrochloride 10 mg and 50 mg Powder for Injection

The following information is intended for medical or healthcare professionals only

Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.

Incompatibilities

Doxorubicin should not be mixed with heparin since it has been reported that these drugs are incompatible to the extent that a precipitate may form. Until specific compatibility data are available, it is not recommended that doxorubicin be mixed with other drugs.

Reconst’rrution and dilution

Single use only

Discard any unused contents

The contents of the vial should be reconstituted with Water for Injection, sodium chloride 0.9%, or dextrose 5% to a solution concentration of 2 mg doxorubicin hydrochloride per ml.

Chemical and physical in-use stability following reconstitution in either sodium chloride 0.9% or Water for Injections in glass or polypropylene containers has been demonstrated for up to 21 days at 2-8°C. From a microbiological point of view, however, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours when stored at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Cytotoxic Handling Guidelines

Doxorubicin is a potent cytotoxic agent which should only be prescribed, prepared and administered by professionals who have been trained in the safe use of the preparation. The following guidelines should be followed when handling, preparing and disposing of doxorubicin.

Preparation: Reconstitution of powder, transfer to syringes or infusion bags should be carried out in designated areas, preferably a laminar flow station.

Personnel must be adequately protected with suitable clothing, gloves, mask and eye shield.

Pregnant women should be excluded from handling cytotoxic agents.

Contamination: In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat transient stinging of skin. Medical advice should be sought if the eyes are affected.

In the event of spillage treat with 1% sodium hypochlorite solution using a cloth/sponge kept in the designate area. Rinse twice with water. Put all cloths into a plastic bag and seal for incineration.

Disposal: All items used during preparation or administration including syringes, containers, absorbent materials, residual solutions should all be placed in a thick plastic bag and incinerated at 700°C.

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