Dacin Injection

DACIN is a medicine used in the treatment of cancer. DACIN helps to stop your cancer cells growing and multiplying.

You should not receive DACIN :

• if you are hypersensitive (allergic) to dacarbazine or any of the other ingredients of DACIN (listed in Section 6).
• if you are pregnant or are breastfeeding your child.
• if you have a low number of white blood cells (leukopenia) or a low number of platelets (thrombocytopenia). If you suffer from leukopenia, you may get infections more frequently, experience tiredness, weakness and shortness of breath. If you suffer from thrombocytopenia, you may bruise more easily or excessively, you may experience bleeding into the skin that appears as a rash of pinpoint-sized reddish-purple spots, usually on the lower legs, you may experience prolonged bleeding from cuts, or bleeding from your gums or nose. You may also see blood in your urine or stools.
• if you have severe liver or kidney problems.
• in combination with yellow fever vaccine.

Warnings and precautions

Take special care with DACIN: During your treatment several tests will be performed to monitor your response to DACIN, such as:

• Tests performed on you blood to determine the number of red and white blood cells and platelets. This will indicate the response of your bone marrow to the treatment.
• Tests performed to determine your liver function. If you experience symptoms such as fever, stomach pain, enlarged liver or jaundice (a yellow colouring of the skin or eyes caused by too much old red blood cells, called bilirubin in the blood), contact your healthcare professional immediately.
• Tests performed to determine your kidney function.
• You should not be vaccinated with a live vaccine as your immune system will be suppressed. Inactivated vaccines may be used.
• DACIN may increase your risk of thrombosis (a blood clot inside a blood vessel, obstructing the flow of blood). Your healthcare professional may prescribe medicine for you to prevent this occurrence.
• You may experience severe stomach reactions, please inform you healthcare professional if this occurs.
• You may experience pain at the injection site.
• Men who are being treated with DACIN are advised to take reliable contraceptive measures during therapy and for 3 months after the end of therapy (refer to the section “Pregnancy and lactation” below.
• DACIN is not recommended for use in children and adolescents as safety and efficacy have not been established.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself DACIN. It will be given to you by a person who is qualified to do so.

The amount you are given is worked out depending on your size (m2 body surface area). Your doctor will tell you how long your treatment with DACIN will last.

If you have the impression that the effect of DACIN is too strong or too weak, tell your doctor or pharmacist.

If you receive more DACIN than you should Since a healthcare professional will administer DACIN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

• If an overdose is suspected, the numbers of your blood cells will be checked and supportive measures such as transfusions may be required.
• An overdose would cause severe damage to your bone marrow (bone marrow toxicity). This can lead to a complete loss of function of your bone marrow (bone marrow aplasia). This can be delayed by up to 2 weeks.
• Episodes of low blood pressure can occur with doses higher than the recommended. Your doctor will treat these episodes.

If you missed a dose of DACIN Do not receive a double dose to make up for the forgotten dose. Contact your doctor to schedule a new time for you to receive the dose you missed.

DACIN can have side effects. Not all side effects reported for DACIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving DACIN, please consult your healthcare provider for advice.

If any of the following happens, stop receiving DACIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, rash or itching. These are all very serious side effects. If you have them, you may have had a serious reaction to DACIN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• flu-like symptoms such as tiredness, chills, fever or muscle pain;
• feeling unwell (malaise);
• fits (seizures);
• adverse effects on your blood, such as:
• anaemia (decreased red blood cells).
• leukopenia (decreased white blood cells).
• thrombocytopenia (decreased platelets).
• bone marrow suppression (decreased formation of all blood cells in the bone marrow).
• blockage of a vein in your liver (also called Budd-chiari syndrome);
• liver tissue damage (necrosis) due to blockage of a vein in your liver. The signs include fever, stomach pain, yellow eyes and skin (jaundice).
• diverse effects on your blood, such as:
• pancytopenia (all blood cells decreased);
• agranulocytosis (marked decrease in one type of white blood cell called a granulocyte).

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

Tell your doctor if you notice any of the following (these side effects occur more frequently):

• injection site irritation;
• loss of appetite (anorexia);
• feeling sick or being sick.

Tell your doctor if you notice any of the following (these side effects occur less frequently):

• abnormal kidney function;
• increased liver enzymes (shown in tests);
• liver damage (hepatotoxicity);
• dark patches on your skin (hyperpigmentation);
• increased sensitivity of your skin to sunlight (photosensitivity);
• hair loss (alopecia);
• feeling confused;
• flushed face;
• transient rash;
• impaired or blurred vision;
• red skin (erythema), a rash with spots and blisters (maculopapular exanthema) or a nettle rash (urticaria);
• feeling sleepy;
• headache;
• pins and needles sensation in the face;
• diarrhoea.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of DACIN.

Store all medicines out of reach of children.

• Store at or below 25 °C. Store in the original package in order to protect from light.
• Do not receive DACIN if the solution is cloudy or has bits floating in it.
• Shelf life of the reconstituted solution Chemical and physical in-use stability has been demonstrated for 8 hours at room temperature and protected from light and for 5 days at 2 °C to 8 °C and protected from light. From a microbiological point of view, the reconstituted solution should be used immediately. If the reconstituted solution is not used immediately, the duration and conditions of storage are the responsibility of the user. The reconstituted solution should not be stored for longer than 24 hours in a refrigerator (2 °C to 8 °C) and protected from light, unless the reconstitution has taken place under controlled and validated aseptic conditions.
• Shelf life of the diluted solution for infusion Chemical and physical in-use stability has been demonstrated for 8 hours at room temperature and protected from light and for 5 days at 2 °C to 8 °C and protected from light. From a microbiological point of view, the diluted solution for infusion should be used immediately. If the diluted solution for infusion is not used immediately, the duration and conditions of storage are the responsibility of the user. The diluted solution for infusion should not be stored for longer than 24 hours in a refrigerator (2 °C to 8 °C) and protected from light, unless the reconstitution and dilution have taken place under controlled and validated aseptic conditions.
• From a microbiological point of view, the reconstituted solution should be used immediately.
• Do not use after the expiry date stated on the label /carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).