Table adapted from Waylivra SmPC.
Always consult the SmPC for further information on Waylivra’s safety profile

The most common adverse events reported among Waylivra-treated patients in the APPROACH trial were injection-site reactions and decreases in platelet counts compared to placebo.²

* The table indicates adverse events which were reported in ≥10% of patients and were more common in the Waylivra group than the placebo group.²

Adapted from Witzum JL et al. N Engl J Med 2019;381(6):531–42.
Always consult the SmPC for further information on Waylivra’s safety profile

Summary of treatment-emergent adverse events in the APPROACH trial²

Adapted from Witzum JL et al. N Engl J Med 2019;381(6):531–42.
Always consult the SmPC for further information on Waylivra’s safety profile

Risk Management Materials

Educational Risk Management Materials to help reduce the risk associated with using this medicine, including a patient and carer guide and a risk management healthcare professional guide, are available as part of the regulatory requirement of Waylivra at: https://www.medicines.org.uk/emc/product/10636/rmms/. 

Thrombocytopenia

Waylivra is associated with reductions in platelet count.¹ Patients should be monitored for thrombocytopenia during treatment.¹

Adverse events reported during the APPROACH study:¹

• Platelet counts below 140 x 10⁹/L and 100 x 10⁹/L were observed in 76% and 47% of Waylivra-treated patients, respectively
   
• Decreased platelet count was reported as an adverse event in 11 (33%) of Waylivra-treated patients 
  versus 1 (3%) of placebo-treated patients
   
• Thrombocytopenia was reported in 4 (12%) of Waylivra-treated patients vs none in the placebo group

Always consult the SmPC for further information on Waylivra’s safety profile

Platelet monitoring

Platelet monitoring is necessary during treatment¹
 

• Prior to initiation of Waylivra, patients should have a platelet count ≥140 × 10⁹/L
   
• During treatment, platelet levels should be monitored at least every 2 weeks and dosing and frequency of monitoring modified accordingly

Adapted from Waylivra SmPC.

* Discontinuation of antiplatelet medicinal products/NSAIDs/anticoagulants should be considered for platelet levels <75 × 10⁹/L. Treatment with these medicinal products must be discontinued at platelet levels <50 × 10⁹/L.¹
† Consultation of a haematologist is needed to reconsider the benefit/risk for possible further treatment with Waylivra in a patient who has discontinued due to severe thrombocyotpenia (<50 x 10⁹/L).¹

AE: adverse event, NSAIDs: non-steroidal anti-inflammatory drugs, SAE: serious adverse event, SmPC: Summary of Product Characteristics, TEAE: treatment-emergent adverse event

References

1. Waylivra Summary of Product Characteristics.
2. Witzum JL et al. N Engl J Med 2019;381(6):531–42.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.  Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Swedish Orphan Biovitrum Ltd at [email protected] or Telephone +44 (0) 800 111 4754