Loading…
CAMCEVI is a brand name for Leuprolide, supplied as a emulsion (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CAMCEVI (leuprolide mesylate) is indicated for: • treatment of adult patients with advanced prostate cancer. 1.1 Pediatrics (< 18 years of age) • No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics (> 65 years of age) • The mean age of the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • CAMCEVI should be administered by a healthcare professional. • CAMCEVI, 42 mg administered subcutaneously is designed to provide continuous extended release of leuprolide for 6 months. 4 ADMINISTRATION). 4 Administration CAMCEVI is administered by subcutaneous injection, whereupon it forms a solid drug delivery depot releasing leuprolide mesylate over 6 months.
The injectable emulsion contains approximately 42 mg of leuprolide base (equivalent to approximately 48 mg leuprolide mesylate). The recommended dosing is 1 subcutaneous injection every 24 weeks. As with other drugs administered by subcutaneous injection, the injection site should vary periodically.
The specific injection location chosen should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injection was administered in the upper- or mid- abdominal area. , with a belt or clothing waistband) should be avoided.
Administration Procedure IMPORTANT:
Allow the product to reach room temperature before using. The use of gloves is recommended during administration [Occupational Health and Safety (OH&S)]. Do NOT substitute any of the components from the kit for administration Follow the instructions as directed to ensure proper preparation of CAMCEVI prior to administration: Product Monograph of CAMCEVI (leuprolide mesylate) Page 6 of 36 CAMCEVI 42 mg kit contains: • One sterile pre-filled plastic syringe closed with elastomeric grey tip cap, plunger and finger grip • One sterile 18-gauge SurGuard®3 safety needle, 5/8 inch needle Syringe Assembly Remove contents Assemble the Needle 1.
Keep contents in their original, sealed blister container and allow pre-filled syringe to sit at room temperature for 30 minutes prior to subcutaneous injection. Return to refrigerator after 30 minutes if not used. 2. On a clean, dry surface, remove pre-filled CAMCEVI 42 mg syringe (A) and needle cartridge (B) from the blister container.
Visually inspect the contents prior to use. Check the expiration date on the syringe. Do not use if the expiration date has passed. Visually inspect the syringe for particulate matter prior to administration. The emulsion should appear off-white to pale yellow, viscous, and opalescent.
Do not use if particulate matter is observed prior to administration. 3. Remove pre-filled syringe (A) from blister tray and open the safety needle (B) package by peeling back the paper tab. Product Monograph of CAMCEVI (leuprolide mesylate) Page 7 of 36 4.
1 Adverse Reaction Overview The safety of CAMCEVI was evaluated in a clinical trial involving patients with advanced prostate cancer who received at least one dose of CAMCEVI. CAMCEVI, like other GnRH analogues, caused a transient increase in serum testosterone concentrations during the first week of treatment, declining thereafter to baseline levels or below by the end of the second week of treatment.
Therefore, potential exacerbations in signs and symptoms of the disease during the first weeks of treatment are of concern in patients with vertebral metastases and/or urinary obstruction or hematuria which, if aggravated, may lead to neurological problems (such as weakness and/or paresthesia of the lower limbs) or increase the obstruction (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 for identifying and approximating rates of adverse drug reactions in real-world use. In an open-label, non-comparative clinical trial (FP01C13-001), patients with advanced prostate cancer received CAMCEVI administered subcutaneously at a dose of 42 mg on Day 0 and Day 168.
Of 137 patients enrolled, 93% received both doses of CAMCEVI. The median follow-up duration was 336 days. Product Monograph of CAMCEVI (leuprolide mesylate) Page 16 of 36 The most common adverse reactions (incidence ≥ 10%) were hot flush, hypertension, injection site reactions, upper respiratory infections, musculoskeletal pain, fatigue, and pain in extremity.
Serious Adverse Events (SAE) occurred in 15% of patients treated with CAMCEVI. 5%). 7%) and acute kidney injury. Discontinuation occurred in 11% of subjects. The most common reason for discontinuation was due to adverse events in 4% of patients including acute kidney injury, atrial fibrillation, cerebrovascular accident, death, hormone refractory prostate cancer and metastatic prostate cancer.
, General) • Pituitary apoplexy (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism) • Osteoporosis (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism). 1 Dosing Considerations • CAMCEVI should be administered by a healthcare professional.
• CAMCEVI, 42 mg administered subcutaneously is designed to provide continuous extended release of leuprolide for 6 months. 4 ADMINISTRATION). 4 Administration CAMCEVI is administered by subcutaneous injection, whereupon it forms a solid drug delivery depot releasing leuprolide mesylate over 6 months.
