Prinolid 11,25 mg Injection

PRINOLID 11,25 is a synthetic hormone which can be used to reduce the levels of testosterone and estrogen circulating in the body. PRINOLID 11,25 is used to treat prostate cancer in men and to treat hormone responsive early stage breast cancer in pre and perimenopausal women at higher risk of recurrence and hormone responsive advanced breast cancer in pre and perimenopausal women. PRINOLID 11,25 can also be used in women to treat endometriosis (often a painful disorder in which tissue similar to the tissue that normally lines the inside of your uterus grows outside your uterus), and for the treatment of uterine fibroids (also known as benign tumours in the womb) for up to six months.

PRINOLID 11,25 should not be administered to you:

• if you are hypersensitive (allergic) to leuprolide acetate, similar medicine, the other ingredients of PRINOLID 11,25 (listed in section 6), or to synthetic gonadotropin releasing hormones or derivates.
• If you are pregnant, planning to become pregnant or are breastfeeding.
• If you have abnormal vaginal bleeding which you have not discussed with your doctor.
• If you are a pre or perimenopausal women, for the treatment of breast cancer:

• your estrogen levels must have been adequately suppressed with PRINOLID 11,25 before you start treatment with an aromatase inhibitors such as exemestane and should be checked every three months during combination treatment with PRINOLID 11,25 and an aromatase inhibitor (see ‘Warnings and precautions’ in the section below for more information).

Warnings and precautions

Tell your doctor or healthcare professional before being given the injection: Take special care with PRINOLID 11,25:

• Both men and women

• If you are diabetic, PRINOLID 11,25 can aggravate existing diabetes therefore, you may need more frequent monitoring of your blood glucose levels.
• If you have diabetes or suffer from heart problems.
• If you experience jaundice (yellowing of the skin) or experience symptoms of low blood pressure (such as dizziness or tiredness).
• If you are taking PRINOLID 11,25 and develop a depressed mood, as there have been reports of depression in patients taking PRINOLID 11,25 which may be severe.
• If you are experiencing seizures, have a history of seizures (convulsions), seizure disorders or have a high risk of developing seizures.

• Men only

• In the event of an abscess occurring at the injection site your doctor may measure your testosterone levels as there could be reduced absorption of leuprorelin from the injection site.
• If you suffer from urinary obstruction or spinal cord compression. Your doctor will supervise you closely for the first few weeks of treatment.
• If you are a man with prostate cancer, and have had injections of a synthetic hormone in the past that has not worked, or you have had an operation to remove your testicles.
• if you have any of the following: Any heart or blood vessel conditions, including heart rhythm problems (dysrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using PRINOLID 11,25.
• If you have high blood glucose levels or are diabetic PRINOLID 11,25 can increase your blood glucose levels or aggravate existing diabetes therefore you may need more frequent monitoring of the blood glucose levels.

• Women only

• If you are at an increased risk of thinning of the bones (osteoporosis) you should tell your doctor before taking PRINOLID 11,25. Risk factors include:

• If you or any of your close family have thinning of the bones.
• If you drink excessive amounts of alcohol, and/or smoke heavily.
• If you take medicines for epilepsy or have taken steroids such as hydrocortisone or prednisolone for a long time.

• If you are a woman with submucous fibroids (benign tumours in the muscle underneath the lining of the womb), PRINOLID 11,25 can cause severe bleeding when the fibroids break-down. Contact your doctor immediately if you experience severe or unusual bleeding or pain.
• If you are a woman and continue to have periods (menstruate) after starting treatment with PRINOLID 11,25.
• If you are a woman of child-bearing age, you should use non-hormonal contraception whilst receiving PRINOLID 11,25. Although PRINOLID 11,25 causes periods to stop, it is not itself a contraceptive. If you are unsure about this talk to your doctor.
• If you are being given PRINOLID 11,25 for the treatment of breast cancer:

• Your doctor may assess your bone density and ovarian function before you start treatment with PRINOLID 11,25 and monitor your bone density and ovarian function throughout treatment.
• PRINOLID 11,25 must be started at least 6-8 weeks before you start treatment with an aromatase inhibitor and should continue throughout treatment with the aromatase inhibitor.
• If you have had chemotherapy, PRINOLID 11,25 treatment should only commence once you have completed chemotherapy and premenopausal status has been confirmed.
• The recommended duration of treatment with PRINOLID 11,25 in combination with other hormone treatments for breast cancer can be very long, repeated every 3 months.
• If you are being given PRINOLID 11,25 in combination with an aromatase inhibitor, your doctor may monitor your blood pressure, heart function and blood glucose levels during treatment.
• If you have depression or a history of depression, please inform you doctor so that they can additionally monitor your symptoms of depression during treatment with PRINOLID 11,25.
• If you are unsure about this, speak to your doctor.

