Brand Name
Augtyro
Generic Name
Repotrectinib
View Brand Information FDA approval date: December 05, 2023
Classification: Kinase Inhibitor
Form: Capsule
What is Augtyro (Repotrectinib)?
AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer [see Dosage and Administration.
Approved To Treat
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Brand Information
Augtyro (repotrectinib)
1DOSAGE FORMS AND STRENGTHS
Capsules: 40 mg, white, opaque, immediate release, Size 0, hard shell capsule, filled with white to off-white powder which may appear as a plug, imprinted with “REP 40” in blue text on the cap.
Capsules: 160 mg, blue, opaque, immediate release, Size 0, hard shell capsule, filled with white to off-white powder which may appear as a plug, imprinted with “REP 160” in white text on the cap.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Central Nervous System Adverse Reactions
- Interstitial Lung Disease (ILD)/Pneumonitis
- Hepatotoxicity
- Myalgia with Creatine Phosphokinase Elevation
- Hyperuricemia
- Skeletal Fractures
- Embryo-Fetal Toxicity
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates reported in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in WARNINGS AND PRECAUTIONS and below reflects exposure to AUGTYRO in 426 patients with
The median age of patients who received AUGTYRO was 57 years (range: 18 to 93); 59% female; 43% White, 47% Asian, 2.8% Black, 0.5% Native Hawaiian or Other Pacific Islander, 0.5% American Indian or Alaska Native, 6.1% race not reported or other, and 0.7% unknown.
Serious adverse reactions occurred in 35% of patients who received AUGTYRO. Serious adverse reactions in ≥2% of patients included pneumonia (6.3%), dyspnea (3.1%), pleural effusion (2.8%), and hypoxia (2.6%). Fatal adverse reactions occurred in 3.5% of patients who received AUGTYRO, including pneumonia, pneumonia aspiration, cardiac arrest, sudden cardiac death, cardiac failure, hypoxia, dyspnea, respiratory failure, tremor, and disseminated intravascular coagulation.
Permanent discontinuation of AUGTYRO due to an adverse reaction occurred in 7% of patients. There were no specific adverse reactions that accounted for ≥1% of permanent discontinuations.
Dosage interruptions of AUGTYRO due to an adverse reaction occurred in 50% of patients. Adverse reactions that required dosage interruption in ≥2% of patients were dizziness, dyspnea, muscular weakness, ataxia, pneumonia, peripheral neuropathy, anemia, and vomiting.
Dose reductions of AUGTYRO due to an adverse reaction occurred in 38% of patients. Adverse reactions that required dosage reductions in ≥2% of patients included dizziness, ataxia, muscular weakness, peripheral neuropathy, and cognitive impairment.
The most common (≥20%) adverse reactions that occurred in patients receiving AUGTYRO were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscular weakness and nausea.
Table 3 summarizes the adverse reactions that occurred in TRIDENT-1.
Clinically relevant adverse reactions occurring in <10% of patients receiving AUGTYRO were pyrexia (9.2%) and fall (3.8%).
Table 4 summarizes the laboratory abnormalities in TRIDENT-1.
4DESCRIPTION
Repotrectinib is a kinase inhibitor. The molecular formula for repotrectinib is C
Repotrectinib is a white to off-white powder.
AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 40 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, and colloidal silicon dioxide.
The white opaque capsule shell contains gelatin and titanium dioxide. The printing ink contains shellac and FD & C blue #2 aluminum lake.
AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 160 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, and colloidal silicon dioxide.
The blue opaque capsule shell contains gelatin, titanium dioxide and FD & C blue #1. The printing ink contains shellac and titanium dioxide.
5HOW SUPPLIED/STORAGE AND HANDLING
AUGTYRO (repotrectinib) 40 mg, Size 0, white opaque cap, white opaque body, hard shell capsules, filled with a white to off-white powder which may appear as a plug, imprinted with “REP 40” in blue text on the cap are supplied as follows:
- Bottles of 60 capsules (NDC 0003-4040-60)
- Bottles of 120 capsules (NDC 0003-4040-12)
AUGTYRO (repotrectinib) 160 mg, Size 0, blue opaque cap, blue opaque body, hard shell capsules, filled with a white to off-white powder which may appear as a plug, imprinted with “REP 160” in white text on the cap are supplied as follows:
- Bottles of 14 capsules (NDC 0003-4160-14)
- Bottles of 60 capsules (NDC 0003-4160-60)
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)
6PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
Central Nervous System (CNS) Effects
- Advise patients to inform their healthcare provider if they experience new or worsening CNS symptoms. Instruct patients not to drive or operate hazardous machinery if they are experiencing CNS adverse reactions
Interstitial Lung Disease (ILD)/Pneumonitis
- Advise patients to inform their healthcare provider if they experience new or worsening pulmonary symptoms indicative of ILD/pneumonitis
Hepatotoxicity
- Advise patients of the need for laboratory tests to monitor liver function and to immediately report symptoms of hepatotoxicity
Myalgia with Creatine Phosphokinase Elevation
- Advise patients to inform their healthcare provider if they experience muscle pain
Hyperuricemia
- Advise patients to inform their healthcare provider if they experience signs or symptoms associated with hyperuricemia
Skeletal Fractures
- Inform patients that bone fractures have occurred in patients taking AUGTYRO and advise patients to report symptoms to their healthcare provider
Embryo-Fetal Toxicity
- Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective non-hormonal contraception during treatment with AUGTYRO and for 2 months after the last dose, since AUGTYRO can render some hormonal contraceptives ineffective
- Advise male patients with female partners of reproductive potential to use effective contraception during treatment with AUGTYRO and for 4 months after the last dose
Lactation
- Advise females not to breastfeed during treatment with AUGTYRO and for 10 days after the last dose
Drug Interactions
- Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products
- Advise patients to avoid grapefruit or grapefruit juice while taking AUGTYRO
- Advise patients that hormonal contraceptives can be ineffective while taking AUGTYRO
Administration
- Advise patients to swallow AUGTYRO capsules whole with or without food
- Instruct patients if they miss a dose, or vomit at any time after taking a dose of AUGTYRO, not to “make it up,” but take the next dose of AUGTYRO at the next scheduled time
For more information, go to www.AUGTYRO.com or call 1-877-284-8976.
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AUGTYRO
7PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0003-4160-14
AUGTYRO
NDC 0003-4160-14
AUGTYRO
NDC 0003-4040-60
AUGTYRO
NDC 0003-4040-60
AUGTYRO
NDC 0003-4040-12
AUGTYRO
