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Drug overview for NUCALA (mepolizumab (recombinant)):
Generic name: MEPOLIZUMAB (RECOMBINANT) (ME-poe-LIZ-ue-mab)
Drug class: Monoclonal Antibody, Human Interleukin 5 Antagonist
Therapeutic class: Respiratory Therapy Agents
Mepolizumab, a recombinant DNA-derived humanized monoclonal antibody specific for interleukin-5 (IL-5), has disease-modifying activity in severe eosinophilic asthma and other eosinophilic conditions. The drug is an IgG1 kappa immunoglobulin.
No enhanced Uses information available for this drug.
Generic name: MEPOLIZUMAB (RECOMBINANT) (ME-poe-LIZ-ue-mab)
Drug class: Monoclonal Antibody, Human Interleukin 5 Antagonist
Therapeutic class: Respiratory Therapy Agents
Mepolizumab, a recombinant DNA-derived humanized monoclonal antibody specific for interleukin-5 (IL-5), has disease-modifying activity in severe eosinophilic asthma and other eosinophilic conditions. The drug is an IgG1 kappa immunoglobulin.
No enhanced Uses information available for this drug.
DRUG IMAGES
NUCALA 100 MG/ML POWDER VIAL
NUCALA 100 MG/ML AUTO-INJECTOR
NUCALA 100 MG/ML SYRINGE
The following indications for NUCALA (mepolizumab (recombinant)) have been approved by the FDA:
Indications:
Chronic rhinosinusitis with nasal polyposis
Eosinophilic asthma
Eosinophilic granulomatosis with polyangiitis
Hypereosinophilic syndrome
Professional Synonyms:
Allergic granulomatosis angiitis
Asthma with eosinophilic phenotype
Asthmatic pulmonary eosinophilia
Churg Strauss syndrome
Indications:
Chronic rhinosinusitis with nasal polyposis
Eosinophilic asthma
Eosinophilic granulomatosis with polyangiitis
Hypereosinophilic syndrome
Professional Synonyms:
Allergic granulomatosis angiitis
Asthma with eosinophilic phenotype
Asthmatic pulmonary eosinophilia
Churg Strauss syndrome
The following dosing information is available for NUCALA (mepolizumab (recombinant)):
If a dose of mepolizumab is missed, the missed dose should be administered as soon as possible and the next dose administered on the usual day of administration. If it is time for the next scheduled dose, then the missed dose should be skipped and the scheduled dose should be administered as planned.
Systemic or inhaled corticosteroid therapy should not be discontinued abruptly upon initiation of mepolizumab therapy. If appropriate, reduction in corticosteroid dosage should be performed gradually and under the direct supervision of a clinician. Reduction in corticosteroid dosage may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by corticosteroid therapy.
Systemic or inhaled corticosteroid therapy should not be discontinued abruptly upon initiation of mepolizumab therapy. If appropriate, reduction in corticosteroid dosage should be performed gradually and under the direct supervision of a clinician. Reduction in corticosteroid dosage may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by corticosteroid therapy.
Mepolizumab is administered by subcutaneous injection only; the drug should not be administered IV. Mepolizumab is commercially available as a solution containing 100 mg/mL in single-use prefilled syringes and autoinjectors, which may be used for self-administration. The drug also is available as a lyophilized powder in single-use vials, which must be reconstituted and administered by a clinician.
Mepolizumab is administered subcutaneously into the upper arm, thigh, or abdomen (except within 2 inches of the navel). Injection into areas where the skin is tender, bruised, erythematous, or indurated should be avoided.
Mepolizumab is administered subcutaneously into the upper arm, thigh, or abdomen (except within 2 inches of the navel). Injection into areas where the skin is tender, bruised, erythematous, or indurated should be avoided.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| NUCALA 100 MG/ML POWDER VIAL | Maintenance | Adults inject 1 milliliter (100 mg) in the abdomen, thigh, or upper arm by subcutaneous route every 4 weeks |
| NUCALA 100 MG/ML AUTO-INJECTOR | Maintenance | Adults inject 100 mg by subcutaneous route every 4 weeks in the abdomen, thigh, or upper arm |
| NUCALA 100 MG/ML SYRINGE | Maintenance | Adults inject 100 mg by subcutaneous route every 4 weeks in the abdomen, thigh, or upper arm |
No generic dosing information available.
The following drug interaction information is available for NUCALA (mepolizumab (recombinant)):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Efgartigimod-alfa SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3) |
VYVGART, VYVGART HYTRULO |
| IgG Antibodies and Derivatives/Nipocalimab-aahu SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
IMAAVY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Rozanolixizumab-noli SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3) DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3) |
RYSTIGGO |
The following contraindication information is available for NUCALA (mepolizumab (recombinant)):
Drug contraindication overview.
*Patients with a history of hypersensitivity to the drug or any ingredient in the formulation.
*Patients with a history of hypersensitivity to the drug or any ingredient in the formulation.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Herpes zoster |
The following adverse reaction information is available for NUCALA (mepolizumab (recombinant)):
Adverse reaction overview.
Adverse reactions reported in at least 5% of patients in studies of approved indications are as follows: *Asthma: headache, injection site reaction, back pain, fatigue. *Chronic rhinosinusitis with nasal polyposis: oropharyngeal pain, arthralgia. *Eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome: most common adverse reactions are similar to those in patients withasthma.
Adverse reactions reported in at least 5% of patients in studies of approved indications are as follows: *Asthma: headache, injection site reaction, back pain, fatigue. *Chronic rhinosinusitis with nasal polyposis: oropharyngeal pain, arthralgia. *Eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome: most common adverse reactions are similar to those in patients withasthma.
