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ZILBRYSQ is a brand name for Zilucoplan, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ZILBRYSQ (zilucoplan injection) is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Patients continued to receive standard therapy throughout the pivotal trial (see 4.1 Dosing Considerations and 14 CLINICAL TRIALS). 1.1…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations ZILBRYSQ is intended for use under the guidance and supervision of health professionals experienced in the management of patients with neuromuscular disorders. Before starting therapy with ZILBRYSQ, patients must be vaccinated against Neisseria meningitidis.
If treatment with ZILBRYSQ needs to start less than 2 weeks after vaccination against meningococcal infection, the patient must receive appropriate prophylactic antibiotic treatment until 2 weeks after the first vaccination dose. Before initiating ZILBRYSQ, obtain baseline lipase and amylase levels (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
ZILBRYSQ was studied in adult gMG patients with a Myasthenia Gravis Foundation of America (MGFA) clinical classification Class II to IV, who remained on their standard of care therapies (see 14 CLINICAL TRIALS). It has not been studied in gMG patients with an MGFA Class V.
2 Recommended Dose and Dosage Adjustment The recommended dose of ZILBRYSQ for adult patients with gMG should be given as a subcutaneous injection once daily and administered about the same time every day. 3 mg/kg.
Pediatrics (< 18 years of age):
The safety and efficacy of ZILBRYSQ in children and adolescents below the age of 18 years has not been established. ZILBRYSQ is not indicated for use in pediatric patients.
Geriatrics (≥ 65 years of age):
The clinical experience with ZILBRYSQ in elderly patients is limited. Based on pharmacokinetic analysis, no dose adjustment is required (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions, Geriatrics).
Hepatic Impairment:
No dose adjustment is required for patients with mild and moderate hepatic impairment. There are no data on patients with severe hepatic impairment and therefore, no dose adjustment recommendation can be made (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency).
Product Monograph ZILBRYSQ (zilucoplan injection) Page 6 of 31 Renal Impairment:
1 Adverse Reaction Overview A total of 86 individual patients were exposed to ZILBRYSQ during the 12-week placebo-controlled period in the Phase 3 study in gMG. 5%). During the long-term open-label safety study, which enrolled 199 patients, a total of 84 patients were exposed to ZILBRYSQ for at least one year and 31 patients received the drug for over 3 years.
0%). 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.
Product Monograph ZILBRYSQ (zilucoplan injection) Page 10 of 31 Table 3:
Adverse Reactions Reported in ≥ 5% or Patients treated with ZILBRYSQ and at a Higher Frequency than Placebo-treated patients in the controlled Phase 3 study. 3) * High Level term, includes the following Preferred terms: injection site bruising, injection site haematoma, injection site pain, injection site reaction, injection site haemorrhage, injection site rash ** High Level term, includes the following Preferred terms: nasopharyngitis, upper respiratory tract infection, sinusitis and tonsillitis Injection site reactions Most common terms were injection site bruising, pain, nodule, pruritus and hematoma.
All cases were non-serious, mild or moderate in severity, and less than 1% of events led to treatment discontinuation. Upper respiratory tract infections Most common terms were nasopharyngitis, upper respiratory tract infection and sinusitis.
More than 95% of the cases were non-serious, mild or moderate in severity and did not lead to treatment discontinuation. Morphea Cases of morphea (common, 1-10%) were observed after long-term treatment during the open-label extension study.
, Meningococcal infection. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX • Meningococcal infections may occur in patients treated with complement C5 inhibitors. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early (see 7 WARNINGS AND PRECAUTIONS, Immune).
• Comply with the most current National Advisory Committee on Immunization (NACI) recommendations for meningococcal vaccination in patients with complement deficiencies. • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of ZILBRYSQ, unless ZILBRYSQ needs to be started earlier because the benefit of starting treatment outweighs the risk.
See 7 WARNINGS AND PRECAUTIONS, Immune for additional guidance on the management of the risk of meningococcal infection. • Patients who initiate treatment with ZILBRYSQ less than 2 weeks after vaccination must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
• Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for signs and symptoms of meningococcal infections and evaluate immediately if infection is suspected. Product Monograph ZILBRYSQ (zilucoplan injection) Page 5 of 31 ZILBRYSQ in Canada is available as part of a controlled distribution program under which prescribers must enrol patients and confirm vaccination with meningococcal vaccine.
Prescribers must also counsel patients about the risk of meningococcal infection and provide them with the patient/carer guide and patient safety card. 1 Dosing Considerations ZILBRYSQ is intended for use under the guidance and supervision of health professionals experienced in the management of patients with neuromuscular disorders.
Before starting therapy with ZILBRYSQ, patients must be vaccinated against Neisseria meningitidis. If treatment with ZILBRYSQ needs to start less than 2 weeks after vaccination against meningococcal infection, the patient must receive appropriate prophylactic antibiotic treatment until 2 weeks after the first vaccination dose.
ZILBRYSQ 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.
