The 10 Latest Novel Drug Approvals
A roundup of the 10 most recent FDA-approved medications.
Tavalisse (fostamatinib disodium hexahydrate, Rigel)
Indications: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
Dosage: 100 mg orally twice daily with or without food. After four weeks, increase to 150 mg twice daily, if needed, to achieve platelet count at least 50 x 109/L as necessary to reduce the risk of bleeding.
Contraindications: None
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Ilumya (tildrakizumab-asmn, Sun Pharmaceuticals)
Indications: Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Dosage: 100 mg at weeks zero, four, and every 12 weeks thereafter.
Contraindications: Serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
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Crysvita (burosumab-twza, Ultragenyx Pharmaceutical)
Indications: Treatment of X-linked hypophosphatemia (XLH) in patients 1 year of age and older.
Dosage: Pediatric XLH: Starting dose regimen is 0.8 mg/kg of body weight rounded to the nearest 10 mg, administered every two weeks. Adult XLH: 1 mg/kg body weight rounded to the nearest 10 mg up to a maximum dose of 90 mg administered every four weeks.
Contraindications: Do not use Crysvita with oral phosphate and active vitamin D analogs. Do not initiate Crysvita if serum phosphorus is within or above the normal range for age. Contraindicated in patients with severe renal impairment or end stage renal disease.
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Akynzeo (fosnetupitant and palonosetron, Helsinn Therapeutics)
Indications: Akynzeo for injection is indicated in combination with dexamethasone in adults for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.
Dosage: One vial of Akynzeo for injection; reconstituted in 50 ml of 5% dextrose injection, USP, or 0.9% sodium chloride injection, USP, and administered as 30-minute infusion starting approximately 30 minutes prior to the start of chemotherapy.
Contraindications: None
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Lucemyra (lofexidine, US WorldMeds)
Indications: Mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.
Dosage: Three 0.18 mg tablets taken orally four times daily at five- to six-hour intervals.
Contraindications: None
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Aimovig (erenumab-aooe, Novartis and Amgen)
Indications: The preventive treatment of migraine in adults.
Dosage: 70 mg injected once monthly.
Contraindications: None
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Lokelma (sodium zirconium cyclosilicate, AstraZeneca)
Indications: The treatment of hyperkalemia in adults.
Dosage: 10 g administered three times a day for up to 48 hours.
Contraindications: None
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Doptelet (avatrombopag, Dova Pharmaceuticals)
Indications: Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Dosage: Patients with a platelet count of <40x109/L receive 60 mg for five days, patients with a platelet count between 40 and <50x109/L receive 40 mg for five days.
Contraindications: None
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Palynziq (pegvaliase-pqpz, BioMarin)
Indications: Reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.
Dosage: 2.5 mg subcutaneously once weekly for four weeks.
Contraindications: None
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Olumiant (baricitinib, Eli Lilly and Incyte Corporation)
Indications: The treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Dosage: 2 mg orally once daily
Contraindications: None
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