Dacarbazine 600mg Powder For Solution For Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
DACARBAZINE 600 mg POWDER FOR SOLUTION FOR INJECTION
Read all of this leaflet carefully before you start using this medicine
Keep this leaflet. You may need to read it again.
If you have any further questions ask your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Dacarbazine Powder for Solution for Injection is and what it is used for
2. Before you use Dacarbazine Powder for Solution for Injection
3. How to use Dacarbazine Powder for Solution for Injection
4. Possible side effects
5. How to store Dacarbazine Powder for Solution for Injection
6. Further information
1. WHAT DACARBAZINE POWDER FOR SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Dacarbazine Powder for Solution for Injection is an anti-cancer medicine, in the form of a powder for solution for injection. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.
Dacarbazine Powder for Solution for Injection may be used for the treatment of some types of cancer, for example: metastatic malignant melanoma (a type of skin cancer that has spread) and Hodgkin’s disease and some types of cancer in soft tissues.
2. BEFORE YOU USE DACARBAZINE POWDER FOR SOLUTION FOR INJECTION Do not use Dacarbazine Powder for Solution for Injection
• if you have shown signs of hypersensitivity (severe allergy) to dacarbazine on previous occasions
• if you have severe liver or kidney diseases
• in combination with yellow fever vaccine
• if you are pregnant, trying to become pregnant or are breast feeding Taking/using other medicines
Special care should be taken if you are taking other medicinal products which could interact with Dacarbazine:
• ciclosporin or tacrolimus (medicines used after having a transplant)
• fotemustine (a medicine used in cancer treatment)
• medicines which could damage your liver
• warfarin (a medicine used to thin the blood). Your doctor may need to do your blood test (INR) more often
Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Taking with Food and Drink
You should avoid alcohol while receiving chemotherapy treatment with dacarbazine.
Pregnancy and breast feeding
Do not use Dacarbazine:
• if you are pregnant or trying to become pregnant
• if you are breast feeding
Driving and using machines
Dacarbazine may influence the ability to drive or operate machinery because of nausea and vomiting or rare adverse reactions affecting the nervous system.
Important information about one of the ingredients of Dacarbazine Powder for Solution for Injection
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free’.
3. HOW TO USE DACARBAZINE POWDER FOR SOLUTION FOR INJECTION
This medicinal product is for intravenous use (injection into a vein).
Your treatment will usually be given to you in hospital.
You will be given Dacarbazine as an infusion (slow injection via a drip) into a vein or a slow intravenous injection(injection into a vein).
Tell your doctor or nurse at once if you notice any pain at the injection site during or shortly after treatment. Pain around the injection site could mean the needle has not been properly inserted into the vein.
The dose of dacarbazine will depend on the illness for which you are being treated. The dose is calculated according to your body surface area (expressed as mg/m2).
Depending on your illness, dosing is typically between 200 and 850 mg/m2 of dacarbazine.
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much. However, tell your doctor or pharmacist if you have any concerns.
4. POSSIBLE SIDE EFFECTS
Like all medicines Dacarbazine Powder for Solution 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 and throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.
This is a very serious side effect. You may need urgent medical attention. This very serious side effect is rare.
If you experience any of the following tell your doctor as soon as possible:
Common (less than 1 in 10 patients but more than 1 in 100):
• blood problems: they are dependent on how strong your dose is and are more likely after 3 to 4 weeks. You may feel tired, look pale, bruise more easily than usual or get more infections than usual. They are shown by blood tests:
• decreased red blood cells (anaemia)
• decreased white blood cells (leukopenia)
• decreased platelets (thrombocytopenia)
• decreased formation of all blood cells in the bone marrow (bone marrow suppression)
• loss of appetite
• nausea/vomiting
Uncommon (Less than 1 in 100 patients but more than 1 in 1000):
• confusion
• fits (seizures)
• numbness of the skin or pins and needles sensation in the face (paraesthesia)
• headache
• blurred vision
• facial flushing
• hair loss (alopecia)
• transient rash
• an influenza (‘flu’) type syndrome of fever, muscle pain (myalgia) and generally feeling unwell (malaise) which may start approximately one week after treatment and may last for up to three weeks
• tiredness and weakness (lethargy)
• abnormal kidney and liver function (shown in tests)
• liver damage (hepatotoxicity)
• blockage of a vein in your liver (also called Budd-Chiari syndrome) resulting in liver tissue damage (necrosis), in some cases even to death. The signs include fever, stomach pain and yellow eyes and skin (jaundice). Your doctor would also be able to see that your liver was larger and you would have changes in the numbers of your blood cells
Rare (less than 1 in 1000 patients but more than 1 in 10,000)
• diarrhoea
• irritation at the injection site
• increased sensitivity of the skin to sunlight (photosensitivity)
Very rare (less than 1 in 10,000)
• swelling of the face, lips, mouth and throat with difficulty breathing (anaphylactic reactions)
• redness of the skin (erythema)
• rash with spots and blisters (maculopapular exanthema)
• nettle rash (urticaria)
• itching
Blood samples will be taken to check for changes in blood cells levels. Blood and urine tests will be performed to check for changes in kidney function. Blood tests may be performed to check that your liver is working properly.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE DACARBAZINE 600 mg POWDER FOR SOLUTION FOR INJECTION
Keep out of the reach and sight of children.
