SUPREFACT Nasal Solution® 1mg/ml

DIN

02225158

Size

1 mg/ml vial

SKU

065914102035

Directions

200 mcg (0.2 mL) daily by subcutaneous injection or intranasal administration 400 mcg (200 mcg into each nostril) 3 times daily

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INFORMATION FOR THE PATIENT

SUPREFACT® nasal solution is used for the palliative treatment (relieves pain and symptoms but not intended to cure disease) of patients with advanced prostate cancer (Stage D) (maintenance therapy ONLY).

SUPREFACT® nasal solution is also used in women for the treatment of endometriosis (a disease associated with premenstrual pain and painful menstruation).

What it does:

SUPREFACT® treatment results in decreasing the levels of sex hormones.

Prostate Cancer
Prostate cancer cells appear to need testosterone for their growth. When the body’s supply of testosterone is lowered, prostate cancer usually shrinks or stops growing, which may result in a reduction of symptoms related to the disease.

Endometriosis
Reduction of the sex hormone can result in a reduction of the symptoms of endometriosis

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.

Causes
Prostate cancer spreads when cancer cells break free from the prostate. These cells enter the bloodstream or lymph nodes. Most cancer cells that break free from the prostate die. But sometimes they spread to other organs and start new tumors. Advanced prostate cancer often moves into the bones before spreading to other organs. Sometimes it spreads to the lungs or liver. It can also spread to the brain.
Diagnosis

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 (en-doe-me-tree-O-sis) is an often painful disorder in which tissue similar to the tissue that normally lines the inside of your uterus — the endometrium — grows outside your uterus. Endometriosis most commonly involves your ovaries, fallopian tubes and the tissue lining your 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 your 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.

Causes

Although the exact cause of endometriosis is not certain, possible explanations include:

  • Retrograde menstruation. In retrograde menstruation, menstrual blood containing endometrial cells flows back through the fallopian tubes and into the pelvic cavity instead of out of the body. These endometrial cells stick to the pelvic walls and surfaces of pelvic organs, where they grow and continue to thicken and bleed over the course of each menstrual cycle.
  • Transformation of peritoneal cells. In what’s known as the “induction theory,” experts propose that hormones or immune factors promote transformation of peritoneal cells — cells that line the inner side of your abdomen — into endometrial-like cells.
  • Embryonic cell transformation. Hormones such as estrogen may transform embryonic cells — cells in the earliest stages of development — into endometrial-like cell implants during puberty.
  • Surgical scar implantation. After a surgery, such as a hysterectomy or C-section, endometrial cells may attach to a surgical incision.
  • Endometrial cell transport. The blood vessels or tissue fluid (lymphatic) system may transport endometrial cells to other parts of the body.
  • Immune system disorder. A problem with the immune system may make the body unable to recognize and destroy endometrial-like tissue that’s growing outside the uterus
Diagnosis

To diagnose endometriosis and other conditions that can cause pelvic pain, your doctor will ask you to describe your symptoms, including the location of your pain and when it occurs.

Tests to check for physical clues of endometriosis include:

  • Pelvic exam. During a pelvic exam, your doctor manually feels (palpates) areas in your pelvis for abnormalities, such as cysts on your reproductive organs or scars behind your uterus. Often it’s not possible to feel small areas of endometriosis unless they’ve caused a cyst to form.
  • Ultrasound. This test uses high-frequency sound waves to create images of the inside of your body. To capture the images, a device called a transducer is either pressed against your abdomen or inserted into your vagina (transvaginal ultrasound). Both types of ultrasound may be done to get the best view of the reproductive organs. A standard ultrasound imaging test won’t definitively tell your doctor whether you have endometriosis, but it can identify cysts associated with endometriosis (endometriomas).
  • Magnetic resonance imaging (MRI). An MRI is an exam that uses a magnetic field and radio waves to create detailed images of the organs and tissues within your body. For some, an MRI helps with surgical planning, giving your surgeon detailed information about the location and size of endometrial implants.
  • Laparoscopy. In some cases, your doctor may refer you to a surgeon for a procedure that allows the surgeon to view inside your abdomen (laparoscopy). While you’re under general anesthesia, your surgeon makes a tiny incision near your navel and inserts a slender viewing instrument (laparoscope), looking for signs of endometrial tissue outside the uterus.A laparoscopy can provide information about the location, extent and size of the endometrial implants. Your surgeon may take a tissue sample (biopsy) for further testing. Often, with proper surgical planning, your surgeon can fully treat endometriosis during the laparoscopy so that you need only one surgery.

PATIENT RESOURCES

PRODUCT MONOGRAPH

Click here to download the Product Monograph

 

PRESCRIBING INFORMATION

Click here to download the prescribing information

 

FREQUENTLY ASKED QUESTIONS

What is Suprefact Nasal Spray and what it is used for

Suprefact Nasal Spray 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”.

What do I need to know before I use Suprefact Nasal Spray?

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 take 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 Nasal Spray (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 a tumour that is not affected by changes in hormone levels
  • You have had an operation to remove your testicles

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 Nasal Spray.

How do I use Suprefact Nasal Spray?
Always use Suprefact Nasal Spray exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to use Suprefact Nasal Spray:

1. Preparing the spray

  • Remove the screw cap from bottle
  • Remove the metered-dose nebulizer from transparent plastic container and take off both protective caps
  • Screw the nebulizer on to the bottle

2. If you are using the spray for the first time

  • Hold the bottle upright
  • Pump 5 to 8 times until an even spray is produced. This initial pumping is for the purpose of filling the system and testing the spray. It should not be repeated after the first use in order to avoid wasting the medicine

3. Using the spray

  • Keep the bottle upright
  • Bend your head slightly over the bottle
  • Spray the solution into the nose

4. After using the spray

  • After use leave the nebulizer on the bottle
  • After replacing the protective cap on the nebulizer, the spray bottle is best stored in its transparent container in an upright position
What are the side effects of using Suprefact 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 nose bleeds and a hoarse voice
  • Changes in your sense of taste or smell
  • 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
How should Suprefact Nasal Spray be stored?

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Suprefact Nasal Spray after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

Store below 25 °C. Do not freeze.

Once opened the product should be used within 1 week. Any remaining spray should be disposed of after this time.

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.