ROZLYTREK (roz lye' trek) (Entrectinib)

ROZLYTREK
(roz lye' trek)
(Entrectinib)

Chemotherapy

ROZLYTREK
(roz lye' trek)
(Entrectinib)

Chemotherapy

What is ROZLYTREK (Entrectinib)?

ROZLYTREK is a prescription medicine used to treat:

It is not known if ROZLYTREK is safe and effective for use in children less than 12 years of age.

What is the most important information I should know about ROZLYTREK?

ROZLYTREK can cause serious side effects. These serious side effects include:

Central nervous system (CNS) effects. ROZLYTREK may cause dizziness, changes in your mood, or may affect how you think and cause confusion, hallucinations, and problems with concentration, attention, memory, and sleep. Tell your healthcare provider right away if you have any of these symptoms.
Bone fractures. ROZLYTREK may increase your risk for bone fractures. Bone fractures may happen with or without a fall or other injury. Tell your healthcare provider if you have pain, changes in movement, or bone abnormalities.
Liver problems (hepatotoxicity). Your healthcare provider will do blood tests to check your liver function during treatment with ROZLYTREK. Tell your healthcare provider right away if you develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop ROZLYTREK if you develop liver problems with ROZLYTREK.
Increased uric acid level in your blood (hyperuricemia). ROZLYTREK may cause an excess of uric acid in your blood. Your healthcare provider may do tests before and during your treatment with ROZLYTREK to check the uric acid level in your blood. Your healthcare provider may prescribe medications if you have high blood uric acid levels.
Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will do tests before and during your treatment with ROZLYTREK to check the electrical activity of your heart and your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during your treatment with ROZLYTREK. These may be symptoms related to QT prolongation.
Vision problems. ROZLYTREK may cause vision problems. Your healthcare provider may stop ROZLYTREK and refer you to an eye specialist if you develop severe vision problems during treatment with ROZLYTREK. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:

How should I take ROZLYTREK?

Take ROZLYTREK exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking ROZLYTREK unless your healthcare provider tells you to.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ROZLYTREK if you develop side effects.
Take ROZLYTREK 1 time each day with or without food.
Swallow whole ROZLYTREK capsules. Do not open, crush, chew or dissolve the capsule contents.
If you miss a dose of ROZLYTREK, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take your next dose at your regular time.
If you vomit right after taking a dose of ROZLYTREK, you may take the dose again.

Important Safety Information

You should not drink grapefruit juice or eat grapefruit during your treatment with ROZLYTREK. It may increase the amount of entrectinib in your blood to a harmful level.
Do not drive or operate heavy machinery until you know how ROZLYTREK affects you. If you experience dizziness, fainting, tiredness, blurred vision, memory loss, changes in mental status, confusion, or hallucinations, do not drive or operate heavy machines until your symptoms resolve.
If you miss a dose of ROZLYTREK, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take your next dose at your regular time.
Females who are able to become pregnant should use effective birth control during treatment with ROZLYTREK and for at least 5 weeks after the final dose.
Males who have female partners that are able to become pregnant should use effective birth control during treatment with ROZLYTREK and for 3 months after the final dose.
It is not known if ROZLYTREK passes into your breast milk. Do not breastfeed during treatment with ROZLYTREK and for 7 days after the final dose of ROZLYTREK.

Ask your healthcare provider if you do not know.

What should I tell my healthcare provider before taking ROZLYTREK?

Tell your healthcare provider about all your medical conditions, including if you:

Have liver or kidney problems
Have any heart problems, including a condition called long QT syndrome
Have nervous system (neurological) problems
Have or have had eye or vision problems
Are pregnant or plan to become pregnant. ROZLYTREK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with ROZLYTREK or think you may be pregnant.
If you are able to become pregnant, your healthcare provider will do a pregnancy test before you start treatment with ROZLYTREK.
Females who are able to become pregnant should use effective birth control during treatment with ROZLYTREK and for at least 5 weeks after the final dose.
Males who have female partners that are able to become pregnant should use effective birth control during treatment with ROZLYTREK and for 3 months after the final dose.
Are breastfeeding or plan to breastfeed. It is not known if ROZLYTREK passes into your breast milk. Do not breastfeed during treatment with ROZLYTREK and for 7 days after the final dose of ROZLYTREK. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

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General information about ROZLYTREK

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ROZLYTREK for a condition for which it was not prescribed. Do not give ROZLYTREK to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in ROZLYTREK?

Active ingredient: Entrectinib

Other ingredient: Tartaric acid, lactose anhydrous, hypromellose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. Yellow opaque capsule shell contains: hypromellose, titanium dioxide, and yellow iron oxide. Orange opaque capsule shell contains: hypromellose, titanium dioxide, and FD&C Yellow No. 6. Printing ink contains: shellac, propylene glycol, strong ammonia solution, and FD&C Blue No. 2 aluminum lake.

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