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VITRAKVI® (Larotrectinib) 20 mg/mL oral solution

VITRAKVI® (Larotrectinib) 25 mg / 100 mg hard capsules

Prescribing Information

(Refer to full Summary of Product Characteristics (SmPC) before prescribing)

 

Presentation: Oral solution: One bottle of 100 mL oral solution. Each mL of oral solution contains larotrectinib sulfate equivalent to 20 mg of larotrectinib. Hard capsules: Each hard capsule contains larotrectinib sulfate equivalent to 25 mg or 100 mg larotrectinib. Indication(s): Larotrectinib as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, - who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and - who have no satisfactory treatment options. VITRAKVI has been authorised under a conditional approval scheme. Posology & method of administration: The presence of an NTRK gene fusion in a tumour specimen should be confirmed by a validated test prior to initiation of treatment with larotrectinib. For oral use. VITRAKVI is available as a capsule or oral solution with equivalent oral bioavailability and may be used interchangeably. Do not take with grapefruit or grapefruit juice. Oral solution: The oral solution should be administered by mouth using an oral syringe of 1 mL or 5 mL volume or enterally by using a nasogastric feeding tube. Do not mix with feeding formulas. Hard capsules: The capsules should be swallowed whole. Adults: The recommended dose is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs. Children & adolescents: Dosing is based on body surface area (BSA). The recommended dose in paediatric patients is 100 mg/m2 larotrectinib twice daily with a maximum of 100 mg per dose until disease progression or until unacceptable toxicity occurs. Refer to SmPC for recommended dose modifications for adverse reactions. Hepatic impairment The starting dose of larotrectinib should be reduced by 50% in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment. No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A). Renal impairment No dose adjustment is required. Elderly No dose adjustment is recommended. Co-administration with strong CYP3A4 inhibitors Reduce larotrectinib dose by 50%, refer to SmPC. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Warnings & precautions: Larotrectinib should only be used if there are no treatment options for which clinical benefit has been established, or where such treatment options have been exhausted (i.e., no satisfactory treatment options). Neurologic reactions including dizziness, gait disturbance and paraesthesia were reported in patients receiving larotrectinib. Withholding, reducing, or discontinuing larotrectinib dosing should be considered, depending on the severity and persistence of these symptoms. ALT and AST increase have been

 

PP-VIT-GB-0427. February 2021

observed therefore liver function including ALT and AST assessments should be monitored before the first dose and monthly for the first 3 months of treatment, then periodically during treatment, with more frequent testing in patients who develop transaminase elevations. Withhold or permanently discontinue larotrectinib based on the severity. If withheld, the larotrectinib dose should be modified when resumed. Avoid co-administration of strong or moderate CYP3A4/ P-gp inducers with larotrectinib due to a risk of decreased exposure. Women of childbearing potential must use highly effective contraception while taking larotrectinib and for at least one month after stopping treatment. Males of reproductive potential with a non-pregnant woman partner of child bearing potential should be advised to use highly effective contraception during treatment with larotrectinib and for at least one month after the final dose. Oral solution: VITRAKVI 20 mg/mL oral solution contains excipients with known effects: sucrose, sorbitol, propylene glycol, parahydroxybenzoate. Essentially sodium free (<1 mmol/5 mL). Interactions: For the effects of other agents on the action of larotrectinib (e.g CYP3A, P-gp and BCRP inhibitors; and CYP3A and P-gp inducers) and the action of larotrectinib on other agents (CYP3A substrates, CYP2B6 substrates, other transporter substrates and PXR regulated enzymes) refer to SmPC. Unknown if larotrectinib interacts with hormonal contraceptives, advise to use additional barrier method and continue for 1 month after final dose. Pregnancy & lactation: Avoid the use of larotrectinib during pregnancy. Breast-feeding should be discontinued during treatment with larotrectinib and for 3 days following the final dose. Effects on ability to drive and use machines: Patients should be advised not to drive and use machines, until they are reasonably certain larotrectinib therapy does not affect them adversely. Undesirable effects: Very common: anaemia, neutrophil count decreased (neutropenia)*, leukocyte count decreased (leukopenia), dizziness, nausea, constipation, vomiting, myalgia, fatigue, alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood alkaline phosphatase increased, weight increased (abnormal weight gain). Common: gait disturbance, paraesthesia, dysgeusia, muscular weakness. Serious: cf. CI/W&P; in addition, the above undesirable effects may also be serious. *Grade 4 reactions were reported. Prescribers should consult the SmPC in relation to other side effects. Overdose: In the event of overdose, physicians should follow general supportive measures and treat symptomatically. Special Precautions for Storage: Oral solution: Store in a refrigerator (2 °C - 8 °C). Do not freeze. Hard capsules: None Legal Category: POM Package Quantities & Basic NHS Costs: Oral solution 100 mL glass bottle £5,000; Hard capsules one bottle of 56 x 25 mg hard capsules £3,500; one bottle of 56 x 100 mg hard capsules £14,000. MA Number(s): EU/1/19/1385/001-003 Further information available from: Bayer plc, 400 South Oak Way, Reading RG2 6AD, United Kingdom. Telephone: 0118 206 3000. Date of preparation: January 2021

 

