Updates from FDA
New drugs
INAVOLISIB
(Itovebi—Genentech)
Drug class: Itovebi is a kinase inhibitor.
Indication: Itovebi is indicated in combination with palbociclib and fulvestrant for the treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, as detected by an FDA test, following recurrence on or after completing adjuvant endocrine therapy.
Recommended dosage and administration: Select patients for treatment with Itovebi based on the presence of one or more PIK3CA mutations in plasma specimen. The recommended dosage is 9 mg orally once daily with or without food. Reduce the starting dose in patients with moderate renal impairment. Dosage modifications may be needed due to adverse reactions.
Common adverse effects: The most common adverse reactions are decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, stomatitis, diarrhea, decreased calcium, fatigue, decreased potassium, increased creatinine, increased ALT, nausea, decreased sodium, decreased magnesium, rash, decreased appetite, COVID-19 infection, and headache.
Warnings and precautions: Itovebi can cause hyperglycemia. Initiate or optimize antihyperglycemic medications as clinically indicated. Interrupt, reduce dose, or discontinue Itovebi if severe hyperglycemia occurs. Stomatitis can occur. Consider treating patients with a corticosteroid-containing mouthwash if stomatitis occurs. Withhold, reduce dose, or permanently discontinue Itovebi based on severity. Itovebi can cause diarrhea, which may be severe, and result in dehydration and acute kidney injury. Advise patients to start antidiarrheal treatment, increase fluids, and notify their health care provider if severe diarrhea occurs. Interrupt, reduce dose, or discontinue Itovebi if severe diarrhea occurs. Advise patients that Itovebi may cause fetal harm and to use effective nonhormonal contraception. Advise patients not to breastfeed during treatment.
SULOPENEM ETZADROXIL
AND PROBENECID
(Orlynvah—Iterum Therapeutics)
Drug class: Sulopenem etzadroxil is a penem antibacterial and probenecid is a renal tubular transport inhibitor.
Indication: Orlynvah is indicated for the treatment of uncomplicated UTIs caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. It is not indicated for the treatment of complicated UTIs or complicated intra-abdominal infections or as step-down treatment after I.V. antibacterial treatment of complicated UTIs or complicated intra-abdominal infections.
Recommended dosage and administration: Orlynvah should only be used to treat infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce the development of drug-resistant bacteria and maintain the drug’s effectiveness. Culture and susceptibility information should be utilized in selecting or modifying antibacterial therapy. The recommended dosage of Orlynvah is one tablet orally twice daily for 5 days. Administration with food is recommended.
Common adverse effects: The most common adverse reactions are diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting.
Warnings and precautions: Orlynvah is contraindicated in patients with a history of hypersensitivity to the components of Orlynvah or other b-lactam antibacterial drugs, patients with blood dyscrasias, patients with uric acid kidney stones, and concomitant use with ketorolac tromethamine. Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, have been reported with b-lactam drugs and probenecid. If an allergic reaction occurs, discontinue the drug and institute appropriate therapy. Evaluate patients for Clostridioides difficile–associated diarrhea if diarrhea occurs. When prescribing Orlynvah to patients with a known history of gout, ensure appropriate therapy of gout is instituted. Concomitant use with ketoprofen is not recommended.
FLURPIRIDAZ F 18
(Flyrcado—GE Healthcare)
Drug class: Flyrcado is a radioactive diagnostic drug.
Indication: Flyrcado is indicated for PET myocardial perfusion imaging under rest or stress in adult patients with known or suspected coronary artery disease to evaluate for myocardial ischemia and infarction.
Recommended dosage and administration: Administer Flyrcado via I.V. infusion. When rest and stress imaging are conducted on the same day, the recommended administered activities are 93 MBq to 111 MBq for rest imaging, 222 MBq to 241 MBq for pharmacologic stress imaging and 333 MBq to 352 MBq for exercise stress imaging. When rest and stress imaging are conducted over 2 days, the recommended rest and stress administered activities, for both pharmacologic and exercise stress, are 93 MBq to 111 MBq.
Common adverse effects: The most common adverse effects are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.
Warnings and precautions: Serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizures may occur with exercise or pharmacologic stress. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. Ensure safe handling of Flyrcado to minimize radiation exposure to patients and health care providers. Patients should temporarily discontinue breastfeeding. Breastmilk should be pumped and discarded for at least 8 hours after Flyrcado administration.
MARSTACIMAB-HNCQ
(Hympavzi—Pfizer)
Drug class: Hympavzi is a tissue factor pathway inhibitor antagonist.
Indication: Hympavzi is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors.
Recommended dosage and administration: The recommended dosage of Hympavzi is a 300 mg (two 150 mg S.C. injections) loading dose. One week after the loading dose, initiate maintenance dosing of 150 mg every week by S.C. injection on the same day each week, at any time of day. Dose adjustments to 300 mg weekly can be considered. Factor VIII and IX inhibitors can be administered for the treatment of breakthrough bleeds in patients receiving Hympavzi. Do not use additional doses of Hympavzi to treat breakthrough bleeds. Temporarily discontinue Hympavzi before major surgeries.
Common adverse effects: The most common adverse effects are injection site reaction, headache, and pruritus.
Warnings and precautions: Thromboembolic events may occur. Interrupt Hympavzi prophylaxis if symptoms occur. Hypersensitivity reactions may occur. In the event of a severe allergic reaction, discontinue Hympavzi. Advise patients of reproductive potential that Hympavzi may cause fetal harm and to use effective contraception.
New dosage forms
FOSCARBIDOPA AND
FOSLEVODOPA INJECTION
(Vyalev—Abbvie)
Drug class: Foscarbidopa is an aromatic amino acid decarboxylation inhibitor, and foslevodopa is an aromatic amino acid.
Indication: Vyalev is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
Recommended dosage and administration: Vyalev is for S.C. administration only, preferably in the abdomen, via the Vyafuser pump. The maximum recommended daily dosage is 3,525 mg of foslevodopa (approximately 2,500 mg levodopa). Information for calculating the base continuous dosage, hourly infusion rate, optional loading dose, and extra dose can be found in the full prescribing information of the package insert. Vyalev is packaged as 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL.
Common adverse effects: The most common adverse reactions include infusion/catheter site reactions, infusion/catheter site infections, hallucinations, and dyskinesia.
Warnings and precautions: Vyalev is contraindicated in patients who are currently taking a nonselective MAOI or have taken one in the previous 2 weeks. Vyalev may cause drowsiness or falling asleep during activities of daily living. Hallucinations and psychosis may respond to a dose reduction. Consider dose reductions or stopping treatment with Vyalev if impulse control behaviors occur. Monitor patients for infusion site reactions and infections and follow aseptic techniques while using this medication. Frequent rotation of the infusion site is recommended to reduce the risk of infection. Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion. Vyalev may cause or exacerbate dyskinesia. Consider dose reductions as needed. Concomitant use with selective MAO-B inhibitors may cause orthostatic hypertension. Concomitant use with antihypertensive drugs may cause symptomatic postural hypotension. Dosage adjustment of the antihypertensive agent may be needed. Dopamine D2 receptor antagonists and isoniazid may reduce the effectiveness of Vyalev. Based on animal data, Vyalev may cause fetal harm. ■