Tucatinib

What is Tucatinib?

• Tucatinib (Tukysa) is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer.

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.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

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.

• Dailymed label info on Tucatinib
• FDA Tucatinib

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