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MEDICINE CABINET:

PIRTOBRUTINIB

Generic Name: Pirtobrutinib

Brand Name: Jaypirca

Drug Classification: Covalent Bruton Tyrosine Kinase (BTK) Inhibitor

INDICATIONS FOR USE

  • Pirtobrutinib is approved for the treatment of CLL and SLL in those whose disease has either relapsed or become refractory after having been previously treated with both a covalent BTK inhibitor (such as ibrutinib, acalabrutinib, or zanubrutinib) and a BCL-2 inhibitor (such as venetoclax).
  • Pirtobrutinib was granted accelerated FDA approval based on response rates observed during clinical trials. Continued approval may be contingent upon verification and description of the clinical benefit through ongoing confirmatory clinical trials.
  • Pirtobrutinib can be used even when the disease has developed resistance to covalent BTK inhibitors.

ADMINISTRATION ROUTE

Taken orally by mouth (in tablet form).

LENGTH OF TIME ADMINISTERED

Taken indefinitely until either the disease progresses while on the medication (which would require switching to a new class of medications to treat the CLL or SLL), or until certain unacceptable side effects occur requiring discontinuation of the drug.

DOSING

200 mg taken once per day, at the same time each day.

MISSED DOSE

  • If you miss a dose of this medication, take it on the same day as soon as you remember as long as you are within 12 hours from the time when you regularly take this medication.
  • If more than 12 hours have elapsed from when you usually take the medication, then skip the dose for that day and begin taking it again the next day at your regularly scheduled time.

HOW TO TAKE THIS MEDICATION

  • Swallow whole with water. Do not cut, crush, or chew the tablets.
  • Do not ingest any starfruit, grapefruit, bitter orange/marmalade products, Seville oranges or pomegranate. Certain citrus products are known to interfere with the metabolism of this medication and can potentially cause toxic levels of the medication to build up in the blood.

COMBINATION THERAPIES

No combination therapies are yet recommended.

COMMON SIDE EFFECTS

Side effects can occur because of any medication, some of which may go away with time as your body adjusts to the new medication. Please notify your healthcare provider right away if any of the following side effects occur:

  • Low neutrophil count, low white blood cell count, or low platelet count
  • Respiratory infections, including pneumonia
  • Shortness of breath
  • Fatigue
  • Muscle, joint, or bone pain
  • Bruising or bleeding
  • Diarrhea
  • Swelling


Side effects not mentioned above may also occur. Notify your healthcare provider of any other unusual symptoms, as they may be able to tell you about ways to prevent or reduce certain side effects.

MANAGING COMMON SIDE EFFECTS

Some side effects are more common than others, many of which will go away after a short period of time after staying on the medication. It is important to talk to your healthcare provider to discuss if you might be able to manage side effects in the short term in order to stay on the therapy until your body has time to adjust to the new medication. Here are some possible ways to help manage some of the most common side effects of pirtobrutinib in consultation with your healthcare provider.

Diarrhea

  • Increase your fluid intake.
  • Take anti-diarrheal medications (such as Imodium) per package instructions.
  • Eat a bland diet (such as bananas, rice, apples/applesauce, toast, or plain pasta).

Constipation

  • Increase your fluid intake.
  • Consume more foods that are high in fiber (such as vegetables and whole grain bread).
  • Consider over-the-counter fiber supplements (such as Fibercon, Miralax, or Metamucil).
  • Move around more, as walking and other forms of light exercise can help.
  • Take over-the-counter stool softeners (such as Colace) to help soften bowel movements.

Fatigue or Tiredness

  • Ensure you are eating a well-rounded diet that includes a balance of lean meats, fruits, vegetables, whole grains, and limited amounts of processed foods.
  • Incorporate light types of exercise (such as walking).
  • If you are able, take one short twenty-minute nap during the day. Frequent or longer naps during the day can affect the amount of sleep you are getting during the night and increase fatigue/tiredness.

Muscle, Joint, or Bone Pain

  • Take acetaminophen (such as Tylenol) per package instructions.
  • It is important to avoid taking anti-inflammatories (such as ibuprofen) for mild pain while taking pirtobrutinib due to the slightly increased risk of bleeding.
  • Antihistamines (such as Allegra, Zyrtec, or Claritin) may help slightly with bone pain.
  • Tonic water or magnesium supplements may help muscle cramping.
  • Gentle stretching and application of heat or ice to the affected area(s) can provide temporary relief.
  • If you are experiencing more severe joint pain, your healthcare provider may prescribe a short course of steroids.

REASONS TO TALK TO YOUR HEALTHCARE PROVIDER

The presence of other medical problems may affect the use of pirtobrutinib. Make sure you share with your healthcare provider if you have any of the following conditions:

  • Heart problems (including palpitations, fast or irregular heartbeat, dizziness, fainting, chest discomfort or shortness of breath)
  • Liver disease or hepatitis
  • Hypertension (high blood pressure)
  • Diabetes
  • Smoking
  • Recent or current infection
  • Kidney disease or reduced kidney function
  • Bleeding problems or if you are on any blood thinning medication
  • If you are pregnant or breastfeeding (or if you plan to become pregnant or breastfeed)

SPECIAL CONSIDERATIONS

  • Pirtobrutinib can have a mild blood-thinning
    effect, so aspirin and other anti-inflammatory pain medications (such as ibuprofen/Advil) may need to be avoided. 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.
  • Serious bacterial, viral, or fungal infections can occur while taking pirtobrutinib. But this can also occur in part from being immunocompromised due to having CLL or SLL. Avoid being near people who are sick and wash your hands often.
  • There are several medications that interfere with the metabolism of pirtobrutinib and can cause toxic levels of the drug to build up in the blood, or that increase the breakdown of pirtobrutinib which can decrease the drug’s effectiveness. It is very important to tell your healthcare provider about all the medications you take, including prescription and over the counter medicines, vitamins, and herbal supplements (particularly in the case of pirtobrutinib you should not be on St. John’s Wort).
  • Secondary cancers have been reported while taking the medication, but this is also a common finding associated with having CLL and SLL. Please be diligent about annual cancer screenings and wearing sun protection when outside in sunlight.
  • You may be advised to briefly stop taking pirtobrutinib for dental or surgical procedures
    for several days before and after the procedure
    to minimize the risk of bleeding. Please let your CLL / SLL healthcare provider know about any planned procedures. Never hold or stop taking
    this medication without the supervision of your healthcare provider.