Imlifidase interacts in the following cases:
Imlifidase is a cysteine protease that specifically cleaves IgG; the species specificity results in degradation of all subclasses of human and rabbit IgG. As a consequence, medicinal products based on human or rabbit IgG may be inactivated if given in connection with imlifidase. Antibody-based medicinal products cleaved by imlifidase include, but are not limited to basiliximab, rituximab, alemtuzumab, adalimumab, denosumab, belatacept, etanercept, rabbit anti-thymocyte globulin (rATG) and intravenous immunoglobulin (IVIg).
IVIg may contain neutralising antibodies against imlifidase, which may inactivate imlifidase if IVIg is given before imlifidase.
Imlifidase does not degrade equine anti-thymocyte globulin and no time interval between administrations needs to be considered. Eculizumab is not cleaved by imlifidase at the recommended dose level.
Recommended time intervals for administration of antibody-based medicinal products after administration of imlifidase:
| Medicinal product | Recommended time interval after administration of 0.25 mg/kg imlifidase |
|---|---|
| equine anti-thymocyte globulin, eculizumab | No time interval needed (can be administered concomitantly with imlifidase) |
| intravenous immunoglobulin (IVIg) | 12 hours |
| alemtuzumab, adalimumab, basiliximab, denosumab, etanercept, rituximab | 4 days |
| rabbit anti-human thymocyte globulin (rATG), belatacept | 1 week |
Also, IVIg may contain neutralising antibodies against imlifidase, which may inactivate imlifidase if IVIg is given before imlifidase. The half-life of IVIg (3-4 weeks) should be considered before imlifidase administration to patients treated with IVIg. In clinical studies, IVIg was not administered within 4 weeks before imlifidase infusion.
Due to the reduced IgG levels after treatment with imlifidase, there is a risk for a temporary reduction of vaccine protection for up to 4 weeks following imlifidase treatment.
There are no data from use of imlifidase in pregnant women since pregnancy is a contraindication to kidney transplantation.
Studies in rabbits do not indicate direct or indirect harmful effects of imlifidase with respect to embryonic/foetal development.
As a precautionary measure, it is preferable to avoid the use of imlifidase during pregnancy.
It is unknown whether imlifidase is excreted in human milk. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued before imlifidase exposure.
No specific studies on fertility and postnatal development have been conducted.
Not relevant.
The most common serious adverse reactions in clinical studies were pneumonia (5.6%) and sepsis (3.7%). The most common adverse reactions were infections (16.7%) (including pneumonia (5.6%), urinary tract infection (5.6%) and sepsis (3.7%)), infusion site pain (3.7%), infusion related reactions (3.7%), alanine aminotransferase increased (3.7%), aspartate aminotransferase increased (3.7%), myalgia (3.7%), headache (3.7%) and flushing (3.7%).
The adverse reactions described in this section were identified in the clinical studies (N=54). The adverse reactions are presented according to MedDRA system organ class and frequency category. The frequency categories are defined as follows: 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).
Adverse reactions:
Very common: Bacterial and viral infection
Common: Abdominal infection, Adenovirus infection, Catheter site infection, Infection, Influenza, Parvovirus infection, Pneumonia, Postoperative wound infection, Sepsis, Upper respiratory tract infection, Urinary tract infection, Wound infection
Common: Anaemia
Common: Transplant rejection
Common: Dizziness postural, Headache
Common: Scleral haemorrhage, Visual impairment
Common: Sinus tachycardia
Common: Flushing, Hypertension, Hypotension
Common: Dyspnoea
Common: Rash
Common: Myalgia
Common: Feeling hot, Infusion site pain
Common: Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased
Common: Infusion related reactions
In the clinical studies, 16.7% of the patients experienced an infection. Nine infections were serious and assessed as related to imlifidase in the clinical studies, whereof 5 started within 30 days after imlifidase treatment. Eight of the 9 related serious infections had a duration of less than 30 days. The incidence and pattern (including infectious agent) of serious or severe infections were not different from those observed in kidney-transplanted patients in general.
Infusion-related reactions, including dyspnoea and flushing were reported in 5.6% of the patients, one resulting in interruption of the imlifidase infusion and the patient not being transplanted. Except for one event of mild rash, all infusion-related reactions started on the day of imlifidase infusion and resolved within 90 minutes.
Myalgia was reported for 2 patients (3.7%) in the clinical studies. One of the patients had severe myalgia without any findings of muscle damage.
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