Haem Arginate

Registered South African indications:

• Acute hepatic porphyria

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Rapid infusion
• Alcoholism
• Epilepsy
• Brain injury or disease

Forms avail. in SA and covered in this monograph: inj

Acute attacks of hepatic porphyria
-Acute intermittent porphyria
-Variegate porphyria
-Hereditary coproporphyria

• IV: 3mg/kg, as an infusion; Treatment duration: 4 days - 1 week

Dilute with normal saline

Infusion to be given in a large antebrachial or central vein using an in-line filter over 30min, thereafter flush with 100ml normal saline

See additional prescribing points for additional dosing information

Not established for use in children

Pregnancy

• Caution
• 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 newborn babies whose mothers were treated with haem arginate during their pregnancy
• Due to limited data, the use of haem arginate cannot be recommended unless clearly necessary during pregnancy

Breastfeeding

• Caution; not recommended
• Haem arginate has not been studied during breastfeeding. However, since numerous substances are excreted in breast milk, it is appropriate to be cautious when administering haem arginate to breastfeeding women
• Due to limited data, the use of haem arginate cannot be recommended unless clearly necessary during breastfeeding

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache

Cardiovascular Disorders

• Poor venous access
• Venous thrombosis

Genitourinary Disorders

• Increased blood creatinine 

Endocrine and Metabolic Disorders

• Increased serum ferritin

Skin and Subcutaneous Tissue Disorders

• Skin discoloration
• Injection site thrombosis 
• injection site erythema
• Injection site pruritus
• Extravasation
• Injection site necrosis
• Infusion site phlebitis
• Infusion site pain
• Infusion site swelling

Immune, Blood and Lymphatic System Disorders

• Anaphylactoid reaction
• Hypersensitivity
• Fever

CYP450 substrates

Serum ferritin

Dosing and administration according to weight

Haem arginate prevents increased activity of delta-aminolaevulinic acid synthase, causes reduced porphyrin synthesis as well as the formation of toxic intermediates, and corrects haem deficiency.

Injection (per ml) 25mg

• Normosang (Equity) originator