Drugs List

Therapeutic Indications

Uses

Early, inflammatory or locally advanced HER2 +ve breast cancer
Metastatic or locally recurrent unresectable HER2 +ve breast cancer

Neoadjuvant treatment of HER2-positive locally advanced, inflammatory or early stage breast cancer at high risk of recurrence in combination with trastuzumab and chemotherapy.

Adjuvant treatment of HER2-positive early stage breast cancer at high risk of recurrence in combination with trastuzumab and chemotherapy.

Treatment of HER2-positive metastatic or locally recurrent unresectable breast cancer, in combination with trastuzumab and docetaxel, in patients who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Administration

For intravenous infusion over 60 minutes.

If well tolerated subsequent infusions may be administered over 30 to 60 minutes.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

History of anthracycline therapy
History of thoracic radiotherapy
Left ventricular ejection fraction below 55%
Congestive cardiac failure
Hepatic impairment
Recent myocardial infarction
Serious cardiac arrhythmias
Severe renal impairment
Uncontrolled hypertension

Advise ability to drive/operate machinery may be affected by side effects
Anti-diarrhoeals may be required during treatment
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
Monitor patient for at least 1 hour after administration
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Staff: Not to be handled by pregnant staff
Suspend treatment or reduce rate until infusion reactions resolve
HER2 testing is mandatory prior to initiation of therapy
Monitor LVEF at baseline and periodically during treatment
Advise patient to report diarrhoea
Consider interrupting if severe diarrhoea that cannot be controlled
Discontinue if adult respiratory distress syndrome occurs
Discontinue if bronchospasm occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue or review if symptoms of congestive heart failure occur
Discontinue permanently if severe hypersensitivity reactions occur
Discontinue treatment and/or reduce dose if LVEF decreases
Female: Contraception required during and for 6 months after treatment
Advise patients on the risk of neutropenia and the significance of fever

Monitor patient closely if prior anthracycline exposure is greater than 360 mg/square metre of doxorubicin or its equivalent.

Left ventricular dysfunction
Early breast cancer
Patients should have a pretreatment left ventricular ejection fraction (LVEF) of greater than or equal to 55% (greater than or equal to 50% after completion of the anthracycline component, if given).
Neoadjuvant : Asses LVEF once during course.
Adjuvant: Asses LVEF every 12 weeks.

Metastatic breast cancer
Patients should have a pretreatment LVEF of greater then or equal to 50%
Asses LVEF every 12 weeks.

Pregnancy and Lactation

Pregnancy

Pertuzumab is contraindicated in pregnancy.

At the time of writing there is a limited amount of data on the use of pertuzumab in pregnant women. Animal studies have shown reproductive toxicity.

The effect of concurrent therapies must also be considered.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Pertuzumab is contraindicated in breastfeeding.

Human IgG is secreted in human milk therefore it is possible that nursing infants could be exposed to pertuzumab. A risk to neonates cannot be excluded.

The effect of concurrent therapies must also be considered.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Alopecia
Anaemia
Anaphylactic reaction
Arthralgia
Asthenia
Chills
Congestive cardiac failure
Constipation
Cough
Cytokine release syndrome
Decreased appetite
Diarrhoea
Dizziness
Dry skin
Dysgeusia
Dyspepsia
Dyspnoea
Epistaxis
Fatigue
Febrile neutropenia
Headache
Hot flushes
Hypersensitivity reactions
Infusion-related symptoms
Insomnia
Interstitial lung disease
Lacrimation
Leucopenia
Mucositis
Myalgia
Nail disorders
Nasopharyngitis
Nausea
Neutropenia
Oedema
Pain
Paronychia
Peripheral neuropathy
Peripheral sensory neuropathy
Pleural effusion
Pruritus
Pyrexia
Rash
Stomatitis
Upper respiratory tract infection
Ventricular dysfunction
Vomiting

Presentation

Infusions containing pertuzumab.

