Mianda 25 mg Solution

MIANDA is used for the treatment of certain types of cancer (cytostatic medicine). MIANDA is used alone (monotherapy) or in combination with other medicines.

MIANDA should not be administered to you :

• if you are hypersensitive (allergic) to bendamustine hydrochloride or to mannitol
• if you are pregnant or breast feeding your baby
• if you have severe liver disease (damage to the functional cells of the liver);
• if you have yellowing of the skin or whites of the eye caused by liver or blood problems (jaundice)
• if you have weakened bone marrow function and serious changes in the number of white blood cells and platelets in your blood
• if you have had major surgery less than 30 days before start of treatment
• if you have any infection, especially infection that reduces your white blood count (leucopenia).
• if you have had a yellow fever vaccination or other live attenuated vaccines.

Warnings and precautions

Special care should be taken with MIANDA :

• if you get severe allergic or hypersensitivity reactions. You should pay attention to infusion reactions after your first cycle of therapy.
• if you develop a reduced capability of the bone marrow to replace blood cells. You doctor should check your full blood count before starting treatment with MIANDA, before each subsequent course of treatment and in the intervals between courses of treatment.
• if you have any existing infections which may include TB (tuberculosis). Your doctor will delay treatment until the infections is cleared. You should contact your doctor if you develop signs of infection, including fever or lung symptoms during treatment.
• if you get reactions on your skin during treatment with MIANDA. Some of these reactions can be life threatening if these reactions increase in severity example severe and painful blistering or peeling of the skin, inform your doctor immediately.
• if you have an existing heart disease (e.g. heart attack, chest pain, disturbed heart rhythm), your doctor will monitor you more closely
• if you notice blood in your urine or a reduced amount of urine. When your disease is very severe, your body may not be able to clear all the waste products from the dying cancer cells. This is called tumour lysis syndrome and can cause kidney failure and heart problems within 48 hours of the first dose of MIANDA. Your doctor will be aware of this and may give you medicines to help prevent it.
• Unintentional injection into the tissue outside blood vessels (extravasal injection) may cause local tissue damage. Your doctor will treat this.
• If you experience fever, chills, itchy skin or a rash, you may be having an allergic reaction to the treatment. Inform your doctor immediately.
• Women should not become pregnant during treatment and men should not father a child up to 6 months after treatment.

Other medicines with MIANDA :

• Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines).
• If MIANDA is used in combination with medicines which inhibit the formation of blood in the bone marrow, the effect on the bone marrow may be intensified.
• You should not be immunised with live attenuated vaccines if you are being treated with MIANDA.

Pregnancy, breastfeeding and fertility:

You should not receive MIANDA if you are pregnant or breastfeeding your baby. If you are pregnant or breastfeeding your baby, please inform your doctor.

Pregnancy:

MIANDA can cause genetic damage and has caused malformations in animal studies. You should not use MIANDA if you are pregnant. If you are a woman of childbearing potential you must use an effective method of contraception both before and during treatment with MIANDA. If you become pregnant during your treatment with MIANDA you must immediately inform your doctor and should get genetic consultation.

Breastfeeding:

MIANDA must not be administered to you if you are breastfeeding your baby. If treatment with MIANDA is necessary, you must stop breastfeeding your baby until your treatment with MIANDA has been completed.

Fertility:

If you are a man, you should not father a child during treatment with MIANDA and for up to 6 months after treatment has stopped. There is a risk that treatment with MIANDA will lead to infertility and you may wish to seek advice on conservation of your sperm cells before your treatment starts. Men and women should use effective contraception during treatment with MIANDA.

Driving and using machinery:

MIANDA may affect your ability to drive or use machinery. Do not drive or operate machinery if you experience side effects such as dizziness or lack of co-ordination.

You will not be expected to give yourself MIANDA. It will be given to you by a person who is qualified to do so. Your doctor will decide exactly how much MIANDA to give you. It will be given to you as an injection into your vein and will take approximately 30 minutes to 1 hour to administer. Treatment should not be started if your white blood cells (leukocytes) have fallen below certain levels. Your doctor will determine this.

