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Updates from FDA
Roger Selvage 1150

Updates from FDA

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New & Approved

New drugs



Drug class: Ritlecitinib is a kinase inhibitor.

Indication: Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. It is not recommended for use in combination with other Janus kinase inhibitors (JAK inhibitors), biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Recommended dosage and administration: The recommended dosage is 50 mg orally once daily.

Common adverse effects: The most common adverse reactions are headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increase, herpes zoster, red blood cell count decrease, and stomatitis.

Boxed warning: There is an increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death, including tuberculosis. Interrupt treatment if serious infection occurs until the infection is controlled. Litfulo should not be given to patients with active tuberculosis. Test for latent tuberculosis before and during therapy and start treating latent tuberculosis prior to use. Monitor all patients for active tuberculosis during treatment, even patients with initial negative latent tuberculosis test. Monitor all patients for signs and symptoms of infection during and after treatment with Litfulo. There is a higher rate of all-cause mortality, including sudden CV death with another JAK inhibitor versus tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. Litfulo is not approved for use in patients with rheumatoid arthritis. Malignancies were reported in patients treated with Litfulo. There is a higher rate of lymphomas and lung cancers with another JAK inhibitor versus TNF blockers in patients with rheumatoid arthritis. There is a higher rate of major adverse CV events with another JAK inhibitor versus TNF blockers in patients with rheumatoid arthritis. Thrombosis has occurred in patients treated with Litfulo. There is an increased incidence of pulmonary embolism, and venous and arterial thrombosis with another JAK inhibitor versus TNF blockers.

Other warnings and precautions: Litfulo is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients. Discontinue Litfulo if a clinically significant hypersensitivity reaction occurs. Perform an absolute lymphocyte count (ALC) and platelet count prior to Litfulo initiation. Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities. Avoid use of live vaccines during or shortly prior to Litfulo treatment. If taken concomitantly with certain CYP3A substrates or certain CYP1A2 substrates, additional monitoring and dose adjustments of the substrate should be considered. Coadministration with strong inducers of CYP3A is not recommended. Breastfeeding is not recommended. The use of Litfulo in severe hepatic impairment is not recommended.

New indications



Drug class: Liletta is a progestin-containing intrauterine system.

Indication: Liletta is indicated for prevention of pregnancy for up to 8 years and treatment of heavy menstrual bleeding for up to 5 years in patients who choose intrauterine contraception as their method of contraception.

Recommended dosage and administration: The initial release rate of levonorgestrel is approximately 20 μg/day and declines progressively to approximately 6.5 μg/day after 8 years. Liletta can be removed at any time but must be removed by the end of the eighth year. Liletta should be inserted into the uterine cavity with the provided inserter by a trained health care professional using aseptic technique. Follow insertion instructions exactly as described. Re-examination and evaluation should be considered 4 to 6 weeks after insertion and during routine care, or more often if clinically indicated.

Common adverse effects: The most common adverse reactions reported in clinical studies were vulvovaginal mycotic infections, vaginal bacterial infections, acne, and nausea or vomiting.

Warnings and precautions: Liletta is contraindicated in pregnancy, congenital or acquired uterine anomaly that distorts the uterine cavity and would be incompatible with correct intrauterine system placement; acute pelvic inflammatory disease; postpartum endometritis or infected abortion in the past 3 months; known or suspected uterine or cervical malignancy; known or suspected breast cancer or other hormone-sensitive cancer; uterine bleeding of unknown etiology; untreated acute cervicitis, vaginitis, or other lower genital tract infections; acute liver disease or liver tumor; increased susceptibility to pelvic infections; a previously inserted intrauterine system that has not been removed; and hypersensitivity to any component of Liletta. Additionally, Liletta should not be used for postcoital or emergency contraception. Remove Liletta if pregnancy occurs with Liletta in place and Liletta is in the uterus. If pregnancy occurs, there is increased risk of ectopic pregnancy, pregnancy loss, septic abortion, and premature labor and delivery. Severe infection or sepsis, including Group A streptococcal sepsis, have been reported following insertion of levonorgestrel-releasing intrauterine systems. Strict aseptic technique is essential during insertion. Before using Liletta, consider the risks of pelvic infection. Perforation may occur and reduce contraceptive effectiveness or require surgery. Risk is increased if inserted in patients who have fixed retroverted uteri, are postpartum, or are lactating. Partial or complete expulsion may occur. Evaluate persistent enlarged ovarian follicles or ovarian cysts. Bleeding patterns can become altered, may remain irregular, and amenorrhea may ensue.



Drug class: Bylvay is an ileal bile acid transporter.

Indication: Bylvay is indicated for the treatment of pruritus in patients 3 months and older with progressive familial intrahepatic cholestasis (PFIC) and the treatment of cholestatic pruritus in patients 12 months and older with Alagile syndrome (ALGS).

Recommended dosage and administration: For use in PFIC, the recommended dosage is 40 μg/kg taken orally once daily in patients 3 months and older. If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 μg/kg increments up to 120 μg/kg once daily, not to exceed a daily dosage of 6 mg/day. For use in ALGS, the recommended dosage is 120 μg/kg taken orally once daily. Administer Bylvay in the morning with a meal. Do not crush or chew the capsules.

Common adverse effects: The most common adverse reactions are liver test abnormalities, diarrhea, abdominal pain, vomiting, fat-soluble vitamin deficiency, hematoma, and decreased weight.

Warnings and precautions: Based on animal data, use of Bylvay during pregnancy may cause cardiac malformations. Obtain baseline liver tests and monitor patients during treatment. Dose reduction or treatment interruption may be required if abnormalities occur. For persistent or recurrent liver test abnormalities, consider treatment discontinuation. Treat dehydration. Treatment interruption or discontinuation may be required for persistent diarrhea. Obtain baseline levels of fat-soluble vitamins and monitor during treatment. Supplement if deficiency is observed. If deficiency persists or worsens despite supplementation, discontinue treatment.

New combinations


(Suflave—Braintree Labs)

Drug class: Suflave is an osmotic laxative.

Indication: Suflave is indicated for cleansing of the colon in preparation for colonoscopy in adults.

Recommended dosage and administration: Administration of two doses of Suflave is required for a complete preparation for colonoscopy. One dose of Suflave is equal to one bottle plus one flavor-enhancing packet. Each bottle must be reconstituted with water before ingestion. An additional 16 oz of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. The recommended split-dose regimen consists of two doses over 2 days. The evening before colonoscopy, one bottle with the flavor-enhancing packet should be ingested. On the morning of the colonoscopy, 5–8 hours prior to the colonoscopy and no sooner than 4 hours from the first dose, one bottle with the flavor-enhancing packet should be ingested.

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

Warnings and precautions: Suflave is contraindicated in patients with a GI obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, or hypersensitivity to any ingredient in Suflave. Adequate hydration should be encouraged, concurrent medications should be assessed, and laboratory assessments should be considered prior to and after each use and there is risk of fluid and electrolyte abnormalities. Consider predose and postcolonoscopy ECGs in patients at increased risk of cardiac arrhythmias. Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. Consider potential for ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. Use caution, ensure adequate hydration, and consider laboratory testing in patients with renal impairment or taking concomitant medications that affect renal function. If a GI obstruction or perforation is suspected, rule out the diagnosis before administration. Observe patients at risk for aspiration during administration. Inform patients to seek immediate medical care if symptoms of hypersensitivity reactions, including anaphylaxis, occur. ■

Also in this issue

FDA approves new buprenorphine treatment option for OUD (see "New buprenorphine treatment option")



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