Loading…
ZOLADEX LA is a brand name for Goserelin, supplied as a implant. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ......................................................................................... 2 TABLE OF CONTENTS…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • ZOLADEX LA should be administered by a healthcare professional experienced in administering deep subcutaneous injections. • 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.
As ZOLADEX LA requires administration by deep subcutaneous injection, caution should be taken while injecting ZOLADEX LA into the anterior abdominal wall due to the proximity of underlying inferior epigastric artery and its branches.
5) or in patients who are fully anticoagulated (INR >2) due to the risk of vascular injury and subsequent bleeding during administration (see General). • Although, isolated cases of vaginal spotting or bleeding during treatment have been reported, this is not associated with lack of pharmacodynamic effect in most instances.
The majority of patients become amenorrheic within 8 weeks of starting treatment. In the small number of women who experience continued menstrual bleeding, estradiol blood levels should be measured. If menstrual bleeding persists and estradiol measurements correspond ZOLADEX® LA Product Monograph Page 6 of 40 to postmenopausal values, appropriate diagnostic measures should be undertaken to rule out an intrauterine pathology.
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 (see Directions for Use attached to sterile pouch).
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. 8 mg goserelin, should injected subcutaneously into the anterior abdominal wall every 12 weeks following the procedure recommended in the administration instructions (see Directions for Use attached to sterile pouch).
1 Adverse Reaction Overview The adverse effects seen with ZOLADEX LA are due primarily to its pharmacological action of sex hormone suppression and may give rise to certain expected effects that vary by sex. Adverse events that have been observed at an equal frequency in both males and females follow.
Very common adverse events (≥10%) consist of: decreased libido, hot flush, and hyperhidrosis. Common adverse reactions (≥1% to <10%) are: paraesthesia, abnormal blood pressure, rash, weight increase, and decrease in bone density. 1% to <1).
1). Following the administration of ZOLADEX LA, skin rashes have been reported as generally mild, often regressing without discontinuation of therapy. Abnormal blood pressure, manifest as hypotension or hypertension, are commonly observed in patients administered ZOLADEX LA.
The changes are usually transient, resolving either during continued therapy or after cessation of therapy with ZOLADEX LA. Such changes have rarely required medical intervention including withdrawal of ZOLADEX LA treatment. In males, erectile dysfunction was reported very commonly (≥10%).
Commonly reported adverse reactions (≥1% to <10%) consist of: impaired glucose tolerance, spinal cord compression, bone pain, gynecomastia, mood swings, depression, cardiac failure and injection site reaction. 1% to <1) are: arthralgia, ureteric obstruction and breast tenderness.
Alopecia, particularly the loss of body hair, is an expected effect of lowered androgen levels and has been reported in males at an unknown frequency. 9%) in patients after the first 12 weeks following ZOLADEX LA administration for prostate cancer treatment in clinical studies.
Serious myocardial infarction and heart failure were observed in a pharmaco-epidemiology study of LHRH agonists and anti-androgens used in the treatment of prostate cancer. The risks for these cardiovascular adverse events appear to be increased when LHRH agonists are used in combination with anti-androgens.
4 Administration ZOLADEX LA is administered by deep subcutaneous injection into the anterior abdominal wall below the navel line. Caution should be taken while injecting ZOLADEX LA due to the proximity of underlying inferior epigastric artery and its branches.
Follow all administration instructions.
Caution:
Use only if pouch is undamaged. Use immediately after opening pouch. Do not depress plunger until Step 5. Read all instructions before use. Step by Step Directions for Use ZOLADEX LA should be administered using an aseptic technique. 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.
Note:
As ZOLADEX LA requires administration by deep subcutaneous injection, caution should be taken while injecting ZOLADEX LA into the anterior abdominal wall due to the proximity of underlying inferior epigastric artery and its branches.
5) as they may be at higher risk of vascular injury. 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 (Figure 1).
3. Grasp the plastic safety tab and pull away from the syringe and discard (Figure 2). 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.
ZOLADEX® LA Product Monograph Page 8 of 40 Correctly lifted skin fold:
• ZOLADEX LA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Women having undiagnosed abnormal vaginal bleeding.
ZOLADEX® LA Product Monograph Page 5 of 40 • Pregnancy:
ZOLADEX LA should not be used during pregnancy. As with other LHRH agonists it is not known whether ZOLADEX LA causes fetal abnormalities in humans. Women of childbearing potential should be carefully examined before treatment to exclude pregnancy.
Non-hormonal methods of contraception should be employed during therapy. 1 Pregnant Women. • Breast-feeding: The use of ZOLADEX LA during breast-feeding is not recommended.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Goserelin in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
While the 12-week schedule should be adhered to, a delay of a few days is permissible. 8 mg goserelin, should be injected subcutaneously into the anterior abdominal wall every 12 weeks following the procedure recommended in the administration instructions (see Directions for Use attached to sterile pouch).
2 hours for male subjects with normal renal function (creatinine clearance >70 mL/min). When ZOLADEX LA is given, as recommended, this change will not lead to any accumulation hence, no change in dosing is necessary for patients with renal failure.
Hepatic Impairment • Hepatic impairment does not compromise the clearance of ZOLADEX LA, therefore a dosage adjustment is not needed for patients with hepatic impairment. Geriatrics • No dosage adjustment is necessary in the elderly.
ZOLADEX® LA Product Monograph Page 7 of 40 Pediatrics • The safety and effectiveness of ZOLADEX LA in children has not been established; therefore, Health Canada has not authorized an indication for pediatric use. See 7 WARNINGS AND PRECAUTIONS.
