Suprefact Depot

Suprefact Depot (Buserelin) is available in injectable forms and nasal solution.

For prostate cancer, the usual starting dose is Suprefact Depot (Buserelin) 500 µg by subcutaneous (under the skin) injection every 8 hours for 7 days. This is followed by maintenance therapy with an injection of 200 µg Suprefact Depot (Buserelin) once daily or 400 µg of nasal spray (2 sprays into each nostril) 3 times daily.

Women using Suprefact Depot (Buserelin) for treatment of endometriosis usually use the Suprefact Depot (Buserelin) nasal solution at a dose of 400 µg (2 sprays into each nostril) 3 times daily. The treatment usually continues for 6 months but should not continue past 9 months.

If using the injectable form, always use the syringes provided in the kit and dispose of the syringes in a safe manner. Carefully read the patient directions for use available in the package insert. Ask your health care professional if you have any questions. To help reduce redness, itching, or swelling where the medication is injected, rotate the place where you are injecting Suprefact Depot (Buserelin).

If using the nasal spray, use the spray pump provided. Each spray delivers 100 µg Suprefact Depot (Buserelin). Carefully read the patient directions for use available in the package insert. Ask your health professional if you have any questions.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use Suprefact Depot (Buserelin) exactly as prescribed by your doctor. If you miss a dose, use it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

For men using Suprefact Depot (Buserelin) for long-term control of prostate cancer, a long-lasting Suprefact Depot (Buserelin) implant (called a "depot") can be implanted under the skin into the abdominal wall by the doctor every 2 or 3 months. If you forget to have your implant given on the correct day, have it administered as soon as possible.

Store Suprefact Depot (Buserelin) at room temperature, away from heat and direct light, and keep it out of the reach of children. The injection can be kept at room temperature for up to 14 days after opening. The nasal spray can be kept at room temperature for up to 5 weeks after opening.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Depot 2 Months
Each applicator contains 1 implant dose consisting of 2 identical cream-coloured, biodegradable, and biocompatible rods. Each implant dose contains a total of 6.6 mg of Suprefact Depot (Buserelin) acetate, equivalent to 6.3 mg of Suprefact Depot (Buserelin) base. Nonmedicinal ingredients: poly-(D,L-lactide-co-glycolide). Sterile ready-to-use disposable applicator with an integrated needle (internal needle diameter of 1.4 mm) for s.c. injection.

Depot 3 Months
Each applicator contains 1 implant dose consisting of 3 identical cream-coloured, biodegradable, and biocompatible rods. Each implant dose contains a total of 9.9 mg of Suprefact Depot (Buserelin) acetate equivalent to 9.45 mg of Suprefact Depot (Buserelin) base. Nonmedicinal ingredients: poly-(D,L-lactide-co-glycolide). Sterile ready-to-use disposable applicator with an integrated needle (internal needle diameter of 1.4 mm) for s.c. injection.

Do not use Suprefact Depot (Buserelin) if you:

• are allergic to Suprefact Depot (Buserelin) or any ingredients of Suprefact Depot (Buserelin)
• are a man with non-hormone dependent cancer
• are pregnant or breast-feeding
• have prostate cancer and have had your testicles removed
• have undiagnosed abnormal vaginal bleeding

There may be an interaction between Suprefact Depot (Buserelin) and any of the following:

• Alfuzosin
• amiodarone
• androgens (e.g., methyltestosterone, nandrolone, testosterone)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Buprenorphine
• chloroquine
• Degarelix
• diabetes medications (e.g., insulin, Glyburide, Gliclazide, Acarbose, Rosiglitazone, Sitagliptin)
• Disopyramide
• dofetilide
• Domperidone
• Dronedarone
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• flecainide
• lopinavir
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• mifepristone
• Pimozide
• Primaquine
• procainamide
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Ofloxacin, sparfloxacin)
• rilpivirine
• saquinavir
• selective serotonin reuptake inhibitors (SSRIs; e.g., Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (e.g., Dolasetron, Granisetron, Ondansetron, Paliperidone)
• sotalol
• Tetrabenazine
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• tyrosine kinase inhibitors (e.g., Lapatinib, Pazopanib, Sunitinib)
• Voriconazole

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Suprefact Depot (Buserelin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Suprefact Depot (Buserelin).

