DaunoXome 2mg/ml (Daunorubicin)
DaunoXome 2mg/ml
(Daunorubicin)
1. Identification of the Medicinal Product
a. Name of the medicinal product
DaunoXome Injection (liposomal daunorubicin).
b. Ingredients
The active ingredient of DaunoXome is daunorubicin. Other, inactive ingredients are distearoylphosphatidylcholine, cholesterol, citric acid, 2.125 grams of sucrose, glycine, calcium chloride and Water for Injection.
c. Pharmaceutical form
DaunoXome is a red, clear or slightly cloudy solution, provided in a glass vial. Each vial contains 50 milligrams of the active ingredient daunorubicin. The product is intended to be diluted with dextrose solution and administered only by intravenous infusion.
d. Pharmaco-therapeutic group
The active ingredient of DaunoXome is daunorubicin. This is an anti-cancer drug. DaunoXome is a special formulation of daunorubicin (liposomes) used to treat a tumour called Kaposi’s sarcoma.
2. When is DaunoXome Used
DaunoXome is used for the treatment of severe Kaposi’s Sarcoma in patients infected with the Human immunodeficiency Virus (the virus which can cause AIDS). Kaposi’s Sarcoma is a form of cancer which predominantly affects the skin but which can also affect the lungs and the intestine.
3. What You Need to Know before receiving DaunoXome
a. When should you not receive DaunoXome
If you are allergic (hypersensitive) to DaunoXome or to any of the other ingredients of DaunoXome.
If you are pregnant or breast feeding
b. What you need to know before you receive DaunoXome
If you have had heart problems, you should tell your doctor. As there is a small possibility that DaunoXome may have an effect on your heart, your doctor will want to monitor your heart function carefully before and during your treatment.
c. Interactions between DaunoXome and other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
DaunoXome may interact with medicines used to treat HIV (protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
DaunoXome can reduce the function of the bone marrow that produces red and white blood cells. Caution is advised if DaunoXome is given at the same time as any other medicine which also reduces the function of the bone marrow. Your doctor may conduct blood tests to monitor how well your bone marrow is functioning.
d. Effect of DaunoXome on driving or the use of machinery
Do not drive or use machines immediately after administration of DaunoXome because this medicinal product can cause dizziness.
e. Use of DaunoXome during pregnancy and breast feeding
Ask your doctor or pharmacist for advise before taking any medicine.
DaunoXome may cause serious birth defects when given during pregnancy.
If you intend to become pregnant or are pregnant, or are breast feeding, you should tell your doctor before you receive DaunoXome. It is strongly recommended that both male and female patients being treated with daunorubicin should use contraceptives in order to prevent pregnancy. You should stop breast feeding when you are treated with DaunoXome.
4. Instructions for the Use
DaunoXome is always given to you by a doctor or nurse.
a. Dosage
The dosage of DaunoXome depends on how large the surface of your body is. Your doctor will calculate the size of the surface of your body (known as your body surface area) from how tall you are and how much you weigh. Normally DaunoXome is started at a dose of 40 milligram per square metre of body surface area, every two weeks. For example, if your body surface area is two square metres, you will usually start with a dose of 80mg of DaunoXome. During the treatment, your doctor may also decide to increase or decrease the amount you receive.
If you think that you have missed a dose tell your doctor
In children and elderly patients, it has not yet been shown how safe DaunoXome is or how well it works.
b. Method of administration
Before use DaunoXome must be diluted with a solution of dextrose (5%) and it must only be administered as an infusion into a vein. Normally the infusion will take 30 to 60 minutes. DaunoXome should not be administered by any other method.
c. Overdose
If you are given more DaunoXome than you should you may experience adverse effects on your bone marrow and heart.
5. Undesirable Effects
Like all medicines, DaunoXome can cause side effects, although not everybody gets them.
The following side effects have occured during treatment with DaunoXome.
Likely to affect more than 1 in every 10 people:
Damage to the bone marrow that produces red and white blood cells. Symptoms: infections; mouth ulcers; bleeding or brusing more easily than normal, fever; tirdness, being short of breath after light activity and looking pale.
Allergic reactions to the infusion. Symptoms: Back pain, flushing, chest tightness, shortness of breath, difficulty breathing, rash and itching.
Pain, swelling, redness of the lining of the mouth
Ulceration of the mouth, nose, throat and rectum
Feeling sick, being sick, tummy ache, diarrhoea
Hair loss
Headache
Tiredness
Weakness
Shivering
Breathlessness
Likely to affect up to 1 in every 10 people:
Dehydration
Depression
Dizziness
Decreased ability of the left side of the heart to pump blood
Pain, swelling, stinging or redness around the area where DaunoXome is infused
Likely to affect up to 1 in every 100 people:
Infection in the blood which can be life threatening
Heart failure
Disease of the heart muscle.
Likely to affect up to 1 in every 1000 people:
Sudden life-threatening allergic reaction. Symptoms: flushing, itching, sickness, swelling of the face, mouth, tongue and airways, often enough to cause difficulty breathing
Very fast or irregular heart beat and racing pulse
Heart attack
Hand-foot syndrome. Symptoms: Swelling, pain, tingling and redness in the palms of the hands or soles of the feet
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
6. Shelf Life
Keep out of the reach and sight of children.
This product should not be used after the expiry date indicated on the label.
Store at 2° – 8° C (in a refrigerator). Do not freeze. Protect against exposure to light. Do not store partially used vials.
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