Drugs List

Therapeutic Indications

Uses

Reduced duration of neutropenia
Reduced incidence of febrile neutropenia

Administration

Administer subcutaneous injection into the thigh, abdomen or upper arm, a minimum of 24 hours after cytotoxic chemotherapy.

The on-body injector should be applied to intact, non-irritated skin on the back of the arm or abdomen.

The on-body injector delivers pegfilgrastim over approximately 45 minutes, around 27 hours after it is applied to the patient's skin.

The on-body injector must only be used with the co-packed pegfilgrastim pre-filled syringe.

Contraindications

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

Precautions and Warnings

Hypersensitivity to latex
Acute myeloid leukaemia
Breast cancer
History of pulmonary infiltrates
Lung cancer
New onset acute myeloid leukaemia in patients below 55 years
Recent history of pneumonia
Sickle cell disease
Sickle cell trait

Incidence of thrombocytopenia and anaemia not reduced by treatment
Treatment to be initiated and supervised by a specialist
Needle cover contains a derivative of latex in some brands
On-body injector contains acrylic adhesive: may cause allergic reactions
Presentations with sorbitol unsuitable in hereditary fructose intolerance
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
Lung or breast cancer: Monitor for MDS and AML
Monitor for symptoms of Capillary Leak Syndrome
Monitor haematocrit values
Monitor patients with sickle cell anaemia
Monitor patients with sickle cell trait
Monitor platelets
Monitor spleen size
Perform regular urinalysis
Advise patient to seek medical advice if signs/symptoms of aortitis occur
Discontinue treatment if Stevens-Johnson syndrome is confirmed
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 if severe hypersensitivity reactions occur
Discontinue or reduce dose if glomerulonephritis occurs
Concurrent cytotoxic drugs: Maintain established dose regime (no increase)
Female: Ensure adequate contraception during treatment
Patient alert card available for some brands

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

If the patient develops Stevens-Johnson syndrome with the use of pegfilgrastim, treatment must not be restarted at any time.

Pregnancy and Lactation

Pregnancy

Pegfilgrastim is contraindicated during pregnancy.

The manufacturer does not recommend using pegfilgrastim during pregnancy. Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out.

Lactation

Pegfilgrastim is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues pegfilgrastim or discontinues breastfeeding. The presence of pegfilgrastim in human breast milk and the effects on exposed infants are unknown.

Side Effects

Acute febrile dermatosis (Sweet's syndrome)
Acute myeloid leukaemia
Adult respiratory distress syndrome
Allergic reaction
Altered liver function tests
Anaphylaxis
Angioedema
Aortitis
Application site reaction
Arthralgia
Back pain
Bone pain
Capillary leak syndrome
Chest pain
Contact dermatitis
Cutaneous vasculitis
Dyspnoea
Erythema
Extremity pain
Flushing
Glomerulonephritis
Haemoptysis
Headache
Hypersensitivity reactions
Hypotension
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increased uric acid level
Interstitial pneumonia
Leucocytosis
Local pain (injection site)
Local reaction at injection site
Musculoskeletal pain
Myalgia
Myelodysplastic syndrome
Nausea
Neck pain
Pulmonary fibrosis
Pulmonary haemorrhage
Pulmonary infiltrates
Pulmonary oedema
Pulmonary reactions (acute)
Rash
Respiratory failure
Sickle cell crisis
Splenic rupture
Splenomegaly
Stevens-Johnson syndrome
Thrombocytopenia
Urticaria

Presentation

Parenteral formulations of pegfilgrastim.

Drugs List

Therapeutic Indications

Uses

Reduced duration of neutropenia
Reduced incidence of febrile neutropenia

Dosage

Adults

Administration

Administer subcutaneous injection into the thigh, abdomen or upper arm, a minimum of 24 hours after cytotoxic chemotherapy.

The on-body injector should be applied to intact, non-irritated skin on the back of the arm or abdomen.

The on-body injector delivers pegfilgrastim over approximately 45 minutes, around 27 hours after it is applied to the patient's skin.

