Selpercatinib

Generic name: Selpercatinib
Brand names: Retevmo
Dosage form: oral capsule (40 mg; 80 mg)
Drug class: Multikinase inhibitors

Usage of Selpercatinib

Selpercatinib is used to treat a certain type of non-small cell lung cancer in adults.

Selpercatinib is also used to treat certain types of thyroid cancer in adults and children at least 12 years old.

selpercatinib is used when the cancer has spread to other parts of the body (metastatic).

Selpercatinib is used only if your cancer has a specific genetic marker (an abnormal "RET" gene). Your doctor will test you for this gene.

Selpercatinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Selpercatinib may also be used for purposes not listed in this medication guide.

Selpercatinib side effects

Get emergency medical help if you have signs of an allergic reaction: hives, rash; fever, joint or muscle pain; difficult breathing; swelling of your face, lips, tongue, or throat.

Selpercatinib may cause serious side effects. Call your doctor at once if you have:

easy bruising or bleeding (nosebleeds, bleeding gums);

coughing up blood or vomit that looks like coffee grounds;

any wound that will not heal;

fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

fever, chills, cough with mucus, chest pain, feeling short of breath; or

liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of selpercatinib may include:

abnormal blood tests;

high blood pressure;

tiredness;

dry mouth;

diarrhea;

swelling;

rash; or

constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Selpercatinib

You should not use selpercatinib if you have untreated or uncontrolled hypertension (high blood pressure).

Tell your doctor if you have ever had:

liver disease; or

long QT syndrome (in you or a family member).

Both men and women using selpercatinib should use effective birth control to prevent pregnancy. Selpercatinib can harm an unborn baby if the mother or father is using this medicine. Keep using birth control for at least 1 week after your last dose.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using selpercatinib.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because selpercatinib can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Relate drugs

How to use Selpercatinib

Usual Adult Dose for Non-Small Cell Lung Cancer:

Usual Adult Dose for Thyroid Cancer:

Less than 50 kg: 120 mg orally 2 times daily (approximately every 12 hours) until disease progression or unacceptable toxicity50 kg or greater: 160 mg orally 2 times daily (approximately every 12 hours) until disease progression or unacceptable toxicityUses:-For the treatment of adult patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.-For the treatment of adult patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

Usual Pediatric Dose for Thyroid Cancer:

12 years and older:Less than 50 kg: 120 mg orally 2 times daily (approximately every 12 hours) until disease progression or unacceptable toxicity12 years and older:50 kg or greater: 160 mg orally 2 times daily (approximately every 12 hours) until disease progression or unacceptable toxicityUses:-For the treatment of pediatric patients 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy-For the treatment of pediatric patients 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What other drugs will affect Selpercatinib

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Selpercatinib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Some medicines can make selpercatinib much less effective when taken at the same time. If you take any of the following medicines, take them separately from your dose of selpercatinib:

an antacid--take selpercatinib 2 hours before or 2 hours after taking the antacid; or

stomach acid medicines (such as cimetidine, famotidine, Axid, Pepcid, Tagamet, and others)--take selpercatinib dose 2 hours before or 10 hours after you take the other medicine.

Other drugs may affect selpercatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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