• Drug Coverage
  • Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Pulmonary Arterial Hypertension
  • Safety & Recalls
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • Type I Diabetes
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Breast Cancer
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

Bayer Recalls One Lot of Vitrakvi Because of Contamination


Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.

Contamination with Penicillium brevicompactum seen during routine ongoing stability testing has led Bayer to recall one lot of Vitrakvi (larotrectinib) oral solution.

Vitrakvi is indicated to treat patients with solid tumors that are NTRK gene fusion positive. Patients who are immunocompromised may be at risk for invasive fungal infections of the blood or pneumonia that can be life-threatening. In a statement, Bayer said there is little data on Penicillium brevicompactum, but there have been cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression.

To date, Bayer has not received any reports of adverse events.

The impacted lot of Vitrakvi is packaged in a 100mL glass bottle with NDC 50419-392-01. The lot number 2114228 with an expiration date of February 29, 2024. This lot was distributed to wholesale distributors and specialty pharmacies nationwide between Jan. 3, 2023, and Feb. 13, 2023.

Qualanex is managing the recall.

Related Videos
Expert on Hematology/Oncology
Related Content
© 2024 MJH Life Sciences

All rights reserved.