FERISTARK

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Feristark. Feristark should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.

4). Posology The posology of Feristark follows a stepwise approach: [1] determination of the individual iron need, [2] calculation and administration of the iron dose(s), and [3] post-iron repletion assessments.

These steps are outlined below:

Step 1: Determination of the iron need The individual iron need for repletion using Feristark is determined based on the patient's body weight and haemoglobin (Hb) level. Refer to Table 1 for determination of the total iron need. 2 doses may be required to replenish the total iron need, see Step 2 for the maximum individual iron doses.

1. 7 15 mg/kg body weight 500 mg 500 mg Step 2: Calculation and administration of the maximum individual iron dose(s) Based on the total iron need determined the appropriate dose(s) of Feristark should be administered taking into consideration the following: Adults and adolescents aged 14 years and older A single Feristark administration should not exceed: • 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion) • 1,000 mg of iron (20 ml Feristark) The maximum recommended cumulative dose of Feristark is 1,000 mg of iron (20 ml Feristark) per week.

If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days apart from the first dose. Children and adolescents aged 1 to 13 years A single Feristark administration should not exceed: • 15 mg iron/kg body weight • 750 mg of iron (15 mL Feristark) The maximum recommended cumulative dose of Feristark is 750 mg of iron (15 mL Feristark) per week.

If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days apart from the first dose.

Step 3:

Post-iron repletion assessments Re-assessment should be performed by the clinician based on the individual patient's condition. The Hb level should be re-assessed no earlier than 4 weeks post final Feristark administration to allow adequate time for erythropoiesis and iron utilisation.

In the event the patient requires further iron repletion, the iron need should be recalculated (see Step 1 above). Children below 1 year of age The efficacy and safety of ferric carboxymaltose has not been investigated in children below 1 year of age.

Ferric carboxymaltose is therefore not recommended for use in children in this age group. 4). In children aged 1 to 13 years with chronic kidney disease requiring haemodialysis, the efficacy and safety of ferric carboxymaltose has not been investigated.

Ferric carboxymaltose is therefore not recommended for use in children aged 1 to 13 years with chronic kidney disease requiring haemodialysis. Method of administration Feristark must only be administered by the intravenous route: • by injection, or • by infusion, or • during a haemodialysis session undiluted directly into the venous limb of the dialyser.

Feristark must not be administered by the subcutaneous or intramuscular route. Intravenous injection Feristark may be administered by intravenous injection using undiluted dispersion. In adults and adolescents aged 14 years and older, the.

The maximum single dose is 15 mg iron/kg body weight but should not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight but should not exceed 750 mg of iron.

The administration rates are as shown in Table 2:

Table 2: Administration rates for intravenous injection of Feristark Volume of Feristark required Equivalent iron dose Administration rate / Minimum administration time 2 to 4 ml 100 to 200 mg No minimal prescribed time >4 to 10 ml >200 to 500 mg 100 mg iron/min >10 to 20 ml >500 to 1,000 mg 15 minutes Intravenous infusion Feristark may be administered by intravenous infusion, in which case it must be diluted.

In adults and adolescents aged 14 years and older, the maximum single dose is 20 mg iron/kg body weight, but should not exceed 1,000 mg iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight but should not exceed 750 mg of iron.

9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Feristark should not be diluted to concentrations less than 2 mg iron/ml (not including the volume of the ferric carboxymaltose dispersion). 6. 9% m/V sodium chloride solution Minimum administration time 2 to 4 ml 100 to 200 mg 50 ml No minimal prescribed time >4 to 10 ml >200 to 500 mg 100 ml 6 minutes >10 to 20 ml >500 to 1,000 mg 250 ml 15 minutes

Table 4 presents the adverse drug reactions (ADRs) reported during clinical studies in which >9,000 subjects (including >100 children and adolescents aged 1 to 17 years) received ferric carboxymaltose, as well as those reported from the post-marketing experience (see table footnotes for details).

9% of the subjects), followed by injection/infusion site reactions, hypophosphataemia, headache, flushing, dizziness and hypertension. Injection/infusion site reactions comprise several ADRs which individually are either uncommon or rare.

The most serious ADR is anaphylactic reactions (rare); fatalities have been reported. 4 for further details.

Table 4:

Adverse drug reactions observed during clinical trials and post- marketing experience System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Immune system disorders Hypersensitivity Metabolism and nutritional disorders Hypophosphataemia Nervous system disorders Headache, dizziness Dysgeusia paraesthesia Psychiatric disorders Cardiac disorders Tachycardia Vascular disorders Flushing, hypertension Hypotension Respiratory thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Nausea Abdominal pain, vomiting, constipation, diarrhoea, dyspepsia Skin and subcutaneous tissue disorders Rash(3), pruritus, urticarial, erythema, Musculoskeletal and connective tissue disorders Arthralgia, myalgia, pain in extremity, back pain, muscle spasms General disorders and administration site conditions Injection/infusion site reactions(4) Pyrexia, fatigue, chills, chest pain, oedema peripheral, malaise Investigations Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased (1) ADRs exclusively reported in the post-marketing setting; estimated as rare.

