Posology Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with FCS. g. uncontrolled diabetes, hypothyroidism) should be excluded or appropriately addressed. 5 ml injected subcutaneously once weekly for 3 months.
Following 3 months, dose frequency should be reduced to 285 mg every 2 weeks. 6 mmol/L after 3 months on volanesorsen 285 mg weekly. After 6 months of treatment with volanesorsen, increase of dose frequency to 285 mg weekly should be considered if response has been inadequate in terms of serum triglyceride reduction as evaluated by the supervising experienced specialist and in the condition that platelet counts are in the normal range.
Patients should be re-downtitrated to 285 mg every 2 weeks if the higher 285 mg once weekly dose does not provide significant additional triglyceride reduction after 9 months. Patients should be instructed to give the injection on the same day of the week, according to medically determined frequency of administration.
3 If a dose is missed and noticed within 48 hours, the patient should be directed to give the missed dose as soon as possible. If not noticed within 48 hours, then the missed dose should be skipped and the next planned injection given.
Platelet monitoring and dose adjustments Before initiation of treatment, platelet count should be measured. If the platelet count is below 140 x 109/L another measurement should be taken approximately a week later to reassess. 3). After commencing treatment, patients should have platelet levels monitored at least every two weeks, depending on the platelet levels.
Treatment and monitoring should be adjusted according to laboratory values in line with Table 1. For any patient dose paused or discontinued due to severe thrombocytopenia, the benefits and risks of returning to treatment once platelet count ≥100 x 109/L should be carefully considered.
For discontinued patients, a haematologist should be consulted prior to resuming treatment. Table 1. 4 for recommendations regarding use of antiplatelet agents/non-steroidal anti- inflammatory drugs (NSAIDs)/anticoagulants b Consultation of a haematologist is needed to reconsider the benefit/risk for possible further treatment with volanesorsen.
Special populations Elderly population No starting dose adjustment is necessary for elderly patients. 2). Renal impairment No starting dose adjustment is necessary in patients with mild to moderate renal impairment. The safety and efficacy in patients with severe renal impairment has not been established and these patients should be closely observed.
4 Hepatic impairment This medicinal product has not been studied in patients with hepatic impairment. The medicinal product is not metabolised via the cytochrome P450 enzyme system in the liver, therefore dose adjustment is unlikely to be required in patients with hepatic impairment.
Paediatric population The safety and efficacy of this medicinal product in children and adolescents below 18 years of age have not yet been established. No data are available. Method of administration This medicinal product is intended for subcutaneous use only.
It should not be administered intramuscularly or intravenously. Each pre-filled syringe is for single use only. Waylivra should be inspected visually prior to administration. The solution should be clear and colourless to slightly yellow.
If the solution is cloudy or contains visible particulate matter, the contents must not be injected and the medicinal product should be returned to the pharmacy. The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional.
Patients and/or caregivers should be trained in the administration of this medicinal product in accordance with the patient information leaflet. The pre-filled syringe should be allowed to reach room temperature prior to injection. It should be removed from refrigerated storage (2 ° to 8 °C) at least 30 minutes before use.
Other warming methods should not be used. It is normal to see a large air bubble. It should not be attempted to remove the air bubble. It is important to rotate sites for injection. Sites for injection include the abdomen, upper thigh region, or outer area of the upper arm.
If injected in the upper arm, the injection should be administered by another person. Injection should be avoided at the waistline and other sites where pressure or rubbing may occur from clothing. This medicinal product should not be injected into tattoos, moles, birthmarks, bruises, rashes, or areas where the skin is tender, red, hard, bruised, damaged, burned, or inflamed.