Rx Product News (August 2020)

: GlaxoSmithKline for ViiV Healthcare

The FDA recently approved dolutegravir tablets for oral suspension to treat HIV-1 infection in combination with other antiretroviral treatments in children aged at least 4 weeks and weighing at least 6.61 lbs. The approval is based on a trial that included 75 adolescents, children, and infants with HIV-1 infection, and the efficacy and safety was determined to be comparable to that of adults receiving the drug. The most common adverse reactions in adult patients are fatigue, headache, and insomnia.

FOR MORE INFORMATION: viivhealthcare.com

INEBILIZUMAB-CDON (UPLIZNA)MANUFACTURED BY: Viela Bio, Inc

As a new treatment for neuromyelitis optica spectrum disorder in adults who are positive for anti-aquaporin-4 (AQP4) antibody, inebilizumab-cdon is the second approved treatment for this rare disorder that affects the optic nerves and spinal cord. The efficacy of the drug was established in a clinical study in which 77% of patients treated with inebilizumab-cdon saw a reduction of relapse. The most common adverse reactions found in the study included back and joint pain, headache, nausea, and urinary tract infection.

FOR MORE INFORMATION: vielabio.com

RELEBACTAM (RECARBRIO)MANUFACTURED BY: Merck Sharp & Dohme Corp

The FDA has approved a new indication for the imipenem-cilastatin and relebactam combination to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 and older. The drug was previously approved for patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options. The most common adverse reactions in patients with HABP/VABP included anemia, diarrhea, hypokalemia, and hyponatremia.

FOR MORE INFORMATION: merck.com

ELAGOLIX, ESTRADIOL, NORETHINDRONE ACETATE CAPSULES (ORIAHNN)MANUFACTURED BY: AbbVie Inc

The FDA has approved elagolix, estradiol, and norethindrone acetate capsules, an estrogen and progestin combination product, for the management of heavy menstrual bleeding associated with

uterine leiomyomas (fibroids) in premenopausal women. Fibroids are benign muscle tumors in the uterus that can cause bladder or bowel problems, heavy menstrual bleeding, infertility, and pain. In a study, 76.5% of patients who received the drug achieved a reduction of 50% or more in menstrual blood loss. The most common adverse effects were fatigue, headache, hot flushes, and irregular

vaginal bleeding.

FOR MORE INFORMATION: abbvie.com