Lynparza Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Lynparza Indications
Indications
Lynparza Dosage and Administration
Adult
Children
Lynparza Contraindications
Not Applicable
Lynparza Boxed Warnings
Not Applicable
Lynparza Warnings/Precautions
Warnings/Precautions
Do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). Monitor CBC for cytopenia at baseline and monthly thereafter during therapy or weekly until recovery (for prolonged hematological toxicities). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Interrupt therapy and evaluate if new or worsening respiratory symptoms occur; discontinue and treat if pneumonitis is confirmed. Monitor for venous thrombosis, pulmonary embolism; treat appropriately. Mild renal impairment: monitor closely. Severe hepatic or severe renal impairment or ESRD (CrCl ≤30mL/min): not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
Lynparza Pharmacokinetics
Absorption
-
Median time to peak plasma concentration: 1.5 hours.
Distribution
-
Mean apparent volume of distribution: 158 ± 136 L.
-
~82% protein bound in vitro.
Elimination
- Renal (44%), fecal (42%). Half-life: 14.9 ± 8.2 hours.
Lynparza Interactions
Interactions
Lynparza Adverse Reactions
Adverse Reactions
Nausea, fatigue, asthenia, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, dyspnea, dizziness, dyspepsia, leukopenia, thrombocytopenia, upper abdominal pain. In combination with bevacizumab or abiraterone and prednisone or prednisolone: also lymphopenia, UTI.
Lynparza Clinical Trials
See Literature
Lynparza Note
Not Applicable
Lynparza Patient Counseling
See Literature
Lynparza Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Lynparza Indications
Indications
Lynparza Dosage and Administration
Adult
Children
Lynparza Contraindications
Not Applicable
Lynparza Boxed Warnings
Not Applicable
Lynparza Warnings/Precautions
Warnings/Precautions
Do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). Monitor CBC for cytopenia at baseline and monthly thereafter during therapy or weekly until recovery (for prolonged hematological toxicities). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Interrupt therapy and evaluate if new or worsening respiratory symptoms occur; discontinue and treat if pneumonitis is confirmed. Monitor for venous thrombosis, pulmonary embolism; treat appropriately. Mild renal impairment: monitor closely. Severe hepatic or severe renal impairment or ESRD (CrCl ≤30mL/min): not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
Lynparza Pharmacokinetics
Absorption
-
Median time to peak plasma concentration: 1.5 hours.
Distribution
-
Mean apparent volume of distribution: 158 ± 136 L.
-
~82% protein bound in vitro.
Elimination
- Renal (44%), fecal (42%). Half-life: 14.9 ± 8.2 hours.
Lynparza Interactions
Interactions
Lynparza Adverse Reactions
Adverse Reactions
Nausea, fatigue, asthenia, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, dyspnea, dizziness, dyspepsia, leukopenia, thrombocytopenia, upper abdominal pain. In combination with bevacizumab or abiraterone and prednisone or prednisolone: also lymphopenia, UTI.
Lynparza Clinical Trials
See Literature
Lynparza Note
Not Applicable
Lynparza Patient Counseling
See Literature
Lynparza Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Lynparza Indications
Indications
Lynparza Dosage and Administration
Adult
Children
Lynparza Contraindications
Not Applicable
Lynparza Boxed Warnings
Not Applicable
Lynparza Warnings/Precautions
Warnings/Precautions
Do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). Monitor CBC for cytopenia at baseline and monthly thereafter during therapy or weekly until recovery (for prolonged hematological toxicities). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Interrupt therapy and evaluate if new or worsening respiratory symptoms occur; discontinue and treat if pneumonitis is confirmed. Monitor for venous thrombosis, pulmonary embolism; treat appropriately. Mild renal impairment: monitor closely. Severe hepatic or severe renal impairment or ESRD (CrCl ≤30mL/min): not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
Lynparza Pharmacokinetics
Absorption
-
Median time to peak plasma concentration: 1.5 hours.
Distribution
-
Mean apparent volume of distribution: 158 ± 136 L.
-
~82% protein bound in vitro.
Elimination
- Renal (44%), fecal (42%). Half-life: 14.9 ± 8.2 hours.
Lynparza Interactions
Interactions
Lynparza Adverse Reactions
Adverse Reactions
Nausea, fatigue, asthenia, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, dyspnea, dizziness, dyspepsia, leukopenia, thrombocytopenia, upper abdominal pain. In combination with bevacizumab or abiraterone and prednisone or prednisolone: also lymphopenia, UTI.
Lynparza Clinical Trials
See Literature
Lynparza Note
Not Applicable
Lynparza Patient Counseling
See Literature
Lynparza Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Lynparza Indications
Indications
Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated (as detected by an FDA-approved test) metastatic castration-resistant prostate cancer in adults who have progressed following prior treatment with enzalutamide or abiraterone. In combination with abiraterone and prednisone or prednisolone for the treatment of deleterious or suspected deleterious BRCA-mutated (BRCAm) (as detected by an FDA-approved test) mCRPC in adults.
Lynparza Dosage and Administration
Adult
Swallow whole. 300mg twice daily. Continue until disease progression or unacceptable toxicity. Should also give a GnRH analog concurrently or should have had bilateral orchiectomy. For BRCAm mCRPC: give abiraterone 1000mg once daily with prednisone or prednisolone 5mg twice daily. Dose adjustments for adverse reactions: reduce to 250mg twice daily; may further reduce to 200mg twice daily. Concomitant strong or moderate CYP3A inhibitors (if unavoidable): reduce olaparib dose to 100mg twice daily (with strong inhibitors) or 150mg twice daily (with moderate inhibitors). Moderate renal impairment (CrCl 31–50mL/min): reduce to 200mg twice daily.
Children
Lynparza Contraindications
Not Applicable
Lynparza Boxed Warnings
Not Applicable
Lynparza Warnings/Precautions
Warnings/Precautions
Do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). Monitor CBC for cytopenia at baseline and monthly thereafter during therapy or weekly until recovery (for prolonged hematological toxicities). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Interrupt therapy and evaluate if new or worsening respiratory symptoms occur; discontinue and treat if pneumonitis is confirmed. Monitor for venous thrombosis, pulmonary embolism; treat appropriately. Mild renal impairment: monitor closely. Severe hepatic or severe renal impairment or ESRD (CrCl ≤30mL/min): not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
Lynparza Pharmacokinetics
Absorption
-
Median time to peak plasma concentration: 1.5 hours.
Distribution
-
Mean apparent volume of distribution: 158 ± 136 L.
-
~82% protein bound in vitro.
Elimination
- Renal (44%), fecal (42%). Half-life: 14.9 ± 8.2 hours.
Lynparza Interactions
Interactions
Lynparza Adverse Reactions
Adverse Reactions
Nausea, fatigue, asthenia, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, dyspnea, dizziness, dyspepsia, leukopenia, thrombocytopenia, upper abdominal pain. In combination with bevacizumab or abiraterone and prednisone or prednisolone: also lymphopenia, UTI.
Lynparza Clinical Trials
See Literature
Lynparza Note
Not Applicable
Lynparza Patient Counseling
See Literature