Brand Name
Retevmo
Generic Name
Selpercatinib
View Brand Information FDA approval date: May 08, 2020
Classification: Kinase Inhibitor
Form: Tablet, Capsule
What is Retevmo (Selpercatinib)?
RETEVMO™ is a kinase inhibitor indicated for the treatment of: Adult patients with metastatic RET fusion-positive non-small cell lung cancer 1.
Approved To Treat
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Brand Information
RETEVMO (selpercatinib)
1DOSAGE FORMS AND STRENGTHS
Capsules:
- 40 mg: gray opaque capsule imprinted with “Lilly”, “3977” and “40 mg” in black ink.
- 80 mg: blue opaque capsule imprinted with “Lilly”, “2980” and “80 mg” in black ink.
Tablets:
- 40 mg: light gray, film coated, round tablet debossed with “Ret 40” on one side and “5340” on the other side.
- 80 mg: dark red-purple, film coated, round tablet debossed with “Ret 80” on one side and “6082” on the other side.
- 120 mg: light purple, film coated, round tablet debossed with “Ret 120” on one side and “6120” on the other side.
- 160 mg: light pink, film coated, round tablet debossed with “Ret 160” on one side and “5562” on the other side.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hepatotoxicity
- Interstitial Lung Disease / Pneumonitis
- Hypertension
- QT Interval Prolongation
- Hemorrhagic Events
- Hypersensitivity
- Tumor Lysis Syndrome
- Risk of Impaired Wound Healing
- Hypothyroidism
- Slipped Capital Femoral Epiphysis/Slipped Upper Femoral Epiphysis in Adolescent Patients
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed 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 safety population described in the WARNINGS and PRECAUTIONS and below reflects exposure to RETEVMO as a single agent administered at 160 mg orally twice daily evaluated in 796 patients with advanced solid tumors in LIBRETTO-001
3.2Postmarketing Experience
The following adverse reaction has been identified during post-approval use of RETEVMO. Because such reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: Stevens-Johnson Syndrome
4DESCRIPTION
RETEVMO contains selpercatinib, a kinase inhibitor. The molecular formula for selpercatinib is C
Selpercatinib is a white to light yellow powder that is slightly hygroscopic. The aqueous solubility of selpercatinib is pH dependent, from sparingly soluble at low pH to practically insoluble at neutral pH.
RETEVMO capsules contain either 40 mg or 80 mg of selpercatinib in hard gelatin capsules for oral use. Each capsule contains inactive ingredients of colloidal silicon dioxide and microcrystalline cellulose. The 40 mg capsule shell is composed of gelatin, titanium dioxide, ferric oxide black and black ink. The 80 mg capsule shell is composed of gelatin, titanium dioxide, FD&C blue #1 and black ink. The black ink is composed of shellac, potassium hydroxide and ferric oxide black.
RETEVMO tablets contain 40 mg, 80 mg, 120 mg, or 160 mg of selpercatinib as film coated, debossed tablets for oral use. Each tablet contains inactive ingredients of croscarmellose sodium, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating material contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating of the 40 mg, 80 mg, and 120 mg tablets contains ferrosoferric oxide and the film coating of the 80 mg, 120 mg, and 160 mg tablets contain ferric oxide.
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hepatotoxicity
Advise patients that hepatotoxicity can occur and to immediately contact their healthcare provider for signs or symptoms of hepatotoxicity
Interstitial Lung Disease (ILD)/Pneumonitis
Advise patients that ILD/ pneumonitis can occur and to contact their healthcare provider immediately for signs or symptoms of ILD including new or worsening cough or shortness of breath
Hypertension
Advise patients that they will require regular blood pressure monitoring and to contact their healthcare provider if they experience symptoms of increased blood pressure or elevated readings
QT Prolongation
Advise patients that RETEVMO can cause QTc interval prolongation and to inform their healthcare provider if they have any QTc interval prolongation symptoms, such as syncope
Hemorrhagic Events
Advise patients that RETEVMO may increase the risk for bleeding and to contact their healthcare provider if they experience any signs or symptoms of bleeding [
Hypersensitivity Reactions
Advise patients to monitor for signs and symptoms of hypersensitivity reactions, particularly during the first month of treatment
Tumor Lysis Syndrome
Advise patients to contact their healthcare provider promptly to report any signs and symptoms of TLS
Risk of Impaired Wound Healing
Advise patients that RETEVMO may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure
Hypothyroidism
Advise patients that RETEVMO can cause hypothyroidism and to immediately contact their healthcare provider for signs or symptoms of hypothyroidism
Slipped Capital Femoral Epiphysis/Slipped Upper Femoral Epiphysis
Advise pediatric patients and caregivers to contact their healthcare provider promptly to report any signs and symptoms indicative of slipped capital femoral epiphysis/slipped upper femoral epiphysis
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the possible risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy
Advise females of reproductive potential to use effective contraception during the treatment with RETEVMO and for 1 week after the last dose
Advise males with female partners of reproductive potential to use effective contraception during treatment with RETEVMO and for 1 week after the last dose
Lactation
Advise women not to breastfeed during treatment with RETEVMO and for 1 week after the last dose
Infertility
Advise males and females of reproductive potential that RETEVMO may impair fertility
Drug Interactions
Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Inform patients to avoid St. John's wort, proton pump inhibitors, H2 receptor antagonists, and antacids while taking RETEVMO.
If PPIs are required, instruct patients to take RETEVMO with food. If H2 receptor antagonists are required, instruct patients to take RETEVMO 2 hours before or 10 hours after the H2 receptor antagonist. If locally-acting antacids are required, instruct patients to take RETEVMO 2 hours before or 2 hours after the locally-acting antacid
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 2020, 2025, Eli Lilly and Company. All rights reserved.
Pat.: www.lilly.com/patents
RET-0009-USPI-20251120