The injectable emulsion contains approximately 42 mg of leuprolide base (equivalent to approximately 48 mg leuprolide mesylate). The recommended dosing is 1 subcutaneous injection every 24 weeks. As with other drugs administered by subcutaneous injection, the injection site should vary periodically.
The specific injection location chosen should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injection was administered in the upper- or mid- abdominal area. , with a belt or clothing waistband) should be avoided.
Administration Procedure IMPORTANT:
Allow the product to reach room temperature before using. The use of gloves is recommended during administration [Occupational Health and Safety (OH&S)]. Do NOT substitute any of the components from the kit for administration Follow the instructions as directed to ensure proper preparation of CAMCEVI prior to administration: Product Monograph of CAMCEVI (leuprolide mesylate) Page 6 of 36 CAMCEVI 42 mg kit contains: • One sterile pre-filled plastic syringe closed with elastomeric grey tip cap, plunger and finger grip • One sterile 18-gauge SurGuard®3 safety needle, 5/8 inch needle Syringe Assembly Remove contents Assemble the Needle 1.
Keep contents in their original, sealed blister container and allow pre-filled syringe to sit at room temperature for 30 minutes prior to subcutaneous injection. Return to refrigerator after 30 minutes if not used. 2. On a clean, dry surface, remove pre-filled CAMCEVI 42 mg syringe (A) and needle cartridge (B) from the blister container.
CAMCEVI is contraindicated in: • patients with hypersensitivity to gonadotropin releasing hormone (GnRH) analogues, or any of the components of CAMCEVI. Anaphylactic reactions including anaphylactic shock to synthetic GnRH or GnRH analogues have been reported in post-marketing surveillance.
For a complete listing, see the section 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • women and paediatric patients. • women who are or may become pregnant. • women who are nursing.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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.
Remove the gray cap from syringe (A). 5. Attach the needle (B) to the end of the syringe (A) by gently screwing clockwise with approximately a three-quarter turn until the needle is secure. Do not overtighten, as the needle hub may become damaged resulting in leakage of the product during injection.
The safety sheath may also be damaged if the needle is overtightened onto the syringe. Administration Procedure Product Monograph of CAMCEVI (leuprolide mesylate) Page 8 of 36 Prepare the Injection Site Expose Needle Administer Treatment Activate Safety Sheath and Discard Needle Using finger/thumb: 1.
2. OR Using flat surface: 1. 2. 1. Choose an injection site on the upper- or mid-abdominal area that has not recently been used. Clean the injection site with an alcohol swab. , with a belt or clothing waistband). (1) Move the safety sheath away from the needle and towards the syringe and (2) remove the clear needle cover immediately before injection.
Note:
Should the needle hub appear to be damaged, or leak, the product should NOT be used. The damaged needle should NOT be replaced and the product should NOT be injected. In the event of damage to the needle hub, use a new replacement CAMCEVI kit.
2. Pull the blue cover off the needle. Use standard sharps safety techniques to avoid needle sticks. 3. Grab and bunch the skin around the injection site with one hand. Insert the needle at a 90° angle, then release the bunched skin. 4. Inject the full contents of the syringe with a slow and steady push, then withdraw the needle at the same 90° angle used for insertion.
Product Monograph of CAMCEVI (leuprolide mesylate) Page 9 of 36 5. Intra-arterial or intravenous injection has to be strictly avoided 6. Immediately following the withdrawal of the needle, activate the safety sheath using a finger/thumb or flat surface and push until it completely covers the needle tip and locks into place.
An audible and tactile “click” verifies a locked position. Check to confirm the safety sheath is fully engaged. 7. After use, place the used syringe with needle protected in a suitable sharps container. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
5 Missed Dose Maintaining testosterone suppression is important in treating the symptoms of hormone- dependent prostate cancer. Missing an appointment by a few days should not disrupt the benefits of treatment, but keeping a consistent schedule of leuprolide injections is an important part of treatment.
Call your healthcare professional for instructions if you miss a dose.
The following adverse events (all grades) occurred in the clinical trial of CAMCEVI and were reported in ≥5% of patients (Table 2). 7 a includes hot flush and flushing b includes hypertension, essential hypertension, and blood pressure increased c includes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmth d includes fatigue and asthenia e includes upper respiratory tract infection, sinusitis, and nasopharyngitis f includes musculoskeletal pain, back pain, and bone pain g includes micturition urgency and dysuria h includes dizziness, dizziness postural, vertigo, and vertigo positional.
