seizure, lethargy, confusion, altered mental function, blindness, and
other visual or neurological disturbances, with or without associated
hypertension. A diagnosis of PRES requires confirmation by brain imaging,
preferably magnetic resonance imaging $(MRI.AU)$. In patients developing PRES,
discontinuation of FRUZAQLA, along with control of hypertension and
supportive medical management of other symptoms, are recommended.
-- Impaired wound healing: Impaired wound healing has been reported in 1
patient (0.1%) treated with FRUZAQLA in clinical studies. Patients are
recommended to withhold FRUZAQLA for at least 2 weeks prior to surgery.
FRUZAQLA should not be resumed for at least 2 weeks after surgery, as
clinically indicated when there is evidence of adequate wound healing.
-- Arterial and venous thromboembolic events: It is recommended to avoid
starting treatment with FRUZAQLA in patients with a history of
thromboembolic events (including deep vein thrombosis and pulmonary
embolism) within the past 6 months or if they have a history of stroke
and/or transient ischemic attack within the last 12 months. If arterial
thrombosis is suspected, FRUZAQLA should be discontinued immediately.
INTERACTIONS
Effects of other medicinal products on the pharmacokinetics of FRUZAQLA
CYP3A inducers
Co-administration of FRUZAQLA with rifampicin (a strong CYP3A inducer) 600 mg once daily decreased FRUZAQLA AUC(inf) by 65% and decreased C(max) by 12%. The concomitant use of FRUZAQLA with strong and moderate CYP3A inducers should be avoided.
CYP3A inhibitors
Co-administration of FRUZAQLA with itraconazole (a strong CYP3A inhibitor) 200 mg twice daily did not result in clinically meaningful changes in the area under the concentration-time curve $(AUC.AU)$ and C(max) of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with CYP3A inhibitors.
Gastric acid lowering agents
Co-administration of FRUZAQLA with rabeprazole (a proton pump inhibitor) 40 mg once daily did not result in clinically meaningful changes in the AUC of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with gastric acid lowering agents.
Effect of FRUZAQLA on the pharmacokinetics of other medicinal products
Medicinal products that are substrates of P-glycoprotein (P-gp)
Co-administration of a single dose of dabigatran etexilate 150 mg (a P-gp substrate) with a single dose of FRUZAQLA 5 mg decreased AUC of dabigatran by 9%. No dose adjustment is recommended for P-gp substrates during concomitant use with FRUZAQLA.
Medicinal products that are substrates of breast cancer resistance protein (BCRP)
Co-administration of a single 10 mg dose of rosuvastatin (a BCRP substrate) with a single 5 mg dose of FRUZAQLA decreased AUC of rosuvastatin by 19%. No dose adjustment is recommended for BCRP substrates during concomitant use with FRUZAQLA.
UNDESIRABLE EFFECTS: The most commonly reported adverse reactions with FRUZAQLA are:
Very common Thrombocytopenia, hypothyroidism, anorexia, hypertension,
(frequency >=1/10) dysphonia, diarrhoea, stomatitis, aspartate
aminotransferase increased, total bilirubin increased,
alanine aminotransferase increased, palmar-plantar
erythrodysesthesia syndrome, musculoskeletal discomfort,
arthralgia, proteinuria, asthenia, and fatigue
------------------- ---------------------------------------------------------
Common Pneumonia, upper respiratory tract infection, bacterial
(>=1/100 to <1/10) infections, leukopenia, neutropenia, hypokalemia,
epistaxis, throat pain, gastrointestinal hemorrhage,
gastrointestinal perforation, pancreatic enzymes
increased, oral pain, rash, and mucosal inflammation
------------------- ---------------------------------------------------------
For US Prescribing Information:
https://www.fruzaqla.com/sites/default/files/resources/fruzaqla-prescribing-information.pdf
For Japan Prescribing Information:
https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/400256_42910H0M1028_1_01
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED's current expectations regarding future events, including but not limited to, its expectations regarding the receipt of the milestone payment, the therapeutic potential of fruquintinib for the treatment of such patients with CRC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support approval of fruquintinib for the treatment of patients with CRC or other indications in other jurisdictions such as Japan, its potential to gain approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED and/or Takeda's ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, each party's ability to satisfy the terms and conditions under the license agreement; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway for fruquintinib; and Takeda's ability to successfully develop and commercialize fruquintinib. In addition, as certain studies rely on the use of other drug products as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
CONTACTS
Investor Enquiries +852 2121 8200 / ir@hutch-med.com
Media Enquiries
+44 20 3727 1030 / +44 7771 913 902
(Mobile) / +44 7779 545 055 (Mobile)
Ben Atwell / Alex Shaw, FTI Consulting / HUTCHMED@fticonsulting.com
+852 9783 6894 (Mobile) /
Zhou Yi, Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley /
Rupert Dearden, Panmure Liberum +44 (20) 7886 2500
__________________________
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(END) Dow Jones Newswires
October 31, 2024 04:30 ET (08:30 GMT)
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