Drugs List

Therapeutic Indications

Uses

Fallopian tube cancer
Primary peritoneal cancer
Relapsed platinum sensitive high grade serous epithelial ovarian cancer

Treatment of first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in adult patients in combination with carboplatin.

Administration

For intravenous infusion only after dilution.

Contraindications

Children under 18 years
Neutrophil count below 1.5 x 10 to the power of 9 / L at baseline
Platelet count below 100 x 10 to the power of 9 / L at baseline
Breastfeeding
Pregnancy
Serum bilirubin above 5 times upper limit of normal
Serum transaminases above 10 times upper limit of normal
Severe renal impairment

Precautions and Warnings

Patients over 75 years
Restricted sodium intake
Cardiac disorder
Moderate hepatic impairment

Monitor cardiac function when a history of exposure to cardiotoxic agents
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Anti-diarrhoeals may be required during treatment
Pre-medicate with corticosteroids, antihistamines and H2 antagonists
Prophylactic G-CSF should be considered
Different formulations are not bioequivalent
Accidental contact of soln with skin/mucous membranes-rinse well with water
Consult local policy on the safe use of anti-cancer drugs
Dilute and use as an infusion
If extravasation occurs follow local policy & seek expert help immediately
Never rechallenge treatment after a severe hypersensitivity reaction
Paclitaxel to be administered before cisplatin when used in combination
Reducing the infusion rate may minimise severity of infusion reactions
Staff: Not to be handled by pregnant staff
Monitor blood counts regularly
Monitor for hypersensitivity reactions during infusion
Advise patient that alopecia may occur
Advise patients at risk of neutropenia to report any signs of infection
Consider dose/ schedule adjustment if neuropathy occurs
Consider the use of anti-emetics before and during therapy
Discontinue if grade 4 toxicity occurs
Discontinue if severe hypersensitivity reactions occur
Interrupt therapy if platelet count less than 100 x 10 to the power of 9/L
Suspend treatment and reduce dose if febrile neutropenia occurs
Female: Contraception required during and for 6 months after treatment
Advise patient to report signs / symptoms of infusion related reactions

This paclitaxel should not be substituted for or with the albumin bound nanoparticle formulation of paclitaxel.

When paclitaxel is used in combination therapy, it should be administered before cisplatin.

Infusion site reactions are very common, especially on the first infusion. These reactions may be improved by slowing the rate of infusion. In patients who experience severe pain or other infusion reactions should be considered for central venous catheter.

Pregnancy and Lactation

Pregnancy

Paclitaxel is contraindiacted during pregnancy.

The manufacturer recommends that paclitaxel should not be used in pregnancy unless the clinical condition requires treatment. There is limited data in the use of paclitaxel in pregnant women, however, paclitaxel is expected to cause serious birth defects. Animal studies have shown foetal toxicities.

Lactation

Paclitaxel is contraindicated during breastfeeding.

The manufacturer recommends that breastfeeding must be discontinued during paclitaxel treatment. Paclitaxel is excreted in human milk and may have serious adverse reactions in breastfed infants.

Side Effects

Abdominal pain
Abscess
Alopecia
Anaemia
Anaphylactic shock
Angina pectoris
Anorexia
Anxiety
Arthralgia
Asthenia
Atrial fibrillation
Back pain
Bone pain
Burning sensation
Cardiac arrest
Cardiac failure
Cellulitis (injection site)
Cerebrovascular accident
Chest discomfort
Coagulation disorders
Cognitive impairment
Coma
Constipation
Cyanosis
Cystitis
Decreased appetite
Dehydration
Depression
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspnoea
Encephalopathy
Erythema
Eye irritation
Facial oedema
Facial palsy
Fatigue
Febrile neutropenia
Flatulence
Flushing
Granulocytopenia
Haematological toxicity
Headache
Herpes simplex
Hydrocephalus
Hyperaemia
Hypersensitivity reactions
Hyperthermia
Hypoaesthesia
Hypokalaemia
Hypomagnesaemia
Hyponatraemia
Hypotension
Hypotonia
Influenza
Infusion site reaction
Insomnia
Intravascular coagulation (disseminated)
Lethargy
Leukopenia
Metastatic pain
Muscle weakness
Musculoskeletal pain
Myalgia
Nasal congestion
Nausea
Neurotoxicity
Neutropenia
Pain
Painful extremities
Palpitations
Pancytopenia
Paraesthesia
Peripheral motor neuropathy
Peripheral neuropathy
Peripheral oedema
Peripheral sensory neuropathy
Phlebitis
Pneumonia
Polyneuropathy
Pruritus
Pyrexia
Rash
Respiratory tract infection
Sepsis
Sinus bradycardia
Sinus tachycardia
Skin infection
Somnolence
Status epilepticus
Stomatitis
Tachycardia
Thrombocytopenia
Tonsillitis
Upper abdominal pain
Urinary tract infections
Urticaria
Vomiting

Presentation

Powder for solution for infusion formulations of paclitaxel.

