Suprefact Injection® (buserelin acetate)
SKU: 065914102028
DIN: 02225166
SIZE: 1mg/ml vials
INDICATIONS: SUPREFACT injection is used for the palliative treatment (relieves pain and symptoms but not intended to cure disease) of patients with advanced prostate cancer (Stage D).
DIRECTIONS: 200 mcg (0.2 mL) daily by subcutaneous injection or intranasal administration 400 mcg (200 mcg into each nostril) 3 times daily.
Product Description
INDICATIONS AND CLINICAL USE
SUPREFACT (buserelin acetate) is indicated for: Subcutaneous injection:
- The palliative treatment (initial and maintenance treatment) of patients with hormonedependent advanced carcinoma of the prostate gland (Stage D).
CONTRAINDICATIONS
- SUPREFACT is contraindicated in patients who are hypersensitive to this drug, to any ingredient in the formulation or component of the container. Isolated cases of anaphylaxis have been reported.
- SUPREFACT is also contraindicated in patients with prostate cancer who do not present with hormone-dependent carcinoma and in patients who have undergone orchiectomy.
- SUPREFACT is contraindicated in women who are pregnant. As with other LHRH agonists, it is not known whether SUPREFACT causes fetal abnormalities in humans. Women of childbearing potential should be carefully examined before treatment to exclude pregnancy (see WARNINGS AND PRECAUTIONS, Special Populations – Pregnant Women).
- The use of SUPREFACT in women who are breast-feeding is contraindicated.
- SUPREFACT should not be administered to females having undiagnosed abnormal vaginal bleeding
WARNINGS
SUPREFACT should be prescribed by a qualified physician experienced in the use of hormonal therapy in endometriosis and prostate cancer, SUPREFACT Injection should be administered under the supervision of a healthcare professional.
ADVERSE REACTIONS
The adverse effects observed in patients treated with SUPREFACT are, principally, directly related to its anticipated pharmacologic action, i.e. suppression of pituitary (gonadotropin) and gonadal (testosterone or estradiol) hormone production with resulting clinical signs and symptoms of hypogonadism. The most frequent adverse events reported in patients with prostatic cancer receiving SUPREFACT are hot flushes, loss of libido, impotence, nasal irritation (nasal solution) and headache (nasal solution).
ABOUT THE DISEASE
Prostate Cancer
Men with advanced prostate cancer often have no symptoms. Advanced prostate cancer can be found by x-rays or tests done for other medical reasons. When there are symptoms, they depend on the size of the new growth and where cancer has spread. For example, when prostate cancer has spread to the pelvic bones, you may feel lower back or hip pain. You may have no symptoms of cancer in the prostate. Or you may have problems urinating or see blood in your urine. When men do have symptoms, they often feel tired or weak, have lost weight, feel pain, or have shortness of breath.
To diagnose advanced cancer, your health care provider looks for cancer outside the prostate. Blood and imaging tests may show where cancer has spread. Your health care provider will want to know how much cancer there is and how it is affecting you. That way they can offer treatment that is best for you.
Advanced cancer may be found before, at the same time, or later than the main tumor. Most men diagnosed with advanced prostate cancer have had biopsy and treatment in the past. When a new tumor is found in someone who has been treated for cancer in the past, it is usually cancer that has spread. Rarely, tests done for other reasons may reveal prostate cancer cells.
Endometriosis
Endometriosis is an often painful disorder in which tissue similar to the tissue that normally lines the inside of the uterus — the endometrium — grows outside the uterus. Endometriosis most commonly involves the ovaries, fallopian tubes and the tissue lining the pelvis. Rarely, endometrial tissue may spread beyond pelvic organs.
With endometriosis, the endometrial-like tissue acts as endometrial tissue would — it thickens, breaks down and bleeds with each menstrual cycle. But because this tissue has no way to exit the body, it becomes trapped. When endometriosis involves the ovaries, cysts called endometriomas may form. Surrounding tissue can become irritated, eventually developing scar tissue and adhesions — abnormal bands of fibrous tissue that can cause pelvic tissues and organs to stick to each other.
Endometriosis can cause pain — sometimes severe — especially during menstrual periods. Fertility problems also may develop. Fortunately, effective treatments are available.
CLINICAL TRIALS
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FREQUENTLY ASKED QUESTIONS
Suprefact Injection contains a medicine called buserelin acetate. This belongs to a group of medicines called gonadotropin releasing hormone analogues. This is a synthetic version of a hormone that occurs naturally in the body. It works by lowering the production of sex hormones.
It is used to treat prostate cancer by lowering the amount of the hormone ‘testosterone’.
Before using Suprefact, your doctor should assess your risk of developing diseases of heart and blood vessels (cardiovascular disease), diabetes mellitus and anaemia. If you develop any of the above, you should be monitored and treated accordingly.
Do not use this medicine and tell your doctor if:
- You are allergic (hypersensitive) to:
- buserelin
- other similar medicines such as goserelin
- any of the other ingredients of Suprefact Injection (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- You have had an operation to remove your testicles
- You have a tumour that is not affected by changes in hormone levels
- This medicine is intended for men only. Another presentation is available for women. It is important that these medicines are not used during pregnancy or breastfeeding.
Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Suprefact Injection.
Suprefact Injection is normally given by a doctor or nurse. This is because it needs to be given as an injection underneath the skin (subcutaneous injection).
How much Suprefact Injection is given
If you are not sure why you are being given Suprefact Injection or have any questions about how much Suprefact Injection is being given to you, speak to your doctor or nurse.
- 0.5ml of Suprefact Injection will be given to you every 8 hours for 7 days
- After 7 days of treatment, you will be given the nasal spray
Like all medicines, Suprefact can cause side effects, although not everybody gets them.
Stop using Suprefact and see a doctor or go to a hospital straight away if;
- You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- You have leg pain, difficulty breathing or being short of breath and chest pain. This could be because of blood clots in your body and lungs
Tell your doctor straight away if you notice any of the following serious side effects:
- You bruise more easily than usual. This could be because of a blood problem called ‘thrombocytopenia’
- You get a lot of infections. Signs include fever, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia
- You have severe headaches and eyesight problems. This is very rare but if it happens it could be due to tumours on the pituitary gland. This gland is found at the base of the brain
- Your blood pressure becomes higher. This is very rare but if it happens you may get symptoms such as crushing chest pain, confusion, problems with your eyesight, tiredness and an uneven heartbeat
- You have problems passing water (urine)
- You have sharp pain or aching in your side in the area between the ribs and the hips. These could be signs of a swollen kidney
- You feel tired and your body is swollen. These could be signs of fluid build up in the tissues called lymphostasis
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Suprefact Injection after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Once opened use within 15 days.
Do not store above 25°C. Do not freeze.
Keep the vials in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.