Mepolizumab interacts in the following cases:
Eosinophils may be involved in the immunological response to some helminth infections. Patients with pre-existing helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with mepolizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women.
Mepolizumab crosses the placental barrier in monkeys. Animal studies do not indicate reproductive toxicity. The potential for harm to a human fetus is unknown.
As a precautionary measure, it is preferable to avoid the use of mepolizumab during pregnancy. Administration of mepolizumab to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
There are no data regarding the excretion of mepolizumab in human milk. However, mepolizumab was excreted into the milk of cynomolgus monkeys at concentrations of less than 0.5% of those detected in plasma.
A decision must be made whether to discontinue breast-feeding or to discontinue mepolizumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
There are no fertility data in humans. Animal studies showed no adverse effects of anti-IL5 treatment on fertility.
Mepolizumab has no or negligible influence on the ability to drive and use machines.
In placebo-controlled studies in adult and adolescent patients with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache (20%), injection site reactions (8%) and back pain (6%).
In a placebo-controlled study in patients with CRSwNP, the most commonly reported adverse reactions during treatment were headache (18%) and back pain (7%).
In a placebo-controlled study in patients with EGPA, the most commonly reported adverse reactions during treatment were headache (32%), injection site reactions (15%) and back pain (13%). Systemic allergic/hypersensitivity reactions were reported by 4% of EGPA patients.
In a placebo-controlled study in patients with HES, the most commonly reported adverse reactions during treatment were headache (13%), urinary tract infection (9%), injection site reactions and pyrexia (7% each).
The table below presents the adverse reactions from placebo-controlled severe eosinophilic asthma studies from patients receiving mepolizumab 100 mg subcutaneously (SC) (n=263), from a randomised, double-blind placebo-controlled 52-week study in patients with CRSwNP receiving mepolizumab 100 mg SC (n=206), in patients with EGPA receiving mepolizumab 300 mg SC (n=68), in a double-blind placebo-controlled 32-week study in patients with HES receiving mepolizumab 300 mg SC (n=54), and from spontaneous post-marketing reports. Safety data is also available from open-label extension studies in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years). The safety profile of mepolizumab in HES patients (n=102) enrolled in a 20-week open label extension study was similar to the safety profile of patients in the pivotal placebo-controlled study.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| System Organ Class | Adverse reactions | Frequency |
|---|---|---|
| Infections and infestations | Lower respiratory tract infection Urinary tract infection Pharyngitis | Common |
| Herpes zoster** | Uncommon | |
| Immune system disorders | Hypersensitivity reactions (systemic allergic)* | Common |
| Anaphylaxis** | Rare | |
| Nervous system disorders | Headache | Very common |
| Respiratory, thoracic and mediastinal disorders | Nasal congestion | Common |
| Gastrointestinal disorders | Abdominal pain upper | Common |
| Skin and subcutaneous tissue disorders | Eczema | Common |
| Musculoskeletal and connective tissue disorders | Back pain Arthralgia** | Common |
| General disorders and administration site conditions | Administration-related reactions (systemic non allergic)*** Local injection site reactions Pyrexia | Common |
* Systemic reactions including hypersensitivity have been reported at an overall incidence comparable to that of placebo in the severe eosinophilic asthma studies.
** From spontaneous post marketing reporting.
*** The most common manifestations associated with reports of systemic non-allergic administration-related reactions from patients in the severe eosinophilic asthma studies were rash, flushing and myalgia; these manifestations were reported infrequently and in <1% of patients receiving mepolizumab 100 mg subcutaneously.
In the 52-week placebo-controlled study, systemic allergic (type I hypersensitivity) reactions were reported in 2 patients (<1%) in the group receiving mepolizumab 100 mg and in no patients in the placebo group. Other systemic reactions were reported by no patients in the group receiving mepolizumab 100 mg and in 1 patient (<1%) in the placebo group.
In the 52-week placebo-controlled study the percentage of patients who experienced systemic (allergic and non-allergic) reactions was 6% in the group receiving 300 mg of mepolizumab and 1% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 4% of patients in the group receiving 300 mg of mepolizumab and 1% of patients in the placebo group. Systemic non-allergic reactions (angioedema) were reported by 1 (1%) patient in the group receiving 300 mg of mepolizumab and no patients in the placebo group.
In the 32-week placebo-controlled study, 1 patient (2%) reported a systemic (other) reaction in the group receiving 300 mg of mepolizumab (multifocal skin reaction) and no patients in the placebo group.
In placebo-controlled studies the incidence of local injection site reactions with mepolizumab 100 mg subcutaneous and placebo was 8% and 3%, respectively. These events were all non-serious, mild to moderate in intensity and the majority resolved within a few days. Local injection site reactions occurred mainly at the start of treatment and within the first 3 injections with fewer reports on subsequent injections. The most common manifestations reported with these events included pain, erythema, swelling, itching, and burning sensation.
In the placebo-controlled study, local injection site reactions (e.g., erythema, pruritus) occurred in 2% of patients receiving mepolizumab 100 mg compared with <1% in patients receiving placebo.
In the placebo-controlled study, local injection site reactions (e.g., pain, erythema, swelling) occurred at a rate of 15% in patients receiving mepolizumab 300 mg compared with 13% in patients receiving placebo.
In the placebo-controlled study, local injection site reactions (e.g., burning, itching) occurred at a rate of 7% in patients receiving mepolizumab 300 mg compared with 4% in patients receiving placebo.
Thirty-seven adolescents (aged 12-17) were enrolled in four placebo-controlled studies (25 mepolizumab treated intravenously or subcutaneously) of 24 to 52 weeks duration. Thirty-six paediatric patients (aged 6-11) received mepolizumab subcutaneously in an open-label study for 12 weeks. After a treatment interruption of 8 weeks, 30 of these patients, received mepolizumab for a further 52 weeks. The safety profile was similar to that seen in adults. No additional adverse reactions were identified.
Four adolescents aged 12 to 17 years were enrolled in the placebo-controlled study 200622, one adolescent received 300 mg of mepolizumab, and 3 adolescents received placebo for 32 weeks. All 4 adolescents continued into a 20-week open-label extension study 205203.
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