Drugs List

Therapeutic Indications

Uses

Fallopian tube cancer
Primary peritoneal cancer
Relapsed platinum sensitive high grade serous epithelial ovarian cancer

Treatment of first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in adult patients in combination with carboplatin.

Dosage

Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

Adults

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For intravenous infusion only after dilution.

Contraindications

Children under 18 years
Neutrophil count below 1.5 x 10 to the power of 9 / L at baseline
Platelet count below 100 x 10 to the power of 9 / L at baseline
Breastfeeding
Pregnancy
Serum bilirubin above 5 times upper limit of normal
Serum transaminases above 10 times upper limit of normal
Severe renal impairment

Precautions and Warnings

Patients over 75 years
Restricted sodium intake
Cardiac disorder
Moderate hepatic impairment

Monitor cardiac function when a history of exposure to cardiotoxic agents
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Anti-diarrhoeals may be required during treatment
Pre-medicate with corticosteroids, antihistamines and H2 antagonists
Prophylactic G-CSF should be considered
Different formulations are not bioequivalent
Accidental contact of soln with skin/mucous membranes-rinse well with water
Consult local policy on the safe use of anti-cancer drugs
Dilute and use as an infusion
If extravasation occurs follow local policy & seek expert help immediately
Never rechallenge treatment after a severe hypersensitivity reaction
Paclitaxel to be administered before cisplatin when used in combination
Reducing the infusion rate may minimise severity of infusion reactions
Staff: Not to be handled by pregnant staff
Monitor blood counts regularly
Monitor for hypersensitivity reactions during infusion
Advise patient that alopecia may occur
Advise patients at risk of neutropenia to report any signs of infection
Consider dose/ schedule adjustment if neuropathy occurs
Consider the use of anti-emetics before and during therapy
Discontinue if grade 4 toxicity occurs
Discontinue if severe hypersensitivity reactions occur
Interrupt therapy if platelet count less than 100 x 10 to the power of 9/L
Suspend treatment and reduce dose if febrile neutropenia occurs
Female: Contraception required during and for 6 months after treatment
Advise patient to report signs / symptoms of infusion related reactions

This paclitaxel should not be substituted for or with the albumin bound nanoparticle formulation of paclitaxel.

When paclitaxel is used in combination therapy, it should be administered before cisplatin.

Infusion site reactions are very common, especially on the first infusion. These reactions may be improved by slowing the rate of infusion. In patients who experience severe pain or other infusion reactions should be considered for central venous catheter.

Pregnancy and Lactation

Pregnancy

Paclitaxel is contraindiacted during pregnancy.

The manufacturer recommends that paclitaxel should not be used in pregnancy unless the clinical condition requires treatment. There is limited data in the use of paclitaxel in pregnant women, however, paclitaxel is expected to cause serious birth defects. Animal studies have shown foetal toxicities.

Lactation

Paclitaxel is contraindicated during breastfeeding.

The manufacturer recommends that breastfeeding must be discontinued during paclitaxel treatment. Paclitaxel is excreted in human milk and may have serious adverse reactions in breastfed infants.

Side Effects

Abdominal pain
Abscess
Alopecia
Anaemia
Anaphylactic shock
Angina pectoris
Anorexia
Anxiety
Arthralgia
Asthenia
Atrial fibrillation
Back pain
Bone pain
Burning sensation
Cardiac arrest
Cardiac failure
Cellulitis (injection site)
Cerebrovascular accident
Chest discomfort
Coagulation disorders
Cognitive impairment
Coma
Constipation
Cyanosis
Cystitis
Decreased appetite
Dehydration
Depression
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspnoea
Encephalopathy
Erythema
Eye irritation
Facial oedema
Facial palsy
Fatigue
Febrile neutropenia
Flatulence
Flushing
Granulocytopenia
Haematological toxicity
Headache
Herpes simplex
Hydrocephalus
Hyperaemia
Hypersensitivity reactions
Hyperthermia
Hypoaesthesia
Hypokalaemia
Hypomagnesaemia
Hyponatraemia
Hypotension
Hypotonia
Influenza
Infusion site reaction
Insomnia
Intravascular coagulation (disseminated)
Lethargy
Leukopenia
Metastatic pain
Muscle weakness
Musculoskeletal pain
Myalgia
Nasal congestion
Nausea
Neurotoxicity
Neutropenia
Pain
Painful extremities
Palpitations
Pancytopenia
Paraesthesia
Peripheral motor neuropathy
Peripheral neuropathy
Peripheral oedema
Peripheral sensory neuropathy
Phlebitis
Pneumonia
Polyneuropathy
Pruritus
Pyrexia
Rash
Respiratory tract infection
Sepsis
Sinus bradycardia
Sinus tachycardia
Skin infection
Somnolence
Status epilepticus
Stomatitis
Tachycardia
Thrombocytopenia
Tonsillitis
Upper abdominal pain
Urinary tract infections
Urticaria
Vomiting

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: July 2022

Reference Sources

Summary of Product Characteristics: Apealea 60mg powder for solution for infusion. Inceptua. Revised December 2021.