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Prescribing Information

SOLIRIS® Eculizumab 300 mg concentrate for solution for infusion prescribing information.

Presentation: 30 ml vial containing 300 mg eculizumab (10 mg/ml).

Indication: Treatment of paroxysmal nocturnal haemoglobinuria (PNH) in adults and children. Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. Treatment of atypical haemolytic uraemic syndrome (aHUS) in adults and children.

Dosage and method of administration: Adult (≥ 18 years of age) PNH initial phase: 600 mg weekly x 4 weeks. Adult (≥18) PNH maintenance phase: 900 mg week 5, followed by 900 mg every 14 (± 2) days. Adult (≥ 18 years of age) aHUS initial phase: 900 mg weekly for 4 weeks. Adult (≥18 years of age) aHUS maintenance phase: 1200 mg week 5, followed by 1200 mg every 14 (± 2) days. aHUS paediatric patients (<18 years of age) ≥40 kg initial phase:  900 mg weekly x 4. aHUS paediatric patients (<18 years of age) ≥ 40 kg maintenance phase: 1200 mg week 5; then 1200 mg every 2 weeks. PNH paediatric patients (<18 years of age); ≥40 kg initial phase: 600 mg weekly x 4. ≥ 40 kg maintenance phase: 900 mg week 5; then 900 mg every 2 weeks. aHUS and PNH paediatric patients 30 - <40 kg initial phase: 600 mg weekly x 2. aHUS and PNH paediatric patients 30 - <40 kg maintenance phase: 900 mg week 3; then 900 mg every 2 weeks. aHUS and PNH paediatric patients 20 - <30 kg initial phase: 600 mg weekly x 2. aHUS and PNH paediatric patients 20 - <30 kg maintenance phase: 600 mg week 3; then 600 mg every 2 weeks. aHUS and PNH paediatric patients 10 - <20 kg initial phase600 mg weekly x 1. aHUS and PNH paediatric patients 10 - <20 kg maintenance phase: 300 mg week 2; then 300 mg every 2 weeks. aHUS and PNH paediatric patients 5 - <10 kg initial phase: 300 mg week x 1. aHUS and PNH paediatric patients 5 - <10 kg maintenance phase: 300 mg week 2; then 300 mg every 3 weeks. Supplemental dosing is required  with  concomitant plasma treatment, please refer to the SmPC. Administration: Dilute to a concentration of 5 mg/ml. Administer via an intravenous infusion over 25 - 45 minutes in adults and 1-4 hours in paediatric patients via gravity feed, a syringe-type pump, or an infusion pump. Patients should be monitored for 1 hour post infusion. Elderly: No evidence to suggest that special precautions are required, although experience is limited. Renal impairment: No dose adjustment. Hepatic impairment: Not studied. Monitoring: aHUS patients should be monitored for thrombotic microangiopathy (TMA). Recommended to continue Soliris treatment unless discontinuation is medically justified. 

Contraindications: Hypersensitivity to active ingredient, murine proteins or other excipients. Must not initiate in patients with unresolved Neisseria meningitidis infection or patients who are not currently vaccinated against Neisseria meningitides (unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination).

Special warnings and precautions: Meningococcal infection, immunization and other systemic infections: Increased risk of meningococcal infection. All patients must be vaccinated against meningococcal infections at least 2 weeks prior to starting Soliris unless the risk of delaying Soliris therapy outweighs the risks of developing a meningococcal infection. Patients initiated with Soliris <2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.  Vaccines against serogroups A, C, Y, W135 and B where available are recommended in preventing the commonly pathogenic meningococcal serogroups. Patients must receive vaccination according to national vaccination guidelines. Patients <18 years must be vaccinated against Haemophilus influenzae and pneumococcal infections. Vaccination may further activate complement. As a result, patients with complement-mediated diseases, including PNH and aHUS, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH) or TMA (aHUS). Therefore, patients should be closely monitored for disease symptoms after recommended vaccination. Vaccination may not be sufficient to prevent meningococcal infection. Cases of serious or fatal meningococcal infection have been reported. All patients should be monitored for early signs of meningococcal infection and evaluated immediately if infection is suspected and treated with appropriate antibiotics if necessary. Patients should be informed of signs and symptoms of infection and steps taken to seek medical care immediately. Physicians must discuss the benefits and risks with patients and provide them with a patient information brochure and a patient safety card. Use with caution in patients with other active systemic infections. Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Infusion reactions: Administration may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions, including anaphylaxis.  Treatment should be interrupted in patients who experience severe infusion reactions and appropriate medical therapy administered. Anticoagulant therapy: Should not be altered. Laboratory Monitoring: PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum LDH levels. During treatment, patients who show signs and symptoms of intravascular haemolysis may require dose adjustment within the recommended 14(± 2) day dosing schedule during the maintenance phase. aHUS  patients should be monitored for TMA by measuring platelet counts, serum LDH and serum creatinine and may require dose adjustment within the recommended 14(± 2) day dosing schedule during the maintenance phase. Discontinuation: PNH patients who discontinue should be monitored for serious intravascular haemolysis for ≥8 weeks. If serious haemolysis occurs, consider: blood transfusion, or exchange transfusion if the PNH red blood cells are >50% of the total red blood cells by flow cytometry; anticoagulation; corticosteroids or reinstitution of Soliris. aHUS patients who discontinue should be monitored closely for severe TMA complications. Monitoring may be insufficient to predict or prevent severe TMA complications in patients with aHUS after discontinuation of Soliris. If severe TMA complications occur consider: reinstitution of Soliris treatment, supportive care with PE/PI, or appropriate organ- specific supportive measures including renal support with dialysis, respiratory support with mechanical ventilation or anticoagulation. TMA complications were observed as early as 4 weeks and up to 127 weeks following discontinuation in aHUS clinical studies. Excipients: 5 mmol sodium per vial.

