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

More information coming soon


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