4 Administration ZOLADEX LA is administered by deep subcutaneous injection into the anterior abdominal wall below the navel line. Caution should be taken while injecting ZOLADEX LA due to the proximity of underlying inferior epigastric artery and its branches.
Follow all administration instructions.
Caution:
Use only if pouch is undamaged. Use immediately after opening pouch. Do not depress plunger until Step 5. Read all instructions before use. Step by Step Directions for Use ZOLADEX LA should be administered using an aseptic technique. 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.
Note:
As ZOLADEX LA requires administration by deep subcutaneous injection, caution should be taken while injecting ZOLADEX LA into the anterior abdominal wall due to the proximity of underlying inferior epigastric artery and its branches.
5) as they may be at higher risk of vascular injury. 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 (Figure 1).
3. Grasp the plastic safety tab and pull away from the syringe and discard (Figure 2). 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.
ZOLADEX® LA Product Monograph Page 8 of 40 Correctly lifted skin fold:
Incorrectly lifted skin fold: With the opening of the […]
ZOLADEX® LA Product Monograph Page 15 of 40 Initially, prostate cancer patients may experience a temporary increase in bone pain, which can be managed symptomatically. In females, very common adverse reactions (≥10%) consist of: vulvovaginal dryness, breast enlargement, injection site reaction and acne (in most cases, acne was reported within one month after the start of ZOLADEX LA).
Common adverse reactions (≥1% to <10%) are: mood alteration including depression, headache, arthralgia and tumour flare/tumour pain. 1) cases of ovarian cyst have been reported. At the beginning of ZOLADEX LA treatment, abdominal pain, bleeding, loss of necrotic tissue and abdominal distension have been reported in patients with uterine fibroid at an unknown frequency.
Loss of head hair (alopecia) has been reported commonly in females, including in younger patients treated for benign conditions. This is usually mild but occasionally can be severe. The use of LHRH agonists may cause a reduction in bone mineral density.
See 7 WARNINGS AND PRECAUTIONS. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Prostate Cancer Pharmacological effects include hot flush, hyperhidrosis and erectile dysfunction, seldom requiring withdrawal of therapy.
Gynecomastia and breast tenderness have been noted infrequently. Initially, prostate cancer patients may experience a temporary increase in bone pain, which can be managed symptomatically. Isolated cases of spinal cord compression have been recorded.
The potential for exacerbation of signs and symptoms during the first few weeks of treatment is a concern particularly in male patients with impending neurologic compromise and in patients with severe obstructive uropathy. See 7 WARNINGS AND PRECAUTIONS.
Following the administration of ZOLADEX implant, isolated cases of ureteric obstruction have been recorded. Two controlled clinical trials were conducted with 157 patients, comparing treatment with ZOLADEX LA versus ZOLADEX implants.
During the comparative phase, patients were randomized to receive either a single ZOLADEX LA implant or three consecutive ZOLADEX implants (one every 4 weeks) over this initial 12-week period. The only adverse event reported in greater than 5% of these patients during this phase, was hot flush, with the ZOLADEX LA group having an incidence of 47% and the ZOLADEX group having 48%.
From Weeks 12-48 all patients were treated with one ZOLADEX LA implant every 12 weeks. 1%). ZOLADEX® LA Product Monograph Page 16 of 40 The following adverse events reported in greater than 1%, but less than 5% of 157 patients treated with ZOLADEX LA implant every 12 weeks are tabulated below.
Some of these would be expected in a proportion of the elderly population. 5) […]
Incorrectly lifted skin fold: 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 (Figure 3).
Do not penetrate into muscle or peritoneum. Incorrect grip and angle of administration is shown (Figure 4).
Note:
The ZOLADEX LA syringe cannot be used for aspiration. If the hypodermic needle penetrates a large vessel, blood will be seen instantly in the syringe chamber. If a vessel is penetrated, withdraw the needle and immediately control any resultant bleeding, monitoring the patient for signs or symptoms of abdominal hemorrhage.
After ensuring the patient is hemodynamically stable another ZOLADEX LA implant may be injected with a new syringe elsewhere. 5) and/or to patients who are fully anticoagulated (INR >2). 5. 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.
Note:
The needle does not retract. 6. Holding the syringe as shown in Figure 5, withdraw the needle and allow protective sleeve to continue to slide and cover needle. Dispose of the syringe in an approved sharps collector.
ZOLADEX® LA Product Monograph Page 9 of 40 Note:
In the unlikely event of the need to surgically remove a ZOLADEX LA implant, it may be localized by ultrasound. 5 Missed Dose Prostate Cancer: While the 3-month (13 week) schedule should be adhered to, a delay of a few days is permissible.
Breast Cancer:
While the 12-week schedule should be adhered to, a delay of a few days is permissible.
Endometriosis:
While the 12-week schedule should be adhered to, a delay of a few days is permissible. 5 OVERDOSAGE The pharmacologic properties of ZOLADEX LA and its mode of delivery make accidental or intentional overdosage unlikely. There is limited experience of overdosage in humans.
In cases where ZOLADEX LA has unintentionally been readministered early or given at a higher dose than recommended, no clinically relevant adverse effects have been seen. If overdosage occurs, this should be managed symptomatically.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging ZOLADEX LA implant is supplied as a cylindrical rod of biodegradable and biocompatible D-L Lactide-glycolide copolymer.
8 mg of goserelin. This implant is presented in a sterile ready-to-use syringe with a 14 gauge needle for a single subcutaneous injection. This single-dose syringe is assembled with a protective sleeve (SafeSystem®) in a sealed, sterile pouch that contains a desiccant.
Instructions for administration are attached. 8 mg goserelin Lactide-glycolide copolymer ZOLADEX® LA Product Monograph Page 10 of 40 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. 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.
See 4 DOSAGE AND 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 […]