Sopilcin 20 mg/10 ml/50 mg/25 ml Solution

SOPILCIN is a chemotherapy medicine. SOPILCIN is used to treat:

• Breast cancer that has spread (metastatic), in patients at an increased risk for heart problems
• Ovarian cancer (cancer of the ovary)
• Multiple myeloma (a cancer of the blood) in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. SOPILCIN is used in combination with another medicine called bortezomib to treat multiple myeloma
• AIDS-related Kaposi’s sarcoma.

SOPILCIN should not be administered to you:

• if you are hypersensitive (allergic) to doxorubicin hydrochloride, peanut or soya, or any of the other ingredients of SOPILCIN (listed in section 6).
• if you are pregnant or breastfeeding
• if you have AIDS-related Kaposi’s sarcoma that may be treated effectively with local therapy or systemic (route of administration where the entire body is affected) alpha-interferon
• if you are younger than 18 years of age, because it is not known how the medicine will affect you.

Warnings and precautions

Special care should be taken with SOPILCIN:

• Tell your doctor if you have heart disease. A heart evaluation is recommended before starting treatment, and a heart function test will be done as your doctor prescribes.
• SOPILCIN can lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for blood clotting. Check with your doctor immediately if you think you are getting an infection or if you notice any unusual bleeding or bruising. Periodic blood tests to monitor your blood count will be ordered by your doctor.
• There is a risk of developing a blood cancer such as leukemia in patients who receive combined treatment with SOPILCIN. Your doctor may continue to do blood checks once treatment has been completed.
• Tell your doctor right away if you notice sores, discolouration or any discomfort in your mouth. These could be symptoms of oral cancer.
• Tell your doctor if you have Kaposi’s sarcoma and have had your spleen removed. You may be at risk for infections and must be monitored.
• This medicine may cause an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you notice flushing, a rash, chest pain, a fast heartbeat, itching, sweating, trouble breathing, facial swelling, a fever or chills, back pain, tightness in the chest and throat and/or lightheadedness or faintness while you are receiving SOPILCIN.
• Tell your doctor if you are diabetic, because SOPILCIN contains sugar which may require an adjustment to the treatment of your diabetes.
• Tell your doctor if you are receiving any treatment for liver disease.

Children and adolescents

SOPILCIN should not be used in children and adolescents, because it is not known how SOPILCIN will affect them.

Other medicines and SOPILCIN

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines). Tell your doctor or pharmacist:

• If you are taking the medicines cyclophosphamide or 6-mercaptopurine;
• About any other cancer treatments you are on or have been taking, as particular care needs to be taken with treatments which reduce the number of white blood cells, as this may cause further reduction in the number of white blood cells.
• If you are unsure about what treatments you have received or any illnesses you have had, discuss these with your doctor.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before receiving this medicine.

• Because the active ingredient, doxorubicin hydrochloride, in SOPILCIN may cause serious birth defects, SOPILCIN should not be administered during pregnancy. It is important to tell your doctor if you think you are pregnant.
• Use a highly effective method of contraception and avoid becoming pregnant while you or your partner are taking SOPILCIN and in the six months following discontinuation of SOPILCIN treatment.
• If you are a man, you should not father a child while receiving treatment with SOPILCIN.
• Do not breastfeed during this treatment because the active ingredient doxorubicin hydrochloride may come through in the breast milk and may be harmful to nursing infants. Women must discontinue breastfeeding before starting treatment with SOPILCIN.

Driving and using machines

Do not drive or use any tools or machines if you feel dizzy or sleepy from treatment with SOPILCIN.

SOPILCIN contains soya oil

SOPILCIN contains soya oil. If you are allergic to peanut or soya, do not use this medicine.

Usual dosages are as follows:

• If you are being treated for breast or ovarian cancer, SOPILCIN will be administered at a dose of 50 mg per square metre of your body surface area (based on your height and weight). The dose is repeated every 4 weeks for as long as the disease does not progress and you are able to tolerate this treatment.
• If you are being treated for multiple myeloma, SOPILCIN will be administered at a dose of 30 mg per square metre of your body surface area (based on your height and weight) as a 1-hour intravenous infusion immediately after bortezomib infusion on day 4 of the bortezomib 3-week regimen. The dose is repeated as long as you respond satisfactorily and tolerate treatment.
• If you are being treated for AIDS-related Kaposi’s sarcoma, SOPILCIN will be administered at a dose of 20 mg per square metre of your body surface area (based on your height and weight). The dose is repeated every 2 to 3 weeks for 2 to 3 months, then as often as necessary to maintain an improvement in your condition.

Your doctor will tell you how long your treatment with SOPILCIN will last. If you have the impression that the effect of SOPILCIN is too strong or too weak, tell your doctor or pharmacist.

You will not be expected to give yourself SOPILCIN. It will be given to you by a person who is qualified to do so. SOPILCIN will be given to you in a drip (infusion) into a vein. Depending on the dose and indication, this may take from 30 minutes to more than one hour (i.e., 90 minutes).

