Updates from FDA
New drugs
PALOPEGTERIPARATIDE
(Yorvipath—Ascendis Pharma)
Drug class: Yorvipath is a parathyroid hormone analog.
Indication: Yorvipath is indicated for the treatment of hypoparathyroidism in adults.
Recommended dosage and administration: Use only one injection to achieve the once daily recommended dosage. The maximum recommended dose is 30 µg subcutaneously once daily. The dosage should be individualized based on serum calcium.
Common adverse effects: The most commons adverse reactions include injection site reactions, vasodilatory signs and symptoms, headache, diarrhea, back pain, hypercalcemia, and oropharyngeal pain.
Warnings and precautions: Yorvipath was not studied for acute postsurgical hypoparathyroidism. The titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment. Yorvipath is contraindicated in severe hypersensitivity to palopegteriparatide or any components of Yorvipath. Use only one daily Yorvipath injection. Using multiple injections to achieve the recommended daily dose increases the variability of the total delivered dose. Serious hypercalcemia and hypocalcemia have occurred with Yorvipath. Periodically measure serum calcium and monitor for signs and symptoms of hypocalcemia and hypercalcemia. Yorvipath is not recommended for patients at an increased risk of osteosarcoma. Orthostatic hypotension has been reported with use of Yorvipath. Monitor for signs and symptoms accordingly. Concomitant use with digoxin may predispose to digitalis toxicity if hypercalcemia develops. With concomitant use, frequently measure serum calcium and digoxin levels, and monitor for signs and symptoms of digoxin toxicity. When Yorvipath is used concomitantly with drugs known to affect calcium levels, measure serum calcium levels more frequently. Monitor breastfed infants for symptoms of hypercalcemia of hypocalcemia. Consider monitoring serum calcium in the breastfed infant.
LAZCLUZE
(Lazertinib—Janssen)
Drug class: Lazcluze is a kinase inhibitor.
Indication: Lazcluze is indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Recommended dosage and administration: The recommended dosage of Lazcluze is 240 mg orally once daily with or without food, given in combination with amivantamab. Continue treatment until disease progression or unacceptable toxicity occurs. Administer Lazcluze any time prior to amivantamab when given on the same day. Administer anticoagulant prophylaxis to prevent venous thromboembolic events for the first 4 months of treatment.
Common adverse effects: The most common adverse reactions in patients using Lazcluze in combination with amivantamab are rash, nail toxicity, infusion-related reactions, musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, ocular toxicity, decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium.
Warnings and precautions: Prophylactic anticoagulation is recommended for the first 4 months of treatment. Monitor for signs and symptoms of venous thromboembolism and treat as medically appropriate. Withhold therapy based on severity. Once anticoagulant treatment has been initiated, resume therapy at the same dose at the discretion of the health care provider. Permanently discontinue amivantamab and continue Lazcluze for recurrent venous thromboembolism despite therapeutic anticoagulation. Monitor for new or worsening symptoms indicative of interstitial lung disease or pneumonitis. Withhold Lazcluze and amivantamab in patients with suspected interstitial lung disease or pneumonitis and permanently discontinue if a definitive diagnosis is made. Lazcluze may cause severe rash including acneiform dermatitis. Administer alcohol-free emollient cream and encourage patients to limit sun exposure during and for 2 months after treatment to reduce the risk of dermatologic reactions. Withhold, reduce the dose, or permanently discontinue Lazcluze based on severity. Promptly refer patients with new or worsening signs and symptoms of ocular adverse reactions, including keratitis, to an ophthalmologist for evaluation. Withhold, reduce the dose, or permanently discontinue amivantamab and continue Lazcluze based on severity. Lazcluze can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. Avoid concomitant use with strong and moderate CYP3A4 inducers. Advise patients not to breastfeed during therapy.
VORASIDENIB
(Voranigo—Servier)
Drug class: Voranigo is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor.
Indication: Voranigo is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
Recommended dosage and administration: The recommended dosage in adults is 40 mg orally once daily. The recommended dosage in pediatric patients 12 years and older is based on body weight. In those greater than or equal to 40 kg, the recommended dose is 40 mg orally once daily and in those less than 40 kg, the recommended dose is 20 mg orally once daily. Voranigo can be taken with or without food.
Common adverse effects: The most common adverse reactions include fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, seizure, increased ALT and AST, increased GGT, and decreased neutrophils.
Warnings and precautions: Monitor liver function tests every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated. Withhold, reduce the dose, or discontinue Voranigo based on severity. Voranigo can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective nonhormonal contraception. Avoid concomitant use with strong and moderate CYP1A2 inhibitors or moderate CYP1A2 inducers and smoking tobacco. Avoid concomitant use with CYP3A substrates, where a minimal concentration change can reduce efficacy. If concomitant use with hormonal contraception cannot be avoided, use with nonhormonal contraception methods. Advise patients not to breastfeed during treatment. Voranigo may impair fertility in males and females.
New dosage forms
EPINEPHRINE NASAL SPRAY
(neffy—ARS Pharmaceuticals)
Drug class: neffy is an a- and b-adrenergic receptor agonist.
Indication: neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weight 30 kg or greater.
Recommended dosage and administration: The recommended dosage is one spray of neffy (2 mg of epinephrine) administered into one nostril. In absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the last dose. neffy is for nasal use only. Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required. It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times.
Common adverse effects: The most common adverse reactions are throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, oral hypoesthesia, nasal congestion, dizziness, nausea, and vomiting.
Warnings and precautions: Absorption of neffy may be affected by underlying structural and anatomical nasal conditions. Administer with caution in patients with heart disease as neffy may aggravate angina pectoris or produce ventricular arrhythmias. neffy may aggravate certain coexisting conditions. The presence of a sulfite in the product should not deter use. neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy. If neffy is administered to a patient taking cardiac glycosides, diuretics, or anti-arrhythmics, observe for development of cardiac arrhythmias. Tricyclic antidepressants, MAOIs, levothyroxine sodium, certain antihistamines, and catechol-O-methyl transferase inhibitors may potentiate effects of epinephrine. b-adrenergic blocking drugs antagonize cardiostimulating and bronchodilating effects of epinephrine. Drugs that are a-adrenergic blockers can antagonize the vasoconstricting and hypertensive effects of epinephrine. Ergot alkaloids may reverse the pressor effects of epinephrine. Older adult patients may be at greater risk of developing adverse reactions. ■