Updates from FDA
APhA Staff
New Combination
AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE
(Voquezna Triple Pak—Phathom Pharmaceuticals, Inc.)
Drug class: Amoxicillin is a penicillin-class antibiotic, clarithromycin is a macrolide antibiotic, and vonoprazan is a potassium-competitive acid blocker.
Indication: Voquezna Triple Pak is indicated for the treatment of Helicobacter pylori infections in adult patients.
Recommended dosage and administration: The recommended dose contained in Voquezna Triple Pak is vonoprazan 20 mg plus amoxicillin 1,000 mg plus clarithromycin 500 mg taken by mouth twice daily for 14 days. The medications can be taken either with or without food; if a dose is missed, it should be taken within 4 hours of the scheduled dose that was missed. Voquezna Triple Pak is supplied as a copackage that contains dose packs for 14 days of treatment. The medications packaged in the dose pack are in the following dosage forms: 20 mg vonoprazan tablets, 500 mg amoxicillin capsules, and 500 mg clarithromycin capsules.
Important note: There is also a Voquezna Dual Pak available that only contains vonoprazan tablets and amoxicillin capsules; the dosage and administration for the Voquezna Dual Pak is different than the dosage and administration for the Voquezna Triple Pak. Before dispensing, ensure that the correct product is being dispensed and that the patient is receiving the correct dosing instructions.
Common adverse effects: Altered sense of taste, diarrhea, vulvovaginal yeast infection, headache, abdominal pain, increased blood pressure.
Warnings and precautions: Risk of hypersensitivity reactions, severe cutaneous adverse reactions, Clostridioides difficile–associated diarrhea, QT prolongation, liver toxicity, embryo-fetal toxicity, and exacerbation of myasthenia gravis.
New Dosage Form
EDARAVONE
(Radicava ORS—Mitsubishi Tanabe Pharma Corp.)
Drug class: Edaravone is a substituted 2-pyrazolin-5-one class medication. It is also known as an antioxidant; however, the exact mechanism of action is unknown.
Indication: Radicava ORS is indicated for the treatment of amyotrophic lateral sclerosis.
Recommended dosage and administration: Radicava ORS is supplied as a 105 mg/5 mL oral suspension. The recommended dose is 5 mL taken once daily. The medication can be taken either orally or given via a feeding tube, and it should be taken first thing in the morning on an empty stomach. Food should be avoided for at least one hour after administration. Treatment with Radicava starts with a 14-day treatment cycle and is followed by a 14-day treatment-free period. Subsequent cycles continue with dosing occurring for 10 days followed by 14 off days. Patients who are already using Radicava injection can switch to the oral suspension; see full prescribing information for instructions on how to switch between dosage forms.
Common adverse effects: Increased bruising, gait disturbances, headache.
Warnings and precautions: Risk of hypersensitivity reactions, risk of sulfite allergic reactions caused by sodium bisulfite ingredient.
New Molecular Entity
TIRZEPATIDE
(Mounjaro—Eli Lilly and Co.)
Drug class: Tirzepatide is a glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 (GLP-1) receptor agonist.
Indication: Mounjaro is indicated as an adjunct therapy for glycemic control in adult patients with type 2 diabetes.
Recommended dosage and administration: Mounjaro is administered as a subcutaneous injection once weekly. The initial dose is 2.5 mg and should be increased to 5 mg after 4 weeks of the 2.5 mg dose. Doses can be increased every 4 weeks by 2.5 mg
increments if additional glycemic control is necessary. Mounjaro is supplied as prefilled single-dose pens in 6 different strengths (2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL, and 15 mg/0.5 mL). The pen should be stored in the refrigerator prior to use but can be left at room temperature for up to 21 days. The liquid in the pen should be colorless to slightly yellow, not cloudy, free from particles, and not frozen. If the pen is dropped on a hard surface, it should be discarded and a new pen should be used due to the glass parts that are contained in the pen. See instructions for use for a visual example on how to counsel patients to use the pen.
Common adverse effects: Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, abdominal pain.
Black box warning: Mounjaro has caused thyroid C-cell tumors in rats but the risk to humans is not known yet; patients who have a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 should not use Mounjaro. All patients receiving Mounjaro should be counseled on the risk of MTC as well as what the symptoms of thyroid tumors are.
Other warnings and precautions: Risk of pancreatitis, hypoglycemia if used concomitantly with insulin, hypersensitivity reactions, acute kidney injury, gastrointestinal disease, and acute gallbladder disease.
TAPINAROF
(Vtama—Dermavant Sciences, Inc.)
Drug class: Tapinarof is an aryl-hydrocarbon receptor agonist.
Indication: Vtama is indicated for use in adult patients as a treatment for plaque psoriasis.
Recommended dosage and administration: Vtama is supplied as a 1% tapinarof topical cream. Vtama should be applied topically to the affected areas once daily. There is no specified duration of treatment, but in the clinical trial that gained Vtama its FDA approval it was used for up to 12 weeks. As with all topical applications, patients who use Vtama should wash their hands prior to and after application.
