ZOLADEX LA 10.8 MG — DIN 02225905

What is ZOLADEX LA?

ZOLADEX LA 10.8 MG contains GOSERELIN (GOSERELIN ACETATE) : 10.8 MG. It is listed in the Health Canada Drug Product Database under DIN 02225905, held by TERSERA THERAPEUTICS LLC, supplied as IMPLANT for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 28-Feb-2018. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is ZOLADEX LA used for?

ZOLADEX LA (goserelin acetate) is indicated for: Prostate Cancer • the palliative treatment of patients with hormone-dependent advanced carcinoma of the prostate (Stage M1 according to the Tumour-Node-Metastasis [TNM] classification system or Stage D2 according to the American Urologic Association [AUA] classification). • use in combination with a non-steroidal antiandrogen and radiation therapy for the management of locally advanced (T3, T4) or bulky Stage T2b, T2c carcinoma of the prostate. Treatment with ZOLADEX LA and a non-steroidal antiandrogen should start 8 weeks prior to initiating radiation therapy and continue until completion of the radiation therapy. • adjuvant hormone therapy to external beam irradiation for patients with locally advanced prostate cancer (Stage T3-T4). Breast Cancer • the management of estrogen receptor (ER)-positive early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and perimenopausal women. Benign Conditions (Endometriosis) • the hormonal management of endometriosis, including pain relief and reduction of endometriotic lesions. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older, treated for 6 months.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

ZOLADEX LA should be administered by a healthcare professional experienced in administering deep subcutaneous injections. Prostate Cancer: One implant of ZOLADEX LA containing goserelin acetate equivalent to 10.8 mg goserelin, should be injected subcutaneously into the anterior abdominal wall every 3 months (13 weeks) following the procedure recommended in the administration instructions. While the 3-month (13 week) schedule should be adhered to, a delay of a few days is permissible. If in exceptional circumstances repeat dosing does not occur at 3 months, data indicate that castrate levels of testosterone are maintained for up to 16 weeks in the majority of patients. When ZOLADEX LA is given in combination with a non-steroidal antiandrogen and radiotherapy for patients with Stage T2b-T4 prostatic carcinoma, treatment should be started 8 weeks prior to initiating radiotherapy and should continue until completion of the radiation therapy. A treatment regimen using a ZOLADEX implant 8 weeks before radiotherapy, followed in 28 days by the ZOLADEX LA implant until completion of the radiation therapy, can be administered. Breast Cancer: One implant of ZOLADEX LA, containing goserelin acetate equivalent to 10.8 mg goserelin, should be injected subcutaneously into the anterior abdominal wall every 12 weeks following the procedure recommended in the administration instructions. While the 12-week schedule should be adhered to, a delay of a few days is permissible. Endometriosis: One implant of ZOLADEX LA containing goserelin acetate equivalent to 10.8 mg goserelin, should be injected subcutaneously into the anterior abdominal wall every 12 weeks following the procedure recommended in the administration instructions. Administration Instructions: 1. Put the patient in a comfortable position with the upper part of the body slightly raised. Prepare an area of the anterior abdominal wall below the navel line with an alcohol swab. 2. Examine the foil pouch and syringe for damage. Remove the syringe from the opened foil pouch and hold the syringe at a slight angle to the light. Check that at least part of the ZOLADEX LA implant is visible. 3. Grasp the plastic safety tab and pull away from the syringe and discard. Remove needle cover. Unlike liquid injections, there is no need to remove air bubbles as attempts to do so may displace the implant. 4. Holding the syringe around the protective sleeve, pinch the skin of the patient's anterior abdominal wall below the navel line. 5. With the opening of the needle facing up, insert needle at a slight angle (30 to 45 degrees) to the skin into the subcutaneous tissue of the anterior abdominal wall below the navel line, until the protective sleeve touches the patient's skin. 6. Moving your hand back to the finger grip, depress the plunger fully, until you can depress no more, to discharge the ZOLADEX LA implant and to activate the protective sleeve. You may hear a 'click' and will feel the protective sleeve automatically begin to slide to cover the needle. If the plunger is not depressed fully the protective sleeve will NOT activate. The needle does not retract. 7. Holding the syringe, withdraw the needle and allow protective sleeve to continue to slide and cover needle. Dispose of the syringe in an approved sharps collector.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

• ZOLADEX LA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. • Women having undiagnosed abnormal vaginal bleeding. • Pregnancy: ZOLADEX LA should not be used during pregnancy. Women of childbearing potential should be carefully examined before treatment to exclude pregnancy. Non-hormonal methods of contraception should be employed during therapy. • Breast-feeding: The use of ZOLADEX LA during breast-feeding is not recommended.

Warnings and precautions

Serious Warnings and Precautions: ZOLADEX LA should be prescribed by a qualified healthcare professional experienced in the use of hormonal therapy in cancer and endometriosis. ZOLADEX LA should be administered by a healthcare professional experienced in administering deep subcutaneous injections. The following are clinically significant adverse events: • Tumour flare reaction • Osteoporosis • Injection site injuries and vascular injuries General: Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX LA. Monitor patients for signs or symptoms of abdominal hemorrhage. As ZOLADEX LA requires administration by deep subcutaneous injection, extra care should be given to patients with a low body mass index or in patients who are fully anticoagulated (INR >2) due to the risk of vascular injury and subsequent bleeding during administration. Initially, ZOLADEX LA transiently increases serum testosterone in males and serum estradiol concentrations in females. Although not necessarily related, isolated cases of short-term worsening of signs and symptoms have been reported during the first four weeks of therapy. Worsening of the clinical condition may occasionally require discontinuation of therapy and/or surgical intervention. Cardiovascular: Androgen deprivation therapy may increase cardiovascular risk in men with prostate cancer on the basis of its adverse impact on demonstrated cardiovascular risk factors, by increasing body weight, reducing insulin sensitivity, and/or resulting in dyslipidemia. Heart failure was commonly reported in patients receiving ZOLADEX for prostate cancer treatment in clinical studies. Assessment of cardiovascular risk and management according to local clinical practice and guidelines should be considered. Androgen deprivation therapy has the potential to prolong QT/QTc interval on ECG. Healthcare professionals should consider whether the benefits of androgen deprivation therapy outweigh the potential risk, including the potential for torsades de pointes, in patients with a history of QT prolongation, with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA, Class III, or Class IC antiarrhythmic medications. In patients at risk of developing QT/QTc interval prolongation, periodic monitoring of ECG and serum electrolyte levels should be considered. Musculoskeletal: Patients with vertebral metastases: During the first month of therapy with ZOLADEX LA, patients with vertebral metastases who are thought to be at particular risk of spinal cord compression should be closely monitored. Changes in bone density: The use of LHRH agonists may cause a reduction in bone mineral density. In men and women, some bone loss can be anticipated as part of the natural aging process. Androgen deprivation therapy is associated with increased risks of osteoporosis and skeletal bone fractures. The risk of skeletal fracture increases with the duration of androgen deprivation therapy. Assessment of osteoporosis risk and management according to clinical practice and guidelines should be considered. Psychiatric: Depression (sometimes severe) has been reported in patients treated with ZOLADEX LA in post-market surveillance. Patients should be informed of the risks, monitored and treated accordingly.