Updates from FDA
New drugs
ELAFIBRANOR
(Iqirvo—Ipsen Global)
Drug class: Iqirvo is a peroxisome proliferator-activated receptor agonist.
Indication: Iqirvo is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Recommended dosage and administration: Before beginning treatment, patients should be evaluated for muscle pain, myopathy, and pregnancy. The recommended dosage is 80 mg orally once daily with or without food.
Common adverse effects: The most common adverse reactions in patients taking Iqirvo are weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash.
Warnings and precautions: Use of Iqirvo is not recommended in patients who have or develop decompensated cirrhosis. Assess for muscle pain and myopathy prior to Iqirvo initiation. Consider periodic assessment and interrupt treatment if there is new or worsening muscle pain. The risk of fractures should be considered and current standards of care for assessing and maintaining bone health should be applied. Iqirvo may cause fetal harm. Advise patients of reproductive potential of the possible risk to a fetus and to use effective contraception.
Drug-induced liver injury can occur so obtain clinical and laboratory assessments at treatment initiation and monitor thereafter according to routine patient management. Interrupt the treatment if liver tests worsen, or patients develop signs and symptoms consistent with clinical hepatitis. Consider permanent discontinuation if liver tests worsen after restarting Iqirvo.
If severe hypersensitivity reactions occur, permanently discontinue Iqirvo. If a mild or moderate hypersensitivity reaction occurs, interrupt Iqirvo and treat promptly. Monitor until symptoms resolve. Avoid use in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt Iqirvo and treat as clinically indicated.
Monitor for signs and symptoms of muscle injury if taking Iqirvo concomitantly with HMG-CoA reductase inhibitors. Monitor the biochemical response when patients initiate rifampin during Iqirvo treatment. Administer Iqirvo at least 4 hours before or 4 hours after taking a bile acid–binding sequestrant, or at as great an interval as possible.
Patients should switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives and for at least 3 weeks after the last dose, as hormonal contraceptives may not be as effective during therapy. Advise patients not to breastfeed during treatment and for 3 weeks after the last dose of Iqirvo. Monitor patients with cirrhosis for evidence of decompensation. Consider discontinuation if the patient progresses to moderate or severe hepatic impairment.
SOFPIRONIUM
(Sofdra—Botanix Pharmaceuticals)
Drug class: Sofdra is an anticholinergic topical gel.
Indication: Sofdra is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years and older.
Recommended dosage and administration: The recommended dosage is 1 pump applied topically to each underarm once daily at bedtime.
Common adverse effects: The most common adverse reactions are dry mouth, blurred vision, application site pain, application site erythema, mydriasis, application site dermatitis, application site pruritus, urinary retention, and application site irritation.
Warnings and precautions: Use of Sofdra is contraindicated in medical conditions that can be exacerbated by the anticholinergic effect of the medication. Use with caution in patients with a history or presence of documented urinary retention. Discontinue use immediately and consult a health care provider should any signs or symptoms of urinary retention develop.
Watch for generalized lack of sweating when in hot or very warm environmental temperatures and avoid using Sofdra if not sweating under these conditions. Transient blurred vision may occur with use of Sofdra. If blurred vision occurs, discontinue use and avoid operating a motor vehicle or other machinery until symptoms resolve. Avoid coadministration of Sofdra with other anticholinergic medications as this may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration with drugs that are strong inhibitors of CYP2D6.
New dosage forms
TADALAFIL
(Chewtadzy—B Better LLC)
Drug class: Chewtadzy is a phosphodiesterase 5 inhibitor.
Indication: Chewtadzy is indicated for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.
Recommended dosage and administration: Chewtadzy should be chewed completely before swallowing and should not be swallowed whole. The recommended starting dosage for erectile dysfunction is 10 mg orally, taken prior to anticipated sexual activity, no more frequently than once daily. If needed, the dose can be increased to 20 mg or decreased to 5 mg, not more frequently than once daily.