3 Less Common Clinical Trial Adverse Reactions The following are selected clinically significant adverse reactions reported in less than 5% of patients receiving CAMCEVI in study FP01C-13-001: Cardiac disorders: Atrial fibrillation, myocardial infarction Cardiovascular: Deep vein thrombosis Eye disorders: Vision blurred Infections and infestations: Urinary tract infection Injury, poisoning and procedural complications: Hip fracture Investigations: Alanine aminotransferase increased, aspartate aminotransferase increased, blood glucose increased, weight increased Metabolism and nutrition disorders: Obesity, decreased appetite, diabetes mellitus Nervous system disorders: Lethargy, amnesia, headache Psychiatric: Affect lability, confusional state, depression, irritability, loss of libido Reproductive system and breast disorders: Gynaecomastia Skin: Cold sweat, erythema, pruritus The safety profile of CAMCEVI was further examined and followed in the open-label, single-arm safety extension study (FP01C-13-001-EX) with 30 subjects enrolled.
No new safety signals were identified in the safety extension study. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Laboratory abnormalities were observed, but it was difficult to assess relationship to the drug treatment as most occurred in <3% of patients and most in 1 subject each.
The following laboratory abnormalities occurred in the clinical trial for CAMCEVI and were reported in > 1% of patients ( Table 3). 7% Note: *Two patients had clinically significant PSA increase in CAMCEVI trial, but only one of them had the increased PSA judged with severe clinical significance.
The following grade 1–2 laboratory abnormalities occurred […]
Visually inspect the contents prior to use. Check the expiration date on the syringe. Do not use if the expiration date has passed. Visually inspect the syringe for particulate matter prior to administration. The emulsion should appear off-white to pale yellow, viscous, and opalescent.
Do not use if particulate matter is observed prior to administration. 3. Remove pre-filled syringe (A) from blister tray and open the safety needle (B) package by peeling back the paper tab. Product Monograph of CAMCEVI (leuprolide mesylate) Page 7 of 36 4.
Remove the gray cap from syringe (A). 5. Attach the needle (B) to the end of the syringe (A) by gently screwing clockwise with approximately a three-quarter turn until the needle is secure. Do not overtighten, as the needle hub may become damaged resulting in leakage of the product during injection.
The safety sheath may also be damaged if the needle is overtightened onto the syringe. Administration Procedure Product Monograph of CAMCEVI (leuprolide mesylate) Page 8 of 36 Prepare the Injection Site Expose Needle Administer Treatment Activate Safety Sheath and Discard Needle Using finger/thumb: 1.
2. OR Using flat surface: 1. 2. 1. Choose an injection site on the upper- or mid-abdominal area that has not recently been used. Clean the injection site with an alcohol swab. , with a belt or clothing waistband). (1) Move the safety sheath away from the needle and towards the syringe and (2) remove the clear needle cover immediately before injection.
Note:
Should the needle hub appear to be damaged, or leak, the product should NOT be used. The damaged needle should NOT be replaced and the product should NOT be injected. In the event of damage to the needle hub, use a new replacement CAMCEVI kit.
2. Pull the blue cover off the needle. Use standard sharps safety techniques to avoid needle sticks. 3. Grab and bunch the skin around the injection site with one hand. Insert the needle at a 90° angle, then release the bunched skin. 4. Inject the full contents of the syringe with a slow and steady push, then withdraw the needle at the same 90° angle used for insertion.
Product Monograph of CAMCEVI (leuprolide mesylate) Page 9 of 36 5. Intra-arterial or intravenous injection has to be strictly avoided 6. Immediately following the withdrawal of the needle, activate the safety sheath using a finger/thumb or flat surface and push until it completely covers the needle tip and locks into place.
An audible and tactile “click” verifies a locked position. Check to confirm the safety sheath is fully engaged. 7. After use, place the used syringe with needle protected in a suitable sharps container. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
5 Missed Dose Maintaining testosterone suppression is important in treating the symptoms of hormone- dependent prostate cancer. Missing an appointment by a few days should not disrupt the benefits of treatment, but keeping a consistent schedule of leuprolide injections is an important part of treatment.
Call your healthcare professional for instructions if you miss a dose. 5 OVERDOSAGE There is no clinical experience with the effects of an acute overdose. There is no known antidote for CAMCEVI overdose. In the event of an overdose, stop CAMCEVI, undertake general supportive measures until clinical […]