Drugs List

Therapeutic Indications

Uses

Early, inflammatory or locally advanced HER2 +ve breast cancer
Metastatic or locally recurrent unresectable HER2 +ve breast cancer

Neoadjuvant treatment of HER2-positive locally advanced, inflammatory or early stage breast cancer at high risk of recurrence in combination with trastuzumab and chemotherapy.

Adjuvant treatment of HER2-positive early stage breast cancer at high risk of recurrence in combination with trastuzumab and chemotherapy.

Treatment of HER2-positive metastatic or locally recurrent unresectable breast cancer, in combination with trastuzumab and docetaxel, in patients who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Dosage

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

When using this agent, specialist literature, national guidelines, cancer networks protocols and Trust chemotherapy protocols should be consulted.

Adults

Additional Dosage Information

Administration

For intravenous infusion over 60 minutes.

If well tolerated subsequent infusions may be administered over 30 to 60 minutes.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

History of anthracycline therapy
History of thoracic radiotherapy
Left ventricular ejection fraction below 55%
Congestive cardiac failure
Hepatic impairment
Recent myocardial infarction
Serious cardiac arrhythmias
Severe renal impairment
Uncontrolled hypertension

Advise ability to drive/operate machinery may be affected by side effects
Anti-diarrhoeals may be required during treatment
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
Monitor patient for at least 1 hour after administration
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Staff: Not to be handled by pregnant staff
Suspend treatment or reduce rate until infusion reactions resolve
HER2 testing is mandatory prior to initiation of therapy
Monitor LVEF at baseline and periodically during treatment
Advise patient to report diarrhoea
Consider interrupting if severe diarrhoea that cannot be controlled
Discontinue if adult respiratory distress syndrome occurs
Discontinue if bronchospasm occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue or review if symptoms of congestive heart failure occur
Discontinue permanently if severe hypersensitivity reactions occur
Discontinue treatment and/or reduce dose if LVEF decreases
Female: Contraception required during and for 6 months after treatment
Advise patients on the risk of neutropenia and the significance of fever

Monitor patient closely if prior anthracycline exposure is greater than 360 mg/square metre of doxorubicin or its equivalent.

Left ventricular dysfunction
Early breast cancer
Patients should have a pretreatment left ventricular ejection fraction (LVEF) of greater than or equal to 55% (greater than or equal to 50% after completion of the anthracycline component, if given).
Neoadjuvant : Asses LVEF once during course.
Adjuvant: Asses LVEF every 12 weeks.

Metastatic breast cancer
Patients should have a pretreatment LVEF of greater then or equal to 50%
Asses LVEF every 12 weeks.

Pregnancy and Lactation

Pregnancy

Pertuzumab is contraindicated in pregnancy.

At the time of writing there is a limited amount of data on the use of pertuzumab in pregnant women. Animal studies have shown reproductive toxicity.

The effect of concurrent therapies must also be considered.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Pertuzumab is contraindicated in breastfeeding.

Human IgG is secreted in human milk therefore it is possible that nursing infants could be exposed to pertuzumab. A risk to neonates cannot be excluded.

The effect of concurrent therapies must also be considered.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Alopecia
Anaemia
Anaphylactic reaction
Arthralgia
Asthenia
Chills
Congestive cardiac failure
Constipation
Cough
Cytokine release syndrome
Decreased appetite
Diarrhoea
Dizziness
Dry skin
Dysgeusia
Dyspepsia
Dyspnoea
Epistaxis
Fatigue
Febrile neutropenia
Headache
Hot flushes
Hypersensitivity reactions
Infusion-related symptoms
Insomnia
Interstitial lung disease
Lacrimation
Leucopenia
Mucositis
Myalgia
Nail disorders
Nasopharyngitis
Nausea
Neutropenia
Oedema
Pain
Paronychia
Peripheral neuropathy
Peripheral sensory neuropathy
Pleural effusion
Pruritus
Pyrexia
Rash
Stomatitis
Upper respiratory tract infection
Ventricular dysfunction
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 2018

Reference Sources

Summary of Product Characteristics: Perjeta 420mg concentrate for solution for infusion. Roche Products Limited. Revised May 2018.