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SUPREFACT is a brand name for Buserelin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS .................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations SUPREFACT should be administered at approximately equal time intervals to ensure that the desired therapeutic effect is maintained. 5 mL) every 8 hours by subcutaneous injection. For patient comfort, vary the injection site.
Maintenance treatment:
Depending upon patient preference, or physician recommendation, maintenance treatment may be by daily subcutaneous injection or by intranasal administration three times daily. 2 mL) daily. For patient comfort, vary the site of injection.
During maintenance dosing by the intranasal administration route, the SUPREFACT dose is 400 mcg (200 mcg into each nostril) three times daily using the metered-dose pump (nebulizer) provided. 1 mL solution. PATIENTS WITH ENDOMETRIOSIS The dose of SUPREFACT in patients with endometriosis is 400 mcg (200 mcg into each nostril) three times daily using the metered-dose pump (nebulizer) provided.
1 mL solution. The treatment duration is usually six months and should not exceed nine months. Missed Dose Should the patient forget to take a dose, the dose should be administered as soon as they remember. However, if it is almost time for the next dose, the patients should skip the missed dose and go back to their regular dosing schedule.
The patient should not double doses. Administration SUPREFACT Injection The SUPREFACT vial is supplied with a plastic cap which can be removed by pressing upwards with the thumb. This cap serves to ensure that the vial has not been previously entered.
After Page 19 of 57 removal (the cap can be discarded) the rubber diaphragm of the vial is exposed. Proceed as follows: 1. Wash your hands, with soap and water, and dry on a clean towel. 2. Clean the rubber diaphragm of the SUPREFACT vial with a cotton swab previously dipped in alcohol.
Leave to dry. 3. Select an appropriate sterile, disposable syringe and needle assembly and remove it from its sterile packaging. 4. Draw the syringe piston as far back as the volume (see syringe cylinder graduation) of solution you wish to withdraw from the vial.
5. Remove the needle sheath (protector). 6. Without touching the needle with your fingers, push the needle through the centre of the rubber diaphragm of the vial. 7. Push on the syringe plunger so that the selected air volume is expelled into the vial.
Serious Warnings and Precautions SUPREFACT should be prescribed by a qualified physician experienced in the use of hormonal therapy in endometriosis and prostate cancer, SUPREFACT Injection should be administered under the supervision of a healthcare professional (see DOSAGE AND ADMINISTRATION section).
g. g. operating a vehicle or machinery). Initially, SUPREFACT transiently increases serum testosterone in males, serum estradiol in females and other gonadal hormones. The administration of LHRH agonists is occasionally related with early, transient (less than 10 days duration usually) exacerbation of the signs and symptoms of metastatic prostatic cancer or endometriosis, which are sometimes, but not necessarily, associated with a transient rise in serum testosterone or estradiol.
PATIENTS WITH PROSTATIC CANCER SUPREFACT, like other LHRH agonists, causes a transient increase in serum concentration of testosterone during the first weeks of treatment. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction.
Cases of spinal cord compression, which may contribute to paralysis with or without complications, have been reported with LHRH agonists. If spinal cord compression or renal impairment due to ureteral obstruction develops, standard treatment of these complications should be instituted.
Patients with metastatic vertebral lesions and/or with urinary tract obstruction should begin buserelin therapy under close supervision. It is strongly recommended that administration of an antiandrogen be started as adjunctive therapy before starting treatment with SUPREFACT.
Page 6 of 57 This adjunctive therapy must be continued in parallel with SUPREFACT therapy for 4-5 weeks. After this time testosterone levels have usually fallen to the castrate level thus therapy with SUPREFACT as a single agent can be continued.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buserelin in Canada.
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8. Keeping the needle in the vial, invert the vial into the vertical position adjusting the needle tip to a position below the surface of the solution in the vial. 9. Draw the required solution from the vial by withdrawing the syringe piston.
10. Carefully withdraw the needle and syringe assembly from the vial. 11. Choose the injection site (vary the site for each injection) and clean the skin with an alcohol impregnated swab. 12. Pinch the site, if you wish, between index finger and thumb and, with the needle at an angle introduce the needle quickly under the skin as far as possible.
13. Withdraw the syringe piston a little and, if no blood is withdrawn into the syringe, then push on the piston steadily to inject the solution. 14. Upon completion of the injection, and resting the alcohol-impregnated swab over the needle entry site, remove the needle in a reverse fashion of the entry motion.
