Updates from FDA
New drugs
ENSIFENTRINE
(Ohtuvayre—Verona Pharm)
Drug class: Ohtuvayre is a phosphodiesterase 3 inhibitor and phosphodiesterase 4 inhibitor.
Indication: Ohtuvayre is indicated for the maintenance treatment of COPD in adult patients.
Recommended dosage and administration: The recommended dosage is 3 mg (one ampule) twice daily administered by oral inhalation using a standard jet nebulizer with a mouthpiece.
Common adverse effects: The most common adverse reactions include back pain, hypertension, UTI, and diarrhea.
Warnings and precautions: Ohtuvayre is contraindicated in patients with a hypersensitivity to ensifentrine or any component of this product. Ohtuvayre should not be used to treat acute symptoms of bronchospasm. If paradoxical bronchospasm occurs, Ohtuvayre should be discontinued and alternative therapy should be initiated. An increase in psychiatric adverse reactions, including suicidality, were reported with use of Ohtuvayre. The risks and benefits of treatment should be considered in patients with a history of depression, suicidal thoughts, or behavior. Ohtuvayre should be used with caution in individuals with hepatic impairment as ensifentrine exposure is increased in these patients.
DEURUXOLITINIB
(Leqselvi—Sun Pharmaceutical Industries)
Drug class: Leqselvi is a janus kinase inhibitor.
Indication: Leqselvi is indicated for the treatment of adults with severe alopecia areata.
Recommended dosage and administration: The recommended dosage is 8 mg orally twice daily.
Common adverse effects: The most common adverse reactions are headache, acne, nasopharyngitis, increased blood creatine phosphokinase, hyperlipidemia, increased weight, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes.
Boxed warning: There is an increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB), that may lead to hospitalization or death. Interrupt treatment with Leqselvi if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy and treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with an initial negative TB test. There is a higher rate of all cause mortality, including sudden cardiovascular death when Leqselvi is taken with another janus kinase inhibitor versus when Leqselvi is taken with a TNF blocker in patients with rheumatoid arthritis. There is also a higher rate of lymphomas, lung cancers, cardiovascular death, myocardial infarction, and death when taken with another janus kinase inhibitor versus with TNF blockers in patients with rheumatoid arthritis. Leqselvi is not approved for use in patients with rheumatoid arthritis. Malignancies and thrombosis have occurred in patients treated with Leqselvi. There is an increased incidence of pulmonary embolism and venous and arterial thrombosis when taken with another janus kinase inhibitor versus TNF blockers.
Other warnings and precautions: Leqselvi is not recommended for use in combination with other janus kinase inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. Leqselvi is contraindicated in patients who are CYP2C9 poor metabolizers and patients using moderate or strong CYP2C9 inhibitors. Monitor patients who may be at increased risk for GI perforation. Evaluate patients presenting with new onset abdominal symptoms promptly. Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Avoid use of live vaccines during or immediately prior to Leqselvi treatment. Breastfeeding is not recommended during treatment. Use is not recommended in severe renal or hepatic impairment.
New indications
VONOPRAZAN
(Voquezna—Phathom Pharmaceuticals)
Drug class: Voquezna is a potassium-competitive acid blocker.
Indication: Voquezna is indicated for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults, to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults, for the relief of heartburn associated with nonerosive gastroesophageal reflux disease in adults. Voquezna is also indicated in combination with amoxicillin and clarithromycin for the treatment of H. pylori infection in adults, and in combination with amoxicillin for the treatment of H. pylori infection in adults.
Recommended dosage and administration: Voquezna can be taken with or without food and should be swallowed whole. For the healing of erosive esophagitis, the recommended dosage is 20 mg once daily for 8 weeks. For maintenance of healed erosive esophagitis, the recommended dosage is 10 mg once daily for up to 6 months. For the relief of heartburn associated with nonerosive gastroesophageal reflux disease, the recommended dosage is 10 mg once daily for 4 weeks. For the treatment of H. pylori infection, the recommended dosage is 20 mg plus amoxicillin 1,000 mg and clarithromycin 500 mg, each given twice daily for 14 days or Voquezna 20 mg given twice daily plus amoxicillin 1,000 mg 3 times daily for 14 days.
Common adverse effects: The most common adverse reactions in patients treated with Voquezna are gastritis, diarrhea, abdominal distention, abdominal pain, nausea, dyspepsia, hypertension, UTI, constipation, dysgeusia, vulvovaginal candidiasis, and nasopharyngitis.
Warnings and precautions: Use is contraindicated in known hypersensitivity to vonoprazan or any component of Voquezna. It is also contraindicated in patients taking rilpivirine-containing products. Symptomatic response to treatment does not preclude the presence of gastric malignancy so additional follow-up and diagnostic testing should be considered. If acute tubulointerstitial nephritis occurs, discontinue treatment and evaluate patients. Voquezna may be associated with an increased risk of Clostridioides difficile-associated diarrhea. Use the shortest duration of treatment appropriate to the condition. Bone fractures, including osteoporosis-related fractures, may occur. Discontinue treatment at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. Long-term use may lead to malabsorption or deficiency of Vitamin B12. Consider monitoring magnesium and calcium levels in patients at risk for hypomagnesemia or hypocalcemia. Increased chromogranin A (CgA) levels may interfere with diagnostic investigations, temporarily stop Voquezna at least 4 weeks before assessing CgA levels. The risk of fundic gland polyps increases with long-term use of Voquezna. Breastfeeding is not recommended during treatment.
New dosage forms
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
(Femlyv—Millicent Pharma)
Drug class: Femlyv is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen.
Indication: Femlyv is indicated for use by females of reproductive potential to prevent pregnancy. The efficacy in females with a BMI of more than 35 kg/m2 has not been evaluated.
Recommended dosage and administration: The recommended dosage is one orally disintegrating tablet (ODT) taken at the same time daily without regard to meals. The ODT should be placed on the tongue, allowed to disintegrate, and then followed by 8 oz of water. The ODTs should be taken in the order directed on the blister pack.
Common adverse effects: The most common adverse reactions in clinical trials were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
Boxed warning: Women over 35 years old who smoke should not use Femlyv. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.
Other warnings and precautions: Femlyv is contraindicated in patients with a high risk of arterial or venous thrombotic diseases; breast cancer or a history of breast cancer; liver tumors, benign or malignant, or hepatic impairment; coadministration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; and undiagnosed abnormal uterine bleeding. Discontinue Femlyv if a thrombotic event occurs. Discontinue at least 4 weeks before through 2 weeks after major surgery.
Start no earlier than 4 weeks after delivery in women who are not breastfeeding. Consider all cardiovascular risk factors before initiating in any female, particularly in the presence of multiple risk factors. Monitor BP periodically and stop use if BP rises significantly. Do not prescribe for women with uncontrolled hypertension or hypertension with vascular disease. Evaluate significant changes in migraines and discontinue if new, recurrent, persistent, or severe migraines occur. Discontinue Femlyv if a hormonally sensitive malignancy is diagnosed. Discontinue use if jaundice or acute or chronic disturbance of liver function occurs. Monitor glucose in females with prediabetes and diabetes taking Femlyv. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia. Consider discontinuing Femlyv in females with symptomatic gallbladder or cholestatic disease. Evaluate irregular bleeding or amenorrhea.
Avoid concomitant use with CYP3A4 inducers as it may lead to contraceptive failure and increased breakthrough bleeding. If concomitant use is unavoidable, use a back up or alternative method of contraception during coadministration and for up to 28 days after discontinuation of the CYP3A4 inducer. Discontinue use if pregnancy occurs and advise postpartum patients that Femlyv can decrease milk production. ■