For benign prostatic hyperplasia, the recommended dose is 5 mg orally once daily. When used concomitantly with finasteride, the recommended dosage is 5 mg orally once daily for up to 26 weeks. Chewtadzy should be taken at the same time daily.
If being used for both erectile dysfunction and benign prostatic hyperplasia, the recommended dosage is 5 mg orally once daily, at the same time daily, without regard to timing of sexual activity. Dosing modifications may be needed for patients with renal impairment, hepatic impairment, and those taking medications that may interact with Chewtadzy.
Common adverse effects: The most common adverse reactions are headache, dyspepsia, back pain, nasal congestion, flushing, and pain in limb.
Warnings and precautions: Use of Chewtadzy is contraindicated with concomitant use of any form of organic nitrate as the hypotensive effects of nitrates may be potentiated. Chewtadzy can also potentiate the hypotensive effects of a-blockers, antihypertensives, and alcohol.
Use is contraindicated with history of known serious hypersensitivity reaction to tadalafil or any component of Chewtadzy and with coadministration of guanylate cyclase stimulators, such as riociguat. Patients should not use Chewtadzy if sex is inadvisable due to cardiovascular status.
Patients should seek emergency treatment if an erection lasts greater than 4 hours. Chewtadzy should be stopped if sudden loss of vision occurs in one or both eyes. It should be used with caution and only when the anticipated benefits outweigh the risks in patients with a history of non-arteritic anterior ischemic optic neuropathy. Patients should stop Chewtadzy and seek prompt medical attention in the event of sudden loss of hearing.
THIOTEPA
(Tepylute—Shorla Oncology)
Drug class: Tepylute is an alkylating drug.
Indication: Tepylute is indicated for treatment of adenocarcinoma of the breast or ovary.
Recommended dosage and administration: The recommended dose of Tepylute is 0.3 mg/kg to 0.4 mg/kg intravenously.
Common adverse effects: The most common adverse reactions are neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria, and rash.
Boxed warning: Tepylute may cause severe marrow suppression or ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Tepylute is potentially carcinogenic in humans.
Other warnings and precautions: Use is contraindicated in patients with a history of hypersensitivity to the active substance and in concomitant use with live or attenuated vaccines. Cutaneous toxicity may occur so the skin should be cleansed at least twice daily through 48 hours after the last dose.
The PEG 400 load from concomitant medications should be considered to ensure PEG 400 toxicity is avoided. Advise patients of reproductive potential of the possible risk to a fetus and to use effective contraception. Advise patients not to breastfeed during treatment.
Patients with moderate or severe renal or hepatic impairment should be monitored frequently for toxicity.
New indications
LACOSAMIDE
(Motpoly XR—Aucta Pharmaceuticals)
Drug class: Lacosamide is an anticonvulsant.
Indication: Motpoly XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and pediatric patients weighing at least 50 kg.
Recommended dosage and administration: In adults, the initial dosage for monotherapy for the treatment of partial-onset seizures is 200 mg once daily and the initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures is 100 mg once daily. The maximum recommended dosage is 400 mg once daily.
In pediatric patients, the recommended dosage for both indications is 100 mg once daily. The dose can be increased based on clinical response and tolerability, no more frequently than once per week.
Dosing adjustments are recommended in severe renal impairment and mild or moderate hepatic impairment. Use is not recommended in individuals with severe hepatic impairment. Motpoly XR capsules should be swallowed whole with liquid. Do not open, chew, or crush the capsules.
Common adverse effects: The most common adverse effects are diplopia, headache, dizziness, nausea, and somnolence.
Warnings and precautions: Monitor patients for suicidal behavior and ideation. Motpoly XR can cause dizziness and ataxia.
Cardiac rhythm and conduction abnormalities may occur so obtaining an ECG before beginning and after titration to steady-state maintenance is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction. These patients should be closely monitored.
Syncope may occur. Discontinue therapy if drug reaction with eosinophilia and systemic symptoms occurs. Motpoly XR should be gradually withdrawn to minimize the potential of increased seizure frequency. Use in pregnancy may cause fetal harm. ■