Pronunciation:

pir-toe-BROO-ti-nib

Brand Names:

• Jaypirca

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Pirtobrutinib is used to treat mantle cell lymphoma (MCL) that has come back or did not respond to previous treatment and who have received at least 2 types of cancer treatment (eg, BTK inhibitor). This medicine is also used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have received at least 2 types of cancer treatment (eg, BTK inhibitor, BCL-2 inhibitor).

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 pirtobrutinib 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 pirtobrutinib in the elderly.

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 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.

• Acalabrutinib
• Alfentanil
• Apalutamide
• Aprepitant
• Avanafil
• Avapritinib
• Boceprevir
• Bosentan
• Bosutinib
• Budesonide
• Buspirone
• Carbamazepine
• Cenobamate
• Clarithromycin
• Cobicistat
• Cobimetinib
• Conivaptan
• Cyclosporine
• Darifenacin
• Darunavir
• Dasatinib
• Digoxin
• Dihydroergotamine
• Dofetilide
• Dronedarone
• Efavirenz
• Eletriptan
• Entrectinib
• Enzalutamide
• Eplerenone
• Ergotamine
• Etravirine
• Everolimus
• Felodipine
• Fentanyl
• Finerenone
• Flibanserin
• Fluticasone
• Fosaprepitant
• Fosphenytoin
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Indinavir
• Itraconazole
• Ivabradine
• Ivacaftor
• Ketoconazole
• Lansoprazole
• Lomitapide
• Lopinavir
• Lorlatinib
• Lovastatin
• Lumacaftor
• Lurasidone
• Maraviroc
• Midazolam
• Mitotane
• Modafinil
• Nafcillin
• Naloxegol
• Nefazodone
• Nelfinavir
• Omeprazole
• Oxycodone
• Paclitaxel
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pimozide
• Posaconazole
• Primidone
• Quetiapine
• Quinidine
• Repaglinide
• Repotrectinib
• Rifabutin
• Rifampin
• Ritonavir
• Rosuvastatin
• Saquinavir
• Sildenafil
• Simvastatin
• Sirolimus
• St John's Wort
• Tacrolimus
• Telaprevir
• Telithromycin
• Temsirolimus
• Ticagrelor
• Tipranavir
• Tolvaptan
• Triazolam
• Ubrogepant
• Vardenafil
• Venetoclax
• Voclosporin
• Voriconazole

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:

• Bleeding problems or
• Heart rhythm problems (eg, atrial fibrillation, atrial flutter) or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Infection (eg, pneumonia)—May decrease your body's ability to fight an infection.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

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.

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

Swallow the tablet whole with a glass of water. Do not cut, crush, or chew it.

Take this medicine at the same time each day.

You may take this medicine with or without food.

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 mantle cell lymphoma, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL):
    • Adults—200 milligrams (mg) once a day. Your doctor may adjust your 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, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose, take it as you normally would. If it is more than 12 hours since your usual dosing time, skip the missed dose and take your next dose at your regular schedule. Do not use extra medicine to make up for a missed dose.

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.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 week after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Call your doctor right away if you start to have a cough that would not go away, weight loss, night sweats, fever, chills, flu-like symptoms (eg, runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may be signs that you have an infection.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Pirtobrutinib may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause heart rhythm problems (eg, atrial flutter, atrial fibrillation). Check with your doctor right away if you have a fast or irregular heartbeat, trouble breathing, lightheadedness, dizziness, or fainting.

Using this medicine may increase your risk of getting new cancers, including skin cancer. Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before and after having surgery.

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

Black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

body aches or pain

chest pain or tightness

cough

decreased amount of urine

diarrhea

dizziness

ear congestion

fainting

fever or chills

headache

increased thirst

loss of appetite

loss of taste or smell

loss of voice

lower back or side pain

nausea

nervousness

pale skin

palpitations

pinpoint red spots on the skin

pounding in the ears

slow or fast heartbeat

sneezing

sore throat

stuffy or runny nose

swelling

swelling of the face, fingers, or lower legs

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight gain

Less common

Confusion

lightheadedness

painful or difficult urination

persistent non-healing sore

pink growth

reddish patch or irritated area

shiny bump

ulcers, sores, or white spots in the mouth

white, yellow, or waxy scar-like area

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

Burning, numbness, tingling, or painful sensations

constipation

cracked lips

difficulty in moving

difficulty in swallowing

falls

joint pain

large, flat, blue or purplish patches in the skin

muscle or bone pain

muscle stiffness

pain, swelling, or redness in the joints

stomach pain

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

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.