TM Owner Roche / Genentech
Pralsetinib Oral 100mg Capsule
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Indications & Clinical Uses
- Pralsetinib Oral 100 mg capsules (this sheet's generic-style listing; no product is actually marketed under the name 'Pralsetinib Oral') contain pralsetinib, a targeted RET (rearranged during transfection) kinase inhibitor.
- This content is based on the approved brand Gavreto, from Genentech, a member of the Roche Group.
- Gavreto is indicated in adults for metastatic RET fusion-positive non-small cell lung cancer (NSCLC), and in adults and children 12 years and older for advanced or metastatic RET fusion-positive thyroid cancer, or RET-mutant medullary thyroid cancer needing systemic therapy that is refractory to or unsuitable for radioactive iodine.
- It is used once a tumour has been confirmed RET-altered by an approved test.
- Gavreto is taken by mouth once daily on an empty stomach and is prescribed and monitored by a cancer specialist; it is not for self-diagnosed use.
Side Effects
- Gavreto (pralsetinib) carries a boxed warning for serious, sometimes fatal infections — including bacterial, fungal, viral and opportunistic infections that can lead to hospitalisation or death — so report fever, chills, cough or any new sign of infection to your cancer care team right away.
- The most common side effects include musculoskeletal pain, constipation, high blood pressure, diarrhoea, fatigue, swelling (oedema), fever and cough.
- Gavreto can also cause interstitial lung disease or pneumonitis, which can be severe or fatal — seek urgent medical help for new or worsening shortness of breath, cough or fever.
- Liver enzymes are checked with regular blood tests, and serious bleeding events have occurred in some patients.
- Tell your care team immediately about unexplained bruising or bleeding, chest pain, severe breathlessness, or yellowing of the skin or eyes.
Precautions & Warnings
- Before starting Gavreto, tumour RET alteration status must be confirmed by an approved test, and blood pressure, liver enzymes (AST/ALT) and lung symptoms are checked regularly — liver tests every 2 weeks for the first 3 months, then monthly.
- Gavreto should be interrupted or stopped if interstitial lung disease/pneumonitis, severe hypertension, significant liver enzyme rises or serious infection occur.
- It can cause tumour lysis syndrome in patients with rapidly growing tumours or a high tumour burden, so kidney function and electrolytes are monitored closely at the start of treatment.
- Gavreto can cause fetal harm; women who could become pregnant and men whose partners could become pregnant must use effective, non-hormonal contraception during treatment and for a defined period afterward, and Gavreto should not be used in pregnancy or while breastfeeding.
- Swallow capsules whole on an empty stomach — do not take with a high-fat meal — and do not open, crush or chew them.
Avoid Interactions
- Gavreto (pralsetinib) is broken down mainly by the CYP3A enzyme, so strong or moderate CYP3A inhibitors (such as ketoconazole, itraconazole, clarithromycin, and grapefruit or grapefruit juice) can raise pralsetinib levels and increase toxicity, and these combinations should be avoided or the dose reduced.
- Strong or moderate CYP3A inducers (such as rifampicin, carbamazepine, phenytoin and St John's Wort) can lower pralsetinib levels and reduce its effectiveness against the cancer, and should also be avoided where possible.
- Tell your care team about all other prescription and over-the-counter medicines, herbal products and supplements you take, including proton pump inhibitors and other gastric-acid reducers, which can lower pralsetinib absorption.
- Do not start or stop any medicine, including herbal remedies, without checking with your oncology team first.
References
Frequently Asked Questions
Pralsetinib is the active ingredient in Gavreto, a targeted cancer capsule for adults with metastatic RET fusion-positive non-small cell lung cancer, and for adults and children 12 and older with RET-altered thyroid cancer. Your tumour must first test positive for a RET gene alteration.
Gavreto capsules are taken by mouth once daily on an empty stomach — at least 1 hour before or 2 hours after food. Swallow capsules whole without opening, crushing or chewing them, at roughly the same time each day, as directed by your oncology team.
Gavreto carries a boxed warning for serious, sometimes fatal infections. Other common effects include musculoskeletal pain, constipation, high blood pressure, diarrhoea and fatigue. Seek urgent care for fever, breathlessness, cough, or signs of lung inflammation (pneumonitis), which can also be serious.
Avoid grapefruit and grapefruit juice, and strong CYP3A-affecting medicines such as ketoconazole, rifampicin or St John's Wort, which change pralsetinib levels in your blood. Avoid pregnancy — use effective non-hormonal contraception — and tell your cancer team about every medicine you take.
While taking Gavreto, expect regular blood pressure checks and liver blood tests — every 2 weeks for the first 3 months, then monthly — plus kidney and electrolyte checks early in treatment to watch for tumour lysis syndrome. Report new breathlessness or cough promptly.
No. Gavreto can harm an unborn baby, so effective non-hormonal contraception is required during treatment and for a period after the last dose, for both patients and partners who could cause pregnancy. Gavreto is not recommended while breastfeeding, so discuss feeding options with your care team.
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