ZILBRYSQ must not be initiated in patients: • who are currently not vaccinated against Neisseria meningitidis • with unresolved Neisseria meningitidis infection See 7 WARNINGS AND PRECAUTIONS, Meningococcal infection.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No dose adjustment is required in patients with renal impairment. There are no data on patients requiring dialysis (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 4 Administration ZILBRYSQ is administered by subcutaneous injection.
Suitable injection sites include front of the thighs, abdomen and the back of the upper arms. Injection sites should be rotated, and injections should not be given in areas where the skin is tender, erythematous, bruised, indurated or where the skin has scars or stretch marks.
Administration should be performed by an individual (patient or their caregiver) who has been trained in injection techniques. Additional information and instructions for the preparation and administration of ZILBRYSQ using the pre-filled syringe are given in the package leaflet and relevant “INSTRUCTIONS FOR USE” (see INSTRUCTIONS FOR USE).
5 Missed Dose If a dose is missed, administer the dose as soon as possible the same day. Thereafter, resume dosing at the regular scheduled time the following day. Do not administer more than one dose per day.
The majority of the cases had a time to onset longer than one year after start of treatment, were mild or moderate in severity and did not lead to treatment discontinuation. 1 Clinical Trial Adverse Reactions – Pediatrics The safety profile of ZILBRYSQ in the pediatric population has not been studied.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Pancreatic enzymes increased Elevations of lipase and/or amylase were observed in clinical studies. These were transient and rarely led to treatment discontinuation (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Blood eosinophils increased Elevations of blood eosinophils were observed in clinical studies. These were transient, not leading to treatment discontinuation and not associated with clinically relevant organ dysfunction. Immunogenicity As with all therapeutic peptides, there is a potential for immunogenicity.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease.
For these reasons, comparison of the incidence of antibodies to ZILBRYSQ in the studies described below with the incidence of antibodies in other studies or to other products is misleading. 3% (2/86) of patients treated with ZILBRYSQ developed antidrug antibodies (ADA).
3% (8/86) of ZILBRYSQ treated patients developed anti-PEG antibodies. Antibody titers were low and there was no evidence of an association between positive ADA status or positive anti-PEG status and the incidence of adverse events. There was no observed impact of ADA and anti-PEG positivity on pharmacokinetics, pharmacodynamics, efficacy and safety.
Before initiating ZILBRYSQ, obtain baseline lipase and amylase levels (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). ZILBRYSQ was studied in adult gMG patients with a Myasthenia Gravis Foundation of America (MGFA) clinical classification Class II to IV, who remained on their standard of care therapies (see 14 CLINICAL TRIALS).
It has not been studied in gMG patients with an MGFA Class V. 2 Recommended Dose and Dosage Adjustment The recommended dose of ZILBRYSQ for adult patients with gMG should be given as a subcutaneous injection once daily and administered about the same time every day.
3 mg/kg.
Pediatrics (< 18 years of age):
The safety and efficacy of ZILBRYSQ in children and adolescents below the age of 18 years has not been established. ZILBRYSQ is not indicated for use in pediatric patients.
Geriatrics (≥ 65 years of age):
The clinical experience with ZILBRYSQ in elderly patients is limited. Based on pharmacokinetic analysis, no dose adjustment is required (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions, Geriatrics).
Hepatic Impairment:
No dose adjustment is required for patients with mild and moderate hepatic impairment. There are no data on patients with severe hepatic impairment and therefore, no dose adjustment recommendation can be made (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency).
Product Monograph ZILBRYSQ (zilucoplan injection) Page 6 of 31 Renal Impairment:
No dose adjustment is required in patients with renal impairment. There are no data on patients requiring dialysis (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 4 Administration ZILBRYSQ is administered by subcutaneous injection.
Suitable injection sites include front of the thighs, abdomen and the back of the upper arms. Injection sites should be rotated, and injections should not be given in areas where the skin is tender, erythematous, bruised, indurated or where the skin has scars or stretch marks.
Administration should be performed by an individual (patient or their caregiver) who has been trained in injection techniques. Additional information and instructions for the preparation and administration of ZILBRYSQ using the pre-filled syringe are given in the package leaflet and relevant “INSTRUCTIONS FOR USE” (see INSTRUCTIONS FOR USE).
5 Missed Dose If a dose is missed, administer the dose as soon as possible the same day. Thereafter, resume dosing at the regular scheduled time the following day. Do not administer more than one dose per day. 5 OVERDOSAGE Limited experience with doses higher than the recommended dose of ZILBRYSQ is available from clinical trials in humans.
6 mg/kg, administered subcutaneously for up to 7 days. 6 mg/kg were injection site reactions and diarrhea. 2 Clinical Trial Adverse Reactions). In cases of overdose, it is recommended that patients are monitored closely for any adverse effects, and appropriate supportive measures should be instituted immediately.
For management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669). Product Monograph ZILBRYSQ (zilucoplan injection) Page 7 of 31 6 […]