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Updates from FDA
Roger Selvage 828

Updates from FDA

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New & Approved

New drugs

QUIZARTINIB

(Vanflyta—Daiichi Sankyo, Inc.)

Drug class: Vanflyta is a kinase inhibitor.

Indication: Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and with cytarabine consolidation, plus as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication (ITD)–positive as detected by an FDA-approved test. Vanflyta is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation.

Recommended dosage and administration: Vanflyta tablets should be taken orally once daily with or without food at approximately the same time each day. A treatment course consists of up to 2 cycles of Vanflyta in combination with induction cytarabine and anthracycline, up to 4 cycles of Vanflyta in combination with high-dose cytarabine consolidation, and up to 36 cycles of Vanflyta as maintenance therapy or until disease progression or unacceptable toxicity. The recommended dosage varies based on the phase of therapy. See the full prescribing information for recommended Vanflyta dosage regimen and dosage modifications.

Common adverse effects: The most common adverse reactions are decreased lymphocytes, decreased potassium, decreased albumin, decreased phosphorus, increased alkaline phosphatase, decreased magnesium, febrile neutropenia, diarrhea, mucositis, nausea, decreased calcium, abdominal pain, sepsis, neutropenia, headache, increased creatine phosphokinase, vomiting, and upper respiratory tract infection.

Boxed warning: Vanflyta prolongs the QT interval. Prior to administration and periodically, perform electrocardiograms, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Torsades de pointes and cardiac arrest have occurred in patients receiving Vanflyta. Do not administer Vanflyta to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome. Do not initiate treatment with Vanflyta or escalate the Vanflyta dose if the QT interval corrected by the Fridericia formula is greater than 450 ms. Monitor electrocardiograms more frequently if concomitant use of drugs known to prolong the QT interval is required. Reduce the Vanflyta dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure. Vanflyta is only available through a restricted program called the Vanflyta REMS.

Other warnings and precautions: Vanflyta is contraindicated in patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes. Monitor electrocardiograms and levels of serum electrolytes. Reduce, interrupt, or permanently discontinue Vanflyta as appropriate. Vanflyta can cause fetal harm. Advise patients of reproductive potential and patients with partners of reproductive potential of the potential risk to a fetus and to use effective contraception. Patients should be advised not to breastfeed while using Vanflyta. If used concomitantly with strong CYP3A inhibitors, reduce the Vanflyta dose. Avoid concomitant use with strong or moderate CTP3A inducers.

LOTILANER OPHTHALMIC SOLUTION

(Xdemvy—Tarsus Pharmaceuticals, Inc.)

Drug class: Xdemvy is an ectoparasiticide.

Indication: Xdemvy is indicated for the treatment of Demodex blepharitis.

Recommended dosage and administration: The recommended dosage is one drop in each eye twice daily and approximately 12 hours apart for 6 weeks.

Common adverse effects: The most common adverse reaction is instillation site stinging and burning.

Warnings and precautions: There are no other warnings or precautions.

New indications

TRIFLURIDINE AND TIPIRACIL

(Lonsurf—Taiho Oncology)

Drug class: Lonsurf is a combination of trifluridine (a nucleoside metabolic inhibitor) and tipiracil (a thymidine phosphorylase inhibitor).

Indication: Lonsurf is indicated for the treatment of adult patients with metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if renin-angiotensin-system wild-type, an anti-EGFR therapy. Lonsurf is also indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate HER2/neu-targeted therapy.

Recommended dosage and administration: The recommended dosage is 35 mg/m2/dose orally twice daily with food on days 1–5 and days 8–12 of each 28-day cycle.

Common adverse effects: The most common adverse reactions are neutropenia, anemia, thrombocytopenia, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, pyrexia, increased AST, increased ALT, increased alkaline phosphatase, and decreased appetite.

Warnings and precautions: Obtain complete blood counts prior to and on day 15 of each cycle as severe myelosuppression may occur. Withhold and resume at the next-lower Lonsurf dosage as recommended. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. Advise patients not to breastfeed. Thrombocytopenia may be more likely to occur in patients 65 years or older. Do not initiate Lonsurf in patients with baseline moderate or severe hepatic impairment. Reduce Lonsurf dose in patients with severe renal impairment.

ROSUVASTATIN

(Ezallor Sprinkle—Sun Pharmaceutical Industries Ltd.)

Drug class: Rosuvastatin is an HMG-CoA reductase inhibitor.

Indication: Ezallor is indicated for adult patients with hypertriglyceridemia as an adjunct to diet, adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet, and adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and Apolipoprotein B. Ezallor has not been studied in Fredrickson Type I and V dyslipidemias.

Recommended dosage and administration: The recommended dosage is 5 mg to 40 mg once daily. Use 40 mg dose only for patients not reaching their LDL-C goal with 20 mg. For adult HoFH, the starting dose is 20 mg once daily. Ezallor can be taken with or without food at any time of day.

Common adverse effects: The most common adverse reactions are headache, myalgia, abdominal pain, asthenia, and nausea.

Warnings and precautions: Ezallor is contraindicated in known hypersensitivity to product components, active liver disease which may include unexplained persistent elevations in hepatic transaminase levels, pregnancy, and lactation. Advise patients of reproductive potential to use effective contraception during treatment with Ezallor. In severe renal impairment in patients not on hemodialysis, the starting dose is 5 mg, not to exceed 10 mg. In the Asian population, consider a 5 mg starting dose. Skeletal muscle effects may occur. The risks increase with use of a 40 mg dose; advanced age; hypothyroidism; renal impairment; and combination use with cyclosporine, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue Ezallor if signs or symptoms appear. Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before initiating therapy and as clinically indicated thereafter. Combination use with cyclosporine increases rosuvastatin exposure, so the Ezallor dose should be limited to 5 mg once daily. Combination use with gemfibrozil should be avoided.

If used together, limit Ezallor dose to 10 mg once daily. Combination use with atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir increases rosuvastatin exposure. Limit Ezallor dose to 10 mg once daily. Combination use with coumarin anticoagulants prolongs the international normalized ratio (INR). Achieve stable INR prior to starting Ezallor. Monitor INR frequently until stable upon initiation or alteration of Ezallor therapy. Use with fibrates or lipid-modifying doses of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with Ezallor. ■

RX to OTC Switch

Opill is a daily oral contraceptive that was approved by FDA for OTC status in July 2023. Opill is a progestin-only pill that works by thickening the cervical mucus, which helps to block sperm from getting to the egg. Patients should take one tablet at the same time every day. It is not approved for use as an emergency contraceptive. Patients should not use Opill if they are allergic to any of the ingredients contained in it, including FD&C Yellow No. 5 (tartrazine). People allergic to aspirin often have a tartrazine allergy, too. Symptoms may include hives, facial swelling, asthma, shock, skin reddening, rash, and blisters. Additionally, patients should not use Opill if they have ever had breast cancer; are already pregnant; or are concomitantly using another birth control pill, vaginal ring, patch, implant, injection, or intrauterine device. Patients should be advised to use a condom, or another barrier method, every time they have sex during the first 2 days of use. It takes 48 hours for this product to begin working. ■

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