Loading…
OXLUMO is a brand name for Lumasiran, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: OXLUMO (lumasiran) is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. 1.1 Pediatrics Pediatrics (< 18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of OXLUMO in pediatric patients…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • OXLUMO (lumasiran) is intended for subcutaneous use and should be administered by a health professional. • It is supplied in a single-use vial, as a ready-to-use solution that does not require additional reconstitution or dilution prior to administration.
• Once the vial is opened, use immediately. 2 Recommended Dose and Dosage Adjustment The recommended dosing regimen of OXLUMO consists of loading doses (once monthly for 3 doses) followed by maintenance doses (beginning 1 month after the last loading dose) as shown in Table 1.
Dosing is based on body weight; therefore, regular weight monitoring is recommended. OXLUMO® (lumasiran injection) Page 5 of 27 Table 1 - OXLUMO Weight-Based Dosing Regimen Body Weight Loading Dose Maintenance Dose (beginning 1 month after the last loading dose) Less than 10 kg 6 mg/kg once monthly for 3 doses 3 mg/kg once monthly, beginning 1 month after the last loading dose.
10 kg to less than 20 kg 6 mg/kg once monthly for 3 doses 6 mg/kg once every 3 months (quarterly): give the first maintenance dose 1 month after the last loading dose and quarterly thereafter. 20 kg and above 3 mg/kg once monthly for 3 doses 3 mg/kg once every 3 months (quarterly): give the first maintenance dose 1 month after the last loading dose and quarterly thereafter.
The patient dose (in mg) and volume (in mL) should be calculated as follows:
Patient body weight (kg) × dose (mg/kg) = total amount (mg) of OXLUMO to be administered. 4 Administration). Use in Pediatrics Dosing is based on body weight. No additional dose adjustments are required for pediatric patients. Limited data are available for patients <2 years of age and weighing <10 kg.
Use in Geriatrics OXLUMO has not been studied in patients ≥65 years of age. 3 Pharmacokinetics, Special Populations and Conditions). 3 Pharmacokinetics, Special Populations and Conditions). 3 Pharmacokinetics, Special Populations and Conditions).
OXLUMO has not been studied in patients with severe hepatic impairment. 3 Reconstitution Reconstitution is not required. 4 Administration OXLUMO is a sterile, preservative-free, clear, colorless-to-yellow solution. It is supplied in a single-use vial, as a ready-to-use solution that does not require additional reconstitution or dilution prior to administration.
1 Adverse Reaction Overview The data reflect placebo-controlled and open-label clinical studies in 98 patients with PH1 which includes 71 pediatric patients and 15 patients on hemodialysis. Patients ranged in age OXLUMO® (lumasiran injection) Page 9 of 27 from 4 months to 61 years at first dose.
Three patients were <1 year of age and 4 patients were between 1 to <2 years of age. 7 months). Overall, 92 patients were treated for at least 6 months, and 78 patients for at least 12 months and 29 patients for at least 24 months. 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.
Placebo-controlled study In the randomized, placebo-controlled, double-blind study (ILLUMINATE-A) in pediatric and adult patients with PH1 aged 6 to 61 years, 26 patients received OXLUMO and 13 patients received placebo. Of these, 25 patients received ≥5 months of treatment.
The most common (≥20%) adverse reaction reported was injection site reaction. All adverse reactions were non- serious, and none resulted in discontinuation of treatment. Table 3 - Adverse Reactions Reported in at Least 10% of Patients Treated with OXLUMO and that Occurred at Least 5% More Frequently than in Patients Treated with Placebo in ILLUMINATE-A during the 6-Month Double-Blind Period System Organ Class Adverse reaction OXLUMO N = 26 n (%) Placebo N = 13 n (%) Gastrointestinal disorders Abdominal paina 4 (15) 1 (8) General disorders and administration site conditions Injection site reaction 10 (38) 0 (0) a Includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort and abdominal tenderness In two single-arm studies in patients with PH1, ILLUMINATE-B (patients <6 years of age) and ILLUMINATE-C (pediatric and adult patients with severe renal impairment including end-stage renal disease and patients on hemodialysis), the OXLUMO safety profile was similar to that seen in ILLUMINATE-A.
, Immune 2025-01 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART 1: HEALTHCARE PROFESSIONAL INFORMATION ...........................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ......................................................
3 Reconstitution ........................................................................................................ 4 Administration .......................................................................................................
