New Naloxone Spray Approved

The U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals’ Naloxone Nasal Spray, 4mg, on March 7, 2023. It was approved as a new formulation, not a generic because it has a patented delivery device. An opioid agonist, naloxone provides temporary reversal of opioid overdoses in emergency settings. One dose (one spray) of naloxone should be given as soon as an overdose is observed or suspected, based on the patient’s breathing difficulty and/or unconsciousness. Emergency medical help should be requested immediately after the first spray. If needed, one additional spray can be given every two to three minutes until professional assistance arrives. In the U.S., naloxone nasal spray, 4mg, can be dispensed without a prescription or it can be prescribed for a caregiver of an at-risk patient, depending on state regulations. Naloxone nasal spray, 4mg, is available as the branded drug, Narcan® and in generic forms. A higher-strength formulation, Kloxxado® (naloxone nasal spray, 8mg) presently has no generic equivalents. Amphastar’s product will be available in boxes containing two single-dose sprays. Its distribution, launch, and pricing plans have not been announced. Check here to see prescribing information for Amphastar’s product.

Emerphed Receives FDA Approval for New Dose Form

Emerphed^® (ephedrine injection) has been FDA-approved for a prefilled syringe form. It is indicated to treat patients whose blood pressure falls significantly while they are under anesthesia. A dose of either 5mg or 10mg is given intravenously (IV) all at once. Additional doses may be given, if needed, to an upper limit of 50mg. Available in two strengths, 25mg/5mL and 50mg/20mL, the single-dose, prefilled syringes are packaged individually or in cartons of 10. The manufacturer, Nexus Pharmaceuticals, launched them upon approval. Emerphed has been available in ready-to-use, single-dose vials for several years. Its prescribing information is here.

Extended Indication for Verzenio

Eli Lilly and Company received FDA approval on March 3, 2023, to expand the indications for Verzenio^® (abemaciclib) tablets. Initially approved in 2017 to treat certain types of metastatic breast cancer, it was given further approval in 2021 to treat early breast cancer (EBC) that is hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) and node-positive; that is highly likely to recur and that reaches at least 20% on the Ki-67 scale, a measure of cell multiplication. Now, the Ki-67 requirement no longer is needed. However, to qualify for its use patients who have HR+, HER2- EBC must have four or more lymph nodes that are positive for cancer cells or at least one positive lymph node and tumors that are five cm or larger and/or that are graded at three or above. Verzenio selectively inhibits cyclin-dependent kinases (CDK) 4 and 6 (CDK4/6), enzymes that promote the proliferation and spread of cancer cells. For its new indication, it is used along with tamoxifen or an aromatase inhibitor, such as anastrozole, exemestane, or letrozole; at a dose of 150mg twice a day. Because Verzenio may damage the liver and interfere with blood cell formation, patients should have baseline liver function tests and complete blood counts (CBC), followed by the same tests every two weeks for the first eight weeks, every four weeks for the next eight weeks and then regularly while treatment continues. Severe diarrhea that Verzenio may cause could lead to dehydration. Taking it could be associated with interstitial lung disease or pneumonitis and it could increase the risk of blood clots. Look here for complete prescribing information.

Auto-Injector Approved for Udenyca

The FDA approved single-dose, prefilled auto-injectors forUdenyca^® (pegfilgrastim-cbqv – Coherus BioSciences) on March 3, 2023. As a biosimilar to Amgen’s Neulasta^®, it is injected subcutaneously (SC) to decrease the risk of infections for patients who receive cancer drugs that interfere with the bone marrow’s production of blood cells and that are associated with a clinically significant incidence of febrile neutropenia, an adverse effect of some chemo. It also is approved to raise the chances of surviving Hematopoietic Subsyndrome of Acute Radiation Syndrome, a result of exposure to radiation high enough or long enough to depress bone marrow activity. Recommended adult dosing is 6mg once during each chemo cycle or two doses of 6mg each one week apart for radiation exposure. Doses for pediatric patients who weigh less than 45kg (99 pounds) are based on weight. Udenyca has been available in the U.S. for several years in single-dose prefilled syringes. It is not interchangeable with Neulasta or any of the other pegfilgrastim biosimilars that also are marketed in the U.S. For revised prescribing information, look here.

New Route of Administration for Some Merck Vaccines

On March 6, 2023, Merck revealed that the FDA had approved intramuscular (IM) dosing for its M-M-R^®II(measles, mumps, and rubella virus vaccine live), Varivax^® (varicella virus vaccine live) and ProQuad^® (measles, mumps, rubella, and varicella virus vaccine live). All three have been available in SC form for years, all can be used for patients as young as one year old and all need two doses – the first at 12 months to 15 months of age and the second between four years and six years of age. For patients who are 13 years old or older and who were not vaccinated against varicella previously, two injections of Varivax are administered one month apart. ProQuad should not be used for patients who are 12 years old or older. Because they use live virus particles, none of the vaccines should be given to individuals who have immunocompromising conditions. Here is prescribing information for M-M-R, here for Varivax, and here for ProQuad.

First Generic for Pylera

One of Endo International’s companies, Par Pharmaceuticals, introduced bismuth subcitrate potassium 140mg/metronidazole 125mg/tetracycline hydrochloride 125mg capsules to the U.S. market after FDA approval on March 6, 2023. The first generic for Pylera^® (Aptalis Pharma), it is taken to eliminate Helicobacter pylori infection for treating duodenal ulcer disease. Patients take three capsules after each meal and at bedtime (a total of 12 capsules) each day for 10 days. It can be used alone or taken with 20mg of omeprazole twice a day after morning and evening meals. Individuals should not drink alcohol or take the medication disulfiram during the use of the product. A boxed warning cautions that some laboratory animals exposed to metronidazole developed cancer, but that effect has not been proven for humans. IQVIA estimates that sales of Pylera amounted to about $30 million for the calendar year 2022.

MedWatch Update

Food Allergen Skin Tests

The FDA issued a safety communication on March 3, 2023, about extracts that are used to test patients for food allergies. Some patients experienced anaphylaxis (severe allergic reactions) when they were exposed to peanuts after testing negative for peanut allergies when specific lots of ALK-Abello’s allergenic extract – peanut (Arachis hypogaea) were used. The company withdrew the lots that were involved. Because extracts used for food allergy testing in the U.S. are not standardized, their strengths may vary between different manufacturers and even between different lots from the same company. Currently, no way exists to determine their strengths. Some patients who test negative actually may be sensitive to an allergen, if the extract is not strong enough to produce a response. The FDA now is requiring all extract manufacturers to add warnings about the possibility of false negative results in the prescribing information for all their products. Health professionals are being advised to consider other types of testing for patients who have negative skin tests, but who are suspected of being allergic to the specific food. More information is in the FDA’s notice.