Tazverik Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Tazemetostat

Indications/Uses

Relapsed or refractory (R/R) follicular lymphoma (FL) in adults whose tumors are +ve for an EZH2 mutation & who have received at least 2 prior systemic therapies.

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Dosage/Direction for Use

800 mg bd.

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Administration

May be taken with or without food: Swallow whole. Do not cut/crush/chew.

Special Precautions

Select patients w/ R/R FL based on the presence of EZH2 mutation of codons Y646, A682, or A692 in tumor specimens. Increased risk of developing secondary malignancies. Avoid co-administration w/ strong or moderate CYP3A inhibitors or inducers. No dose adjustment is recommended for patients w/ mild hepatic impairment. Has not been studied in patients w/ moderate or severe hepatic impairment. Can cause fetal harm. Females of reproductive potential should use effective non-hormonal contraception during treatment & for 6 mth after the final dose. Males w/ female partners of reproductive potential should use effective contraception during treatment & for 3 mth after the final dose. Do not breastfeed during treatment & for 1 wk after the final dose. Safety & effectiveness in ped patients <16 yr have not been established.

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Use In Pregnancy & Lactation

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Adverse Reactions

Fatigue, URTI, musculoskeletal pain, nausea, abdominal pain.

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Drug Interactions

Increased plasma conc w/ strong or moderate CYP3A inhibitors. Decreased plasma conc w/ strong or moderate CYP3A inducers. Decreased conc & reduced efficacy of CYP3A substrates, including hormonal contraceptives.

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Storage

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Description

View Tazverik description for details of the chemical structure and excipients (inactive components).

Action

View Tazverik mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01XX72 - tazemetostat ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.

Regulatory Classification

P₁S₁S₃

Patient Counseling Information

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Presentation/Packing

Form

Tazverik FC tab 200 mg

Packing/Price

240's

Tazverik

tazemetostat

Manufacturer:

HUTCHMED

Distributor:

DCH Auriga - Healthcare