Drugs List

Therapeutic Indications

Uses

Reduced duration of neutropenia
Reduced incidence of febrile neutropenia

Contraindications

Children under 18 years
Breastfeeding
Chronic myeloid leukaemia
Hereditary fructose intolerance
Myelodysplastic syndrome
Pregnancy
Secondary acute myeloid leukaemia

Precautions and Warnings

History of pulmonary infiltrates
Recent history of pneumonia
Sickle cell disease

Incidence of thrombocytopenia and anaemia not reduced by treatment
Treatment to be initiated and supervised by a specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
For single use only
Record name and batch number of administered product
Monitor full blood count and differential WBC before and during therapy
Consider splenic rupture if patient has abdominal or shoulder pain
Monitor for symptoms of Capillary Leak Syndrome
Monitor haematocrit values
Monitor patients with sickle cell anaemia
Monitor platelets
Monitor serum potassium regularly
Monitor spleen size
Perform regular urinalysis
Advise patient to seek medical advice if signs/symptoms of aortitis occur
Antibodies to ingredient may develop
Seek urgent medical attention if symptoms of Capillary Leak Syndrome occur
May affect bone imaging results
Discontinue if adult respiratory distress syndrome occurs
Discontinue if leucocyte count exceeds 50x10 to the power of 9/L
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue or reduce dose if glomerulonephritis occurs
Concurrent cytotoxic drugs: Maintain established dose regime (no increase)

If aortitis is suspected it can usually be diagnosed by CT scan and generally resolves after withdrawal of lipegfilgrastim.

Pregnancy and Lactation

Pregnancy

Lipegfilgrastim is contraindicated during pregnancy.

The manufacturer recommends lipegfilgrastim is not used during pregnancy.

There are very limited data on the use of lipegfilgrastim in pregnant women. Animals studies have shown reproductive toxicity.

Lactation

Lipegfilgrastim is contraindicated during breastfeeding.

The manufacturer recommends that breastfeeding should be discontinued during treatment with lipegfilgrastim.

It is not known whether lipegfilgrastim and its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded.

Side Effects

Acute febrile dermatosis (Sweet's syndrome)
Adult respiratory distress syndrome
Angioedema
Antibody formation
Aortitis
Back pain
Bone pain
Capillary leak syndrome
Chest pain
Cough
Cutaneous vasculitis
Dyspnoea
Erythema
Fever
Glomerulonephritis
Haemoptysis
Headache
Hypersensitivity reactions
Hypokalaemia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Interstitial pneumonia
Leucocytosis
Local pain (injection site)
Local reaction at injection site
Myalgia
Nausea
Pulmonary fibrosis
Pulmonary haemorrhage
Pulmonary infiltrates
Pulmonary oedema
Raised neutrophil count
Rash
Respiratory failure
Sickle cell crisis
Splenic rupture
Splenomegaly
Thrombocytopenia
Urticaria

Presentation

Injection containing lipegfilgrastim.

This product has been produced by recombinant DNA technology using E.coli.

Drugs List

Therapeutic Indications

Uses

Reduced duration of neutropenia
Reduced incidence of febrile neutropenia

Dosage

Adults

Contraindications

Children under 18 years
Breastfeeding
Chronic myeloid leukaemia
Hereditary fructose intolerance
Myelodysplastic syndrome
Pregnancy
Secondary acute myeloid leukaemia

Precautions and Warnings

History of pulmonary infiltrates
Recent history of pneumonia
Sickle cell disease

Incidence of thrombocytopenia and anaemia not reduced by treatment
Treatment to be initiated and supervised by a specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
For single use only
Record name and batch number of administered product
Monitor full blood count and differential WBC before and during therapy
Consider splenic rupture if patient has abdominal or shoulder pain
Monitor for symptoms of Capillary Leak Syndrome
Monitor haematocrit values
Monitor patients with sickle cell anaemia
Monitor platelets
Monitor serum potassium regularly
Monitor spleen size
Perform regular urinalysis
Advise patient to seek medical advice if signs/symptoms of aortitis occur
Antibodies to ingredient may develop
Seek urgent medical attention if symptoms of Capillary Leak Syndrome occur
May affect bone imaging results
Discontinue if adult respiratory distress syndrome occurs
Discontinue if leucocyte count exceeds 50x10 to the power of 9/L
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue or reduce dose if glomerulonephritis occurs
Concurrent cytotoxic drugs: Maintain established dose regime (no increase)

If aortitis is suspected it can usually be diagnosed by CT scan and generally resolves after withdrawal of lipegfilgrastim.

Pregnancy and Lactation

Pregnancy

Lipegfilgrastim is contraindicated during pregnancy.

The manufacturer recommends lipegfilgrastim is not used during pregnancy.

There are very limited data on the use of lipegfilgrastim in pregnant women. Animals studies have shown reproductive toxicity.

Lactation

Lipegfilgrastim is contraindicated during breastfeeding.

The manufacturer recommends that breastfeeding should be discontinued during treatment with lipegfilgrastim.

It is not known whether lipegfilgrastim and its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded.

Side Effects

Acute febrile dermatosis (Sweet's syndrome)
Adult respiratory distress syndrome
Angioedema
Antibody formation
Aortitis
Back pain
Bone pain
Capillary leak syndrome
Chest pain
Cough
Cutaneous vasculitis
Dyspnoea
Erythema
Fever
Glomerulonephritis
Haemoptysis
Headache
Hypersensitivity reactions
Hypokalaemia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Interstitial pneumonia
Leucocytosis
Local pain (injection site)
Local reaction at injection site
Myalgia
Nausea
Pulmonary fibrosis
Pulmonary haemorrhage
Pulmonary infiltrates
Pulmonary oedema
Raised neutrophil count
Rash
Respiratory failure
Sickle cell crisis
Splenic rupture
Splenomegaly
Thrombocytopenia
Urticaria

Effects on Laboratory Tests

Positive bone imaging findings have been associated with growth factor therapy due to the increase in haematopoietic activity in the bone marrow. This effect should be considered when bone-images are taken.

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: Lonquex 6mg solution for injection. Teva Pharma B.V. Revised July 2019.

HPRA Drug Safety Update June 2018 Edition 88
Available at: https://www.hpra.ie/homepage/about-us/publications-forms/newsletters
Last accessed: 17 September 2019