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ELOCTA – Safety profile

 
Over ~5 years of treatment in adults, adolescents and children show that ELOCTA® is generally well-tolerated1–6
Data

ELOCTA offers a proven risk-benefit profile to provide confidence and help PwH to feel safe

*Patients with a prior history of, or currently detectable inhibitor were excluded.1,2 Inhibitor development has been observed in clinical practice (as with other approved rFVIII products).5

Patients with a history of anaphylaxis associated with any Factor VIII or intravenous immunoglobulin administration were excluded from the trials.1,2

Adverse reactions reported for ELOCTA® in clinical trials5

The frequencies of adverse reactions in the table below were observed in a total of 276 patients with severe haemophilia A in phase III clinical studies and an extension study with a duration of up to four years. The total number of exposure days was 80,848 with a median of 294 (range 1-735) exposure days per subject.5

The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level)

Data

*Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).5
Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs= previously treated patients, PUPs= previously untreated patients.
Investigator term: vascular pain after injection of ELOCTA.5

Contraindications5

Hypersensitivity to efmoroctocog alfa (recombinant human coagulation FVIII, and/or Fc domain) or to any of the excipients.

Precautions and Warnings5

Allergic type hypersensitivity reactions are possible with ELOCTA. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. In case of anaphylactic shock, standard medical treatment for shock should be implemented.

In general, all patients treated with coagulation FVIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected FVIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for FVIII inhibitor presence should be performed. In patients with high levels of inhibitor, FVIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of haemophilia and FVIII inhibitors.

In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.

If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.

It is strongly recommended that every time that ELOCTA is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.

The listed warnings and precautions apply both to adults, children and adolescents.

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

Interactions5

No interactions of human coagulation FVIII (rDNA) with other medicinal products have been reported. No interaction studies with ELOCTA have been performed.

Undesirable Effects5

Hypersensitivity or allergic reactions (which may include swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hypotension, lethargy, nausea, restlessness, tachycardia) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).

Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with FVIII, including with ELOCTA. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted. Consult the SmPC for further information about adverse events.

See SmPC for more information on safety for ELOCTA. https://www.ema.europa.eu/documents/product-information/ELOCTA-epar-product-information_en.pdf

 FVIII, Factor VIII; rFVIII, recombinant Factor VIII.

 References

  1. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25.

  2. Young G, Mahlangu J, Kulkarni R, Nolan B, Liesner R, Pasi J, et al. Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in children with severe hemophilia A. J Thromb Haemost. 2015 Jun;13(6):967–77.

  3. Nolan B, Konkle BA, Mahlangu J, Pasi KJ, Perry DJ, Rangarajan S, et al. Efficacy and safety of rFVIIIFc prophylaxis in pediatric, adolescent, and adult subjects with severe hemophilia A over 3–4 years: the ASPIRE study. Poster presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8–13; Berlin, Germany. PB1774.

  4. Nolan B, Mahlangu J, Young G, Konkle B, Pasi KJ, Oldenburg J, et al. ASPIRE Final Results Confirm Established Safety and Sustained Efficacy for Up to 4 Years of Treatment With rFVIIIFc in Previously Treated Subjects With Severe Hemophilia A. Poster presented at the 60th American Society of Hematology Annual Meeting & Exposition, December 1–4, 2018, San Diego, CA, USA. Poster 1192.

  5. ELOCTA Summary of Product Characteristics. 2019.

  6. Chowdary P, Ragni MV, Pabinger I, Feng J, Lethagan S, Barnowski C, Mahlangu JN. Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Efficacy for Perioperative Haemostatic Management in Severe Haemophilia A. Poster preseted at the World Federation of Hemophilia 16th International Musculoskeletal Congress, May 10–12, 2019, Madrid, Spain. P-14.

ELOCTA – Safety profile

 
Over ~5 years of treatment in adults, adolescents and children show that ELOCTA® is generally well-tolerated1–6
Data

ELOCTA offers a proven risk-benefit profile to provide confidence and help PwH to feel safe

*Patients with a prior history of, or currently detectable inhibitor were excluded.1,2 Inhibitor development has been observed in clinical practice (as with other approved rFVIII products).5

Patients with a history of anaphylaxis associated with any Factor VIII or intravenous immunoglobulin administration were excluded from the trials.1,2

Adverse reactions reported for ELOCTA® in clinical trials5

The frequencies of adverse reactions in the table below were observed in a total of 276 patients with severe haemophilia A in phase III clinical studies and an extension study with a duration of up to four years. The total number of exposure days was 80,848 with a median of 294 (range 1-735) exposure days per subject.5

The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level)

Data

*Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).5
Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs= previously treated patients, PUPs= previously untreated patients.
Investigator term: vascular pain after injection of ELOCTA.5

Contraindications5

Hypersensitivity to efmoroctocog alfa (recombinant human coagulation FVIII, and/or Fc domain) or to any of the excipients.

Precautions and Warnings5

Allergic type hypersensitivity reactions are possible with ELOCTA. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. In case of anaphylactic shock, standard medical treatment for shock should be implemented.

In general, all patients treated with coagulation FVIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected FVIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for FVIII inhibitor presence should be performed. In patients with high levels of inhibitor, FVIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of haemophilia and FVIII inhibitors.

In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.

If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.

It is strongly recommended that every time that ELOCTA is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.

The listed warnings and precautions apply both to adults, children and adolescents.

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

Interactions5

No interactions of human coagulation FVIII (rDNA) with other medicinal products have been reported. No interaction studies with ELOCTA have been performed.

Undesirable Effects5

Hypersensitivity or allergic reactions (which may include swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hypotension, lethargy, nausea, restlessness, tachycardia) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).

Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with FVIII, including with ELOCTA. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted. Consult the SmPC for further information about adverse events.

See SmPC for more information on safety for ELOCTA. https://www.ema.europa.eu/documents/product-information/ELOCTA-epar-product-information_en.pdf

 FVIII, Factor VIII; rFVIII, recombinant Factor VIII.

 References

  1. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25.

  2. Young G, Mahlangu J, Kulkarni R, Nolan B, Liesner R, Pasi J, et al. Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in children with severe hemophilia A. J Thromb Haemost. 2015 Jun;13(6):967–77.

  3. Nolan B, Konkle BA, Mahlangu J, Pasi KJ, Perry DJ, Rangarajan S, et al. Efficacy and safety of rFVIIIFc prophylaxis in pediatric, adolescent, and adult subjects with severe hemophilia A over 3–4 years: the ASPIRE study. Poster presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8–13; Berlin, Germany. PB1774.

  4. Nolan B, Mahlangu J, Young G, Konkle B, Pasi KJ, Oldenburg J, et al. ASPIRE Final Results Confirm Established Safety and Sustained Efficacy for Up to 4 Years of Treatment With rFVIIIFc in Previously Treated Subjects With Severe Hemophilia A. Poster presented at the 60th American Society of Hematology Annual Meeting & Exposition, December 1–4, 2018, San Diego, CA, USA. Poster 1192.

  5. ELOCTA Summary of Product Characteristics. 2019.

  6. Chowdary P, Ragni MV, Pabinger I, Feng J, Lethagan S, Barnowski C, Mahlangu JN. Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Efficacy for Perioperative Haemostatic Management in Severe Haemophilia A. Poster preseted at the World Federation of Hemophilia 16th International Musculoskeletal Congress, May 10–12, 2019, Madrid, Spain. P-14.