Children

Do not give PRINOLID 11,25 to children as it is unlikely to be safe.

Other medicines and PRINOLID 11,25

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) PRINOLID 11,25 might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other medicines (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

PRINOLID 11,25 with food and drink

PRINOLID 11,25 can be taken with or without food.

Pregnancy and breastfeeding

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 using this PRINOLID 11,25. PRINOLID 11,25 must not be administered in pregnant or breastfeeding women.

Driving and using machines

Do not drive or operate machinery if you experience drowsiness, dizziness or visual disturbances whilst being treated with PRINOLID 11,25. It is not always possible to predict to what extent PRINOLID 11,25 may interfere with your daily activities. You should ensure that you do not engage in activities requiring mental alertness, judgment and/or sound coordination and vision e.g. driving, riding, flying, sailing or operating machines/equipment until you are aware of the measure to which PRINOLID 11,25 affects you.

Do not share medicines prescribed for you with any other person. Route of administration: subcutaneous or intramuscular. You will not be expected to give yourself PRINOLID 11,25. It will be given to you by a person who is qualified to do so. The injection will normally be given in your arm, thigh or abdomen. The injection site should be varied at regular intervals. You will normally be given an injection once every 3 months.

Prostate cancer

If you have prostate cancer, you will be given PRINOLID 11,25 every 3 months.

Endometriosis/Uterine fibroids

If you have endometriosis/uterine fibroids, you will be given PRINOLID 11,25 for a period of six months only.

Breast cancer

If you have early breast cancer, you will be given PRINOLID 11,25 every three months in combination with tamoxifen or an aromatase inhibitor. A minimum of one injection of PRINOLID 11,25 should be given before you start treatment with an aromatase inhibitor or tamoxifen. If you have advanced breast cancer, you will be given PRINOLID 11,25 every three months as an add-on to your other breast cancer treatment.

If you take use more PRINOLID 11,25 than you should

Since a healthcare professional will administer PRINOLID 11,25, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you missed a dose of PRINOLID 11,25

Since a healthcare professional will administer PRINOLID 11,25, it is unlikely that the dose will be missed. Women only If PRINOLID 11,25 injection is missed, breakthrough bleeding or ovulation may occur with the potential for conception. If you think you may be pregnant you should stop using PRINOLID 11,25 and contact your doctor immediately.

If you stop taking PRINOLID 11,25

If you are being given PRINOLID 11,25 for the treatment of advanced or early breast cancer, you must not stop your treatment with PRINOLID 11,25 whilst you are taking an aromatase inhibitor. If you are going to discontinue treatment with PRINOLID 11,25, your aromatase inhibitor treatment must also be discontinued within 3 months of your last PRINOLID 11,25 injection.

PRINOLID 11,25 can have side effects. Not all side effects reported for PRINOLID 11,25 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PRINOLID 11,25, please consult your health care provider for advice.

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

• severe rash,
• itching,
• shortness of breath.

These are all very serious side effects. If you have them, you may have had a serious reaction to PRINOLID 11,25. 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:

• If you get a severe headache which does not get better when you take painkillers.
• If you suffer from any unexplained bruising or bleeding or feel generally unwell whilst taking PRINOLID 11,25. These could be symptoms of changes in the number of red or white blood cells.

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

Tell your doctor if you notice any of the following:

Men

When men with prostate cancer first start treatment with PRINOLID 11,25, levels of testosterone can increase and in some people this may cause a temporary increase in local pain. In some cases, to prevent this from happening, your doctor may give you another type of medicine (anti-androgen medicine) before and just after your first PRINOLID 11,25 injection. If you do get worsening pain, weakness or loss of feeling in your legs or difficulty passing urine, contact your doctor immediately.

There may be an increased risk of loss of blood to the pituitary area (if you have an existing pituitary lesion), which may cause permanent damage.

Blood sugar levels may be altered during treatment with PRINOLID 11,25, which may affect control in diabetic patients and require more frequent monitoring.

If you have a blood test your doctor may notice a change in blood lipid (cholesterol) levels or in values for tests on how the liver is working. These changes do not usually cause any symptoms.