There are 7 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Influenza |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Bronchospastic pulmonary disease Herpes zoster Hypersensitivity drug reaction Hypotension |
There are 29 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Back pain Fatigue Headache disorder Injection site sequelae |
Allergic rhinitis Bronchitis Cystitis Dizziness Dyspnea Eczema Fever Flushing General weakness Infection of ear Injection site erythema Muscle spasm Musculoskeletal pain Myalgia Nasal congestion Nausea Pharyngitis Pruritus of skin Toothache Upper abdominal pain Urinary tract infection Viral infection Vomiting |
| Rare/Very Rare |
|---|
|
Skin rash Urticaria |
The following precautions are available for NUCALA (mepolizumab (recombinant)):
Safety and efficacy of mepolizumab for the treatment of severe eosinophilic asthma have not been established in pediatric patients younger than 6 years of age. Safety and efficacy of mepolizumab in pediatric patients 6-11 years of age with severe eosinophilic asthma are based on extrapolation of efficacy data from clinical trials conducted in adults and adolescents 12 years of age or older in addition to pharmacokinetic, pharmacodynamic, and safety data in children 6-11 years of age. Simulations based on pharmacokinetic data in pediatric patients 6-11 years of age with asthma indicate that a mepolizumab dosage of 40 mg subcutaneously every 4 weeks, regardless of body weight, results in exposures similar to those observed in adults and adolescents receiving the recommended dosage.
The safety profile and pharmacodynamics of mepolizumab in patients 6-11 years of age with severe eosinophilic asthma were similar to those observed in adults and adolescents 12 years of age or older. Phase 3 clinical studies in patients with severe asthma included 28 adolescent patients 12-17 years of age, 19 of whom received mepolizumab. The overall adverse effect profile in adolescents generally was similar to that seen in adults.
In the 9 adolescents who received mepolizumab 100 mg subcutaneously, the mean apparent clearance of the drug was 35% less than that of adults. Safety and efficacy of mepolizumab for the treatment of chronic rhinosinusitis with nasal polyps have not been established in patients younger than 18 years of age. Safety and efficacy of mepolizumab for the treatment of eosinophilic granulomatosis with polyangiitis have not been established in patients younger than 18 years of age. Safety and efficacy of mepolizumab for the treatment of hypereosinophilic syndrome in pediatric patients younger than 12 years of age have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
The safety profile and pharmacodynamics of mepolizumab in patients 6-11 years of age with severe eosinophilic asthma were similar to those observed in adults and adolescents 12 years of age or older. Phase 3 clinical studies in patients with severe asthma included 28 adolescent patients 12-17 years of age, 19 of whom received mepolizumab. The overall adverse effect profile in adolescents generally was similar to that seen in adults.
In the 9 adolescents who received mepolizumab 100 mg subcutaneously, the mean apparent clearance of the drug was 35% less than that of adults. Safety and efficacy of mepolizumab for the treatment of chronic rhinosinusitis with nasal polyps have not been established in patients younger than 18 years of age. Safety and efficacy of mepolizumab for the treatment of eosinophilic granulomatosis with polyangiitis have not been established in patients younger than 18 years of age. Safety and efficacy of mepolizumab for the treatment of hypereosinophilic syndrome in pediatric patients younger than 12 years of age have not been established.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as pregnancy progresses with potential effects on the fetus being more likely during the second and third trimesters. However, there was no evidence of fetal harm in cynomolgus monkeys following IV administration of mepolizumab throughout pregnancy at dosages that produced exposures up to approximately 30 times the exposure at the maximum recommended human dosage.
There are no data on the presence of mepolizumab in human milk, or its effects on the breast-fed child or milk production. However, the drug is distributed into the milk of cynomolgus monkeys. Since IgG is distributed into milk in humans, it is expected that mepolizumab will be present in human milk. The potential risks of infant exposure to mepolizumab should be weighed against the mother's clinical need for the drug as well as the known benefits of breast-feeding.
The manufacturer makes no specific dosage recommendations for geriatric patients. Clinical studies of mepolizumab did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger adults. Other reported clinical experience has not identified differences in responses between geriatric and younger patients, but greater sensitivity in some older patients cannot be ruled out.
The following prioritized warning is available for NUCALA (mepolizumab (recombinant)):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for NUCALA (mepolizumab (recombinant))'s list of indications:
| Chronic rhinosinusitis with nasal polyposis | |
| J32 | Chronic sinusitis |
| J32.8 | Other chronic sinusitis |
| J32.9 | Chronic sinusitis, unspecified |
| J33 | Nasal polyp |
| J33.0 | Polyp of nasal cavity |
| J33.1 | Polypoid sinus degeneration |
| J33.8 | Other polyp of sinus |
| J33.9 | Nasal polyp, unspecified |
| Eosinophilic asthma | |
| J82.83 | Eosinophilic asthma |
| Eosinophilic granulomatosis with polyangiitis | |
| M30.1 | Polyarteritis with lung involvement [churg-strauss] |
| Hypereosinophilic syndrome | |
| D72.11 | Hypereosinophilic syndrome [HEs] |
| D72.110 | Idiopathic hypereosinophilic syndrome [IHEs] |
| D72.111 | Lymphocytic variant hypereosinophilic syndrome [LHEs] |
| D72.118 | Other hypereosinophilic syndrome |
| D72.119 | Hypereosinophilic syndrome [HEs], unspecified |
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