SUPREFACT Injection® M.D. 1mg/ml – vials

DIN

02225166

Size

1 mg/ml vial

SKU

065914102028

Directions

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

Categories: ,

INFORMATION FOR THE PATIENT

What the medication is used for:

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).

What it does:

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

When it should not be used:

• If you have experienced a prior allergic reaction to buserelin acetate or if you are allergic to any of the components of SUPREFACT or component of the container.
• If you do not have a hormone-dependent prostate cancer or if you have undergone castration.
• The solution for injection should not be used in pregnancy and breast-feeding women.

What the medicinal ingredient is:

Buserelin acetate

What the nonmedicinal ingredients are:

Benzyl alcohol, monobasic sodium phosphate buffer, sodium chloride, sodium hydroxide.

What dosage forms it comes in:

Each mL of sterile aqueous injection solution contains: 1.00 mg buserelin as buserelin acetate.

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.

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 Injection and what it is used for

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’.

What do I need to know before I take Suprefact Injection?

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.

How should Suprefact Injection be used?

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
What are the side effects of using Suprefact Injection?

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
How should Suprefact Injection be stored?

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.