Pronunciation:

oh-sim-ER-ti-nib

Brand Names:

• Tagrisso

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Osimertinib is used to treat non-small cell lung cancer (NSCLC) in patients who have certain types of abnormal epidermal growth factor (EGFR) genes. This medicine is used to prevent NSCLC from coming back in patients whose tumor has been removed by surgery. It is also used as a first-line treatment of metastatic (cancer that has spread to other parts of the body) NSCLC. This medicine is also used to treat metastatic NSCLC in patients who have already received EGFR tyrosine kinase inhibitor (TKI) therapy, which did not work. It is also used in combination with other cancer medicines (eg, pemetrexed, platinum-based chemotherapy) as a first-line treatment of metastatic or locally advanced (cancer that has spread to nearby tissues) NSCLC. Your doctor will perform a test to check for the EGFR gene before you use this medicine.

Osimertinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of osimertinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of osimertinib in the elderly. However, elderly patients are more likely to have serious unwanted effects, which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumacaftor
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Repotrectinib
• Ribociclib
• Rifampin
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Electrolyte or mineral imbalance (eg, high or low sodium, potassium, or magnesium) or
• Heart disease (eg, congestive heart failure) or
• Heart rhythm problems (eg, congenital long QT syndrome) or
• Keratitis (inflammation of the cornea of the eye) or
• Lung disease or breathing problems (eg, interstitial lung disease, pneumonitis), history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

If you have trouble swallowing the tablet:

• Dissolve it in 2 ounces (60 milliliters [mL]) of water. Do not use carbonated water or other liquids.
• Stir until the tablet is in small pieces. Do not crush or heat.
• Drink the liquid right away.
• Add 4 to 8 ounces (120 to 240 mL) of water in the same container, and drink it right away.
• It may also be given through a nasogastric tube. Dissolve the tablet in 15 mL of non-carbonated water, then add another 15 mL of water to transfer any medicine to the syringe.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For lung cancer:
    • Adult—80 milligrams (mg) once a day. Your doctor may adjust the dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects. Your dose may be reduced, or the medicine withheld or stopped, if certain side effects occur.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use effective birth control during treatment and for at least 6 weeks after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 4 months after the last dose. If you think you or your partner becomes pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a slow, fast, pounding, or uneven heartbeat.

This medicine may cause heart problems. Tell your doctor right away if you have fast, pounding, or uneven heartbeat, lightheadedness, trouble breathing, or swelling of your ankles or feet.

Check with your doctor right away if you have any changes to your eyes, such as eye pain or redness, or vision changes while you are using this medicine. Your doctor may want you to have your eyes checked by an eye doctor (ophthalmologist).

Serious skin reactions (eg, Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills ,cough, diarrhea, joint pain, red irritated eyes, red skin lesions, severe acne or skin rash, sore throat, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause cutaneous vasculitis (swelling of the blood vessels in the skin). Check with your doctor right away if you have blisters on the skin, purple spots or redness of the skin that does not fade when pressed on the lower arms, lower legs, or buttocks, or large hives on the trunk that do not go away within 24 hours and look bruised.

Check with your doctor right away if you have chest pain or tightness, chills, cough, fever, headache, sores, ulcers, or white spots in the mouth, swollen or painful glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These maybe symptoms of a blood problem (eg, aplastic anemia).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Anxiety

cough

dizziness, lightheadedness, or fainting

eye or vision changes

fast, pounding, or uneven heartbeat

pain in the chest, groin, or legs, especially the calves

pain, redness, or swelling in the arm or leg

slurred speech

sudden loss of coordination

sudden, severe headache

sudden, severe weakness or numbness in the arm or leg

trouble breathing

Less common

Blurred vision

chills

fever

general feeling of discomfort or illness

inability to speak

seizures

sneezing

sore throat

sudden, severe weakness on one side of the body

temporary blindness

thickening of bronchial secretions

Rare

Chest pain or tightness

eye redness, irritation, or pain

headache

swollen or painful glands

unusual bleeding or bruising

Incidence not known

Blistering, peeling, loosening of the skin

diarrhea

itching

joint or muscle pain

red skin lesions, often with a purple center

sore throat

sores, ulcers, or white spots in the mouth or on the lips

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

changes in the fingernails or toenails, including brittleness, inflammation, pain, redness, tenderness, separation from nail bed, or shedding of the nails

constipation

decreased appetite

nausea

skin rash or dryness of the skin

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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