TM Owner Eli Lilly
Retevmo 80mg Capsule
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Indications & Clinical Uses
- Retevmo 80 mg (selpercatinib) is an oral kinase inhibitor that blocks abnormal RET (rearranged during transfection) proteins driving certain cancers.
- It is approved in the US for adults with locally advanced or 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 needing systemic therapy; for adults and children 2 years and older with advanced or metastatic RET fusion-positive thyroid cancer that no longer responds to radioactive iodine; and for adults and children 2 years and older with locally advanced or metastatic RET fusion-positive solid tumours that have progressed on prior treatment or have no satisfactory alternative.
- All uses require a test confirming RET alteration in the tumour.
- Retevmo is supplied as both capsules (40 mg, 80 mg) and tablets (40, 80, 120, 160 mg); this listing is for the 80 mg capsule and the two formulations are not automatically interchangeable dose-for-dose without prescriber guidance.
Side Effects
- Very common effects (affecting more than 1 in 4 adults) include musculoskeletal pain, swelling (oedema), diarrhoea, tiredness, dry mouth, high blood pressure, stomach pain, rash, nausea, constipation, headache, vomiting, cough, shortness of breath and bleeding events.
- Laboratory changes are frequent too, including raised liver enzymes (ALT in over half of patients, some severe) and abnormal heart-rhythm findings (QT prolongation).
- Children have a broadly similar pattern, with musculoskeletal pain, diarrhoea, nausea, bleeding and fever most common.
- Serious but less frequent risks include severe hepatotoxicity (liver injury), clinically significant QT prolongation, major bleeding, and rare Stevens-Johnson syndrome (a severe skin reaction) reported after approval.
- There is no FDA boxed warning on the current Retevmo label.
- Seek urgent medical help for yellowing of the skin or eyes, severe bleeding, fainting, palpitations, or a blistering or peeling skin rash.
Precautions & Warnings
- Before and during Retevmo treatment, liver enzymes (ALT and AST) are checked regularly — before starting, every 2 weeks for the first 3 months, then monthly — and the dose may be reduced, paused or stopped for liver injury.
- An ECG is used to monitor heart rhythm because Retevmo can prolong the QT interval, and electrolytes (potassium, magnesium, calcium) are checked and corrected as needed; the drug is used with caution alongside other QT-prolonging medicines.
- Retevmo can cause serious bleeding and should be stopped permanently for severe or life-threatening haemorrhage.
- It can harm an unborn baby, so effective contraception is advised during treatment and for at least one week after the last dose for both female and male patients with partners of reproductive potential.
- Retevmo is taken by mouth at home, twice daily, exactly as prescribed.
Avoid Interactions
- Strong and moderate CYP3A4 inhibitors (such as certain antifungals, some antibiotics and HIV medicines) raise Retevmo levels and generally require a reduced Retevmo dose or should be avoided; strong CYP3A4 inducers (such as rifampin, carbamazepine and St John's Wort) lower Retevmo levels and reduce its effect, so they should be avoided.
- Retevmo can raise levels of other drugs that depend on CYP2C8, CYP3A, P-glycoprotein or BCRP for clearance, so doses of those medicines may need adjusting.
- Stomach-acid-reducing medicines — proton pump inhibitors, H2-blockers and antacids — can lower Retevmo absorption and require specific timing or taking Retevmo with food instead.
- Tell your healthcare provider about every prescription, over-the-counter medicine and supplement you take, and about any other medicine known to affect heart rhythm (QT interval).
References
Frequently Asked Questions
Retevmo (selpercatinib) treats certain RET-altered cancers: RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer, RET fusion-positive thyroid cancer, and other RET fusion-positive solid tumours. It is used in adults and, for most indications, children aged 2 and over, after a tumour test confirms a RET alteration.
Retevmo is taken by mouth, usually twice daily, as capsules or tablets, with or without food, exactly as your oncologist prescribes based on your body weight. Capsules come in 40 mg and 80 mg strengths; swallow them whole and do not switch between capsule and tablet forms without medical advice.
Very common Retevmo side effects include musculoskeletal pain, swelling, diarrhoea, fatigue, dry mouth, high blood pressure, and raised liver enzymes. Serious risks include liver injury, abnormal heart rhythm (QT prolongation) and bleeding. Get urgent help for yellowing skin, severe bleeding, fainting, or a blistering skin rash.
Avoid strong CYP3A4 inhibitors and inducers (some antifungals, antibiotics, HIV drugs, rifampin, St John's Wort) and space out acid-reducing medicines like PPIs and antacids, as they change Retevmo levels. Tell your care team about every medicine and supplement, and about anything affecting heart rhythm.
Yes. Liver enzymes are checked before starting Retevmo, every 2 weeks for the first 3 months, then monthly, because liver injury is common. Your provider also monitors your heart rhythm (ECG) and blood electrolytes, since Retevmo can prolong the QT interval on the heart's electrical tracing.
Retevmo can harm an unborn baby, so it is generally avoided in pregnancy. Effective contraception is recommended during treatment and for at least one week after the last dose, for patients and partners of reproductive potential. Discuss pregnancy plans and breastfeeding with your oncology team before starting.
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