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Selpercatinib 80mg Capsule
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Indications & Clinical Uses
- Selpercatinib 80 mg capsules contain the active substance selpercatinib, a highly selective RET (rearranged during transfection) kinase inhibitor; it is marketed by Eli Lilly under the brand names Retevmo in the United States and Retsevmo in the European Union — this sheet lists it by its generic name.
- Selpercatinib is approved for adults with metastatic RET fusion-positive non-small cell lung cancer, for adults and children 2 years and older with advanced or metastatic RET-mutant medullary thyroid cancer requiring systemic therapy, for RET fusion-positive thyroid cancer that is radioactive-iodine-refractory (adults and children 2 years and older), and, under an accelerated tumour-agnostic pathway, for other advanced RET fusion-positive solid tumours that have progressed on prior therapy or have no satisfactory alternative.
- Selpercatinib requires confirmed RET gene alteration testing before use and is specialist-prescribed by an oncologist, though the capsules are taken at home.
Side Effects
- Very common side effects of Retevmo/Retsevmo (selpercatinib) include musculoskeletal pain, dry mouth, diarrhoea, fatigue, oedema (swelling), abdominal pain, nausea, headache, constipation, rash and cough.
- Laboratory testing frequently shows raised liver enzymes (AST/ALT), which can indicate hepatotoxicity; in clinical trials raised AST occurred in more than 6 in 10 patients, including severe (Grade 3-4) elevations in about 1 in 10.
- Hypertension is common and can be severe, affecting roughly 4 in 10 patients.
- Selpercatinib can prolong the heart's QT interval, which may cause dangerous irregular heartbeats, and it can cause serious bleeding events in a small proportion of patients.
- There is no boxed warning on the current US or EU label, but liver function, blood pressure, ECG and bleeding symptoms are monitored closely during treatment.
- Seek urgent medical attention for yellowing of the skin or eyes, severe swelling, chest pain, palpitations, fainting, or unusual bleeding or bruising.
Precautions & Warnings
- Before starting selpercatinib (Retevmo/Retsevmo), blood pressure must be controlled, and liver function tests, an ECG and electrolytes should be checked at baseline and monitored periodically during treatment because of the risks of hepatotoxicity, hypertension and QT prolongation.
- Interstitial lung disease or pneumonitis has been reported and requires prompt evaluation of new or worsening breathing symptoms.
- Selpercatinib can impair wound healing, so it is usually paused before and after planned surgery.
- Hypersensitivity reactions, including severe skin reactions, have occurred, usually within the first weeks of treatment.
- Selpercatinib can cause fetal harm, so effective, non-hormonal contraception is required during treatment and for a period afterward in both women and men with partners of reproductive potential, and it should not be used in pregnancy or while breastfeeding.
- Use in severe hepatic or renal impairment has not been fully established and may require dose adjustment; discuss any planned dental or surgical procedures with the prescribing oncologist first.
Avoid Interactions
- Selpercatinib is broken down mainly by the CYP3A4 liver enzyme, so strong CYP3A4 inhibitors — including ketoconazole, itraconazole, clarithromycin, ritonavir and grapefruit or grapefruit juice — can raise selpercatinib levels and increase toxicity, and should be avoided or require a reduced dose.
- Strong CYP3A4 inducers, such as rifampicin, carbamazepine, phenytoin and St John's Wort, can lower selpercatinib levels and reduce its cancer-fighting effect, and should also be avoided.
- Because selpercatinib can prolong the QT interval, combining it with other QT-prolonging medicines (certain antiarrhythmics, some antibiotics and antipsychotics) increases the risk of serious heart rhythm problems and needs careful review.
- Proton-pump inhibitors and other acid-reducing medicines may lower selpercatinib absorption.
- Patients should tell their oncologist and pharmacist about every prescription medicine, over-the-counter product, herbal remedy and supplement they take, including anything new started during treatment, so interactions can be checked before each change.
References
Frequently Asked Questions
Selpercatinib, sold as Retevmo in the US and Retsevmo in the EU, treats certain RET-driven cancers: RET fusion-positive lung cancer, RET-mutant medullary thyroid cancer, RET fusion-positive thyroid cancer, and other RET fusion-positive solid tumours. Your tumour must first test positive for a RET gene change before this Eli Lilly capsule is prescribed.
Selpercatinib capsules are swallowed whole, twice daily, roughly 12 hours apart, with or without food. Do not open, crush or chew them. Take doses at the same times each day and avoid grapefruit or grapefruit juice, which can raise drug levels. Your oncologist sets the exact dose by body weight.
Common Selpercatinib (Retevmo) side effects include tiredness, dry mouth, diarrhoea, joint or muscle pain, swelling and nausea. It can raise liver enzymes, blood pressure and the heart's QT interval, and rarely causes serious bleeding or lung inflammation. Report yellowing skin, chest pain, fainting, unusual bruising or breathlessness to your care team right away.
Avoid grapefruit, strong CYP3A4 inhibitors (like ketoconazole or clarithromycin) and inducers (like rifampicin or St John's Wort), as they change selpercatinib levels. Effective non-hormonal contraception is required during treatment, since Retevmo/Retsevmo can harm an unborn baby. Tell your oncologist about every medicine and supplement you take.
Before and during Selpercatinib treatment, you'll have regular blood pressure checks, liver function tests, ECG heart tracings and blood counts, because the drug can affect the liver, blood pressure, heart rhythm and clotting. Tell your oncologist promptly about swelling, chest pain, palpitations, unusual bleeding or breathing changes between visits.
Yes, for RET-mutant medullary thyroid cancer and RET fusion-positive thyroid or other solid tumours, Retevmo/Retsevmo is approved for children aged 2 years and older, alongside adults. Dosing is based on body weight. It is not approved under age 2, and treatment should always be managed by a specialist oncology team.
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