Anemia: Reduced testosterone levels contribute to low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, pale skin, or feeling unusually tired, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Blood pressure: If you have high blood pressure, Suprefact Depot (Buserelin) may increase your blood pressure. Your blood pressure should be checked regularly while using Suprefact Depot (Buserelin).

Depression: Changed levels of hormones in the body have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Suprefact Depot (Buserelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Suprefact Depot (Buserelin), and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, or notice them in a family member who is taking Suprefact Depot (Buserelin), contact your doctor as soon as possible.

Diabetes: Suprefact Depot (Buserelin) may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Suprefact Depot (Buserelin).

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Suprefact Depot (Buserelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Suprefact Depot (Buserelin), and whether any special monitoring is needed.

Disease symptoms: Sometimes when Suprefact Depot (Buserelin) is started, you may experience a temporary worsening of your symptoms that will last usually less than 10 days. If you have prostate cancer, you may also experience new symptoms such as bone pain, tingling or numbness, or blood in the urine, and your doctor may prescribe a medication to help prevent this. If you experience worsening of your symptoms or any new symptoms, contact your doctor.

Dizziness: Suprefact Depot (Buserelin) can cause dizziness. Do not drive or operate machinery until you know Suprefact Depot (Buserelin) does not affect your ability to perform these tasks safely.

Heart problems: Suprefact Depot (Buserelin) may increase the risk of heart problems such as changes in heart rhythm. You may be more at risk of experiencing heart problems if you have congenital long QT syndrome, electrolyte (e.g., potassium) abnormalities, or Congestive Heart Failure, or you are taking medications that affect heart rhythm (e.g., quinidine, procainamide, Amiodarone, Sotalol, Flecainide). Discuss with your doctor how Suprefact Depot (Buserelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Suprefact Depot (Buserelin), and whether any special monitoring is needed.

Men and the heart: There may be an increased risk of heart-related events (e.g., heart attacks, Stroke, heart-related death) in men being treated for prostate cancer with GnRH medications.

Before you start treatment, tell your doctor if you have diabetes or heart disease, have had a previous Heart Attack or stroke, or have cardiovascular risk factors (e.g., high blood pressure, smoking, or cholesterol). If you have any of these conditions, discuss with your doctor how Suprefact Depot (Buserelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Suprefact Depot (Buserelin), and whether any special monitoring is needed.

Osteoporosis: Suprefact Depot (Buserelin) can decrease bone density that can lead to osteoporosis and bone factures. Your doctor will monitor you for this while you are using Suprefact Depot (Buserelin). If you have osteoporosis or are at risk for it (e.g., have been smoking or drinking excessive amounts of alcohol for a long time, have a family history of osteoporosis, or are taking medications such as Prednisone or anti-seizure medications), discuss with your doctor how Suprefact Depot (Buserelin) may affect your medical condition and whether any special monitoring is needed.

Pregnancy: Suprefact Depot (Buserelin) should not be used by pregnant women. Use an effective nonhormonal method of birth control (e.g., condom, diaphragm, IUD) while you are using Suprefact Depot (Buserelin). If you become pregnant while using Suprefact Depot (Buserelin), stop using the medication and contact your doctor immediately.

Breast-feeding: Suprefact Depot (Buserelin) passes into breast milk. If you are a breast-feeding mother and are taking Suprefact Depot (Buserelin), it may affect your baby. Women should not breast-feed while using Suprefact Depot (Buserelin).

Children: The safety and effectiveness of using Suprefact Depot (Buserelin) have not been established for children and adolescents less than 18 years of age.