Suprefact Nasal Solution® (1mg/ml)

Suprefact Nasal Solution® (buserelin acetate)

SKU: 065914102035
DIN: 02225158
SIZE: 1mg/ml (10ml multi-dose bottle)
INDICATIONS: SUPREFACT nasal solution is indicated for:

  • The palliative treatment (maintenance treatment) of patients with hormone-dependent advanced carcinoma of the prostate gland (Stage D).
  • The treatment of endometriosis in patients who do not require surgery as primary therapy. The duration of treatment is usually six months and should not exceed nine months.

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:

Nasal solution:

  • The palliative treatment (maintenance treatment) of patients with hormone-dependent advanced carcinoma of the prostate gland (Stage D).
  • The treatment of endometriosis in patients who do not require surgery as primary therapy. The duration of treatment is usually six months and should not exceed nine months.

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 nasal solution 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.

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 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

Please check back later

RESOURCES

PRODUCT MONOGRAPH

Click here to download the Product Monograph

 

 

PRESCRIBING INFORMATION

Click here to download 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.