TAGRISSO (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

80 mg tablets: beige, oval and biconvex tablet marked with “AZ 80” on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1350-30).

40 mg tablets: beige, round and biconvex tablet marked with “AZ 40” on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1349-30).

Store TAGRISSO bottles at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Interstitial Lung Disease/Pneumonitis

Inform patients of the risks of severe or fatal ILD, including pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms [see Warnings and Precautions (5.1)].

QTc Interval Prolongation

Inform patients of symptoms that may be indicative of significant QTc prolongation including dizziness, lightheadedness, and syncope. Advise patients to report these symptoms and to inform their physician about the use of any heart or blood pressure medications [see Warnings and Precautions (5.2)].

Cardiomyopathy

Inform patients that TAGRISSO can cause cardiomyopathy. Advise patients to immediately report any signs or symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.3)].

Keratitis

Advise patients to contact their healthcare provider immediately if they develop eye symptoms (eye inflammation, lacrimation, light sensitivity, eye pain, red eye or changes in vision) [see Warnings and Precautions (5.4)].

Erythema multiforme and Stevens-Johnson syndrome

Inform patients of signs and symptoms that may be indicative of EM or SJS. Advise patients to contact their healthcare provider immediately if they develop target lesions or severe blistering or peeling of skin [see Warnings and Precautions (5.5)].

Cutaneous Vasculitis

Inform patients of signs and symptoms that may be indicative of cutaneous vasculitis. Advise patients to contact their healthcare provider immediately if they develop multiple, non-blanching red papules on their forearms, lower legs, or buttocks or large hives on their trunk that do not go away within 24 hours and develop a bruised appearance [see Warnings and Precautions (5.6)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider if they become pregnant or if pregnancy is suspected, while taking TAGRISSO [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1)].

Females and Males of Reproductive Potential

Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose [see Use in Specific Populations (8.3)].
Advise males to use effective contraception during treatment and for 4 months after the final dose of TAGRISSO [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with TAGRISSO and for 2 weeks after the final dose [see Use in Specific Populations (8.2)].

Distributed by:
AstraZeneca Pharmaceuticals LPWilmington, DE 19850

TAGRISSO is a registered trademark of the AstraZeneca group of companies.

©AstraZeneca 2021

Patient Information TAGRISSO® (tuh-GRISS-oh) (osimertinib) tablets

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

TAGRISSO may cause serious side effects, including:

lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever.
heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your healthcare provider right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded.
eye problems. TAGRISSO may cause eye problems. Tell your healthcare provider right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO.
skin problems. TAGRISSO may cause skin problems. Tell your healthcare provider right away if you develop target lesions (skin reactions that look like rings), severe blistering or peeling of the skin.
inflammation of the blood vessels in your skin. TAGRISSO may cause blood vessel problems in your skin. Tell your healthcare provider right away if you develop purple spots or redness of the skin that does not fade in color when pressed (non-blanching) on your lower arms, lower legs, or buttocks or large hives on the main part of your body (trunk) that do not go away within 24 hours and look bruised.

See “What are the possible side effects of TAGRISSO?” for more information about side effects.

What is TAGRISSO?

TAGRISSO is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has certain abnormal epidermal growth factor receptor (EGFR) gene(s):

to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery, or
as your first treatment when your lung cancer has spread to other parts of the body (metastatic), or
when your lung cancer has spread to other parts of the body (metastatic) and you have had previous treatment with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working.
Your healthcare provider will perform a test to make sure that TAGRISSO is right for you.

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

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

have lung or breathing problems.
have heart problems, including a condition called long QTc syndrome.
have problems with your electrolytes, such as sodium, potassium, calcium or magnesium.
have a history of eye problems.
are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant.
o
Females who are able to become pregnant should have a pregnancy test before starting treatment with TAGRISSO. You should use effective birth control during treatment with TAGRISSO and for 6 weeks after the final dose of TAGRISSO.
o
Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the final dose of TAGRISSO.
are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your final dose of TAGRISSO. 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. Especially tell your healthcare provider if you take a heart or blood pressure medicine.

How should I take TAGRISSO?

Take TAGRISSO exactly as your healthcare provider tells you to take it.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TAGRISSO if you have side effects.
Take TAGRISSO 1 time each day.
You can take TAGRISSO with or without food.
If you miss a dose of TAGRISSO, do not make up for the missed dose. Take your next dose at your regular time.
If you cannot swallow TAGRISSO tablets whole:
o
place your dose of TAGRISSO in a container that contains 60 mL (2 ounces) of water. Do not use carbonated water or any other liquids.
o
stir the TAGRISSO tablet and water until the TAGRISSO tablet is in small pieces (the tablet will not completely dissolve). Do not crush, heat, or use ultrasound to prepare the mixture.
o
drink the TAGRISSO and water mixture right away.
o
add 120 mL to 240 mL (4 to 8 ounces) of water into the container and drink to make sure that you take your full dose of TAGRISSO.

What are the possible side effects of TAGRISSO?

TAGRISSO may cause serious side effects, including:

See “What is the most important information I should know about TAGRISSO?”
Severe blistering or peeling of skin – seek medical attention right away if you develop these symptoms.
Target lesions, which are skin reactions that look like rings – seek medical attention right away if you develop these symptoms.

The most common side effects of TAGRISSO are:

low white blood cell counts
low platelet counts
diarrhea
low red blood cell counts (anemia)
rash
muscle, bone, or joint pain
changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
dry skin
mouth sores
tiredness
cough

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TAGRISSO. For more information, ask your healthcare provider or pharmacist.

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 TAGRISSO?

Store TAGRISSO at room temperature between 68°F to 77°F (20°C to 25°C).
Safely throw away medicine that is out of date or that you no longer need.
Keep TAGRISSO and all medicines out of the reach of children.

General information about the safe and effective use of TAGRISSO.

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

What are the ingredients in TAGRISSO?

Active ingredient: osimertinib

Inactive ingredients: mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and sodium stearyl fumarate. Tablet coating contains: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, ferric oxide yellow, ferric oxide red and ferric oxide black.

For more information, go to www.Tagrisso.com or call 1-800-236-9933.

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

© AstraZeneca 2020

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2020

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