Hold swab to injection site for a few seconds, then remove. 15. Discard needle and syringe assembly along with the swab in a safe manner. Return the SUPREFACT vial to its storage area. There is no information available on possible incompatibilities between SUPREFACT solution Page 20 of 57 or SUPREFACT injection and other agents.
5 mg/kg/IV (mouse) nor 1 mg/kg/IV (rat) produced evidence of toxic signs. Two groups of 6 and 4 healthy volunteers, aged 26-40 years and 31-40 years respectively, were given 1 mg buserelin or 5 mg buserelin orally as a single dose. No luteinizing hormone (LH) or follicle stimulating hormone (FSH) release was observed.
No clinical effects were observed. Overdose may lead to signs and symptoms such as asthenia, headache, nervousness, hot flushes, dizziness, nausea, abdominal pain, edemas of the lower extremities, and mastodynia. For the injectable formulation, local reactions at the injection site such as pain, haemorrhage and induration.
Therapy for overdose is directed to the symptoms. For management of a suspected drug overdose, contact your regional Poison Control Centre. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Buserelin acetate is a synthetic peptide analog of the natural gonadotropin releasing hormone (GnRH/LHRH) with enhanced biological activity.
After repeated administration of SUPREFACT, the secretion of gonadotrophin release and gonadal steroids is significantly inhibited. The pharmacological effect is attributable to the down-regulation of pituitary LHRH receptors. In male individuals the elimination of gonadotrophin release results in a reduction in the synthesis and secretion of testosterone.
In female individuals the elimination of pulsatile gonadotrophin release inhibits the secretion of estrogen. Pharmacodynamics The substitution of glycine in position 6 by D-serine, and that of glycinamide in position 10 by ethylamide, leads to a nonapeptide with a greatly enhanced LHRH effect.
The effects of buserelin on FSH and LH release are 20 to 170 times greater than those of LHRH. Buserelin also has a longer duration of action than natural LHRH. Page 21 of 57 Investigations in healthy adult males and females have demonstrated that the increase in plasma LH and FSH levels persist for at least 7 hours and that a return to basal values requires […]
Co-administration of anti-androgens with SUPREFACT should be initiated to block testosterone flare. The majority of clinical studies demonstrating the efficacy of SUPREFACT were completed without concomitant therapy with antiandrogens during the first weeks of treatment.
g. condoms) should be employed during therapy (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnancy). Worsening of the clinical condition may occasionally require discontinuation of therapy and/or surgical intervention. Cardiovascular In treated hypertensive patients, hypertensive crisis may occur.
It is recommended that blood pressure be monitored regularly in these patients. PATIENTS WITH PROSTATIC CANCER There may be a relationship between androgen deprivation therapy and cardiovascular risk in men with prostate cancer on the basis of the demonstrated adverse impact of androgen deprivation on traditional cardiovascular risk factors, including serum lipoproteins, insulin sensitivity, and obesity (see References section).
Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential cardiovascular risk. Androgen deprivation therapy has the potential to prolong QT/QTc interval on ECG. g. g. g. flecainide, propafenone) antiarrhythmic medications.
(See DRUG INTERACTIONS, Patients with Prostatic Cancer) SUPREFACT should not be administered to patients with congenital long QT syndrome, and should be discontinued in patients that develop QT prolongation during treatment. Page 7 of 57 Assessment of cardiovascular risk and management according to local clinical practice and guidelines should be considered.
Endocrine and Metabolism Isolated cases of loss of diabetic control (reduction in glucose tolerance) have been observed. Blood glucose levels should be checked regularly in diabetic patients. PATIENTS WITH PROSTATIC CANCER While hypogonadism is a pharmacologic consequence of long-term LHRH agonist treatment, its reversibility has not been established in patients suffering with prostatic carcinoma.
Reduction in glucose tolerance A reduction in glucose tolerance and an increase in diabetic risk have been observed in men treated with androgen deprivation therapy through orchiectomy or a LHRH agonist. Therefore, diabetic patients and other patients at risk may require more frequent monitoring of blood glucose when receiving androgen deprivation therapy.
Hematologic PATIENTS WITH PROSTATIC CANCER Anemia is a known physiologic consequence of testosterone suppression. Assessment of anemia risk and management according to local clinical practice and guidelines should be considered. Hepatic/Biliary/Pancreatic Studies have not been conducted in patients with hepatic impairment.
g. reddening of the skin, itching, skin rash (including urticaria) and allergic asthma with dyspnea as well as in isolated cases, anaphylactic/ anaphylactoid shock have been observed in patients treated with SUPREFACT, necessitating early treatment of such conditions.
Musculoskeletal Decreased bone mineral density (BMD) can be […]