Nucala (mepolizumab)

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.

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.

No dosing information is available for this tab.

Specific drug interaction studies have not been conducted with mepolizumab.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

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)

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)

Moderate Interaction: Assess the risk to the patient and take action as needed.

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)

*Patients with a history of hypersensitivity to the drug or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

• Parasitic infection

• Herpes zoster

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 with asthma.

*COPD: back pain, diarrhea, cough.

Less Frequent

• Influenza

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Bronchospastic pulmonary disease
• Herpes zoster
• Hypersensitivity drug reaction
• Hypotension

More Frequent

• Back pain
• Fatigue
• Headache disorder
• Injection site sequelae

Less Frequent

• Allergic rhinitis
• Arthralgia
• Bronchitis
• Cough
• Cystitis
• Diarrhea
• Dizziness
• Dry nose
• Dyspnea
• Eczema
• Fever
• Flushing
• Gastroenteritis
• General weakness
• Infection of ear
• Injection site erythema
• Lower respiratory infection
• Muscle spasm
• Musculoskeletal pain
• Myalgia
• Nasal congestion
• Nausea
• Pain in extremities
• Pain in oropharynx
• Pharyngitis
• Pruritus of skin
• Toothache
• Upper abdominal pain
• Urinary tract infection
• Viral infection
• Vomiting

Rare or Very Rare

• Skin rash
• Urticaria

No enhanced messaging available.

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.

Safety and efficacy of mepolizumab for the treatment of COPD have not been established in patients younger than 18 years of age.

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.

In clinical studies of mepolizumab for severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, and COPD, 1073 (26%) patients were >=65 years of age and 241 (6%) patients were >=75 years of age. No overall differences in efficacy and safety were noted between these and younger patients. 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.