Enatinib
Generic Name
Enatinib 10 mg capsule
Manufacturer
Taiho Oncology, Inc.
Country
United States
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| enatinib 10 mg capsule | ৳ 1,730.00 | N/A |
Description
Overview of the medicine
Enatinib is an oral targeted therapy indicated for the treatment of adult patients with rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) and RET fusion-positive thyroid cancer.
Uses & Indications
Dosage
Adults
Recommended dose is 400 mg orally once daily. Continue until disease progression or unacceptable toxicity.
Elderly
No specific dose adjustment recommended for elderly patients based on age alone.
Renal_impairment
No dose adjustment recommended for mild or moderate renal impairment. Severe renal impairment (CrCl <30 mL/min) or end-stage renal disease: reduce dose to 200 mg once daily.
How to Take
Take capsules orally once daily with or without food at approximately the same time each day. Swallow capsules whole. Do not open, chew, or crush capsules.
Mechanism of Action
Enatinib is a highly selective and potent oral inhibitor of rearranged during transfection (RET) receptor tyrosine kinase. It inhibits RET kinase activity and downstream signaling pathways, leading to inhibition of tumor cell proliferation and induction of apoptosis in RET fusion-positive cancer cells.
Pharmacokinetics
Onset
Not specified, but clinical responses observed within weeks.
Excretion
Mainly fecal (approx. 86%), minor renal (approx. 13%).
Half life
Approximately 20-25 hours (terminal half-life).
Absorption
Rapidly absorbed, Tmax 4-6 hours. Absolute bioavailability not determined.
Metabolism
Primarily metabolized by CYP3A4 and UGT1A1.
Side Effects
Contraindications
- No specific contraindications are listed by the manufacturer, but hypersensitivity reactions may occur.
Drug Interactions
UGT1A1 inhibitors
Monitor for increased enatinib exposure and potential toxicity.
Strong CYP3A inducers
Avoid coadministration. If unavoidable, consider increasing enatinib dose (e.g., to 600 mg daily) under close monitoring.
Strong CYP3A inhibitors
Avoid coadministration or reduce enatinib dose (e.g., to 200 mg daily).
Storage
Store at room temperature (20°C to 25°C; 68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep in the original container to protect from moisture. Keep out of reach of children.
Overdose
No specific antidote exists. In case of overdose, discontinue enatinib and provide supportive care. Monitor for adverse reactions.
Pregnancy & Lactation
May cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose. Advise against breastfeeding during treatment and for 1 week after the last dose due to potential for serious adverse reactions in breastfed infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Check specific product labeling for shelf life (typically 24-36 months).
Availability
Specialty pharmacies
Approval Status
FDA Approved
Patent Status
Patented
Clinical Trials
Approved based on results from the ARROW clinical trial (NCT03037385) in patients with RET fusion-positive NSCLC and advanced thyroid cancer, demonstrating significant overall response rates and duration of response.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) before initiation, every 2 weeks for the first 3 months, then monthly and as clinically indicated.
- Serum creatinine and electrolytes (e.g., potassium, magnesium) at baseline and periodically.
- Electrocardiograms (ECGs) at baseline, 8 days after first dose, and periodically, especially in patients with risk factors for QT prolongation.
- Thyroid stimulating hormone (TSH) at baseline and monthly, especially in patients with RET-fusion positive thyroid cancer.
Doctor Notes
- Confirm RET gene fusion status with an FDA-approved test prior to initiation.
- Careful monitoring of liver function, electrolytes, and ECG is essential due to potential adverse effects.
- Educate patients on potential adverse reactions and when to seek medical attention.
Patient Guidelines
- Take enatinib exactly as prescribed by your doctor.
- Do not open, crush, or chew the capsules. Swallow them whole.
- Inform your doctor about all medications, herbal products, and supplements you are taking.
- Report any new or worsening symptoms to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as possible on the same day. If more than 12 hours have passed or if the next dose is due, skip the missed dose and take the next scheduled dose. Do not take two doses at the same time to make up for a missed dose.
Driving Precautions
Enatinib may cause fatigue, dizziness, or visual disturbances. Advise patients to use caution when driving or operating machinery until they know how enatinib affects them.
Lifestyle Advice
- Maintain a healthy diet and stay hydrated.
- Avoid grapefruit products.
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Global Brand Names
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