Gavreto Capsule: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Gavreto Capsule contains pralsetinib, a kinase inhibitor used to treat certain cancers caused by an altered RET gene, including RET fusion-positive non-small cell lung cancer and certain RET-altered thyroid cancers. It works by blocking the abnormal RET fusion protein that drives uncontrolled cancer cell growth. Gavreto is taken as capsules on an empty stomach, and treatment requires regular monitoring for side effects such as lung inflammation, high blood pressure, and liver problems.

What is Gavreto Capsule

Gavreto is a prescription cancer medicine that contains the active substance pralsetinib. It is used to treat certain cancers caused by an altered RET gene.

Gavreto Capsule uses

• Treatment of adult patients with RET fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor
• Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
• Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory

Benefits of Gavreto Capsule

• Treats certain RET fusion-positive cancers
• Used for metastatic RET fusion-positive NSCLC in adults
• Used for certain advanced or metastatic RET fusion-positive thyroid cancers in patients aged 12 years and older
• Blocks abnormal RET kinase signaling
• Provides an oral targeted-treatment option

How Gavreto Capsule works

In cancers caused by an altered RET gene, the gene change causes the body to make an abnormal RET fusion protein that drives uncontrolled cell growth. Gavreto blocks the action of this RET fusion protein, which may slow or stop tumor growth and may help shrink the cancer.

Gavreto Capsule dosage

Take Gavreto on an empty stomach; do not eat for at least two hours before and at least one hour after taking it. Swallow the capsules whole with a glass of water; do not chew or crush them. Take once daily at around the same time each day, and continue treatment until your doctor tells you to stop, due to disease progression or unacceptable side effects.

If you vomit after taking a dose, do not take an extra dose; just continue with your next scheduled dose. If you miss a dose, take it as soon as possible on the same day, then resume your regular daily schedule the next day. Avoid drinking grapefruit juice and eating grapefruit or Seville oranges during treatment.

Your doctor may change your dose, or temporarily or permanently stop treatment if you have side effects; do not change your dose or stop taking Gavreto unless your doctor tells you to. No dose adjustment is needed based on age for elderly patients. Gavreto is not for use in children or adolescents under 18 years of age for the lung cancer indication, and safety and effectiveness have not been established in children under 12 years old for the thyroid cancer indications.

Available forms and strengths

• Hard capsules (100 mg)

Side effects of Gavreto Capsule

Common

• Constipation
• Fatigue (tiredness)
• Muscle or bone pain
• Diarrhea
• High blood pressure
• Decreased red blood cells (anaemia)
• Decreased white blood cells (e.g., neutrophils, lymphocytes)
• Low platelet level
• Altered taste
• Headache
• Bleeding
• Lung inflammation
• Cough
• Shortness of breath
• Dryness affecting eyes, mouth and skin
• Abdominal (belly) pain
• Vomiting
• Nausea
• Rash
• Swelling (e.g. feet, ankle, face, eye, joint)
• Fever
• Abnormal liver blood tests (AST, ALT, alkaline phosphatase, bilirubin)
• Increased blood creatinine
• Increased creatine phosphokinase
• Lung infection (pneumonia)
• Urinary tract infection

Serious

• Severe, life-threatening, or fatal lung inflammation (pneumonitis/interstitial lung disease)
• Severe high blood pressure
• Serious liver injury (transaminase elevations)
• Serious or life-threatening bleeding events
• QT prolongation (abnormal heart electrical activity)
• Tuberculosis, mostly extrapulmonary
• Tumor lysis syndrome
• Impaired wound healing
• Sepsis
• Serious infections including pneumonia

Warnings and precautions

• Gavreto can cause severe, life-threatening, or fatal lung inflammation (pneumonitis/interstitial lung disease). Report any new or worsening breathing symptoms to your doctor right away.
• Gavreto can cause high blood pressure, and treatment should not be started if blood pressure is uncontrolled. Blood pressure should be monitored regularly during treatment.
• Severe liver enzyme elevations have occurred with Gavreto. Liver function tests should be checked before and periodically during treatment.
• Serious, including fatal, bleeding events can occur with Gavreto.
• Gavreto can cause QT interval prolongation, an abnormal heart rhythm change seen on ECG, so heart monitoring is needed before and during treatment.
• Cases of tuberculosis, mostly outside the lungs, have been reported in patients taking Gavreto. Patients should be evaluated for active or latent tuberculosis before starting treatment.
• Gavreto may cause fetal harm, so effective non-hormonal contraception is required during treatment and for some time after the last dose for both women and men with partners who could become pregnant.
• Gavreto may impair wound healing, so it should be stopped before planned surgery and not restarted until wounds have healed.
• Tumor lysis syndrome, caused by rapid breakdown of cancer cells, has been reported in patients receiving Gavreto and can be serious.
• Gavreto is not recommended during pregnancy because it may harm an unborn baby. Pregnancy status should be checked before starting treatment, and effective non-hormonal contraception is required during and after treatment.
• It is not known if Gavreto passes into breast milk, and a risk to a breastfed child cannot be excluded, so breastfeeding should be stopped during treatment and for one week after the final dose.
• No dose adjustment is needed for mild to moderate kidney impairment. Gavreto has not been studied in patients with severe kidney impairment or end-stage kidney disease, but no dose adjustment is expected to be required since the kidneys remove very little of the drug.
• No dose adjustment is recommended for patients with mild, moderate, or severe liver impairment, but liver function should be monitored closely during treatment because serious liver problems can occur.
• There is no specific guidance on alcohol in the official product information, but alcohol can worsen some side effects like diarrhea, dizziness, and nausea, and both alcohol and this medicine can affect the liver.
• Gavreto has a minor effect on the ability to drive or use machines, mainly because it can cause fatigue; caution is advised.

Storage

• This medicine does not require any special temperature storage conditions
• Store in the original package in order to protect from moisture
• Do not swallow the desiccant sachet found in the bottle
• Keep out of the sight and reach of children
• Do not use after the expiry date stated on the bottle label and outer carton
• Do not use if you notice that the bottle is damaged or shows signs of tampering
• Do not throw away any medicines via wastewater or household waste; ask your pharmacist how to dispose of medicines you no longer use

When to see a doctor

• Get medical help right away if you have new or worsening breathing problems such as shortness of breath, cough with or without mucus, or fever.
• Seek medical advice if you notice signs of liver problems such as yellowing of skin or eyes, dark urine, itchy skin, reduced appetite, nausea or vomiting, tiredness, or easy bleeding or bruising.
• Seek medical help right away for any signs of serious bleeding, including vomiting blood or coffee-ground-like vomit, coughing up blood or blood clots, pink or brown urine, black tarry stools, unusual bruising, heavier than normal menstrual bleeding, frequent nosebleeds, or drowsiness that is hard to wake from.
• Contact your doctor if you feel light-headed or notice heart palpitations, which may be a sign of an abnormal heart rhythm (ECG change).
• Contact your healthcare provider immediately if you become pregnant or think you might be pregnant while taking this medicine.
• Get emergency medical help right away if you develop symptoms that may indicate tumor lysis syndrome, such as nausea, vomiting, weakness, swelling, shortness of breath, or muscle cramps.

Alternatives

• Retevmo (selpercatinib)
• Vandetanib
• Cabozantinib