Pralsetinib

What Is Pralsetinib?

• Pralsetinib (Gavreto) is a kinase inhibitor ,a prescription medicine used to treat certain cancers.

What are the uses of this medicine?

This medicine is indicated to treat certain cancers caused by abnormal rearranged during transfection (RET) genes in:

• adults with non-small cell lung cancer (NSCLC) that has spread.
• adults and children 12 years of age and older with advanced medullary thyroid cancer (MTC) or MTC that has spread who require a medicine by mouth or injection (systemic therapy).
• adults and children 12 years of age and older with advanced thyroid cancer or thyroid cancer that has spread who require a medicine by mouth or injection (systemic therapy) and who have received radioactive iodine and it did not work or is no longer working.

How does this medicine work?

• An orally bioavailable selective inhibitor of mutant forms of and fusion products involving the proto-oncogene receptor tyrosine kinase RET, with potential antineoplastic activity.
• Upon administration, pralsetinib binds to and targets various RET mutants and RET-containing fusion product.
• RET gene mutations and translocations result in the upregulation and/or activation of RET tyrosine kinase activity in various cancer cell types; dysregulation of RET activity plays a key role in the development and regression of these cancers.

Who Should Not Use this medicine ?

• This medicine have no usage limitations

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• Select patients for treatment with Gavreto based on the presence of a RET gene fusion or gene mutation.
• The recommended dosage in adults and pediatric patients 12 years and older is 400 mg orally once daily on an empty stomach.

Administration

• Take your prescribed dose of Gavreto 1 time each day.
• Take Gavreto on an empty stomach.
• Do not eat for at least 2 hours before and at least 1 hour after taking Gavreto.
• Do not change your dose or stop taking Gavreto unless your healthcare provider tells you to.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Gavreto if you develop side effects.
• If you miss a dose of Gavreto, take it as soon as possible on the same day.
• Then take your next dose of Gavreto at your regular time the next day.
• If you vomit after taking a dose of Gavreto, do not take an extra dose.
• Take your next dose of Gavreto at your regular time the next day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 100 mg Capsules

This medicine is available in fallowing brand namesː

• Gavreto

What side effects can this medication cause?

Common possible side effects of this medicine include:

• constipation
• high blood pressure
• tiredness
• muscle and joint pain
• diarrhea
• decreased white blood cell, red blood cell, and platelet counts
• decreased levels of phosphate in the blood
• decreased levels of calcium in the blood
• decreased levels of body salt (sodium) in the blood
• abnormal liver function blood tests

Gavreto may cause serious side effects, including:

• Lung problems
• High blood pressure (hypertension)
• Liver problems
• Bleeding problems
• Tumor lysis syndrome (TLS)
• Risk of wound healing problems

What special precautions should I follow?

• Permanently discontinue this medication for recurrent ILD/pneumonitis.
• Do not initiate Gavreto in patients with uncontrolled hypertension. Optimize blood pressure (BP) prior to initiating Gavreto. Monitor BP after 1 week, at least monthly thereafter and as clinically indicated. Withhold, reduce dose, or permanently discontinue Gavreto based on severity.
• Permanently discontinue Gavreto in patients with severe or life-threatening hemorrhage.
• Closely monitor patients at risk of Tumor Lysis Syndrome.
• Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Gavreto after resolution of wound healing complications has not been established.
• This medicine cause cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Gavreto can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Gavreto have been established in pediatric patients aged 12 years and older for RET-mutant MTC and RET-fusion thyroid cancer.
• The safety and effectiveness of Gavreto have not been established in pediatric patients in pediatric patients younger than 12 years old.

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F).
• Protect from moisture.

• Dailymed label info on Pralsetinib
• FDA Pralsetinib

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