Impaired liver or kidney function

Depending on the degree of impairment of your liver or kidney function it may be necessary to adjust your dose. Your attending doctor will decide whether a dosage adjustment is necessary.

How it is administered

Treatment with MIANDA should be undertaken only by doctors experienced in cancer therapy. Your doctor will give you the exact dose of MIANDA and use the necessary precautions. Your attending doctor will administer the solution for infusion after preparation as prescribed. The solution is administered into a vein as a short-term infusion over 30 - 60 minutes.

Duration of use

There is no time limit laid down as a general rule for treatment with MIANDA. Duration of treatment depends on your disease and your response to treatment.

If you are at all worried or have any questions regarding treatment with duration MIANDA, please speak to your doctor.

If you use more MIANDA than you should Since a health care provider will administer MIANDA, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use MIANDA Since a health care provider will administer MIANDA, it is unlikely that the dose will be missed.

MIANDA can have side effects. Not all side-effects reported for MIANDA are included in this leaflet. Should your general health worsen or if you experience any untoward effects during treatment with MIANDA, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• Swelling of the face or throat area
• Painful rash, red or peeling skin
• Difficulty breathing.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MIANDA. 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:

• chest pain (angina),
• heart attack,
• change in the way your heart beats (palpitations, tachycardia),
• signs of infection such as fever or chills.

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

Tell your doctor if you notice any of the following:

Frequent side effects:

• Low counts of white blood cells (leucocytopenia).
• Decrease in the red pigment of blood (haemoglobin).
• Low counts of platelets (thrombocytopenia).
• Low counts of neutrophils (white blood cell).
• Infections including herpes zoster, cytomegalovirus, hepatitis B.
• Hypersensitivity reactions such as allergic inflammation of the skin (dermatitis), nettle rash (urticaria).
• Fatigue.
• Feeling sick (nausea).
• Vomiting.
• Fever.
• Mucosal inflammation.

Less frequent side effects:

• Opportunistic Infection (Pneumocystis iiroveci pneumonia and TB)
• Accumulation of fluid in the heart sac (escape of fluid into the pericardial space).
• Infection of the blood (sepsis).
• Severe allergic hypersensitivity reactions (anaphylactic reactions).
• Signs similar to anaphylactic reactions (anaphylactoid reactions).
• Drowsiness.
• Loss of voice (aphonia).
• Acute circulatory collapse (failure of blood circulation).
• Reddening of the skin (erythema).
• Inflammation of the skin (dermatitis).
• Itching (pruritus).
• Skin rash (macular exanthema).
• Excessive sweating (hyperhidrosis).
• Primary atypical inflammation of the lungs (pneumonia).
• Break-down of red blood cells (haemolytic anaemia).
• Rapid decrease in blood pressure sometimes with skin reactions or rash (anaphylactic shock).
• Disturbed sense of taste.
• Altered sensations (paraesthesia).
• Malaise and pain in the limbs (peripheral neuropathy).
• Disease of the nervous system (anticholinergic syndrome).
• Neurological (brain and spinal cord) disorders.
• Lack of coordination (ataxia).
• Inflammation of the brain (encephalitis).
• Increased heart rate (tachycardia).
• Heart attack, chest pain (myocardial infarct).
• Heart failure.
• Inflammation of the veins (phlebitis).
• Formation of scar tissue in the lungs (fibrosis of the lungs).
• Inflammation and bleeding of the gullet (haemorrhagic oesophagitis).
• Bleeding of stomach or gut.
• Infertility.
• Multiple organ fail.

There have been reports of secondary tumours (myelodysplastic syndrome, acute myeloid leukaemia, bronchial carcinoma) following treatment with MIANDA. Severe skin reactions (Stevens - Johnson Syndrome and Toxic Epidermal Necrolysis) have been reported.

If any of the side effects worsen, contact your doctor or pharmacist.

Tell your doctor if any of the above side effects gets serious or lasts longer than a few days.

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, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of MIANDA

Store all medicines out of reach of children.

• Store below 25 °C.
• Keep the vial in the outer carton to protect from light.