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 locally advanced or metastatic non-small cell lung cancer with a rearranged during transfection gene fusion, as detected by an FDA-approved test.
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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 857 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
Chemical Structure
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).