The vials should be stored at 2 - 8°C with the vials kept in the outer carton (in order to protect from light). This medicine should not be used after the expiry date printed on the vial label.
If the vial appears discoloured, visible particles can be seen or if the vial has leaked, do not use and discard.
6. FURTHER INFORMATION
What Dacarbazine Powder for Solution for Injection contains
The medicine is presented in glass containers called vials containing 600 mg dacarbazine. Each pack contains 1 vial.
• the active substance is dacarbazine
• the other ingredients are citric acid monohydrate, mannitol and sodium hydroxide
The powder is a white or pale yellow solid.
The vial containing the powder is a glass container with a rubber stopper.
Each single-dose vial contains 600 mg of Dacarbazine. When reconstituted each ml of solution contains 10 mg of dacarbazine.
The 600 mg presentation of Dacarbazine is sold in packs containing 1 vial of powder.
Marketing Authorisation Holder and Manufacturer
The Marketing authorisation holder and manufacturer is Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK.
This leaflet was last revised in 09/2015.
The following information is intended for medical or healthcare professionals only:
Further to the information included in Section 3 practical information on the preparation/handing of the medicinal product is provided here.
Incompatibilities
Dacarbazine Powder for Solution for Injection is incompatible with hydrocortisone sodium succinate in solution, forming an immediate precipitate. It is also incompatible with L-cysteine and sodium hydrogen carbonate. It has been reported to be incompatible with heparin, although only with concentrated solutions (25 mg/ml). Dacarbazine Powder for Solution for Injection must not be mixed with other medicinal products except with Dextrose Injection 5% or Sodium Chloride Injection 0.9%.
Preparation Instructions
This is a cytotoxic medicinal product; please follow your local policy guidelines for instructions on the safe handling/destruction of cytotoxics.
General Cytotoxic Handling Guidelines: The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used, in conditions that guarantee the protection of the environment and, in particular, the protection of the personnel handling the medicines. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area.
Pregnant women must be warned to avoid handling cytotoxic agents.
Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area and collection bags for waste.
In case of contact of the medicinal product with the eye, wash the eye thoroughly with water. If the substance is splashed accidentally onto the skin, wash the skin with large amounts of water and then with a soft soap. Rinse thoroughly.
The patient’s excreta and vomit must be handled with care.
Preparation: All operations such as reconstitution and dilution should be carried out only under aseptic conditions in a suite or cabinet dedicated for the assembly of cytotoxics.
Dacarbazine Powder for Solution for Injection 600 mg vials should be reconstituted with 59.1 ml of Water for Injections BP. The resulting solution contains the equivalent of 10 mg/ml of dacarbazine and has a pH of 3 to 4. The resultant solution is hypo-osmolar and therefore should be given by slow intravenous injection over one to two minutes.
Dacarbazine is sensitive to light. Reconstituted solutions should be suitably protected from light.
If desired, the reconstituted solution can be further diluted with 125 - 250 ml of Dextrose Injection 5% or Sodium Chloride Injection 0.9% and administered by intravenous infusion over 15 - 30 minutes. During administration, the infusion set should be protected from exposure to daylight e.g. by using light-resistant PVC infusion sets. If normal infusion sets are used, then these should be covered to protect from light.
Before being administered, the solution should be visually inspected in order to detect possible presence of particles or discolouration. Dacarbazine is photosensitive, with exposure to light causing a colour change from pale yellow to pink. The product should not be used if it appears pink in colour.
Disposal: Vials, materials that have been utilised for dilution, and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerated.
Any broken container must be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in suitably labelled rigid containers.
Storage
Reconstituted and diluted solutions should be protected from light.
The physical and chemical in-use stability:
Storage conditions
Reconstituted solution 24 hours at 2 - 8°C
Further diluted with 5% dextrose or 0.9% sodium chloride 24 hours at 2 - 8°C
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution or dilution has taken place in controlled and validated aseptic conditions.
Warning: As with all parenteral products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration. Solution showing haziness, particulate matter, precipitate, discolouration or leakage should not be used. Discard unused portion.
5