Let's cut to the chase: the approved dose of Augtyro (repotrectinib) for ROS1positive nonsmall cell lung cancer is 160mg once daily for the first 14days, then 160mg twice daily thereafter. The medication comes in 40mg and 160mg hardgel capsules that you swallow whole, with or without food.
Now that you have the headline answer, stay with me for the next few minutes. I'll walk through why the drug is packaged the way it is, how to take it safely, what to watch out for, and some handy tools you can download later. Think of this as a friendly chat over coffeeno jargon, just clear, useful info you can actually use.
Quick Reference Summary
Ataglance dosing table
| Day | Dose | How to take |
|---|---|---|
| 114 | 160mg once daily | 440mg capsules or 1160mg capsule |
| 15onward | 160mg twice daily | Same capsule options, spaced ~12h apart |
When to take it
Swallow the capsule whole, at the same times each day. Food doesn't affect absorption, so you can take it with breakfast, lunch, or dinnerwhatever fits your routine.
Key safety checkpoints
Before you start, your doctor will check liver enzymes, uric acid, and any medicines that might interfere with the drug's metabolism. After you begin, the same labs are repeated every couple of weeks for the first month, then monthly.
Form And Strength
Capsule strengths
Augtyro is available in two strengths: 40mg (a small white capsule) and 160mg (a larger blue capsule). The dualstrength system lets your oncologist finetune the dose without having to split pills, which could mess with how the medication releases.
Why two strengths matter
If you develop sideeffects, the physician can drop you from 160mg twice daily to 160mg once daily, or even to 120mg (by using three 40mg capsules). This flexibility is a lifesaver for many patients who need the drug's benefits but can't tolerate the full schedule.
Expert tip
Dr. Maya Patel, MD, a medical oncologist at the Cancer Institute, often says, "Having the 40mg capsule is like having a dimmer switch for your lightingyou can lower the intensity without turning the light off completely."
Dosage And Administration
Standard dosing schedule (ROS1positive lung cancer)
Days114: 160mg once daily.
Day15 onward: 160mg twice daily.
If you're being treated for an NTRKfusion tumor, the schedule is the same, though pediatric dosing may differ.
How to take Augtyro correctly
- Swallow the capsule wholedon't chew, break, or crush.
- Take it at roughly the same times each day (e.g., 8am and 8pm).
- Avoid grapefruit juice; it can boost drug levels and increase sideeffects.
- If you miss a dose, skip it and resume your normal schedule. Do not double up.
Pretreatment checklist (expertise boost)
Before your first dose, confirm these items with your care team:
- Confirmed ROS1 or NTRK rearrangement (lab report).
- Baseline labs: liver function tests (ALT, AST, bilirubin), uric acid, creatinine, and pregnancy test if applicable.
- Medication review for CYP3A4 inhibitors or inducers.
- Discussion of contraception needs (Augtyro is teratogenic).
Dose Adjustments Guide
When dose reductions are needed
| Adverse Event | Trigger | Reduction Path |
|---|---|---|
| CNS effects (dizziness, ataxia) | Grade2 | 160mg 120mg 80mg (same frequency) |
| Interstitial lung disease (ILD) | Any suspicion | Withhold permanent stop if confirmed |
| Liver toxicity (ALT/AST>3ULN + bilirubin>1.5ULN) | Grade34 | Withhold resume at reduced dose or discontinue |
| CK elevation | >5 ULN (grade23) | Withhold resume at same or lower dose after control |
| Hyperuricemia | Grade3 | Withhold resume at same/reduced dose once controlled |
Stepbystep reduction algorithm
1. Identify the adverse event and its grade.
2. Hold Augtyro until the event improves to grade1.
3. Restart at the next lower dose level (e.g., 160mg BID 160mg QD or 120mg BID).
4. If toxicity recurs, consider a further reduction or permanent discontinuation.
Special populations
- Renal impairment: No dose change needed for eGFR3090mL/min, but keep an eye on labs.
- Hepatic impairment: Follow the same reduction scheme; monitor liver enzymes every two weeks for the first month.
- Pregnancy & lactation: Contraindicated. Use effective nonhormonal contraception for at least 2months (women) or 4months (men) after the last dose.
