Loading…
NUCALA is a brand name for Mepolizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 11/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 09/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose & Dosage Adjustment 09/2022 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 09/2022 4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose 09/2022 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations 11/2021 7…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women 11/2023 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 ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................
4 1 INDICATIONS ...................................................................................................................... 1 Pediatrics ..................................................................................................................................
2 Geriatrics .................................................................................................................................. 5 2 CONTRAINDICATIONS ..........................................................................................................
5 4 DOSAGE AND ADMINISTRATION .......................................................................................... 1 Dosing Considerations ..........................................................................................................
2 Recommended Dose and Dosage Adjustment ..................................................................... 3 Reconstitution .......................................................................................................................
4 Administration ...................................................................................................................... 5 Missed Dose ..........................................................................................................................
9 5 OVERDOSAGE ..................................................................................................................... 9
). Consider varicella vaccination if medically appropriate prior to starting therapy with Nucala. 1 Pregnant Women No studies have been conducted with Nucala in pregnant women, and there are no fertility data in humans (see 16 NON-CLINICAL TOXICOLOGY).
In clinical trials there were too few pregnancies reported to inform on maternal and fetal health and development outcomes. Nucala should not be used by pregnant women, unless the expected benefit to the mother justifies the potential risk to the fetus.
Women should be advised to contact their physicians if they become pregnant while receiving Nucala, or during the 4 months after treatment is stopped. 2 Breast-feeding There are no data regarding the presence of mepolizumab in human milk, the effects on the breastfed infant, or the effects on milk production (see 16 NON-CLINICAL TOXICOLOGY).
A decision should be made whether to discontinue breast-feeding or discontinue Nucala, taking into account the importance of breast-feeding to the infant and the importance of the drug to the mother. 3 Pediatrics Pediatrics (< 18 years of age): Patients less than 6 years of age were not included in the severe eosinophilic asthma clinical trials with Nucala.
There is limited efficacy and safety experience with Nucala in pediatric patients less than 18 years of age. 1%) patients age 12 to 17 years old were enrolled in the placebo- controlled severe asthma clinical trials with Nucala; and 36 patients age 6 to 11 years old were enrolled in the uncontrolled severe asthma clinical trial with Nucala.
Patients less than 18 years of age were not included in the chronic rhinosinusitis with nasal polyps clinical trial with Nucala. December 19, 2022 NUCALA, Mepolizumab Page 13 of 85 Patients less than 18 years of age were not included in the eosinophilic granulomatosis with polyangiitis clinical trial with Nucala.
1 Pregnant Women 11/2023 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 ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................
4 1 INDICATIONS ...................................................................................................................... 1 Pediatrics ..................................................................................................................................
2 Geriatrics .................................................................................................................................. 5 2 CONTRAINDICATIONS ..........................................................................................................
5 4 DOSAGE AND ADMINISTRATION .......................................................................................... 1 Dosing Considerations ..........................................................................................................
2 Recommended Dose and Dosage Adjustment ..................................................................... 3 Reconstitution .......................................................................................................................
4 Administration ...................................................................................................................... 5 Missed Dose ..........................................................................................................................
Nucala is contraindicated in patients who are hypersensitive to mepolizumab, to any ingredient(s) in the formulations, or component(s) of the containers. 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.
Nucala is not indicated for hypereosinophilic syndrome in patients under 18 years of age. 4 Geriatrics There is limited efficacy and safety experience with Nucala in patients over 65 years of age. 0%) patients age 65 and older were enrolled in the placebo-controlled severe asthma clinical trials with Nucala.
CRSwNP:
A total of 56/407 (14%) patients age 65 and older were enrolled in the chronic rhinosinusitis with nasal polyps clinical trial with Nucala.
EGPA:
A total of 17/136 (13%) patients age 65 and older were enrolled in the eosinophilic granulomatosis with polyangiitis clinical trial with Nucala.
