Pertuzumab and trastuzumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of pertuzumab and trastuzumab.
Drugs List
Therapeutic Indications
Uses
Early, inflammatory or locally advanced HER2 +ve breast cancer
Metastatic or locally recurrent unresectable HER2 +ve breast cancer
In combination with chemotherapy for the neoadjuvant treatment of adult patients with HER2 positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
In combination with chemotherapy for the adjuvant treatment of adult patients with HER2 positive early breast cancer at high risk of recurrence.
In combination with docetaxel for the treatment of adult patients with HER2 positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Dosage
Adults
Loading dose: 1200mg pertuzumab and 600mg trastuzumab.
Maintenance dose (every 3 weeks): 600mg pertuzumab and 600mg trastuzumab.
Metastatic breast cancer
Pertuzumab and trastuzumab should be administered in combination with docetaxel. Treatment with pertuzumab and trastuzumab may be continued until disease progression or unmanageable toxicity even if treatment with docetaxel is discontinued.
Early breast cancer
In the neoadjuvant setting, pertuzumab and trastuzumab should be administered for 3 to 6 cycles in combination with chemotherapy, as part of a complete treatment regimen for early breast cancer.
In the adjuvant setting, pertuzumab and trastuzumab should be administered for a total of one year (up to 18 cycles or until disease recurrence or unmanageable toxicity) as part of a complete regimen for early breast cancer and regardless of the timing of surgery. Treatment should include standard anthracycline and/or taxane based chemotherapy. Pertuzumab and trastuzumab should start on day 1 of the first taxane containing cycle and should continue even if chemotherapy is discontinued.
Additional Dosage Information
In patients receiving a taxane, pertuzumab and trastuzumab should be administered prior to the taxane.
In patients receiving an anthracycline based regimen, pertuzumab and trastuzumab should be administered following completion of the entire anthracycline regimen.
Delayed or missed doses
If the time between two injections is less than 6 weeks, the maintenance dose of 600mg pertuzumab and 600mg trastuzumab should be administered as soon as possible. Thereafter, the 3-weekly schedule should be continued.
If the time between two injections is 6 weeks or more, a loading dose of 1200mg pertuzumab and 600mg trastuzumab should be re-administered followed by maintenance dose of 600mg pertuzumab and 600mg trastuzumab every 3 weeks thereafter.
Left ventricular dysfunction
Pertuzumab and trastuzumab treatment should be suspended for at least 3 weeks for any signs and symptoms suggestive of congestive heart failure. If symptomatic heart failure is confirmed pertuzumab and trastuzumab should be discontinued.
If the LVEF has not improved after repeat assessment within approximately 3 weeks, or has declined further, discontinuation of pertuzumab and trastuzumab should be strongly considered.
Metastatic breast cancer
Pertuzumab and trastuzumab should be withheld for at least 3 weeks if:
A drop in LVEF to less than 40% or LVEF of 40% to 45% associated with a fall of 10% (or more) points below pre-treatment values. Treatment may be resumed if the LVEF has recovered to greater than 45% or 40% to 45% associated with less than 10% points below pre-treatment value.
Early breast cancer
Pertuzumab and trastuzumab should be withheld for at least 3 weeks if:
A drop in LVEF to less than 50% associated with a fall of 10% (or more) points below pre-treatment values. Treatment may be resumed if the LVEF has recovered to equal to or greater than 50% or to a difference of less than 10% points below pre-treatment values.
Administration
For subcutaneous injection only.
Injection duration should be 8 minutes for the loading dose, maintenance dose should have an injection duration of 5 minutes.
The injection site should be alternated between the right and left thigh only.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Severe dyspnoea at rest secondary to advanced malignancy
Precautions and Warnings
History of anthracycline therapy
History of thoracic radiotherapy
Left ventricular ejection fraction below 55%
Patients over 75 years
Hepatic impairment
History of congestive cardiac failure
History of severe cardiac disorder
Interstitial lung disease
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
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Staff: Not to be handled by pregnant staff
HER2 testing is mandatory prior to initiation of therapy
Monitor LVEF at baseline and periodically during treatment
Advise patient to report any symptoms of interstitial lung disease
Advise patient to report diarrhoea
Consider interrupting if severe diarrhoea that cannot be controlled
Monitor for hypersensitivity reactions for 30 minutes after administration
Advise patient to seek advice at first indications of pregnancy
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 7 months after treatment
Breastfeeding: Do not breastfeed during & for 7 months after treatment
Advise patient to seek medical advice if adverse reactions occur
Advise patients on the risk of neutropenia and the significance of fever
Left ventricular dysfunction
Metastatic breast cancer
Patients should have a pre-treatment left ventricular ejection fraction (LVEF) of greater than or equal to 50%.
Assess LVEF prior to initiation of pertuzumab and trastuzumab and once every 12 weeks during course of treatment.
Early breast cancer
Patients should have a pre-treatment LVEF of greater than or equal to 55% (or greater than or equal to 50% after the completion of the anthracycline component of chemotherapy, if given).
Assess LVEF prior to initiation of pertuzumab and trastuzumab and once during course in neoadjuvant treatment.
Assess LVEF prior to initiation of pertuzumab and trastuzumab and once every 12 weeks during course in adjuvant treatment.
Pregnancy and Lactation
Pregnancy
Pertuzumab and trastuzumab is contraindicated during pregnancy.
The manufacturer recommends that pertuzumab and trastuzumab should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. 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 with pertuzumab. There are post-marketing cases of reproductive toxicity in women receiving trastuzumab treatment. Animal studies have not been able to determine whether trastuzumab can affect reproductive capacity. The effect of concurrent therapies must also be considered.
Lactation
Pertuzumab and trastuzumab is contraindicated during breastfeeding.
The manufacturer recommends that women should not breastfeed during pertuzumab and trastuzumab therapy and for at least 7 months after the last dose. Human IgG is secreted in human milk therefore it is possible that nursing infants could be exposed to pertuzumab and trastuzumab. A risk to neonates cannot be excluded.
The effect of concurrent therapies must also be considered.
Side Effects
Abdominal pain
Alopecia
Anaemia
Anaphylactic reaction
Arthralgia
Asthenia
Cardiac failure
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
Hypomagnesaemia
Increased lacrimation
Infusion related reaction
Injection site reactions
Insomnia
Interstitial lung disease
Left ventricular dysfunction
Leucopenia
Mucosal inflammation
Myalgia
Nail disorders
Nasopharyngitis
Nausea
Neutropenia
Neutropenic sepsis
Oedema
Pain
Painful extremities
Paraesthesia
Paronychia
Peripheral neuropathy
Peripheral oedema
Peripheral sensory neuropathy
Pleural effusion
Pneumonia
Pruritus
Pyrexia
Rash
Stomatitis
Tumour lysis syndrome
Upper respiratory tract infection
Vomiting
Weight loss
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: Phesgo 1200 mg/600 mg solution for injection. Roche Products Limited. Revised December 2020.
Summary of Product Characteristics: Phesgo 600 mg/600 mg solution for injection. Roche Products Limited. Revised December 2020.
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