VITRAKVI® is a trademark of the Bayer Group

VITRAKVI® (Larotrectinib) 20 mg/mL oral solution

VITRAKVI® (Larotrectinib) 25 mg / 100 mg hard capsules

Prescribing Information

(Refer to full Summary of Product Characteristics (SmPC) before prescribing)

 

Presentation: Oral solution: One bottle of 100 mL oral solution. Each mL of oral solution contains larotrectinib sulfate equivalent to 20 mg of larotrectinib. Hard capsules: Each hard capsule contains larotrectinib sulfate equivalent to 25 mg or 100 mg larotrectinib. Indication(s): Larotrectinib as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, - who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and - who have no satisfactory treatment options. VITRAKVI has been authorised under a conditional approval scheme. Posology & method of administration: The presence of an NTRK gene fusion in a tumour specimen should be confirmed by a validated test prior to initiation of treatment with larotrectinib. For oral use. VITRAKVI is available as a capsule or oral solution with equivalent oral bioavailability and may be used interchangeably. Do not take with grapefruit or grapefruit juice. Oral solution: The oral solution should be administered by mouth using an oral syringe of 1 mL or 5 mL volume or enterally by using a nasogastric feeding tube. Do not mix with feeding formulas. Hard capsules: The capsules should be swallowed whole. Adults: The recommended dose is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs. Children & adolescents: Dosing is based on body surface area (BSA). The recommended dose in paediatric patients is 100 mg/m2 larotrectinib twice daily with a maximum of 100 mg per dose until disease progression or until unacceptable toxicity occurs. Refer to SmPC for recommended dose modifications for adverse reactions. Hepatic impairment The starting dose of larotrectinib should be reduced by 50% in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment. No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A). Renal impairment No dose adjustment is required. Elderly No dose adjustment is recommended. Co-administration with strong CYP3A4 inhibitors Reduce larotrectinib dose by 50%, refer to SmPC. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Warnings & precautions: Larotrectinib should only be used if there are no treatment options for which clinical benefit has been established, or where such treatment options have been exhausted (i.e., no satisfactory treatment options). Neurologic reactions including dizziness, gait disturbance and paraesthesia were reported in patients receiving larotrectinib. Withholding, reducing, or discontinuing larotrectinib dosing should be considered, depending on the severity and persistence of these symptoms. ALT and AST increase have been observed therefore liver function including ALT and AST assessments should be monitored before the first dose and monthly for the first 3 months of treatment, then periodically during treatment, with more frequent testing in patients who develop transaminase elevations. Withhold or permanently discontinue larotrectinib based on the severity. If withheld, the larotrectinib dose should be modified when resumed. Avoid co-administration of strong or moderate CYP3A4/ P-gp inducers with larotrectinib due to a risk of decreased exposure. Women of childbearing potential must use highly effective contraception while taking larotrectinib and for at least one month after stopping treatment. Males of reproductive potential with a non-pregnant woman partner of child bearing potential should be advised to use highly effective contraception during treatment with larotrectinib and for at least one month after the final dose. Oral solution: VITRAKVI 20 mg/mL oral solution contains excipients with known effects: sucrose, sorbitol, propylene glycol, parahydroxybenzoate. Essentially sodium free (<1 mmol/5 mL). Interactions: For the effects of other agents on the action of larotrectinib (e.g CYP3A, P-gp and BCRP inhibitors; and CYP3A and P-gp inducers) and the action of larotrectinib on other agents (CYP3A substrates, CYP2B6 substrates, other transporter substrates and PXR regulated enzymes) refer to SmPC. Unknown if larotrectinib interacts with hormonal contraceptives, advise to use additional barrier method and continue for 1 month after final dose. Pregnancy & lactation: Avoid the use of larotrectinib during pregnancy. Breast-feeding should be discontinued during treatment with larotrectinib and for 3 days following the final dose. Effects on ability to drive and use machines: Patients should be advised not to drive and use machines, until they are reasonably certain larotrectinib therapy does not affect them adversely. Undesirable effects: Very common: anaemia, neutrophil count decreased (neutropenia)*, leukocyte count decreased (leukopenia), dizziness, nausea, constipation, vomiting, myalgia, fatigue, alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood alkaline phosphatase increased, weight increased (abnormal weight gain). Common: gait disturbance, paraesthesia, dysgeusia, muscular weakness. Serious: cf. CI/W&P; in addition, the above undesirable effects may also be serious. *Grade 4 reactions were reported. Prescribers should consult the SmPC in relation to other side effects. Overdose: In the event of overdose, physicians should follow general supportive measures and treat symptomatically. Special Precautions for Storage: Oral solution: Store in a refrigerator (2 °C - 8 °C). v001_0 Page 2 of 2 Do not freeze. Hard capsules: None Legal Category: POM Package Quantities & Basic NHS Costs: Oral solution 100 mL glass bottle £5,000; Hard capsules one bottle of 56 x 25 mg hard capsules £3,500; one bottle of 56 x 100 mg hard capsules £14,000. MA Number(s): EU/1/19/1385/001-003 Further information available from: Bayer plc, 400 South Oak Way, Reading RG2 6AD, United Kingdom. Telephone: 0118 206 3000. Date of preparation: PP-VIT-GB-0427, February 2021

 

VITRAKVI® is a trademark of the Bayer Group

Report Adverse Events
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to Bayer plc. Tel.: 0118 206 3500, Fax: 0118 206 3703, Email: pvuk@bayer.com