Pralsetinib
What Is Pralsetinib?[edit | edit source]
- Pralsetinib (Gavreto) is a kinase inhibitor ,a prescription medicine used to treat certain cancers.
What are the uses of this medicine?[edit | edit source]
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?[edit | edit source]
- 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 ?[edit | edit source]
- This medicine have no usage limitations
Is this medicine FDA approved?[edit | edit source]
- It was approved for use in the United States in 2020.
How should this medicine be used?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- Gavreto can cause fetal harm when administered to a pregnant woman.
Can this medicine be used in children?[edit | edit source]
- 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?[edit | edit source]
- 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.
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