Rienso

Rienso 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. Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso.

4). Posology Treatment Course The recommended course of Rienso is based on the patient’s pre-treatment haemoglobin and body weight as provided in Table 1. Each 510 mg dose is administered as an intravenous infusion for at least 15 minutes.

Medicinal product no longer authorised 3 Table 1:

Recommended Dosing Table for Rienso Administration Total Amount of Rienso to Administer mg of Iron (Number of vials) Haemoglobin ≤ 50 kg Body Weight > 50 kg Body Weight > 10-12 g/dl 510 mg iron (1 vial) 2 × 510 mg iron (2 vials) ≤ 10 g/dl 2 × 510 mg iron (2 vials) 2 × 510 mg iron (2 vials) The maximum dose is 1020 mg (2 vials) and the two doses of Rienso must not be administered at the same time.

4). Patients should be re-assessed at least one month after the completion of a course of Rienso and this should include laboratory testing of haematologic and blood iron parameters. Re-treatment To maintain the target haemoglobin value, re-treatment with Rienso may be given after the patient has been re-assessed and confirmed to be iron deficient.

g. Revised European Best Practice Guidelines) should be followed. Paediatric population The safety and efficacy of Rienso in children and adolescents below the age of 18 years has not been established. No data are available. 1). Special population – patients receiving haemodialysis For patients receiving haemodialysis, Rienso should be administered once the blood pressure is stable and the patient has completed at least one hour of haemodialysis.

Hepatic Impairment Rienso has not been specifically studied in patients with hepatic impairment; clinical experience is limited to 8 patients. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment.

No change in dosage is recommended from Table 1. Method of administration Intravenous use by infusion. 6).

2% were considered serious. 5% of patients. 2% (3/1562) of subjects with CKD who received Rienso during the clinical studies. One of these three cases was also characterized as an anaphylactoid reaction. Tabulated list of adverse reactions Table 2 presents all adverse experiences observed during the clinical studies in which 1562 subjects with CKD received two injections of 510 mg of Rienso separated by an interval of 2 to 8 days and post-marketing experience.

Table 2:

Adverse reactions observed during clinical studies and post-marketing experience SYSTEM ORGAN CLASS COMMON (≥ 1/100 to < 1/10) UNCOMMON (≥ 1/1,000 to < 1/100) RARE (≥ 1/10,000 to < 1/1,000) FREQUENCY NOT KNOWN (CANNOT BE ESTIMATED FROM AVAILABLE DATA) Blood and lymphatic system disorders Eosinophilia Immune system disorders Hypersensitivity including anaphylaxis* Life-threatening Anaphylactic/Anaphylactoid reactions* Metabolism and nutrition disorders Decreased appetite Increased appetite Dehydration Gout Hyperkalaemia Nervous system disorders Dizziness Dysgeusia Headache Somnolence Burning sensation Paraesthesia Syncope Unresponsiveness Loss of consciousnessMedicinal product no longer authorised 7 SYSTEM ORGAN CLASS COMMON (≥ 1/100 to < 1/10) UNCOMMON (≥ 1/1,000 to < 1/100) RARE (≥ 1/10,000 to < 1/1,000) FREQUENCY NOT KNOWN (CANNOT BE ESTIMATED FROM AVAILABLE DATA) Eye disorders Lacrimation increased Vision blurred Cardiac disorders Tachycardia/Arrhythmia, Cardiac arrest Cardio-respiratory arrest Myocardial infarction Cyanosis Congestive heart failure Vascular disorders Hypotension (hypotension, blood pressure decreased) Flushing (flushing, hot flush) Hypertension (hypertension, accelerated hypertension) Vasodilation Respiratory, thoracic and mediastinal disorders Dyspnoea Epistaxis Bronchospasm Cough Hyperventilation Hypoxia Laryngeal oedema Pharyngeal oedema Respiratory arrest Respiratory failure Throat irritation Throat tightness Wheezing Gastrointestinal disorders Diarrhoea Constipation Nausea Abdominal pain (Abdominal distension, abdominal pain upper, abdominal discomfort) Vomiting Faeces discoloured Dry mouth Dyspepsia Glossodynia Lip swelling Swollen tongue Hepatobiliary disorders Hepatic function abnormalMedicinal product no longer authorised 8 SYSTEM ORGAN CLASS COMMON (≥ 1/100 to < 1/10) UNCOMMON (≥ 1/1,000 to < 1/100) RARE (≥ 1/10,000 to < 1/1,000) FREQUENCY NOT KNOWN (CANNOT BE ESTIMATED FROM AVAILABLE DATA) Skin & subcutaneous tissue disorders Rash (rash, rash generalised, rash pruritic, urticaria) Pruritus (pruritus generalised) Ecchymosis Sweating (hyperhidrosis, night sweats) Skin hyperpigmentation Skin reaction Angioedema Musculoskeletal and connective tissue disorders Muscle/joint pain or stiffness (arthralgia, myalgia, muscular weakness, musculoskeletal stiffness) Back pain Muscle spasms General disorders and administration site conditions Injection site reactions (infusion/injection site bruising, pain, reaction, swelling, warmth, haemorrhage, irritation, rash) Fatigue (asthenia, fatigue) Chest pain (chest discomfort, chest pain) Chills Fever (feeling hot, pyrexia) Injection site discolouration Injection site pruritus Investigations Serum ferritin increased Blood glucose decreased Pulse absent Oxygen saturation decreased Injury, poisoning and procedural complications Contusion Description of selected adverse reactions In clinical trials, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 Rienso-treated patients included hypotension, infusion site swelling, increased serum ferritin levels, chest pain, diarrhoea, dizziness, ecchymosis, pruritis, chronic renal failure and urticaria.

Hypersensitivity Reactions Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.

3). g. systemic lupus erythematosus, rheumatoid arthritis). Rienso 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.

Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso. In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter.

If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution.

Additional treatment with antihistamines and/or corticosteroids should be given as appropriate. Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting. 8). Elderly patients (> 65 years of age) or patients with multiple co-morbidities who experience a serious hypersensitivity reaction may have more severe outcomes.

Hypotension Severe adverse reactions of clinically significant hypotension have been reported. 8). Patients should be monitored for signs and symptoms of hypotension following each Rienso administration. Iron Overload Rienso should not be administered to patients with iron overload.

1 • Patients with any known history of drug allergy including hypersensitivity to other parenteral iron products • Evidence of iron overloadMedicinal product no longer authorised 4 • Anaemia not caused by iron deficiency