(2) ADRs reported in the post-marketing setting which are also observed in the clinical setting. (3) Includes the following preferred terms: rash (individual ADR determined to be uncommon) and rash erythematous, -generalised, -macular, -maculo-papular, -pruritic (all individual ADRs determined to be rare).

(4) Includes, but is not limited to, the following preferred terms: injection/infusion site -pain, -haematoma, -discolouration, -extravasation, -irritation, -reaction, (all individual ADRs determined to be uncommon) and -paraesthesia (individual ADR determined to be rare).

Paediatric population The safety profile for children and adolescents aged 1 to 17 years is comparable with that of adults. 110 paediatric patients received ferric carboxymaltose in 7 clinical studies. No serious ADRs were reported. The reported non-serious ADRs were hypophosphataemia (n = 5), urticaria (n = 5), injection/infusion site reactions (n = 4), abdominal pain (n = 2), flushing (n =2), headache (n = 2), pyrexia (n = 2), liver enzymes increased (n = 2) and rash (n = 2).

Constipation, gastritis, hypertension, pruritus and thirst were reported only once. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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4. 1. 3 PHARMACEUTICAL FORM Dispersion for injection/infusion. Dark brown, non-transparent, aqueous solution. 1): • oral iron preparations are ineffective. • oral iron preparations cannot be used. • there is a clinical need to deliver iron rapidly.

The diagnosis of iron deficiency must be based on laboratory tests. 2 Posology and method of administration Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Feristark.

Feristark should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. 4). Posology The posology of Feristark follows a stepwise approach: [1] determination of the individual iron need, [2] calculation and administration of the iron dose(s), and [3] post-iron repletion assessments.

These steps are outlined below:

Step 1: Determination of the iron need The individual iron need for repletion using Feristark is determined based on the patient's body weight and haemoglobin (Hb) level. Refer to Table 1 for determination of the total iron need. 2 doses may be required to replenish the total iron need, see Step 2 for the maximum individual iron doses.

1. 7 15 mg/kg body weight 500 mg 500 mg Step 2: Calculation and administration of the maximum individual iron dose(s) Based on the total iron need determined the appropriate dose(s) of Feristark should be administered taking into consideration the following: Adults and adolescents aged 14 years and older A single Feristark administration should not exceed: • 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion) • 1,000 mg of iron (20 ml Feristark) The maximum recommended cumulative dose of Feristark is 1,000 mg of iron (20 ml Feristark) per week.

If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days apart from the first dose. Children and adolescents aged 1 to 13 years A single Feristark administration should not exceed: • 15 mg iron/kg body weight • 750 mg of iron (15 mL Feristark) The maximum recommended cumulative dose of Feristark is 750 mg of iron (15 mL Feristark) per week.

If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days apart from the first dose.

Step 3:

Post-iron repletion assessments Re-assessment should be performed by the clinician based on the individual patient's condition. The Hb level should be re-assessed no earlier than 4 weeks post final Feristark administration to allow adequate time for erythropoiesis and iron utilisation.

In the event the patient requires further iron repletion, the iron need should be recalculated (see Step 1 above). Children below 1 year of age The efficacy and safety of ferric carboxymaltose has not been investigated in children below 1 year of age.

Ferric carboxymaltose is therefore not recommended for use in children in this age group. 4). In children aged 1 to 13 years with chronic kidney disease requiring haemodialysis, the efficacy and safety of ferric carboxymaltose has not been investigated.

Ferric carboxymaltose is therefore not recommended for use in children aged 1 to 13 years with chronic kidney disease requiring haemodialysis. Method of administration Feristark must only be administered by the intravenous route: • by injection, or • by infusion, or • during a haemodialysis session undiluted directly into the venous limb of the dialyser.

Feristark must not be administered by the subcutaneous or intramuscular route. Intravenous injection Feristark may be administered by intravenous injection using undiluted dispersion. In adults and adolescents aged 14 years and older, the.

The maximum single dose is 15 mg iron/kg body weight but should not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight but should not exceed 750 mg of iron.

The administration rates are as shown in Table 2:

Table 2: Administration rates for intravenous injection of Feristark Volume of Feristark required Equivalent iron dose Administration rate / Minimum administration time 2 to 4 ml 100 to 200 mg No minimal prescribed time >4 to 10 ml >200 to 500 mg 100 mg iron/min >10 to 20 ml >500 to 1,000 mg 15 minutes Intravenous infusion Feristark may be administered by intravenous infusion, in which case it must be diluted.

In adults and adolescents aged 14 years and older, the maximum single dose is 20 mg iron/kg body weight, but should not exceed 1,000 mg iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight but should not exceed 750 mg of iron.

9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Feristark should not be diluted to concentrations less than 2 mg iron/ml (not including the volume of the ferric carboxymaltose dispersion). For further instructions on […]

1. • known serious hypersensitivity to other parenteral iron products. g. other microcytic anaemia. • evidence of iron overload or disturbances in the utilisation of iron.