Patient information: uses, side effects, how to take - Ibtrozi

What is IBTROZI?

IBTROZI is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread within your chest or to other parts of the body and is caused by an abnormal ROS1 gene.

It is not known if IBTROZI is safe and effective in children.

Before taking IBTROZI tell your healthcare provider about all of your medical conditions, including if you:

have liver problems.
have lung or breathing problems other than lung cancer.
have any heart problems, including a condition called long QT syndrome.
have gout.
are pregnant or plan to become pregnant. IBTROZI can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with IBTROZI.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with IBTROZI.
- You should use effective birth control (contraception) during treatment and for 3 weeks after the last dose of IBTROZI.
- Talk to your healthcare provider about birth control methods that may be right for you.
Males with female partners who are able to become pregnant:
- You should use effective birth control (contraception) during treatment and for 3 weeks after the last dose of IBTROZI.
are breastfeeding or plan to breastfeed. It is not known if IBTROZI passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after the last dose of IBTROZI. 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.

IBTROZI may affect the way other medicines work, and other medicines may affect how IBTROZI works.

You should not start or stop any medicine before you talk with your healthcare provider that prescribed IBTROZI.

How should I take IBTROZI?

Take IBTROZI exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking IBTROZI unless your healthcare provider tells you to.
Take IBTROZI on an empty stomach. Do not eat food for at least 2 hours before or 2 hours after taking IBTROZI.
Take IBTROZI at about the same time each day.
Swallow IBTROZI capsules whole. Do not open, crush, chew or dissolve the capsule before swallowing.
Avoid taking proton pump inhibitor (PPI), or H2 blocker medicine. If you take an antacid, take it at least 2 hours before or 2 hours after taking IBTROZI.
If you miss a dose or vomit at any time after taking a dose of IBTROZI, take your next dose at your regularly scheduled time the next day.

What should I avoid while taking IBTROZI?

You should limit time in the sun during treatment with IBTROZI. IBTROZI may make your skin sensitive to sunlight. Wear a hat and clothes that cover your skin and use sunscreen with sun protective factor (SPF) if you are in the sun during treatment with IBTROZI and for at least 5 days after your last dose of IBTROZI.
You should avoid grapefruit, grapefruit juice, or products that contain grapefruit during your treatment with IBTROZI. Grapefruit may increase the amount of IBTROZI in your blood, which may increase the risk of IBTROZI side effects.

What are the possible side effects of IBTROZI?

IBTROZI can cause serious side effects, including:

Liver problems. Changes in liver function can happen during treatment with IBTROZI and can lead to liver injury and death. Your healthcare provider will do blood tests to check your liver function before starting, every 2 weeks during the first 2 months of treatment, then monthly as needed during your treatment with IBTROZI. Tell your healthcare provider right away if you develop signs and symptoms of liver problems including:

yellowing of your skin or the white part of your eyes (jaundice)
dark or “tea-colored” urine
light-colored stools (bowel movements)

loss of appetite
nausea or vomiting
pain on the upper right side of your stomach
feeling tired or weak

Lung problems. IBTROZI can cause lung problems that are severe, life-threatening or lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough (with or without mucus), or fever.
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 IBTROZI 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 IBTROZI. These may be symptoms related to QT prolongation.
Increased uric acid level in your blood (hyperuricemia). Your healthcare provider will check your uric acid blood level before and during your treatment with IBTROZI. Your healthcare provider may prescribe medicine to lower uric acid if needed. Tell your healthcare provider if you develop any of the following symptoms of hyperuricemia:
red, hot, tender or swollen joints, especially in your big toe
pain in your stomach-area
nausea or vomiting
pink or brown urine
Muscle pain, tenderness, and weakness (myalgia). IBTROZI can cause myalgia with or without an increase in the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your CPK blood levels every 2 weeks during the first month and as needed if you experience unexplained muscle pain, tenderness, or weakness during your treatment with IBTROZI. Tell your healthcare provider if you develop unexplained muscle pain, tenderness, or weakness.
Bone fractures. IBTROZI can increase your risk of bone fractures. Bone fractures may happen with or without a fall or other injury. Tell your healthcare provider if you develop pain, changes in movement, or bone abnormalities.

The most common side effects of IBTROZI include:

diarrhea
nausea
vomiting
dizziness
rash
constipation
tiredness
changes in your liver function tests
decreased white blood cell levels

IBTROZI may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

Your healthcare provider may decrease your dose, temporarily stop, or completely stop your treatment with IBTROZI if you have serious side effects.

These are not all the possible side effects of IBTROZI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store IBTROZI?

Store IBTROZI at room temperature between 68°F to 77°F (20°C to 25°C).

Keep IBTROZI and all medicines out of the reach of children.

General information about the safe and effective use of IBTROZI.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IBTROZI for a condition for which it was not prescribed. Do not give IBTROZI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IBTROZI that is written for health professionals.

What are the ingredients of IBTROZI?

Active ingredient: taletrectinib adipate

Inactive ingredients: colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, mannitol, pregelatinized starch, sodium stearyl fumarate. Capsule shell contains hypromellose and titanium dioxide. Blue printing ink contains butyl alcohol, dehydrated alcohol, FD&C Blue#1 Aluminum Lake, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, and titanium dioxide.

Distributed by: Nuvation Bio Inc., Burlington, MA 01803

IBTROZI^®is a trademark of Nuvation Bio Inc.

For more information, go to www.IBTROZI.com or call 1-844-688-4550.

Ibtrozi (Taletrectinib adipate): Uses, Side Effects and Dosage