Interactions with other medicinal products: No studies.

Pregnancy: Should be given only if clearly needed. Women of childbearing potential have to use effective contraception during treatment and for 5 months after treatment.

Breast-feeding: Unknown whether Soliris is excreted into human milk. Should be discontinued during treatment and for 5 months after treatment.

Undesirable effects: The most common adverse reaction was headache and among meningococcal infections, the most serious adverse reaction was meningococcal sepsis. Very common side effects ( ≥1/1 0): Headache. Common  side effects (≥1/100 to <1/10): Pneumonia, Upper respiratory tract infection, Nasopharyngitis, Urinary tract infection, Leukopenia,  Anaemia, Insomnia, Dizziness, Dysgeusia, Tremor, Hypertension, Cough, oropharyngeal pain, Diarrhoea, Vomiting, Nausea, Abdominal pain, Rash, Alopecia, Pruritus, Arthralgia, Myalgia, Pain in extremity, Pyrexia, Chills, Fatigue, Influenza like illness. Please refer to the SmPC for a full list of adverse events. In PNH and aHUS clinical trials   the most serious adverse event was meningococcal septicaemia. Antibodies to Soliris were detected in 2% of PNH patients using an ELISA assay and 3% of patients with aHUS using the ECL bridging format assay. Cases of haemolysis have been reported with missed or delayed Soliris dose in PNH clinical trials. Cases of TMA complication have been reported in the setting of missed or delayed Soliris dose in aHUS clinical trials. The most common adverse reaction in paediatric PNH patients was headache. The safety profile in the different paediatric subsets of age appears similar.

Overdose: No cases reported.

MA number: EU/1/07/393/001

MAH: Alexion Europe SAS, 25 1-15, avenue Edouard Belin 92500 Rueil-Malmaison France. Further information available from Alexion Pharma UK, 3 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1EZ. Tel 0800 689 1592. 

Date of Authorisation: 20-06-2007.

Legal Category: POM.

UK Cost: £3,150.00 per vial.
Irish Cost: €4557.50 per vial.

Preparation date: March 2017.

UK:
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk.
Adverse events should also be reported to Alexion Pharma UK Ltd on 0800 321 3902 or uk.adverseevents@alexion.com

Ireland:
Adverse events should be reported. Information on reporting adverse events can be found at www.hpra.ie. or Email: medsafety@hpra.ie.
Adverse events should also be reported to Alexion Pharma UK Ltd on 1800 936 544 or uk.adverseevents@alexion.com


 

Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Due to its mechanism of action, the use of Soliris increases the patient’s susceptibility to meningococcal infection (Neisseria meningitidis).

  • To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving Soliris unless the risk of delaying Soliris therapy outweighs the risks of developing a meningococcal infection. 
  • Patients who initiate Soliris treatment less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
  • Vaccines against serogroups A, C, Y, W135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups. Patients must receive vaccination according to current national vaccination guidelines for vaccination use.
  • Vaccination may further activate complement. As a result, patients with complement-mediated diseases, including PNH and aHUS, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH) or TMA (aHUS). Therefore, patients should be closely monitored for disease symptoms after recommended vaccination.

 

Indications and usage

Soliris® is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).

Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

Treatment of atypical haemolytic uraemic syndrome (aHUS) in adults and children.

Contraindications

Do not initiate Soliris® in patients:

  • with unresolved serious Neisseria meningitidis infection
  • who are not currently vaccinated against Neisseria meningitidis

Warnings and precautions

Other infections: Soliris® blocks terminal complement; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. Use caution when administering Soliris® to patients with any systemic infection.

Monitoring after Soliris® discontinuation

If PNH patients discontinue treatment with Soliris® they should be closely monitored for signs and symptoms of serious intravascular haemolysis. Serious haemolysis is identified by serum LDH levels greater than the pre-treatment level, along with any of the following: greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in one week or less; a haemoglobin level of <5 g/dL or a decrease of >4 g/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis. Monitor any patient who discontinues Soliris® for at least 8 weeks to detect serious haemolysis and other reactions.

If serious haemolysis occurs after Soliris® discontinuation, consider the following procedures/treatments: blood transfusion (packed RBCs), or exchange transfusion if the PNH RBCs are >50% of the total RBCs by flow cytometry; anticoagulation; corticosteroids; or reinstitution of Soliris®.

In PNH clinical studies, 16 patients discontinued the Soliris® treatment regimen. Serious haemolysis was not observed.

Infusion reactions

Administration of Soliris® may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis), though immune system disorders within 48 hours of Soliris® administration did not differ from placebo treatment in PNH studies conducted with Soliris®. In clinical trials, no PNH patients experienced an infusion reaction which required discontinuation of Soliris®. Soliris® administration should be interrupted in all patients experiencing severe infusion reactions and appropriate medical therapy administered.

Thrombosis prevention and management

Treatment with Soliris® should not alter anticoagulant management.