The on-body injector must only be used with the co-packed pegfilgrastim pre-filled syringe.

Contraindications

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

Precautions and Warnings

Hypersensitivity to latex
Acute myeloid leukaemia
Breast cancer
History of pulmonary infiltrates
Lung cancer
New onset acute myeloid leukaemia in patients below 55 years
Recent history of pneumonia
Sickle cell disease
Sickle cell trait

Incidence of thrombocytopenia and anaemia not reduced by treatment
Treatment to be initiated and supervised by a specialist
Needle cover contains a derivative of latex in some brands
On-body injector contains acrylic adhesive: may cause allergic reactions
Presentations with sorbitol unsuitable in hereditary fructose intolerance
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
Lung or breast cancer: Monitor for MDS and AML
Monitor for symptoms of Capillary Leak Syndrome
Monitor haematocrit values
Monitor patients with sickle cell anaemia
Monitor patients with sickle cell trait
Monitor platelets
Monitor spleen size
Perform regular urinalysis
Advise patient to seek medical advice if signs/symptoms of aortitis occur
Discontinue treatment if Stevens-Johnson syndrome is confirmed
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 if severe hypersensitivity reactions occur
Discontinue or reduce dose if glomerulonephritis occurs
Concurrent cytotoxic drugs: Maintain established dose regime (no increase)
Female: Ensure adequate contraception during treatment
Patient alert card available for some brands

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

If the patient develops Stevens-Johnson syndrome with the use of pegfilgrastim, treatment must not be restarted at any time.

Pregnancy and Lactation

Pregnancy

Pegfilgrastim is contraindicated during pregnancy.

The manufacturer does not recommend using pegfilgrastim during pregnancy. Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out.

Lactation

Pegfilgrastim is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues pegfilgrastim or discontinues breastfeeding. The presence of pegfilgrastim in human breast milk and the effects on exposed infants are unknown.

Counselling

Advise the patient that if they suspect a device failure or malfunction with the on-body injector they must immediately inform their healthcare provider.

On-body injector: Patient alert card available. Remind patient of the importance of carrying alert card with them at all times.

Side Effects

Acute febrile dermatosis (Sweet's syndrome)
Acute myeloid leukaemia
Adult respiratory distress syndrome
Allergic reaction
Altered liver function tests
Anaphylaxis
Angioedema
Aortitis
Application site reaction
Arthralgia
Back pain
Bone pain
Capillary leak syndrome
Chest pain
Contact dermatitis
Cutaneous vasculitis
Dyspnoea
Erythema
Extremity pain
Flushing
Glomerulonephritis
Haemoptysis
Headache
Hypersensitivity reactions
Hypotension
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increased uric acid level
Interstitial pneumonia
Leucocytosis
Local pain (injection site)
Local reaction at injection site
Musculoskeletal pain
Myalgia
Myelodysplastic syndrome
Nausea
Neck pain
Pulmonary fibrosis
Pulmonary haemorrhage
Pulmonary infiltrates
Pulmonary oedema
Pulmonary reactions (acute)
Rash
Respiratory failure
Sickle cell crisis
Splenic rupture
Splenomegaly
Stevens-Johnson syndrome
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.

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: March 2021

Reference Sources

Summary of Product Characteristics: Neulasta pre-filled syringe. Amgen Ltd. Revised November 2020.
Summary of Product Characteristics: Neulasta on body injector. Amgen Ltd. Revised November 2020.
Summary of Product Characteristics: Pelgraz 6mg solution for injection in pre-filled injector. Accord Healthcare Ltd. Revised November 2019.
Summary of Product Characteristics: Pelgraz 6mg solution for injection in pre-filled syringe. Accord Healthcare Ltd. Revised November 2019.
Summary of Product Characteristics: Pelmeg 6mg solution for injection in pre-filled syringe. Napp Pharmaceuticals Ltd. Revised October 2020.
Summary of Product Characteristics: Ziextenzo 6mg solution for injection in pre-filled syringe. Sandoz Limited. Revised January 2020.