Tucatinib

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What is Tucatinib?

Tucatinib.svg


What are the uses of this medicine?

This medicine is used with the medicines trastuzumab and capecitabine to treat adults with:

  • human epidermal growth factor receptor-2 (HER2) positive breast cancer that has spread to other parts of the body such as the brain (metastatic), or that cannot be removed by surgery, and
  • who have received one or more anti-HER2 breast cancer treatments.

How does this medicine work?

  • Tucatinib An orally bioavailable inhibitor of the human epidermal growth factor receptor tyrosine kinase ErbB-2 (also called HER2) with potential antineoplastic activity.
  • Tucatinib selectively binds to and inhibits the phosphorylation of ErbB-2, which may prevent the activation of ErbB-2 signal transduction pathways, resulting in growth inhibition and death of ErbB-2-expressing tumor cells.
  • ErbB-2 is overexpressed in a variety of cancers and plays an important role in cellular proliferation and differentiation.

Who Should Not Use this medicine ?

  • This medicine have no usage limitations.

What drug interactions can this medicine cause?

Avoid concomitant use with :

  • strong CYP3A inducers or moderate CYP2C8 inducers.
  • Strong CYP2C8 Inhibitors
  • CYP3A Substrates
  • P-gp Substrates

Is this medicine FDA approved?

  • It was approved for use in the United States in 2020.

How should this medicine be used?

Recommended Dosage

  • The recommended dosage of TUKYSA is 300 mg taken orally twice daily in combination with trastuzumab and capecitabine until disease progression or unacceptable toxicity.
  • For patients with severe hepatic impairment, the recommended dosage is 200 mg orally twice daily.

Administration

  • Take TUKYSA exactly as your healthcare provider tells you.
  • TUKYSA is used with the medicines trastuzumab and capecitabine. Your healthcare provider will tell you the dose of trastuzumab and capecitabine you will take and how you will receive them.
  • Take TUKYSA 2 times a day, with or without a meal.
  • Take TUKYSA about 12 hours apart or at the same times every day.
  • Swallow TUKYSA tablets whole. Do not chew, crush, or split TUKYSA tablets before swallowing. Do not take TUKYSA tablets if they are broken, cracked, or damaged.
  • If you vomit or miss a dose of TUKYSA, take your next dose at your regular time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

  • As Tablets: 50 mg and 150 mg

This medicine is available in fallowing brand namesː

  • TUKYSA

What side effects can this medication cause?

Common possible side effects and laboratory abnormalities of this medicine include:

  • diarrhea
  • rash, redness, pain, swelling or blisters on the palms of your hands or soles of your feet
  • nausea
  • tiredness
  • increased liver function blood tests
  • vomiting
  • mouth sores (stomatitis)
  • decreased appetite
  • stomach-area (abdomen) pain
  • headache
  • low red blood cell counts (anemia)
  • rash

TUKYSA may cause serious side effects, including:

  • Diarrhea: Diarrhea is common with TUKYSA and can sometimes be severe.
  • Liver Problems: TUKYSA can cause severe liver problems.

What special precautions should I follow?

  • Severe diarrhea, including dehydration, acute kidney injury, and death, has been reported. Administer antidiarrheal treatment as clinically indicated. Interrupt dose, then dose reduce, or permanently discontinue TUKYSA based on severity.
  • Severe hepatotoxicity has been reported on TUKYSA. Monitor ALT, AST and bilirubin prior to starting TUKYSA, every 3 weeks during treatment and as clinically indicated. Interrupt dose, then dose reduce, or permanently discontinue TUKYSA based on severity.
  • TUKYSA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

  • In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

Can this medicine be used in pregnancy?

  • TUKYSA can cause fetal harm when administered to a pregnant woman.
  • There are no available human data on TUKYSA use in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

  • The safety and effectiveness of TUKYSA in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

  • Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) .
  • Dispense to patient in original container only. Store in original container to protect from moisture.
  • Replace cap securely each time after opening. Do not discard desiccant.
  • Once opened, use within 3 months.
  • Discard any unused tablets 3 months after opening the bottle.

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