Anofer 100 mg/5 ml (IV Injection or Infusion)

Indications

• Treatment of Anofer deficiency
• Rapid Anofer supply
• Patients intolerant to oral Anofer therapy
• Patients with non-compliance to oral Anofer therapy
• Treatment in active inflammatory bowel disease
• Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients
• Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients
• Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients
• Treatment for Anofer deficiency anaemia in surgical procedures
• Treatment for postpartum patients

Pharmacology

• Therapeutic class: haematinic
• Aqueous complex of Polynuclear Iron (III) Hydroxide in Sucrose
• Approximately 30% Sucrose w/v (300 mg/ml)
• pH of 10.5-11.1
• Intravenous use
• Dissociation into Iron and Sucrose by the reticuloendothelial system
• Transfer of Iron to liver and bone marrow
• Iron storage in ferritin
• Iron binding to plasma transferrin
• Transferrin transportation of Iron within the plasma and extracellular fluid

Dosage

• Adult dosage: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week
• Children dosage: Limited data, not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week

Administration

• Intravenous injection
• Slow intravenous injection at recommended rate
• Administration of test dose before therapeutic dose
• Administration by drip infusion
• Dilution in 0.9% w/v Sodium Chloride
• Infusion time based on Iron dosage

Interaction

• No studied drug-drug interactions
• Avoid concomitant use with oral iron preparations
• 5-day interval between oral Anofer therapy and last injection

Contraindications

• Evidence of Iron overload
• Known hypersensitivity to Iron Sucrose or inactive components
• Anaemia not caused by Iron deficiency
• History of allergic disorders, asthma, eczema, anaphylaxis, liver disease, infections

Side Effects

• Hypotension
• Leg cramps
• Nausea
• Headache
• Vomiting
• Diarrhea
• Fever
• Chest pain
• Hypertension
• Dizziness
• Musculoskeletal pain
• Respiratory issues
• Pruritus
• Hypersensitivity reactions

Pregnancy & Lactation

• Pregnancy Category-B
• Limited studies in pregnant women
• Caution during lactation

Precautions & Warnings

• Monitoring of hematologic and haematinic parameters
• Caution in presence of evidence of tissue Iron overload
• Periodic monitoring of Anofer parameters
• Caution in hypersensitivity reactions
• Caution in hemodialysis patients

Use in Special Populations

• Pediatric use not established
• No overall differences in safety for elderly subjects
• Injection into dialyser
• Specific administration for different CKD patient types

Overdose Effects

• Accumulation of Iron in storage sites
• Symptoms associated with overdosage
• Treatment for symptoms

Therapeutic Class

• Parenteral Iron Preparations

Storage Conditions

• Store in cool and dry place (15°C-30°C)
• Protection from light
• Keep out of reach of children
• Avoid freezing

Related Brands

• Anefer 100 mg/5 ml (IV Injection or Infusion) - opsonin-pharma-ltd