Iron (III)-Hydroxide Sucrose Complex

Registered South African indications:

• Severe iron deficiency in adult patients not tolerating or responding to oral iron

Recommended for use only where the indication is definite and confirmed by appropriate investigations

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Known hypersensitivity to iron mono-, disaccharide complexes
• Pregnancy, first trimester
• Breastfeeding
• Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis)
• Anaemia not caused by iron deficiency (e.g haemolytic anaemias)
• Clinical or biochemical evidence of liver damage
• Infectious hepatitis
• Acute or chronic infection
• A history of asthma, eczema, other allergic disorders or anaphylactic reactions
• Safety in  children has not been established

• Hypersensitivity reactions
• Renal imapirment
• Patients with known allergies
• Immune or inflammatory conditions
• Facilities for cardiorespiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available
• Hypotension
• Acute or chronic infection
• Paravenous leakage

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

Severe iron deficiency anaemia not tolerating or responding to oral therapy

• IV: Initial: Test dose (see below); Maintenance: Continue dosing 1-3 times per week (max 200mg/24hrs three times a week) until total number of calculated ampules given

Administer test dose of 25mg iron sucrose; If no adverse reaction occurs within a waiting period of at least 15min, the remaining portion of initial dose my be given

Can be administered as IV injection or IV infusion: See additional prescribing points

• Contraindicated

Pregnancy

South African recommendations

• 1st trimester: Contraindicated
• 2nd & 3rd trimester: Safe
• Iron (III)-hydroxide sucrose complex is recommended for use in the second and third trimester and not for use during the first trimester in pregnancy

Breastfeeding

South African recommendations

• Contraindicated
• Safety during lactation has not been established

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Clinical or biochemical evidence of liver damage: Contraindicated

South African recommendations

• No dose adjustment recommended

Central Nervous System Disorders

• Dysgeusia
• Headache
• Dizziness
• Paraesthesia
• Hypoaesthesia
• Syncope
• Somnolence
• Confusional state
• Loss of consciousness
• Anxiety
• Tremor
• Fatigue
• Asthenia

Cardiovascular Disorders

• Hypotension 
• Hypertension
• Flushing
• Phlebitis
• Circulatory collapse
• Thrombophlebitis
• Tachycardia
• Palpitations
• Oedema
• Chest pain
• Bradycardia

Respiratory Disorders

• Bronchospasm
• Dyspnoea

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Diarrhoea
• Constipation

Hepatobiliary Disorders

• Increased alanine aminotransferase
• Increased aspartate aminotransferase
• Increased Gamma-glutamyltransferase

Genitourinary Disorders

• Chromaturia

Musculoskeletal Disorders

• Muscle spasm
• Myalgia
• Arthralgia
• Pain in extremity
• Back pain

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Urticaria
• Rash
• Erythema

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Anaphylactoid reactions
• Angioedema
• Increased serum ferritin
• Increased blood lactate dehydrogenase

Others

• Injection/infusion site reaction
• Chills

• Oral iron preparations

Iron level

Administration instructions

• IV injection: Inject slowly at a rate no faster than 1ml/min (undiluted solution)
• IV infusion: 

Iron (III)-hydroxide sucrose complex is composed of a polynuclear iron hydroxide core surrounded by sucrose. Following intravenous administration, the polynuclear iron core from the complex is taken up predominantly by the reticuloendothelial system in the liver, spleen, and bone marrow. In a second step, the iron is used for the synthesis of haemaglobin, myoglobin and other iron-containing enzymes, or stored primarily in the liver in the form of ferritin.

Injection (per ml) 20mg

• Innofer injection (Innovata Pharmaceuticals)
• Sucrofer (Pharma Dynamics)
• Venofer (Takeda) originator
• Zypiron 20 (Zydus)

Injection (per 5ml) 100mg

• Equifer (Equity Pharma)
• Rautevene (Actor)