Volanesorsen parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of volanesorsen.
Drugs List
Therapeutic Indications
Uses
Familial chylomicronemia syndrome (FCS)
Treatment in patients with confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, when response to diet and triglyceride lowering therapy has been inadequate.
Dosage
Adults
First 3 months of treatment: 285mg once weekly
After 3 months: 285mg once every 2 weeks
After 6 months: Consider increase to 285mg weekly if response has been inadequate in terms of serum triglyceride reduction and in the condition that platelet counts are in the normal range. Re-downtitrate to 285mg every 2 weeks if the higher 285mg weekly dose does not provide significant additional triglyceride reduction after 9 months.
Platelet count greater than or equal to 140 x 10 to the power of 9/L
Initial dose:285mg once weekly
After 3 months: 285mg once every 2 weeks
Monitor platelet counts every 2 weeks.
Platelet count between 100 and 139 x 10 to the power of 9/L
285mg once every 2 weeks. Monitor platelet counts weekly.
Platelet count between 75 and 99 x 10 to the power of 9/L
Pause treatment for 4 weeks or longer. Resume treatment when platelet levels are greater than or equal to 100 x 10 to the power of 9/L. Monitor platelet counts weekly.
Platelet count between 50 and 74 x 10 to the power of 9/L
Pause treatment for 4 weeks or longer. Resume treatment when platelet levels are greater than or equal to 100 x 10 to the power of 9/L. Monitor platelet counts every 2 to 3 days.
Platelet count less than 50 x 10 to the power of 9/L
Discontinue treatment. Glucocorticoids recommended. Monitor platelet counts daily.
Additional Dosage Information
Missed doses
If a dose is missed and noticed within 48 hours, the missed dose should be given as soon as possible. If not noticed within 48 hours, the missed dose should be skipped and the next scheduled injection given.
Administration
For subcutaneous injection only, on the same day of the week.
Contraindications
Children under 18 years
Platelet count below 140 x 10 to the power of 9/ L at baseline
Breastfeeding
Pregnancy
Precautions and Warnings
Elderly
Weight below 70kg
Severe renal impairment
Thrombocytopenia
Exclude secondary causes of hypertriglyceridaemia before starting treatment
Treatment to be initiated and supervised by a specialist
Avoid injection into broken or bruised skin
Use only if the solution is clear and colourless
Vary injection site during prolonged therapy
Warm to room temperature prior to use
Monitor platelets before starting and during treatment
Monitor erythrocyte sedimentation rate every 3 months
Monitor hepatic function regularly
Monitor renal function
Advise patients to seek medical advice if signs of bleeding occur
Discontinue if AST or ALT level exceeds 5x ULN and persists
Discontinue if AST or ALT level exceeds 8 x ULN
Discontinue if eGFR falls below 30ml/minute/1.73 m squared
Discontinue if raised AST/ALT and bilirubin > 2 x ULN
Discontinue if raised AST/ALT and INR > 1.5
Discontinue if symptoms of hepatic disease occur
Discontinue treatment if proteinuria is > 499mg/24 hours
Measure platelet count prior to initiation of treatment. If platelet count is less than 140 x 10 to the power of 9/L, reassess measurement one week later. If platelet count remains less than 140 x 10 to the power of 9/L, treatment should not be initiated.
Monitor for evidence of nephrotoxicity by routine urine dipstick on a quarterly basis. Discontinue treatment if proteinuria is greater than or equal to 500mg over 24 hours or an increase in serum creatinine greater or equal to 0.3mg/dL (26.5micromol/L) above the upper limit of normal or eGFR greater than or equal to 30mL/minute/1.73metre squared.
Monitor hepatotoxicity through serum liver enzymes and bilirubin on a quarterly basis.
Monitor for inflammation through a quarterly assessment of erythrocyte sedimentation rate (ESR).
Consider discontinuing concurrent antiplatelet medicinal products/NSAIDs/anticoagulants if platelet levels are less than 75 x 10 to the power of 9/L.
Discontinue treatment if serum triglycerides are reduced by less than 25% or in patients who fail to achieve serum triglycerides below 22.6mmol/L after 3 months on volanesorsen 285mg weekly.
Pregnancy and Lactation
Pregnancy
Volanesorsen is contraindicated during pregnancy.
The manufacturer does not recommend using volanesorsen during pregnancy. At the time of writing there is limited published information regarding the use of volanesorsen during pregnancy. Potential risks are unknown.
Lactation
Volanesorsen is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues volanesorsen or discontinues breastfeeding. The presence of volanesorsen in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abdominal distension
Abdominal pain
Abnormal INR
Arthralgia
Arthritis
Asthenia
Blurred vision
Bruising at injection site
Burning (injection site)
Chills
Conjunctival haemorrhage
Contusion
Cough
Decrease in creatinine clearance
Diabetes mellitus
Diarrhoea
Discolouration (injection site)
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
Ecchymosis
Elevated serum LDL cholesterol
Eosinophilia
Epistaxis
Erythema
Erythema at injection site
Fatigue
Feeling hot
Gingival bleeding
Gingival swelling
Haematoma
Haematoma (injection site)
Haematuria
Haemoglobin decrease
Haemorrhage
Haemorrhage (injection site)
Headache
Hot flushes
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Immune reaction
Increase in blood urea or creatinine
Increase in serum transaminases
Increases in hepatic enzymes
Induration (injection site)
Inflammation (injection site)
Influenza-like syndrome
Injection site reactions
Insomnia
Joint inflammation
Leukopenia
Local pain (injection site)
Localised areas of paraesthesia
Localised urticaria
Malaise
Migraine
Mouth haemorrhage
Muscle spasm
Myalgia
Myositis
Nasal congestion
Nausea
Night sweats
Non-cardiac chest pain
Oedema
Oedema (injection site)
Pain
Painful extremities
Pallor
Papules
Petechiae
Pharyngeal oedema
Polymyalgia rheumatica
Presyncope
Proteinuria
Pruritus
Pyrexia
Rash
Reduced platelet count
Salivary gland enlargement
Serum sickness-like reactions
Skin hypertrophy
Swelling (injection site)
Swelling of lips and face
Syncope
Thrombocytopenia
Thrombocytopenic purpura
Tremor
Urticaria
Vesicles
Vomiting
Wheezing
White blood cell count decreased
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2019
Reference Sources
Summary of Product Characteristics: Waylivra (volanesorsen) 285mg solution for injection in pre-filled syringe. Akcea Therapeutics UK Ltd. Revised May 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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