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Pralsetinib (Oral)

Commonly used brand name(s)

In the U.S.

  • Gavreto

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses for pralsetinib

Pralsetinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) and in patients whose tumors have RET fusion-positive genes. Your doctor will perform a test to check for the RET gene fusion before you use pralsetinib.

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

Pralsetinib is available only with your doctor's prescription.

Before using pralsetinib

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 pralsetinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pralsetinib 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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pralsetinib in the elderly.

Breastfeeding

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.

Interactions with 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 pralsetinib, 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 pralsetinib 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.

  • Apalutamide
  • Boceprevir
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Enzalutamide
  • Fosphenytoin
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Lumacaftor
  • Mitotane
  • Nefazodone
  • Nelfinavir
  • Phenytoin
  • Posaconazole
  • Rifampin
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Voriconazole

Interactions with food/tobacco/alcohol

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 pralsetinib. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Liver disease or
  • Lung problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.
  • Hypertension (high blood pressure), uncontrolled or—This condition must be corrected first before using and during treatment with pralsetinib.
  • Surgery, recent—Use with caution. May cause side effects to become worse.

Proper use of pralsetinib

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

Take pralsetinib 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.

Pralsetinib comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Swallow the capsule whole. Do not crush, open, or chew it.

It is best to take pralsetinib on an empty stomach. Do not eat for at least 2 hours before and 1 hour after taking pralsetinib.

Dosing

The dose of pralsetinib 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 pralsetinib. 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 (capsules):
    • For non-small cell lung cancer (NSCLC):
      • Adults—400 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 pralsetinib, 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 vomit after taking a dose of pralsetinib, do not take an extra dose. Take your next dose at your regular time the next day.

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 pralsetinib

It is very important that your doctor check your progress at regular visits to make sure that pralsetinib is working properly. Blood tests may be needed to check for unwanted effects.

Using pralsetinib while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using pralsetinib to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 2 weeks after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.

Pralsetinib 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.

Check with your doctor right away if you have blurred vision, dizziness, nervousness, headache, pounding in the ears, or slow or fast heartbeat occurs during or after treatment with pralsetinib. These can be symptoms of hypertension (high blood pressure).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Pralsetinib can cause serious bleeding problems that may be life-threatening. Check with your doctor right away if you have coughing up blood, increased menstrual flow or vaginal bleeding, nosebleeds, red or black, tarry stools, red or dark brown urine, vomiting of blood or material that looks like coffee grounds, or any unusual bleeding or bruising.

Pralsetinib may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using pralsetinib. You may need to stop using pralsetinib several days before and after having surgery.

Talk with your doctor before using pralsetinib if you plan to have children. Some men and women using pralsetinib have become infertile (unable to have children).

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.

Pralsetinib side effects

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

  • Bleeding gums
  • blurred vision
  • chest pain
  • chills
  • cough
  • coughing up blood
  • dark urine
  • difficulty in breathing or swallowing
  • dizziness
  • fever
  • general feeling of discomfort or illness
  • headache
  • increased menstrual flow or vaginal bleeding
  • loss of appetite
  • nausea
  • nervousness
  • nosebleeds
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • slow or fast heartbeat
  • stomach pain, severe
  • swelling around the eye
  • swelling of the eyelids
  • swelling or puffiness of the face
  • thickening of bronchial secretions
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Less common

  • Black, tarry stools
  • bladder pain
  • bloody or cloudy urine
  • chest pain or tightness
  • confusion
  • difficult, burning, or painful urination
  • fast heartbeat
  • frequent urge to urinate
  • lightheadedness
  • lower back or side pain
  • pale skin
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising

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

  • Bone pain
  • constipation
  • difficulty in moving
  • dry mouth
  • joint pain
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains or stiffness
  • neck pain
  • pain, swelling, or redness in the joints
  • stomach cramps
  • tenderness
  • watery or bloody diarrhea

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.