Hemin Other names: Haem

During treatment with hemin the enzyme activity of the P450 enzymes increases. The metabolism of concomitantly administered drugs that are metabolised by cytochrome P450 enzymes (such as oestrogens, barbiturates and steroids) may increase during administration of hemin, leading to lower systemic exposure.

In the absence of specific experimental and clinical data, the risks during pregnancy are not defined; to date, however, no after-effects have been observed in new-born babies whose mothers were treated with hemin during their pregnancy.

Hemin has not been studied during breast-feeding. However, since numerous substances are excreted in breast milk, it is appropriate to be cautious when administering hemin during lactation.

Due to limited data the use of hemin can not be recommended unless clearly necessary during pregnancy and breast-feeding.

There is no evidence to suggest that hemin affects adversely the ability to drive or use machines.

The most commonly reported ADRs are infusion site reactions especially occurring if infusion takes place into veins which are too small.

Reported adverse reactions are listed below, by system organ class and by 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).

Immune system disorders

Rare: anaphylactoid reaction, hypersensitivity (such as dermatitis medicamentosa and tongue oedema).

Nervous system disorders:

Not known: headache

Vascular disorders

Very common: poor venous access

Not known: injection site thrombosis, venous thrombosis

General disorders and administration site conditions

Common: infusion site phlebitis, infusion site pain, infusion site swelling

Rare: pyrexia

Not known: injection site erythema, injection site pruritus, extravasation, injection site necrosis

Investigations

Uncommon: serum ferritin increased

Not known: blood creatinine increase

Increased serum ferritin concentrations have been reported after several years of treatment with repeated infusions, which may indicate an iron overload.

Skin disorders

Not known: skin discoloration