Updates from FDA
New drugs
ELAGOLIX, ESTRADIOL, NORETHINDRONE ACETATE; ELAGOLIX
(Oriahnn—AbbVie)
Drug class: Gonadotropin-releasing hormone receptor agonist, estrogen and progestin co-formulation
Indication: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women
Recommended dosage: One capsule (elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) in the morning and one capsule (elagolix 300 mg) in the evening for up to 24 months
Common adverse effects: Hot flushes, headache, fatigue, metrorrhagia
Boxed warning: Increased risk of thromboembolic disorders and vascular events
Other warnings and precautions: Bone loss, suicidal ideation and mood disorders, hepatic impairment and transaminase elevations, elevated blood pressure, change in menstrual bleeding pattern and reduced ability to recognize pregnancy, risk of allergic reactions due to the inactive ingredient (FD&C Yellow No. 5)
Contraindications: High risk of arterial, venous thrombotic, or thromboembolic disorder, pregnancy, osteoporosis, current or history of breast cancer or other hormonally sensitive malignancies, liver impairment or disease, undiagnosed abnormal uterine bleeding, hypersensitivity to ingredients of the drug
RIPRETINIB
(Qinlock—Deciphera Pharmaceuticals)
Drug class: Kinase inhibitor
Indication: First new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST) in patients who have received prior treatment with 3 or more kinase inhibitors, including imatinib
Recommended dosage: 150 mg orally once daily with or without food
Common adverse effects: Alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, vomiting, increased lipase, decreased phosphate
Warnings and precautions: Palmar-plantar erythrodysesthesia syndrome, new primary cutaneous malignancies, hypertension, cardiac dysfunction, risk of impaired wound healing, embryo-fetal toxicity
Drug interactions: Avoid concomitant use of strong CYP3A inducers; monitor frequently during such use.
New indications
IMIPENEM, CILASTATIN, AND RELEBACTAM
(Recarbrio—Merck)
Drug class: Combination of penem antibacterial, renal dehydropeptidase inhibitor, and beta-lactamase inhibitor
Indication: Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients aged 18 years and older
Recommended dosage: Administer 1.25 grams by I.V. infusion over 30 minutes every 6 hours in patients with creatinine clearance 90 mL/min or greater.
Common adverse effects: Increased alanine aminotransferase, increased aspartate aminotransferase, anemia, diarrhea, hypokalemia, hyponatremia
Warnings and precautions: Hypersensitivity reactions to beta-lactam drugs, seizures and central nervous system adverse reactions, Clostridioides difficile–associated diarrhea
Drug interactions: Avoid concomitant use with ganciclovir, valproic acid, or divalproex sodium.
SOLIFENACIN SUCCINATE
(Vesicare LS oral suspension—Astellas Pharma US)
Drug class: Muscarinic antagonist
Indication: Treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older
Recommended dosage: The recommended once daily dose is based on patient weight. Dosing should be initiated at the recommended starting dose. Dosage may be titrated to the lowest effective dose but should not exceed the maximum recommended dose.
Common adverse effects: Constipation, dry mouth, and urinary tract infection
Warnings and precautions: Angioedema and anaphylactic reactions, urinary retention, GI disorders, central nervous system effects, controlled narrow-angle glaucoma, QT prolongation in patients at high risk of QT prolongation
Drug interactions: Do not exceed the recommended starting dose with concomitant use of strong CYP3A4 inhibitors.