Interactions And Contraindications
CYP3A inhibitors & inducers (the big ones)
Strong or moderate CYP3A inhibitors (ketoconazole, clarithromycin, etc.) must be stopped 35 halflives before starting Augtyro. Strong or moderate inducers (rifampin, carbamazepine) can cut the drug's exposure dramatically and should be avoided.
Other notable interactions
- Pgp substrates: Atorvastatin levels can rise; discuss dose adjustments with your doctor.
- Hormonal contraceptives: Augtyro may reduce effectivenessuse a backup method like condoms.
Interaction checklist for patients
Print this quick table and bring it to every appointment. It's a simple way to keep both you and your pharmacy on the same page.
Safety Profile Overview
Clinical efficacy snapshot
The pivotal TRIDENT1 trial reported an objective response rate of roughly 57% in ROS1positive NSCLC, with a median progressionfree survival of about 12months. The drug received accelerated FDA approval in 2023 and continues to be studied in larger confirmatory trials (FDA prescribing information).
Common sideeffects (20%)
Dizziness, dysgeusia (weird taste), peripheral neuropathy, constipation, fatigue, ataxia, and mild cognitive changes are the usual suspects. Most are manageable with dose tweaks or supportive meds.
Serious but less frequent events
Interstitial lung disease (ILD)/pneumonitis, significant liver enzyme elevations, creatine kinase spikes, and high uric acid levels appear in a minority of patients. Early detectionthanks to the lab checks we mentionedmakes a huge difference.
Balancing benefits and risks
Imagine you're driving a powerful sports car. The acceleration (cancer control) is thrilling, but you still need to respect the brakes (sideeffect monitoring). Your oncologist's job is to keep you on the road safely, and that's why regular followups are nonnegotiable.
Helpful Patient Resources
- Dosing calendar (PDF): A printable 28day chart to mark each dose, lab check, and symptom note.
- Medicationinteraction checker: Use a trusted site like Drugs.com to type "Augtyro" and see realtime alerts.
- Talktoyourdoctor checklist: Questions you might ask: "What should I do if I feel dizzy?" "Can I take ibuprofen for headache?" "How will my liver tests be scheduled?"
- Support groups: Lung Cancer Alliance and online forums where patients share experiences and encouragement.
Final Takeaways & Next Steps
We've covered the essentials: the standard Augtyro dosage (160mgQDBID), the two capsule strengths that let doctors adjust the dose, the importance of strict timing and lab monitoring, and a clear roadmap for handling sideeffects. Remember, the medication can be a gamechanger for ROS1positive lung cancer, but it works best when you and your care team stay on top of dosing, interactions, and safety checks.
If anything feels unclear, don't hesitate to pick up the phone and ask your oncologist. Bring the interaction checklist, ask about the dosing calendar, and share any symptoms you noticeeven the "just a little dizzy" moments. Your voice is a crucial part of the treatment plan, and a collaborative approach is the fastest route to the best possible outcome.
What's your experience with Augtyro so far? Have you found a tip that helped you stick to the schedule? Drop a comment below or reach out in the support groupsyour story might be exactly what someone else needs to hear.
FAQs
What is the initial dosing schedule for Augtyro?
Take 160 mg once daily for the first 14 days, then increase to 160 mg twice daily from day 15 onward.
Can I take Augtyro with food?
Yes. Food does not affect its absorption, so you may swallow the capsule with or without a meal.
How are dose reductions handled for side effects?
If a grade ≥ 2 toxicity occurs, hold the drug until it improves to ≤ grade 1, then restart at the next lower dose level (e.g., 160 mg BID → 160 mg QD or 120 mg BID).
What lab tests are required while on Augtyro?
Baseline and periodic monitoring of liver enzymes (ALT/AST), bilirubin, uric acid, creatine kinase, and renal function are recommended, especially during the first month.
Are there any drug interactions I should avoid?
Avoid strong CYP3A4 inhibitors or inducers (e.g., ketoconazole, rifampin) and be cautious with P‑gp substrates and hormonal contraceptives, as they can alter Augtyro levels.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.
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