If you receive more SOPILCIN than you should

Since a health care provider will administer SOPILCIN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you miss a dose of SOPILCIN

Since a health care provider will administer SOPILCIN, it is unlikely that the dose will be missed. Inform your doctor if you are unable to present for treatment on your scheduled date.

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

During the infusion of SOPILCIN, the following reactions may occur: flushing of the face, shortness of breath, chills, tightness in the chest and/or throat, low or increase in blood pressure, rapid heart beat, puffing of the face, fever, dizziness, chest pain, back pain, itching, rash and sweating. In very rare cases, seizures (convulsions) have occurred. Stinging or swelling of the skin at the site of injection may also occur. If the drip stings or hurts while you are receiving a dose of SOPILCIN, tell your doctor immediately.

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

• serious skin reactions such as widespread peeling skin, blisters as well as mucous membrane erosion (Stevens-Johnson syndrome/toxic epidermal necrolysis); These are very serious side effects. If you have them, you may have had a serious reaction to SOPILCIN. You may need urgent medical attention or hospitalisation.
• Tell your doctor immediately if any of the following happens:
• you get reddening painful skin on your hands and feet;
• you get painful reddening of the skin and/or blisters on the body or in the mouth;
• you get heart problems;
• you get mouth sores;
• you develop a fever or any other sign of infection;
• you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or coughing;
• you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain which gets worse when you stand or walk.

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

Other side effects: Tell your doctor if you notice any other side effects. Between infusions, the following may occur:

Frequent side effects:

• redness, swelling and sores on the palms of your hands and feet. These effects have been seen frequently, and are sometimes severe. In severe cases, these effects may interfere with certain daily activities, and may last 4 weeks or longer before resolving completely. The doctor may wish to delay the start and/or reduce the dose of the next treatment. (see Strategies to prevent and treat hand-foot syndrome, below);
• pain or sores in mouth or throat, nausea, vomiting, diarrhoea, constipation, loss of appetite, weight loss;
• decrease in the number of white blood cells, which can increase the chances of infections. Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding. In rare cases, having low white blood cells may lead to severe infection. It is because of some of the potential changes in your blood cells that you will have regular blood tests. Some of these effects may be related to your disease and not to SOPILCIN;
• general feeling of tiredness, weakness, feeling of pins and needles or pain in hands and feet;
• hair loss;
• stomach pain;
• oral thrush (a fungal infection in the mouth), sores in nose, bleeding from your nose, cold sores, and tongue inflammation;
• changes in laboratory values related to the function of the liver while on SOPILCIN;
• sleepiness, dizziness, fainting, bone pain, breast pain, abnormal muscle tension, muscle pain, leg cramps or swelling, general swelling, inflammation of the retina (the light-detecting membrane of the eye), increased tear production, blurred vision;
• inflammation of hair follicles, scaly skin, inflammation or rash, abnormal skin pigmentation (colouring), and nail disorder;
• heart problems, e.g., irregular heart beat, enlarged blood vessels;
• fever, increased temperature or any sign of infection which may be related to your disease;
• respiratory problems, i.e., difficulty in breathing or coughing which may be linked to infections you have caught as a result of your disease;
• not enough water in the body (dehydration), severe weight loss and muscle wasting, low levels of calcium, magnesium, potassium or sodium in the blood, high levels of potassium in the blood;
• inflamed gut, inflamed stomach lining, difficulty swallowing, dry mouth, passing wind, inflamed gums (gingivitis), change in sense of taste;
• inflammation of the vagina;
• pain when passing urine;
• if you have previously had skin reactions, i.e., pain, redness and dryness of skin, during treatment with radiotherapy, this may also happen with SOPILCIN;
• joint pain, decreased or abnormal sensation to stimulation, redness of the eye, redness of the scrotum.
• anxiety, depression, difficulty sleeping, headache.

Less frequent side effects:

• confusion;
• inflammation of the veins and formation of blood clots in the veins which could lead to blockage of blood flow to your lungs causing difficulty breathing, chest pain and palpitations.
• serious skin reactions such as widespread peeling skin, blisters as well as mucous membrane erosion (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• oral cancer may occur when SOPILCIN is taken for a long time (more than one year).

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

Reporting of side effects

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of SOPILCIN.

Strategies to prevent and treat hand-foot syndrome:

• soak hands and/or feet in basins of cool water when possible;
• take cool baths during hot weather;
• avoid exposure of skin to very hot water;
• swim;
• keep hands and feet uncovered (no socks, gloves or shoes that are tight-fitting);
• stay in cool places.

Pyridoxine (vitamin B6):

take pyridoxine (vitamin B6) at a dose of 50 – 150 mg daily beginning at the first signs of redness or tingling.

Store all medicines out of reach of children. Stored in a refrigerator (2 °C to 8 °C). Do not freeze. Retain vial in carton until time of use in order to protect from light.

After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C. From a microbiological point of view, 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 should not be longer than 24 hours at 2 °C to 8 °C. Partially used vials must be discarded. Do not use SOPILCIN after the expiry date which is stated on the label and carton.

Do not use SOPILCIN if you notice that it shows evidence of precipitation or any other particulate matter. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).