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Dosage and Administration: The recommended dose of TREZILENT is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food [see Pharmacology: Pharmacokinetics under Actions].
Continue treatment until disease progression or unacceptable toxicity occurs [see Dose Modifications for Adverse Reactions as follows].
Patients should take their dose of TREZILENT at approximately the same time each day.
Swallow TREZILENT tablets whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.
If a dose of TREZILENT is missed, it can be taken with food within 9 hours after the time it is usually taken. After more than 9 hours, skip the dose for that day. The next day, take TREZILENT at the usual time.
If the patient vomits after taking the dose, advise the patient not to take an additional dose on that day, and to resume the dosing schedule the next day at the usual time.
When given with TREZILENT, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter. Refer to the Full Prescribing Information for fulvestrant.
Dose Modifications for Adverse Reactions: The recommended dose modifications for adverse reactions (ARs) are listed in Table 2. (See Table 2.)
Click on icon to see table/diagram/imageTables 3, 4, 5, and 6 summarize recommendations for dose interruption, reduction, or discontinuation of TREZILENT in the management of specific adverse reactions.
Cutaneous Adverse Reactions: If a severe cutaneous adverse reaction (SCAR) is confirmed, permanently discontinue TREZILENT. Do not reintroduce TREZILENT in patients who have experienced previous SCAR during TREZILENT treatment [see Severe Cutaneous Adverse Reactions under Precautions]. (See Table 3.)
Click on icon to see table/diagram/imageHyperglycemia: Before initiating treatment with TREZILENT, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose.
Consider premedication with metformin prior to the initiation of TREZILENT in combination with fulvestrant based on patient risk factors for hyperglycemia, gastrointestinal tolerability, and clinical situation [see Hyperglycemia under Precautions and Clinical Trial Experience under Adverse Reactions].
After initiating treatment with TREZILENT, monitor fasting glucose (FPG or fasting blood glucose) at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated. Monitor HbA1c every 3 months and as clinically indicated. In patients with risk factors for hyperglycemia, monitor fasting glucose more closely and as clinically indicated [see Hyperglycemia under Precautions]. (See Table 4.)
Click on icon to see table/diagram/imageDiarrhea or Colitis: See Table 5.
Click on icon to see table/diagram/imageOther Toxicities: See Table 6.
Click on icon to see table/diagram/imageRefer to the Full Prescribing Information of fulvestrant for dose modification guidelines in the event of toxicity and for other relevant safety information.
Special populations: Renal impairment: Based on population pharmacokinetic analysis, no dose adjustment is necessary in patients with mild or moderate renal impairment. Caution should be used in patients with severe renal impairment as there is no experience with TREZILENT in this population.
Hepatic impairment: Based on a hepatic impairment study in non-cancer subjects with impaired hepatic function, no dose adjustment is necessary in patients with mild, moderate and severe hepatic impairment (Child-Pugh class A, B or C, respectively).
Refer to the product information of fulvestrant for dose modifications related to hepatic impairment.
Paediatric use: The safety and efficacy of TREZILENT in paediatric patients have not been established.
Use in the elderly: No dosage regimen adjustment is required in patients 65 years or above.