Frequent side effects:

• weight changes,
• hot flushes,
• sweating,
• muscle weakness,
• bone pain,
• loss of interest in sexual intercourse,
• inability to have an erection,
• a reduction in size and function of the testes,
• tiredness,
• skin reactions at the injection site (these include skin hardening, redness, pain, abscesses, swelling, nodules, ulcers, skin damage),
• loss of appetite,
• difficulty sleeping,
• depression,
• mood changes (with long-term use),
• nausea (feeling sick),
• abnormalities in liver function or liver blood tests,
• joint pain,
• swelling of the breast tissue,
• swelling in your ankles.

Less frequent side effects:

• mood changes (with short-term use),
• dizziness,
• tingling in the hands or feet,
• diarrhoea,
• vomiting,
• muscle ache,
• weakness in the legs.

Side effects with an unknown frequency:

• blood tests may show anaemia (low red cell counts), low counts in white cells or platelets,
• allergic reactions (may include symptoms of rash, itching, wheals or a serious allergic reaction which causes difficulty breathing or dizziness),
• changes in blood lipids (cholesterol) or blood sugar,
• paralysis,
• seizure,
• altered vision,
• pounding heartbeats,
• changes in ECG (QT prolongation),
• blood clots in lungs,
• high or low blood pressure,
• jaundice,
• fracture of the spine,
• thinning of bone,
• difficulty passing urine,
• fever,
• inflammation of lungs or lung disease.

Women

Many of the side effects of PRINOLID 11,25 are related to the decrease in estrogen level. Estrogen level returns to normal after treatment is stopped. Common side effects include hot flushes, mood swings, depression and vaginal dryness.

As can happen naturally when women reach the menopause, PRINOLID 11,25 can cause a small amount of bone thinning.

Vaginal bleeding may occur during treatment.

If you have an existing pituitary lesion, there may be an increased risk of loss of blood to the area, which may cause permanent damage.

Blood sugar levels may be altered during treatment with PRINOLID 11,25, which may affect control in diabetic patients and require more frequent monitoring.

If you have a blood test your doctor may notice a change in blood lipid (cholesterol) levels or in values for tests on how the liver is working. These changes do not usually cause any symptoms.

Inflammation of lungs or lung disease.

Frequent side effects:

• difficulty sleeping,
• headaches,
• hot flushes,
• weight changes,
• mood changes,
• depression,
• tingling in hands or feet,
• dizziness,
• nausea,
• joint pain,
• muscle weakness,
• breast tenderness,
• changes in breast size,
• vaginal dryness,
• swelling in ankles or skin reactions at the injection site (these include skin hardening, redness, pain, abscesses, swelling, nodules, ulcers and skin damage).

Less frequent side effects:

• loss of appetite,
• changes in blood lipids (cholesterol),
• altered vision,
• pounding heartbeats,
• diarrhoea,
• vomiting,
• abnormalities in liver blood tests,
• hair loss, acne, hair growth, excessive sweating,
• muscle aches,
• fever,
• tiredness.

Side effects with an unknown frequency:

• blood tests may show anaemia (low red cell counts), low counts in white cells or platelets,
• allergic reactions (may include symptoms of rash, itching, swelling or a serious allergic reaction causing difficulty breathing or dizziness),
• changes in blood sugar,
• paralysis,
• blood clots in the lungs,
• high or low blood pressure,
• jaundice,
• abnormalities in liver function,
• fracture of the spine,
• seizure,
• thinning of bone,
• vaginal bleeding,
• inflammation of lungs or lung disease.

Side effects when used for breast cancer in combination with either tamoxifen or an aromatase inhibitor

Frequent side effects:

• nausea,
• feeling very tired,
• joint and muscle pain,
• hot flushes,
• excessive sweating,
• difficulty in sleeping,
• depression,
• frequent urination,
• increased body temperature,
• fever,
• back pain, bone pain, neck pain,
• redness and swelling at injection site,
• upper respiratory tract inflammation,
• headache,
• dizziness,
• eye infection (conjunctivitis),
• deafness, motion sickness and outer ear swelling,
• pounding heartbeat.

Less frequent side effects:

• upper respiratory tract infections,
• reduction in the number of white blood cells,
• anorexia,
• increased body temperature.

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 nurse. This includes any possible side effects not listed in this leaflet. 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 PRINOLID 11,25.

Store all medicines out of reach of children.

• Store at or below 30 °C.
• Protect from light.

Reconstituted suspension: Since PRINOLID 11,25 microspheres and their solvent contains no preservative, the reconstituted suspension should be used immediately after preparation and any unused portion should be discarded. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Discard the needle in an appropriate manner (i.e. medical sharps waste bin).