Updates from FDA
New formulation
NALOXONE HYDROCHLORIDE
(ZIMHI—Adamis Pharmaceuticals Corporation)
Drug class: Opioid antagonist.
Indication: Emergency treatment for known or suspected opioid overdose in adult and pediatric patients.
Recommended dosage and administration: ZIMHI is a single-dose syringe that is prefilled with 5 mg/0.5 mL of naloxone hydrochloride. Person receiving ZIMHI should be placed in a supine position, then injected into the anterolateral part of the thigh. It can either be administered intramuscularly or subcutaneously and can be injected through clothing if necessary. Like other naloxone products, emergency personnel should be called immediately after use. Additional doses may be administered every 2 to 3 minutes, if needed.
Common adverse effects: Nausea, dizziness, lightheadedness, elevated bilirubin.
Warnings and precautions: Increased risk of recurrent respiratory and CNS depression, limited efficacy if patient is using partial opioid agonists or mixed agonists/antagonists. May induce severe opioid withdrawal.
VARENICLINE TARTRATE
(TYRVAYA—Oyster Point Pharma)
Drug class: Cholinergic agonist.
Indication: Treatment of the signs and symptoms of dry eye disease.
Recommended dosage and administration: Sprayed into each nostril twice daily. Each actuation delivers a 0.03 mg/0.05 mL dose of varenicline.
Currently, it is supplied as a package of 2 amber vials, each containing a 15-day supply and must be primed 7 times prior to the first use. The bottle does not need to be primed prior to each use, but if it has been more than 5 days since the last spray it should be primed with one spray.
Common adverse effects: Sneezing, coughing, throat irritation, nose irritation.
Warnings and precautions: None.
New patient population
LACOSAMIDE
(VIMPAT—UCB)
Drug class: Antiepileptic.
Indication: VIMPAT was previously approved for patients 4 years and older for the treatment of partial-onset seizures as well as an adjunct therapy for primary generalized tonic-clonic seizures. In October 2021, FDA expanded use to patients aged 1 month and older for partial-onset seizures.
Recommended dosage and administration: Dose is dependent on age as well as indication. Additionally, pediatric dosing is based on weight. Patients will generally start with an initial dose and then titrate to a maintenance dose that is dependent on clinical response and patient tolerability. If titrating a dose, it should be done over a week.
See full prescribing information for doses and titration regimens for specific patient populations. VIMPAT is supplied as a film coated tablet for oral use, an oral solution, and an injection for intravenous use.
Both oral formulations can be taken with or without food. The tablet should not be split or crushed. Oral solution can be administered via a nasogastric tube or gastrostomy tube. Note: For adults with partial-onset seizures, doses higher than 400 mg per day did not show any clinical benefit and was associated with greater adverse effects.
Common adverse effects: Double vision, headache, dizziness, nausea, sleepiness.
Warnings and precautions: Patients should be counseled on and monitored for suicidal behavior and ideation. VIMPAT may cause dizziness and syncope. Patients with underlying proarrhythmic conditions or are concomitantly taking medications that affect cardiac conduction should receive a baseline ECG and be monitored regularly. If discontinuing VIMPAT therapy, dose should be slowly titrated down and not abruptly stopped. Increased risk of DRESS/multi-organ hypersensitivity.
New combination product
CELECOXIB AND TRAMADOL
HYDROCHLORIDE
(SEGLENTIS—Esteve)
Drug class: Nonsteroidal anti-inflammatory drug (celecoxib) and opioid agonist (tramadol).
Indication: Acute pain in adults where opioid use is warranted, and other treatments have not been adequate in reducing pain.
Recommended dosage and administration: Seglentis is supplied as coated tablets that contain celecoxib 56 mg and tramadol hydrochloride 44 mg. The dose is 2 tablets every 12 hours as needed for pain and should not be exceeded. Patients should not take other tramadol- or celecoxib-containing products while taking Seglentis.
Common adverse effects: Nausea, vomiting, dizziness, headache, sleepiness.
Boxed warning: Potential for addiction, abuse, or misuse. Increased risk of severe or life-threatening respiratory depression; patients should be monitored closely for initial 24 hours to 72 hours. Accidental ingestion by children may result in a fatal overdose. Contraindicated in coronary artery bypass surgery. NSAIDs increase risk of serious gastrointestinal adverse events (e.g., bleeding, ulceration). Contraindicated in children younger than 12 years old. Prolonged use in pregnancy may result in neonatal opioid withdrawal syndrome; avoid use in pregnant women. Significant CYP3A4 and CYP2D6 interactions; check for drug–drug interactions and weigh risk versus benefits when dispensing. Concomitant use of opioids with benzodiazepines or other CNS depressants may result in increased sedation, respiratory depression, or death.
Other warnings and precautions: Significant number of additional warnings and precautions, including risk of serotonin syndrome—see full prescribing information for all contraindications, warnings, and precautions.
New biosimilar
ADALIMUMAB-ADBM
(CYLTEZO—Boehringer Ingelheim)
Drug class: Tumor necrosis factor (TNF) inhibitor.
Indication: Cyltezo is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
In October 2021, Cyltezo was FDA-approved as the first interchangeable biosimilar to Humira. Although it has been FDA-approved, it likely will not become available until 2023.
Recommended dosage and administration: Cyltezo will be available as a single-dose, prefilled syringe and is administered via subcutaneous injection.
Common adverse effects: Infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, rash.
Boxed warning: Increased risk of serious infections (e.g., tuberculosis, bacterial sepsis). Patients should be tested for tuberculosis prior to initiation of treatment.
If a serious infection occurs, medication should be discontinued. Increased risk for lymphoma and other malignancies.
Other warnings and precautions: Cyltezo should not be initiated if patient has an infection.
Empiric antifungal therapy should be considered in patients who develop a systemic illness if they live in or travel to areas where mycoses are endemic. Potential for anaphylactic reaction to therapy. See package insert for full list of warnings and precautions.
Pfizer-BioNTech COVID-19 vaccine given EUA for children aged 5 to 11 years
In their press release, FDA listed key points for parents and caregivers, broken down into effectiveness and safety. The vaccine was found to be 90.7% effective in preventing COVID-19 in children aged 5 through 11 years old; as of late October, there had been no serious adverse effects from the over 3,000 children in this age range who received the vaccine. Children aged 5 through 11 years will receive a 2-dose series 3 weeks apart. The 10-microgram dose is lower than the 30-microgram dose administered to those 12 years and older. The most-reported adverse effects in the trial were injection site pain, redness and swelling, fatigue, headache, muscle/joint pain, chills, fever, swollen lymph nodes, nausea, and decreased appetite.
FDA updates compounding guidance for hospitals and health-systems
In 2016, FDA released a draft guidance document to address compounding that occurs prior to receiving a patient-specific prescription order in hospitals and health system pharmacies. The purpose of the document was to provide some flexibility to these pharmacies; however, in its original iteration it only allowed distribution of compounded products within a one-mile radius of the compounding pharmacy. After receiving and reviewing comments from different stakeholders, FDA has updated the draft guidance to remove the one-mile radius provision. The new draft “describes circumstances under which the agency generally does not intend to take action against a [non-outsourcing] hospital or health system pharmacy.” Additionally, any medication that is compounded prior to a patient-specific prescription may “be administered only to patients within the hospital or health system and the drugs are used or discarded within 24 hours of leaving the pharmacy.”