As a part of a continuous regimen containing trastuzumab + capecitabine

TUKYSA IS AN ORAL MEDICATION TAKEN TWICE EVERY DAY1

Dosing of the TUKYSA regimen should continue until disease progression or unacceptable toxicity1

Dosing of the TUKYSA regimen should continue until disease
progression or unacceptable toxicity1

TUKYSA regimen recommended dosing TUKYSA regimen recommended dosing

Select Safety Information

Drug Interactions

  • Strong CYP3A/Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
  • Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
  • CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
  • P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.
Please click here for Important Safety Information.

Additional dosing and administration information1

  • For patients with severe hepatic impairment (Child-Pugh C), the recommended starting dose is 200 mg orally twice daily
  • Avoid coadministration with strong CYP2C8 inhibitors during treatment with TUKYSA; if coadministration with a strong CYP2C8 inhibitor cannot be avoided, reduce the starting TUKYSA dose to 100 mg orally twice daily
  • TUKYSA tablets should be swallowed whole; they should not be chewed, crushed, or split prior to swallowing
  • If the patient vomits or misses a dose of TUKYSA, the next dose should be taken at the regularly scheduled time
  • Please refer to the full Prescribing Information to learn how to modify the dose for select adverse reactions associated with TUKYSA

Monitor ALT, AST, and bilirubin every 3 weeks, or as clinically indicated.

ALT = alanine aminotransferase; AST = aspartate aminotransferase.

Trastuzumab and capecitabine dosing can be modified in accordance with the respective Prescribing Information for each agent1

Seagen is here to help your patients access TUKYSA

TUKYSA prescriptions are filled through specialty pharmacies in the TUKYSA network or through dispensing physician practices and hospital pharmacies that can purchase the product though their specialty distributors.

SPECIALTY PHARMACIES
  • Biologics
  • Onco360
IN-OFFICE DISPENSERS
(Medically integrated
dispensaries)
IDN SPECIALTY PHARMACIES
AND HOSPITAL PHARMACIES

Physician practices can obtain TUKYSA from one of the following specialty distributors

ASD HEALTHCARE
CALL 800-746-6273 | FAX 800-547-9413
VISIT asdhealthcare.com
CARDINAL HEALTH SPECIALTY DISTRIBUTION
CALL 855-740-1871 | FAX 888-345-4916
VISIT cardinalhealth.com
MCKESSON PLASMA AND BIOLOGICS, LLC
CALL 877-625-2566 | FAX 888-752-7626
VISIT mckesson.com
MCKESSON SPECIALTY HEALTH
CALL 800-482-6700 | FAX 800-800-5673
VISIT mckessonspecialtyhealth.com
ONCOLOGY SUPPLY
CALL 800-633-7555 | FAX 800-248-8205
VISIT oncologysupply.com

These Specialty Pharmacies are authorized to dispense TUKYSA

CALL 800-850-4306
FAX 800-823-4506
VISIT biologics.mckesson.com
CALL 877-662-6633
FAX 877-662-6355
VISIT onco360.com

Important Safety Information

Warnings and Precautions

  • Diarrhea: TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 and 0.5% with Grade 4. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. Median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to TUKYSA dose reductions in 6% of patients and TUKYSA discontinuation in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.

    If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
  • Hepatotoxicity: TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to TUKYSA dose reductions in 8% of patients and TUKYSA discontinuation in 1.5% of patients.

    Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
  • Embryo-Fetal Toxicity: TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA; those occurring in ≥2% of patients were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were decreased phosphate, increased ALT, decreased potassium, and increased AST.

The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

  • Strong CYP3A/Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
  • Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
  • CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
  • P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.

Use in Specific Populations

  • Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
  • Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
  • Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.

Indication

TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

Please see full Prescribing Information.

Reference

  • 1. TUKYSA [Prescribing Information]. Bothell, WA: Seattle Genetics, Inc. April 2020.