HES:
A total of 14/108 (13%) patients age 65 and older were enrolled in the hypereosinophilic syndrome clinical trial with Nucala. 3 Pharmacokinetics). 1 Adverse Reaction Overview In clinical studies that enrolled adult and adolescent patients with severe eosinophilic asthma, the most commonly reported adverse drug reactions (events considered to be possibly related to treatment with mepolizumab) during treatment with Nucala were headache, injection site reaction, and back pain.
In a clinical study that enrolled children with severe eosinophilic asthma, the most commonly reported adverse drug reactions were headache, injection site reaction, abdominal pain upper, eczema, and pharyngitis. In a clinical study that enrolled adult patients with chronic rhinosinusitis with nasal polyps, the most commonly reported adverse drug reaction during treatment with Nucala was headache.
In a clinical study that enrolled adult patients with eosinophilic granulomatosis with polyangiitis, the most commonly reported adverse drug reaction during treatment with Nucala was headache. In a clinical study that enrolled adult patients with hypereosinophilic syndrome, the most commonly reported adverse drug reaction during treatment with Nucala was headache.
Hypersensitivity reactions, including anaphylaxis, swelling of the face, mouth, and/or tongue; fainting, dizziness, or lightheadedness; hives; breathing problems; and rash have been reported within hours or days of receiving treatment with Nucala.
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. 5 years). A total of 1,327 adult and adolescent patients with severe eosinophilic asthma received either a subcutaneous (SC) dose or an intravenous (IV) dose of mepolizumab or placebo during randomized controlled trials.
The safety profile was comparable between groups that received mepolizumab SC (Nucala 100 mg) or IV (75 mg, 250 mg and 750 mg). Two of the three placebo-controlled studies (MEA115588 and MEA115575) included Nucala 100 mg SC. Adverse events from the placebo-controlled studies that were reported by 1% or more of patients with Nucala 100 mg SC and that were reported more frequently than placebo (≥1% difference from placebo) are presented in Table 2.
Table 2 On-treatment Adverse Events with ≥1% incidence with Nucala and ≥1% more common with Nucala than placebo in adult and adolescent subjects with severe eosinophilic asthma from placebo-controlled studies (MEA115588 and MEA115575) Adverse Events1 Nucala 100 mg SC (N = 263) n (%) Placebo (N = 257) n (%) Eye […]
9 5 OVERDOSAGE ..................................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................................... 10 7 WARNINGS AND PRECAUTIONS .........................................................................................
1 Special Populations ................................................................................................................ 1 Pregnant Women ............................................................................................................
2 Breast-feeding ................................................................................................................. 3 Pediatrics .........................................................................................................................
4 Geriatrics ......................................................................................................................... 13 8 ADVERSE REACTIONS.........................................................................................................
1 Adverse Reaction Overview ................................................................................................ 2 Clinical Trial Adverse Reactions ..........................................................................................
3 Less Common Clinical Trial Adverse Reactions ................................................................... 5 Post-Market Adverse Reactions ............................................................................................
28 9 DRUG INTERACTIONS ........................................................................................................ 2 Drug Interactions Overview ...................................................................................................
4 Drug-Drug Interactions .......................................................................................................... 5 Drug-Food Interactions ..........................................................................................................
6 Drug-Herb Interactions .......................................................................................................... 7 Drug-Laboratory Test Interactions .........................................................................................
28 10 ACTION AND CLINICAL PHARMACOLOGY ............................................................................ 1 Mechanism of Action ...........................................................................................................
2 Pharmacodynamics .............................................................................................................. 3 Pharmacokinetics .................................................................................................................
30 11 STORAGE, STABILITY AND DISPOSAL .................................................................................. 32 12 SPECIAL HANDLING INSTRUCTIONS ....................................................................................
33 PART II: SCIENTIFIC INFORMATION................................................................................................. 34 13 PHARMACEUTICAL INFORMATION .....................................................................................
34 14 CLINICAL TRIALS ................................................................................................................ 1 Clinical Trials by Indication ...................................................................................................
34 Severe Eosinophilic Asthma ........................................................................................................... 34 Chronic Rhinosinusitis with Nasal Polyps […]