Common adverse effects: Folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Warnings and precautions: None listed in prescribing information.
New Formulation
TREPROSTINIL
(Tyvaso DPI—United Therapeutics Corp.)
Drug class: Treprostinil is a prostacyclin mimetic.
Indication: Tyvaso DPI is indicated to improve exercise ability in patients with pulmonary arterial hypertension and in patients with pulmonary hypertension associated with interstitial lung disease.
Recommended dosage and administration: Tyvaso DPI should be administered 4 times per day during waking hours, with each dose being administered approximately 4 hours apart. When patients are starting treatment with Tyvaso DPI, the initial dose is a 16 mcg dose 4 times a day. The target maintenance dose is generally 48 mcg or 64 mcg administered 4 times a day. Doses should be titrated up by 16 mcg increments every one to two weeks until the target dose is reached. Tyvaso DPI is supplied in kits that contain Tyvaso DPI Inhalers as well as single-dose cartridges that contain the inhalation powder. There are several different options for titration kits as well as maintenance kits. The cartridges are single-use cartridges that are placed into the Tyvaso DPI Inhaler prior to inhalation.
The Tyvaso DPI Inhalers are meant to be used for 7 days. After 7 days, the inhaler should be discarded, and a new inhaler should be used. Once the cartridge is placed into the inhaler, the dry powder is released into the inhaler—the patient should inhale slowly and deeply, and then hold their breath for as long as they can. Only one inhalation per cartridge is required to get the entire dose. Similar to other dry powder inhalers, the inhaler should not be turned upside down to prevent the medication from spilling out of the inhaler. The inhaler should not be washed with water and should only be wiped down with a dry towel if it gets dirty. See instructions for use for full visual demonstration of how to use the inhaler.
Common adverse effects: Cough, headache, throat irritation, nausea, flushing, difficulty breathing, and fainting.
Warnings and precautions: Increased risk of symptomatic hypotension, risk of bleeding due to inhibition of platelet aggregation, potential for bronchospasm, and potential for drug interactions with CYP2C8 inducers or inhibitors.
TECOVIRIMAT
(Tpoxx—SIGA Technologies, Inc.)
Drug class: Tecovirimat is an orthopoxvirus VP37 envelope wrapping protein inhibitor.
Indication: Tpoxx is indicated in adults and pediatric patients who weigh at least 3 kg to treat human smallpox disease.
Recommended dosage and administration: Tpoxx was previously approved in 2018 as an oral capsule. The new approval is for Tpoxx injection for intravenous infusion. For patients who weigh 3 kg to less than 35 kg, the dose is 6 mg/kg Tpoxx to be administered intravenously over 6 hours every 12 hours for 14 days. For patients who weigh 35 kg to less than 120 kg, the dose is 200 mg to be administered intravenously over 6 hours every 12 hours for 14 days. For patients who weigh 120 kg and more, the dose is 300 mg to be administered intravenously over 6 hours every 12 hours for 14 days. Tpoxx injection is supplied in single-dose 20 mL vials that contain 200 mg/20 mL of tecovirimat. See full prescribing information for information on sterile preparation for administration.
Common adverse effects: The most commonly reported adverse effects for the Tpoxx injection are administration site reactions and headache. The most commonly reported adverse effects for the Tpoxx capsules are headache, nausea, abdominal pain, and vomiting.
Warnings and precautions: Increased risk of hypoglycemia if coadministered with repaglinide. ■
Dupixent now approved for treatment of eosinophilic esophagitis
In late May 2022, FDA granted approval for Dupixent (dupilumab) for the treatment of eosinophilic esophagitis. Currently, it is the only FDA-approved treatment for this condition. The recommended dose for patients with eosinophilic esophagitis is a 300 mg subcutaneous injection given once weekly. The most commonly reported adverse effects in clinical trials for patients with eosinophilic esophagitis were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
Dietary supplement education initiative
On June 2, 2022, FDA launched the Supplement Your Knowledge initiative, which provides resources regarding dietary supplements for both the general public as well as for health care providers. The consumer/general public section has several different PDFs about understanding dietary supplements, how to talk to a health care provider about supplements, and how FDA works to keep consumers safe. There are also several videos that give overviews of dietary supplements and how they can interact with other medications. The health care provider website also offers several videos on what physicians should know about dietary supplements in addition to PDF handouts for physicians as well as pharmacists. For more information, see FDA’s Supplement Your Knowledge website.
COVID-19 vaccine update
As of May 17, 2022, the Pfizer-BioNTech COVID-19 vaccine is authorized to be given as a booster dose for children between the ages of 5 years and 11 years. The dose should be given at least 5 months after the primary series has been completed. This authorization is based on data collected from the ongoing clinical trial that showed an increased antibody level in children who received a booster dose 7 to 9 months after their initial dose when compared to antibody levels prior to being given the booster.