Reslizumab 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 reslizumab therapy. If patients become infected whilst receiving treatment with reslizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of reslizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of reslizumab during pregnancy. Reslizumab has a long half-life. This should be taken into consideration.
It is unknown whether reslizumab is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of reslizumab in milk. In humans, during the first few days after birth antibodies may be transferred to the newborns through milk. In this short period, a risk to the suckling child cannot be excluded. Afterwards, reslizumab could be used during breast-feeding if appropriate.
There are no fertility data in humans. Available non-clinical data do not suggest an effect on fertility.
Reslizumab has no or negligible influence on the ability to drive and use machines.
The most frequently reported adverse reaction during treatment was increased blood creatine phosphokinase, which occurred in approximately 2% of patients. Anaphylactic reaction occurred in less than 1% of patients.
During controlled clinical studies, the proportion of patients who discontinued due to any adverse event was 5% for both the 3 mg/kg reslizumab and placebo groups.
Overall, 2,195 subjects received at least one dose of reslizumab. Of these subjects, 1,006 asthma patients were exposed for at least 6 months, 759 exposed for at least 1 year and 237 exposed for longer than 2 years (up to 3 years).The following adverse reactions have been reported with reslizumab during placebo-controlled asthma studies for up to 52 weeks of treatment with a 3 mg/kg dose given intravenously (1,028 patients). Adverse reactions are listed below by system organ class and frequency (frequencies are defined as: 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), not known (cannot be estimated from the available data).
Uncommon: Anaphylactic reaction*
Uncommon: Myalgia*
Common: Blood creatine phosphokinase increased*
* See subsection “Description of selected adverse reactions” below
The serious adverse reaction of anaphylactic reaction was reported and considered related to reslizumab in 3 patients (0.19%) during placebo-controlled and open-label asthma studies. These reactions were observed during or within 20 minutes after completion of the reslizumab infusion and were reported as early as the second dose of reslizumab. They were fully resolved with standard treatment with no residual effect. Manifestations included skin or mucosal involvement, dyspnoea, wheezing, gastrointestinal symptoms and chills. These cases resulted in the discontinuation of treatment. Due to an overlap in signs and symptoms, it was not possible to distinguish between an anaphylactic reaction, another hypersensitivity reaction and an infusion-related reaction in all cases.
Myalgia was reported in 0.97% of patients (10 out of 1,028) in the 3 mg/kg reslizumab group of the placebo-controlled asthma studies compared with 0.55% of patients (4 out of 730) in the placebo group.
Blood creatine phosphokinase elevations were transient and asymptomatic, and did not lead to treatment discontinuation.
In placebo-controlled clinical studies, 6 out of 1,028 patients (0.6%) receiving 3 mg/kg reslizumab had at least one malignant neoplasm reported compared to 2 out of 730 patients (0.3%) in the placebo group. The malignancies observed in reslizumab-treated patients were diverse in nature and without clustering of any particular tissue type.
Experience in paediatric patients is limited. The data did not indicate a difference in the safety profile of reslizumab in paediatric patients compared with that in adult patients.
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