Talazoparib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of talazoparib.
Drugs List
Therapeutic Indications
Uses
BRCA mutated HER2 -ve locally advanced or metastatic breast cancer
Monotherapy treatment of adults with germline BRCA 1/2 mutations, who have HER2- negative locally advanced or metastatic breast cancer.
Dosage
Adults
1mg once daily.
Patients with Renal Impairment
Moderate renal impairment
Starting dose: 750micrograms once daily.
Severe renal impairment
Starting dose: 500micrograms once daily.
Additional Dosage Information
Missed doses
If a dose is missed no additional doses should be taken. The next prescribed dose should be taken at the usual time.
Dose modification First dose reduction: 750micrograms once daily Second dose modification: 500micrograms once daily Third dose modification: 250micrograms once daily
Adverse drug reactions requiring dose modification
Haemoglobin less than 8g/dL: Withhold treatment until levels resolve to greater than or equal to 9g/dL, then resume treatment at next lower dose. Platelet count less than 50 x 10 to the power of 9/L: Withhold treatment until levels resolve to greater than or equal to 75 x 10 to the power of 9/L, then resume treatment at next lower dose. Neutrophil count less than 1 x 10 to the power 9/L: Withhold treatment until levels resolve to greater than or equal to 1.5 x 10 to the power of 9/L, then resume treatment at next lower dose. Non-haematological adverse reaction grade 3 or 4: Withhold treatment until levels resolve to less than or equal to grade 1, then consider resuming treatment at next lower dose or discontinue treatment.
Dose modification with concomitant interacting drugs
If co-administration of a potent P-glycoprotein inhibitor is unavoidable, the talazoparib dose should be reduced to the next lower dose.
Contraindications
Children under 18 years
Breastfeeding
Haemodialysis
Pregnancy
Precautions and Warnings
History of radiotherapy
Moderate renal impairment
Reduce dose in patients with moderate renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Confirm BRCA1 or BRCA2 mutation status prior to treatment
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Exclude pregnancy prior to initiation of treatment
Perform blood counts before and at monthly intervals during treatment
Monitor haematological parameters regularly throughout treatment
Monitor hepatic function in patients with hepatic impairment
Discontinue if leukaemia occurs
Discontinue if myelodysplastic syndrome occurs
Interrupt if haemoglobin falls below 8 g/dL
Suspend therapy &/or reduce dose if neutrophil count <1 x 10 to power 9/L
Suspend therapy &/or reduce dose if platelets below 50 x 10 to power 9/L
Suspend treatment and/or reduce dose in grade 3 non-haematological toxicity
Advise patient not to take St John's wort concurrently
Male: May cause infertility
Female: Contraception required during and for 7 months after treatment
Female: Non-hormonal contraception required during and after treatment
Female: Two reliable methods of contraception should be used simultaneously
Male: Contraception required during and for 4 months after treatment
Breastfeeding: Do not breastfeed during & for 1 month after treatment
Pregnancy and Lactation
Pregnancy
Talazoparib is contraindicated during pregnancy.
The manufacturer states that talazoparib is not recommended during pregnancy. Animal studies have shown embryo-foetal toxicities. At the time of writing there is limited data of use of talazoparib in pregnant women. The potential risks are unknown.
Lactation
Talazoparib is contraindicated during breastfeeding.
The manufacturer states that breastfeeding is not recommended during talazoparib treatment and for at least one month following the last dose. It is not known whether talazoparib is excreted in human milk and therefore a risk to the breastfeeding infant cannot be excluded.
Side Effects
Abdominal pain
Alopecia
Anaemia
Decreased appetite
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Fatigue
Headache
Leucopenia
Lymphopenia
Nausea
Neutropenia
Stomatitis
Thrombocytopenia
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: January 2023
Reference Sources
Summary of Product Characteristics: Talzenna 0.25mg hard capsules. Pfizer Ltd. Revised March 2023.
Summary of Product Characteristics: Talzenna 1mg hard capsules. Pfizer Ltd. Revised March 2023.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 January 2023
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.