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Burosumab

Interactions

Active ingredient Burosumab interacts in the following cases:

Effects on ability to drive and use machines

Burosumab may have a minor influence on the ability to drive and use machines. Dizziness may occur following administration of burosumab.

Fertility

Studies in animals have shown effects on male reproductive organs. There are no clinical data available on the effect of burosumab on human fertility. No specific fertility studies in animals with burosumab were conducted.

Lactation

It is unknown whether burosumab/metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from burosumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Pregnancy

There are no or limited amount of data from the use of burosumab in pregnant women. Studies in animals have shown reproductive toxicity. Burosumab is not recommended during pregnancy and in women of childbearing potential not using contraception.

Calcimimetic medicinal products

Caution should be exercised when combining burosumab with calcimimetic medicinal products (i.e. agents that mimic the effect of calcium on tissues by activating the calcium receptor). Co-administration of these medicinal products has not been studied in clinical trials and could potentially exacerbate hypocalcaemia.

Ectopic mineralisation

Ectopic mineralisation, as manifested by nephrocalcinosis, has been observed in patients with XLH treated with oral phosphorous and vitamin D analogues; these medicinal products should be stopped at least 1 week prior to initiating burosumab treatment.

Monitoring for signs and symptoms of nephrocalcinosis, e.g. by renal ultrasonography, is recommended at the start of treatment and every 6 months for the first 12 months of treatment, and annually thereafter. Monitoring of plasma alkaline phosphatases, Calcium, PTH and creatinine is recommended every 6 months (every 3 months for children 1-2 years) or as indicated. Monitoring of urine calcium and phosphate is suggested every 3 months.

Pregnancy

There are no or limited amount of data from the use of burosumab in pregnant women.

Studies in animals have shown reproductive toxicity.

Burosumab is not recommended during pregnancy and in women of childbearing potential not using contraception.

Nursing Mothers

It is unknown whether burosumab/metabolites are excreted in human milk.

A risk to newborns/infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from burosumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Carcinogenesis, Mutagenesis and Fertility

Fertility

Studies in animals have shown effects on male reproductive organs. There are no clinical data available on the effect of burosumab on human fertility. No specific fertility studies in animals with burosumab were conducted.

Effects on Ability to Drive and Use Machines

Burosumab may have a minor influence on the ability to drive and use machines. Dizziness may occur following administration of burosumab.