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Agalsidase alfa

Interactions

Active ingredient Agalsidase alfa interacts in the following cases:

Renal impairment

The presence of extensive renal damage (eGFR <60mL/min)may limit the renal response to enzyme replacement therapy, possibly due to underlying irreversible pathological changes. In such cases, the loss of renal function remains within the expected range of the natural progression of disease.

Limited data are available in patients on dialysis or post-kidney transplantation, no dose adjustment is recommended.

Breast-feeding

It is not known whether agalsidase alfa is excreted in human milk. Caution should be exercised when prescribing to pregnant or breast-feeding women.

Pregnancy

Very limited clinical data on pregnancies exposed to agalsidase alfa (n=4) have shown no adverse effects on the mother and newborn child. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development when exposed during organogenesis.

Idiosyncratic infusion related reactions

13.7% of adult patients treated with agalsidase alfa in clinical trials have experienced idiosyncratic infusion related reactions. Four of 17 (23.5%) paediatric patients ≥7 years of age enrolled in clinical trials experienced at least one infusion reaction over a period of 4.5 years of treatment (mean duration of approx. 4 years). Three of 8 (37.5%) paediatric patients <7 years of age experienced at least one infusion related reaction over a mean observation time of 4.2 years. The most common symptoms have been rigors, headache, nausea, pyrexia, flushing and fatigue. Serious infusion reactions have been reported uncommonly; symptoms reported include pyrexia, rigors, tachycardia, urticaria, nausea/vomiting, angioneurotic oedema with throat tightness, stridor and swollen tongue. Other infusion-related symptoms may include dizziness and hyperhidrosis. A review of cardiac events showed that infusion reactions may be associated with hemodynamic stress triggering cardiac events in patients with pre-existing cardiac manifestations of Fabry disease.

The onset of infusion related reactions has generally occurred within the first 2-4 months after initiation of treatment with agalsidase alfa although later onset (after 1 year) has been reported as well. These effects have decreased with time. If mild or moderate acute infusion reactions occur, medical attention must be sought immediately and appropriate actions instituted. The infusion can be temporarily interrupted (5 to 10 minutes) until symptoms subside and the infusion may then be restarted. Mild and transient effects may not require medical treatment or discontinuation of the infusion. In addition, oral or intravenous pre-treatment with antihistamines and/or corticosteroids, from 1 to 24 hours prior to infusion may prevent subsequent reactions in those cases where symptomatic treatment was required.

Hypersensitivity reactions

Hypersensitivity reactions have been reported. If severe hypersensitivity or anaphylactic reactions occur, the administration of agalsidase alfa should be discontinued immediately and appropriate treatment initiated. The current medical standards for emergency treatment are to be observed.

Pregnancy

There is very limited data on pregnancies exposed to agalsidase alfa. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonic/fetal development when exposed during organogenesis. Caution should be exercised when prescribing to pregnant women.

Nursing mothers

It is not known whether agalsidase alfa is excreted in human milk. Caution should be exercised when prescribing to breast-feeding women.

Carcinogenesis, mutagenesis and fertility

Fertility

No effects on male fertility were seen in reproductive studies in male rats.

Effects on ability to drive and use machines

Agalsidase alfa has no or negligible influence on the ability to drive and use machines.