5 Missed Dose ........................................................................................................... 6 5 OVERDOSE ................................................................................................................
OXLUMO is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
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.
Inspect visually for particulate matter and discoloration. Do not use if discolored or if foreign particles are present. Use aseptic technique. • Calculate the required volume of OXLUMO based on the recommended weight-based dosage (see 4 DOSAGE AND ADMINISTRATION).
• Administer OXLUMO with a sterile 25- to 31-gauge needle with a 1/2- inch or 5/8-inch needle length for subcutaneous injection. 3 mL syringe is recommended. 5 mL. 5 mL should be administered as multiple injections to minimise potential injection site discomfort due to injection volume.
5 mL equally into multiple syringes. • Avoid having OXLUMO on the needle tip before the needle is in the subcutaneous space. Consider changing the needle prior to administration, if possible. • Administer subcutaneous injection into the abdomen, thigh, or the side or back of the upper arms.
Rotate injection sites. Do not inject into scar tissue or areas that are reddened, inflamed, or swollen. o If injecting into the abdomen, avoid the area around the navel. o If more than one injection is needed for a single dose of OXLUMO, the injection sites should be at least 2 cm apart.
o Discard any unused portion of the drug. Patients on Hemodialysis Administer OXLUMO following hemodialysis if administered on dialysis days. 5 Missed Dose If a dose is delayed or missed, administer OXLUMO as soon as possible. Resume prescribed monthly or quarterly dosing, from the most recently administered dose.
5 OVERDOSE No cases of overdose with OXLUMO have been reported in clinical trials. In case of overdose, it is recommended that patients be monitored as medically indicated for any signs or symptoms OXLUMO® (lumasiran injection) Page 7 of 27 of adverse effects and given appropriate treatment.
Description of selected adverse reactions Injection site reactions (ISRs) In placebo-controlled and open-label clinical studies, injection site reactions were reported in 34 of 98 patients (35%) treated with OXLUMO, occurring in 8% of injections.
The most commonly reported symptoms were erythema, swelling, pain, hematoma, pruritus, and OXLUMO® (lumasiran injection) Page 10 of 27 discoloration. The majority of ISRs had an onset within 1 to 3 days of the injection (with onset ranging from same day of administration to 29 days after the most recent dose).
ISRs have been mild, transient, and have not resulted in discontinuation of treatment. Abdominal Pain In placebo-controlled and open-label clinical studies, abdominal pain was reported in 16 of 98 patients (16%) treated with OXLUMO.
The adverse reaction of abdominal pain included abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort and abdominal tenderness. Most of the adverse reactions of abdominal pain were mild in severity, transient and none led to the discontinuation of treatment.
7 patient years. 0 months. The safety profile in the open-label extension period was generally consistent with the known safety profile of OXLUMO from the placebo-controlled double-blind period of the study. 5 Post-Market Adverse Reactions Table 4 - Adverse Reactions Reported During Post Marketing use of OXLUMO System organ class Adverse reaction Frequency Immune system disorders Hypersensitivity Not knowna a Events are reported from a population of uncertain size, it is not possible to reliably determine frequency from the available data.
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 7 7 WARNINGS AND PRECAUTIONS ................................................................................. 7 Immune ..............................................................................................................................
7 Renal .................................................................................................................................. 7 Reproductive Health ..........................................................................................................
1 Special Populations ................................................................................................ 1 Pregnancy...........................................................................................................
2 Breastfeeding ..................................................................................................... 3 Pediatrics............................................................................................................
4 Geriatrics ............................................................................................................ 8 OXLUMO® (lumasiran injection) Page 3 of 27 8 ADVERSE REACTIONS.................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 5 Post-Market Adverse Reactions...........................................................................
10 9 DRUG INTERACTIONS .............................................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 11 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
4 Immunogenicity ................................................................................................... 13 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 14 PART 2: SCIENTIFIC INFORMATION .....................................................................................
15 13 PHARMACEUTICAL INFORMATION .......................................................................... 15 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indications ................................................................................. 16 16 NON-CLINICAL TOXICOLOGY .................................................................................... 22 PATIENT MEDICATION INFORMATION ................................................................................
24 OXLUMO® (lumasiran injection) Page 4 of 27 PART 1: HEALTHCARE PROFESSIONAL INFORMATION 1 INDICATIONS OXLUMO (lumasiran) is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.
1 Pediatrics Pediatrics (< 18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy […]