FDA Approved Drugs: January 2021

The Express Scripts Office of Clinical Evaluation and Policy lists the drugs that were approved by the Food and Drug Administration (FDA) in December 2020.
FDA Update

Xolair Receives Additional FDA Approval

The FDA approved Genentech’s monoclonal antibody, Xolair® (omalizumab), for a third indication on Nov. 30, 2020. The new approval is to treat adults who have nasal polyps that have not responded to nasally inhaled corticosteroids. By blocking immunoglobulin E (IgE), Xolair reduces inflammation. While steroid therapy continues, Xolair will be administered by a healthcare provider as a subcutaneous (SC) injection once every two weeks or once every four weeks. Doses vary based on the patient’s weight and IgE blood levels. Injections must be given in a healthcare facility staffed and equipped to manage emergencies because Xolair may cause anaphylaxis (severe allergic reactions), as described in a boxed warning on its labeling. Patients should stay under observation at the provider site for enough time after each injection to be sure no reaction will occur. Originally indicated to treat patients at least six years old for persistent allergic asthma that resists inhaled corticosteroid treatment, Xolair has an additional FDA approval for patients age 12 and older who have hives due to chronic idiopathic urticaria (CIU) that has not responded adequately to antihistamines. Look here for complete prescribing information.

New Indications for Gavreto

First FDA approved in September 2020 for treating adults who have metastatic non-small lung cancer (NSCLC) that is positive for mutations in the rearranged during transfection (RET+) gene, Gavreto (pralsetinib) capsules, was granted an additional approval on Dec. 1, 2020. A targeted kinase inhibitor, Gavreto selectively blocks overactive RET signals, without changing the activity of other kinases. It now is indicated for patients 12 years old and older who need systemic treatment for metastatic or progressed RET+ medullary thyroid cancer (MTC) or for RET+ thyroid cancer that cannot be treated by radioactive iodine. About 53,000 Americans are diagnosed with thyroid cancer every year. The four major types of thyroid cancer (anaplastic, follicular, medullary and papillary) are determined by how the cells look under a microscope. Follicular and papillary types are very similar, slow-growing tumors that together make up around 90% of all thyroid cancers. RET fusions are found in between 10% and 20% of papillary thyroid cancers. MTC accounts for only about 5% of thyroid cancers, but 60% to 90% of patients with MCT have RET mutations. To treat one of the RET+ thyroid cancers, Gavreto’s recommended dose is 400mg (four capsules) once every day at least two hours after and one hour before eating. The manufacturer, Blueprint Medicines, co-markets Gavreto with Genentech. A similar drug, Retevmo (selpercatinib – Loxo Oncology) capsules was FDA approved on May 8, 2020, for treating RET+ NSCLC, as well as for the same thyroid cancers as Gavreto. The two medications had comparable results in clinical trials. Complete prescribing information for Gavreto is here.

Hetlioz Gets New Indication and New Dosage Form

Hetlioz® (tasimelteon – Vanda Pharmaceuticals) has been approved by the FDA as the first drug to treat irregular sleep patterns resulting from Smith-Magenis Syndrome (SMS). The new indication was granted on Dec. 1, 2020, the same day that a new liquid formulation, Hetlioz LQ™ oral suspension, also was FDA approved. A rare genetic condition that affects behavior, growth and learning; SMS generally is caused by spontaneous mutations in the RAI1 gene. Approximately one person in 15,000 to 25,000 is estimated to have the disorder. Patients who have SMS usually have difficulty sleeping at night. To help normalize sleep timing, patients between the ages of three and 16 and who weigh at least 28kg (about 62 pounds) will take 0.7mg/kg of liquid Hetlioz; patients age 16 and older will take one 20mg capsule. All doses should be at the same time every evening – approximately one hour before the patient’s bedtime. The two dosage forms are not interchangeable and children should not take Hetlioz capsules. Vanda plans to release the 4mg/mL oral suspension on the U.S. market in the first quarter of 2021. The capsule formulation also has FDA approval to treat Non-24-Hour Wake-Sleep disorder (Non-24), a chronic sleep disturbance that affects most individuals who are totally blind. See prescribing information for both forms of Hetlioz here.

Orladeyo Approved to Prevent Hereditary Angioedema Episodes

Orladeyo™ (berotralstat) capsules was approved by the FDA on Dec. 3, 2020. It is the first oral drug indicated to prevent attacks of hereditary angioedema (HAE) for patients who are at least 12 years old. HAE is a rare, inherited disease caused by a deficiency of the C1 inhibitor protein. Between 6,000 and 10,000 Americans are affected, according to the U.S. Hereditary Angioedema Association. About two-thirds of patients have HAE symptoms by the time they reach their teens. Other C1 esterase inhibitors approved to prevent HAE attacks must be given by IV infusions or SC injections. At a recommended daily dose of 150mg for most patients, Orladeyo  decreases blood levels of kallikrein, an enzyme involved in promoting pain and swelling caused by HAE. The manufacturer, BioCryst, expects to release Orladeyo in the U.S. before the end of 2020 at a wholesale acquisition cost (WAC) cost of $37,308 for a carton containing 28 capsules of either 150mg or 110mg, the recommended daily dose for patients who have liver conditions, who take certain other medications or who experience severe gastrointestinal (GI) side effects. Check here for complete prescribing information.

FDA Approves New Age Range for Saxenda  

Novo Nordisk’s glucagon like peptide 1 (GLP-1) receptor agonist, Saxenda® (liraglutide) injection, was FDA approved on Dec. 4, 2020, for use by patients as young as 12 years old. It will supplement a reduced-calorie diet and increased exercise for adolescents who weigh 60kg (about 120 pounds) or more and who are considered to be obese compared to others of the same age and gender. Available in 3mL pre-filled syringes that contain 18mg of Saxenda for SC injection, it can be administered by the patient or a caregiver. Recommended dosing starts at 0.6mg daily for seven days. Then, the daily dose is increased by 0.6mg to 1.2mg/day for the second week, 1.8mg/day for the third and 2.4mg/day for the fourth. Beginning with the fifth week of treatment, the daily maintenance dose is 3mg. In clinical studies, some teens had GI side effects -- such as diarrhea, nausea and vomiting -- at the 3mg/day dose, so doses may need to be lowered if side effects are intolerable. Patients also should be watched for signs of serious allergic reactions, gallbladder attacks, heart rate irregularities, kidney damage, excessively low blood sugar and pancreatitis during treatment. First FDA approved for adult weight management six years ago, Saxenda also has been marketed at a lower dose and under the name Victoza® since January 2010, to treat type 2 diabetes. Saxenda is not FDA approved to treat any type of diabetes. GLP-1 agonists may cause some types of thyroid tumors, so they all have boxed warnings against their use by patients or close relatives of patients who have medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). Here is Saxenda’s full, updated prescribing information.

Januvia Products

In a Safety Communication released on Dec. 4, 2020, the FDA authorized labeling changes for Merck’s dipeptidyl peptidase-4 (DPP-4) inhibitors, Januvia® (sitagliptin), Janumet® (sitagliptin/metformin) and Janumet® XR (sitagliptin/metformin extended release), against their use in pre-teens and adolescents. All are approved – along with dietary changes and increased activity – to treat adult patients who have type 2 diabetes. However, additional studies did not find effectiveness for any of the drugs in treating patients between the ages of 10 and 18 for type 2 diabetes. In three clinical trials, none of the drugs was statistically more successful than placebo at improving hemoglobin A1c (HbA1c) levels following 20 weeks of active treatment, whether or not the patient had been treated before. During an additional 34 weeks, approximately equal numbers of patients in both the actively treated group and the one receiving placebo needed to be treated with metformin or insulin to manage blood sugar. No studies have been conducted for sitagliptin’s use in patients younger than 10 years old. More information is in the FDA’s notice, which can be found here.

RecallAvKARE Sildenafil and Trazodone

On Dec. 9, 2020, AvKARE issued a joint recall to the consumer level for one lot each of sildenafil tablets 100mg (NDC# 42291-0748-01) and trazodone tablets 100mg (42291-0834-10). The two drugs were mixed together in some stock containers. Sildenafil, used to treat erectile dysfunction, may interact with drugs containing nitrates to decrease blood pressure drastically. Unprescribed use of trazodone, an antidepressant, could cause dizziness, drowsiness or visual disturbances that may be serious enough to increase the risk of falling. For more information, the FDA notice is here.

RecallTorrent Anagrelide

Also on Dec. 9, 2020, Torrent Pharmaceuticals recalled one lot of the antiplatelet agent, anagrelide capsules, 1mg. In testing of stored samples, some capsules in the lot did not dissolve properly, possibly resulting in doses too low to prevent blood clots or too high, which could cause unexpected bleeding, for patients who have thrombocythemia. Additional information is in the FDA’s notice.

Generics Released for Saphris

Three generic companies -- Alembic Pharmaceuticals, Breckenridge Pharmaceutical and Sigmapharm Laboratories – introduced asenapine, the generic to Allergan’s Saphris® sublingual tablets, soon after FDA approval on Dec. 10, 2020. The atypical antipsychotic is used in combination with lithium or divalproex to treat adults who have bipolar I disorder. Alembic and Sigmapharm have approval for 5mg and 10mg tablets; Breckenridge for 2.5mg and 10mg. According to IQVIA, the three strengths together accounted for $239 million in sales for the twelve-month period that ended on Sept. 30, 2020.

Emergency Use Authorizations for the First COVID-19 Vaccines

As expected, the FDA has approved emergency use authorizations (EUA) for COVID-19 vaccines. The Pfizer/BioNTech vaccine, BNT162b2, was authorized on Dec. 11, 2020 and Moderna’s vaccine one week later. Both rely on a new technique using mRNA. They prime the immune system to produce antibodies that attack proteins on the spiked parts of COVID-19 viruses. Both are given as a series of two intramuscular (IM) injections spaced several days apart. Millions of doses of each vaccine have been distributed throughout the U.S. with supplies determined by each state’s population and doses allocated according to state rules. No cost will be charged for the vaccines, although administration fees may apply in some cases. Full FDA approval, expected to be requested in early 2021 by both manufacturers, will depend on further results from ongoing studies of the vaccines’ effectiveness and safety, including for children. Each vaccine is provided with fact sheets for healthcare providers and patients.

Available in multi-use vials containing five 30mcg doses of vaccine, BNT162b2 is indicated to vaccinate individuals who are 16 years old and older. Given on a three-week schedule, it must be maintained at an extremely low temperature, which may complicate its delivery and administration. Fact sheets for the Pfizer/BioNTech vaccine can be found here and here.

Moderna’s vaccine, with doses administered 28 days apart, is indicated for patients at least 18 years old. It can be stored and shipped at temperatures of -20⁰C (-4⁰F), which is about the same temperature as regular freezers. Additionally, it can be refrigerated for up to one month or kept at room temperature for as long as 12 hours and still be effective. Look here and here for Moderna’s vaccine fact sheets.

FDA Approves Klisyri

Athenex received FDA approval on Dec. 14, 2020, for Klisyri® (tirbanibulin) ointment, 1%. It is a topical microtubule inhibitor indicated to treat adults who have actinic keratoses (skin patches from sun exposure) on the face and scalp. As many as 15% of actinic keratoses lead to skin cancers. Almirall will collaborate with Athenex to introduce Klisyri during the first quarter of 2021. Recommended dosing is one packet (250mg) per day on the affected areas for five days in a row. Areas around the eyes and mouth should be avoided completely. Hands should be washed thoroughly, right away; but treated skin should not be washed for at least eight hours after each application. Opened packets should be discarded after each application, even if the entire contents have not been used. In clinical studies, actinic keratoses resolved completely for 45 of the approximately 350 patients who were treated with Klisyri. Adverse effects generally were mild to moderate. They included flaking, itching, redness and swelling. Check here for Klisyri’s detailed prescribing information.

Infusion Time Reduced for Ocrevus

On Dec. 14, 2020, Ocrevus® (ocrelizumab) injection, a Genentech monoclonal antibody, was granted approval for a shorter infusion time. Initially FDA approved in March 2017, it treats both primary progressive multiple sclerosis (PPMS) and relapsing forms of the disease (RMS). Most of the estimated 400,000 Americans who have MS experience remissions – periods when disease symptoms lessen. However, up to 15% of patients have PPMS, which typically worsens steadily with few or no remissions and which generally causes more disability than other forms of MS. Although Ocrevus works by interfering with the activity of CD20-positive B cells that damage nerve cells (axons) and their coverings (myelin sheaths), it does not seem to affect any other types of B cells or normal immune function. Recommended dosing is one IV infusion of 600mg given by a health professional once every six months after the first two doses of 300mg each, administered two weeks apart. Infusions have been given over three and one-half hours. Results from a new clinical trial show that decreasing infusion time to two hours was about as effective and safe as the longer dosing time, so infusion times may be decreased. Patients still will need to be monitored for side effects for one hour or longer after each treatment. Here is updated prescribing information.

New Indication for Benlysta

Under Priority Review and as a Breakthrough Therapy, Benlysta® (belimumab – GlaxoSmithKline) got an additional indication from the FDA on Dec. 16, 2020. It now is approved to treat adults who have active nephritis (kidney inflammation) that is associated with the autoimmune condition, systemic lupus erythematosus (SLE). A novel monoclonal antibody, Benlysta inhibits a protein, B-lymphocyte stimulator (BLyS), which is above normal levels in patients who have SLE. BLyS contributes to the production of cells that attack patients’ blood vessels and organ systems. With an estimated incidence of 16,000 cases per year and a prevalence of about 1.5 million in the U.S., SLE affects many more women than men. It also is more prevalent among non-Caucasians, who tend to have symptoms that appear and worsen earlier than among other patients. One-half of patients who have SLE are believed to have lupus-associated nephritis; and about 10% of them develop end stage renal disease (ESRD). Benlysta has both IV and SC forms. In April 2019, the IV form was approved to treat SLE for children as young as five years old. The SC version is indicated only for treating adults who have SLE and lupus nephritis; it has not been approved for use by patients under the age of 18. By IV, dosing for lupus nephritis is 10mg/kg once every two weeks for the first three doses, then once every four weeks. SC doses are given weekly at 400mg (two prefilled syringes or two auto-injectors) for four weeks, then reduced to 200mg. All patients continue with ancillary treatments, such as corticosteroids, cyclophosphamide and immunosuppressants. Find complete, updated prescribing information here.

Margenza Approved to Treat Breast Cancer

Margenza™ (margetuximab-cmkb – MacroGenics) injection was FDA approved on Dec. 16, 2020. A monoclonal antibody, it attacks human epidermal growth factor receptor 2 (HER2), proteins that are on some cancer cells. It is indicated for treating adults who have (HER2+) breast cancer that has been treated at least twice with other HER2 inhibitors. One or more of the previous treatments must have been administered following metastasis. Chemotherapy (chemo) will be given along with Margenza. It is dosed once every three weeks as IV infusions at 15mg/kg. After the first dose is given over two hours, later infusion times can be reduced to as little as 30 minutes, depending on patient tolerance. Its labeling has a boxed warning that Margenza can cause problems with left ventricular functioning, so patients using it need to have cardiac evaluations before and during treatment. It also can damage a developing baby, which means that women of reproductive age need to be tested for pregnancy before starting treatment and then use contraception while receiving Margenza treatment. Launch is planned for March 2021in the U.S. Other drugs already approved to treat HER2+ breast cancer include Herceptin® (trastuzumab – Genentech and biosimilars), Kadcyla (ado-trastuzumab emtansine - Genentech), Perjeta® (pertuzumab – Genentech) and Tykerb® (lapatinib – GlaxoSmithKline). In the decisive clinical trial, patients who received Margenza and chemo with either capecitabine tablets, Halaven® (eribulin) injection, gemcitabine injection or vinorelbine injection were 24% less likely to die or experience worsening disease compared with patients who received one of the chemo drugs along with Herceptin.Margenza will be added to Express Script’s specialty drug list. For full prescribing information, look here.

Third Biosimilar Approved for Rituxan

Riabni™ (rituximab-arrx), Amgen’s biosimilar to Rituxan® (rituximab – Celgene), was approved by the FDA on Dec 17, 2019. It is indicated to treat adults who have non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL) or granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). A monoclonal antibody, it causes B cells to disintegrate by binding to CD20 proteins on their cell surfaces. Administered as IV infusions, it has to be given by a health professional in a facility equipped to handle emergency treatment of serious side effects that it may cause. A boxed warning and patient Medication Guide outline its potentially fatal adverse effects, including infusion-related reactions, mucocutaneous reactions, progressive multifocal leukoencephalopathy (PML) and reactivation of hepatitis B. Doses vary according to the condition under treatment. Riabni is not interchangeable with Rituxan or with Rituxan’s other biosimilars, Truxima® (rituximab-abbs – Celltrion/Teva) and Ruxience(rituximab-pvvr – Pfizer), which already are available in the U.S. Amgen plans to launch Riabni as single-dose vials in January 2021 Riabni will be added to Express Script’s specialty drug list. Its wholesale acquisition cost (WAC) is $716.80 for a 100mg vial and $3,584.00 for a 500mg vial. Here is  full prescribing information for Riabni.

Orgovyx Approved to Treat Prostate Cancer

The FDA approved Orgovyx (relugolix – Myovant Sciences) on Dec. 18, 2020. As an oral drug in the gonadotropin-releasing hormone (GnRH) receptor antagonist class, it will be taken daily to treat advanced prostate cancer. Other GnRH receptor antagonists for prostate cancer have to be injected or inserted under the skin. Typically, though, a treatment with one of them is needed only once a month or even once a year depending on the drug and the dosage form. Approximately 190,000 Americans – mostly over the age of 65 -- are diagnosed with prostate cancer annually; and an estimated 3.1 million survivors are living with the disease in the U.S., according to the American Cancer Society. After a 360mg dose (three tablets) on Day 1, recommended dosing for Orgovyx is one 120mg tablet each day either with food or on an empty stomach. No plans for launch, pricing or distribution have been announced. Complete prescribing information may be found here.

Expanded Indication for Xpovio

Karyopharm Therapeutics received an additional approval on Dec. 18, 2020, for Xpovio®(selinexor) tablets. Xpovio is a nuclear export inhibitor that works by keeping tumor suppressor proteins (TSP) inside cancer cell nuclei where they cause the cells to disintegrate. Originally, it was FDA approved in July 2019 for use with dexamethasone to treat adult patients who have recurrences of multiple myeloma despite four or more courses of treatment with two or more proteasome inhibitors, two or more immunomodulatory agents and one or more anti-CD38 monoclonal antibodies. Now, it also is indicated in a regimen with bortezomib and dexamethasone as second-line therapy for adults who have multiple myeloma that has been treated at least once. For the new indication, recommended dosing is 100mg (five tablets) taken together once each week. Xpovio also has an indication for treating diffuse large B-cell lymphoma (DLBCL) in adults. Check here for its complete prescribing information.

Tagrisso’s Indication Extended

Under the FDA’s Breakthrough Therapy, Orphan Drug and Real-Time Oncology Review programs, AstraZeneca’s tyrosine kinase inhibitor (TKI), Tagrisso® (osimertinib) tablets has a new approval from the FDA. Awarded on Dec. 18, 2020, the new indication is for adjuvant (secondary) therapy to treat adults who have early stages of non-small cell lung cancer (NSCLC) that tests positive for specific mutations (exon 19 deletions and/or exon 21 L858R mutations) in epidermal growth factor (EGFRm). NSCLC makes up between 80% and 85% of about 229,000 lung cancer cases diagnosed annually in the United States. Up to 15% of Caucasians and 40% of Asians who have NSCLC also are believed to have EGFR mutations; and around one-third of those patients have tumors that can be removed surgically. To treat the 10,000 patients that AstraZeneca expects will be candidates for therapy with it, Tagrisso will be taken following tumor-removal surgery and chemo. Recommended dosing is 80mg once daily for up to three years, until the cancer worsens or until the drug’s side effects are no longer bearable. In an international clinical trial, 89% of patients taking Tagrisso survived without a cancer recurrence for two years or longer, but only 52% of those taking placebo tablets did. It has previous approvals as initial treatment for advanced NSCLC with EGFRm or EGFR T790M mutations. Find complete updated prescribing information here.

Pediatric Indication Approved for Xeomin

Xeomin® (incobotulinumtoxinA - Merz Therapeutics) injection was FDA approved on Dec. 18, 2020, to treat chronic sialorrhea for children as young as two years old. Excessive drooling, chronic sialorrhea is associated with several conditions, including brain injuries, cerebral palsy and strokes, which may affect children and teens. Merz estimates a potential population of approximately 300,000 children will be eligible for Xeomin treatment to manage sialorrhea. Dosing in children, which is based on body weight, is administered in a 3:2 dose ratio into the parotid glands and submandibular glands, respectively. Treatment sessions should occur no more frequently than once every 16 weeks. In addition to a cosmetic indication, Xeomin also is FDA approved for treating patients two years of age and older who have upper limb spasticity (excluding those who have cerebral palsy) and for treating adults who have blepharospasms, cervical dystonia or upper limb spasticity. All botulinum toxin products have Medication Guides and boxed warnings that they may migrate away from the areas where they are injected — possibly causing widespread side effects, such as muscle weakness and vision changes. Rarely, serious breathing or swallowing problems can occur. Migration and side effects can happen even several months after the product has been injected. Children may be especially prone to having adverse effects. The new indication was given Priority Review by the FDA. Here is revised prescribing information.

Second Treatment for Ebola Receives FDA Approval

A monoclonal antibody, Ebanga (ansuvimab-zykl - Ridgeback Biotherapeutics) was approved by the FDA on Dec. 21, 2020, to treat ebolavirus infections caused by the Zaire strain of the virus. By blocking proteins on Ebola cells, it keeps the virus from getting into host cells. Approved for children as well as adults, it is given to patients as one IV infusion of 50mg/kg. In a clinical trial, about 14% fewer patients who received Ebanga died within 28 days of treatment as compared with patients who were treated with another investigational agent. Ebanga’s approval was granted with the FDA’s Breakthrough Therapy, Orphan Drug and Priority Review designations. In October 2020, Regeneron’s Inmazeb®(atoltivimab/maftivimab/ odesivimab-ebgn) injection, became the first FDA-approved treatment for Zaire Ebola. Ervebo® (Ebola Zaire vaccine, live - Merck), the first vaccine for the prevention of Ebola virus disease was approved by the FDA in December 2019. It is indicated to protect individuals who are at least 18 years old from the Zaire strain of Ebola. None of the three is effective for any other strains of Ebola or for the similar Marburgvirus.Launch, pricing and prescribing information for Ebanga are not yet available.

Cystic Fibrosis Drugs Receive Expanded Indications

The indications for three of Vertex Pharmaceuticals’ cystic fibrosis (CF) drugs, Kalydeco®(ivacaftor), Symdeko® (tezacaftor/ivacaftor and ivacaftor) and Trikafta®(elexacaftor/tezacaftor/ivacaftor and ivacaftor), were broadened by the FDA on Dec. 21, 2020. Kalydeco now is indicated to treat patients as young as four months old who have CF with specific mutations of the CF transmembrane conductance regulator (CFTR) gene that laboratory testing shows are susceptible to treatment with it. Symdeko has the same new indication, but only for patients six years of age and older. All three drugs also can be used for patients at least 12 years old for 100 or more other identified CFTR mutations that respond to treatment with the drug during testing in a laboratory. Kalydeco, which is available as tablets or oral granules, is taken as one dose based on body weight every 12 hours. For Symdeko, dosing depends on age and weight -- with one combination tablet taken each morning and one tablet that contains only ivacaftor taken 12 hours later. Trikafta’s recommended dose for all patients is one combination tablet in the morning and one ivacaftor-only tablet 12 hours later. All should be taken with a fat-containing food, such as peanut butter or yogurt. Vertex estimates that the extended indications will make about 600 more patients eligible for treatment with one of the drugs. Additional information, including details on which mutations can be treated, are in the prescribing information for Kalydeco, Symdeko and Trikafta.

Kineret Granted a New Indication

The FDA gave a new indication to Kineret® (anakinra - Sobi) injection on Dec. 22, 2020. It is an approval to treat deficiency of interleukin-1 receptor (IL-1R) antagonist (DIRA), a very rare autoimmune disorder with only a few known cases worldwide. Caused by IL 1R gene mutations, DIRA is evident as systemic inflammation soon after birth. The often fatal condition produces bone pain, enlargement of the liver and spleen, a distinctive skin rash, swollen joints and other symptoms that lead to multiple organ failure. Currently, corticosteroids are the usual treatment for DIRA. At a SC dose of 1mg/kg/day to 2mg/kg/day, Kineret blocks the attachment of IL-1 to its receptors, thereby reducing inflammation. Doses can be modified to a maximum of 8mg/day, if needed to control severe inflammation. In a ten-year long natural history study that involved nine children who were between birth and nine years of age at the start, Kineret decreased inflammation for all the participants. Additionally, rashes and bone inflammation resolved; and all patients were able to stop using corticosteroids. On the U.S. market for nearly 20 years, Kineret originally was FDA approved to treat rheumatoid arthritis (RA). It also has an indication for another rare condition, neonatal-onset multisystem inflammatory disease (NOMID). Its complete prescribing information is here.

Gemtesa Approved to Treat Overactive Bladder

Approved by the FDA on Dec. 23, 2020, Gemtesa® (vibegron) tablets, is a new drug to treat adults who have overactive bladder (OAB). It is a beta-3 adrenergic receptor (β3) agonist that is indicated for relieving OAB symptoms, such as dribbling urine, the sudden need to urinate and urinating too frequently. It allows the bladder to retain more urine by loosening the bladder’s detrusor muscle. Recommended dosing is one tablet (75mg) daily. Although several other drugs are available to treat OAB, only one, Myrbetriq® (mirabegron – Astellas Pharma) tablets acts in the same way as Gemtesa does. Gemtesa’s manufacturer, Urovant Sciences, expects to launch it in the first quarter of 2021.Look here for its full prescribing information.

MedWatch Update: Hand Sanitizers

The FDA continues to recall hand sanitizers that contain a potentially dangerous ingredient, methanol, instead of the ethanol that is listed on their labels. Most recently, several products made by Innovative Marketing Consultants, also known as Shane Erickson, Inc., were recalled on Dec. 23, 2020. They include some lots of imc Wash-Free, Thrifty White Pharmacy Wash-Free and Wash-Free brands. Sometimes called wood alcohol, methanol is intended for industrial use in products such as pesticides and solvents. It has no medical uses, and it never should be ingested. If it is absorbed through the skin or consumed, methanol can cause dangerous acid buildup in the blood. Immediate symptoms of methanol poisoning include blurred vision, confusion, dizziness, drowsiness, headache and nausea. Prolonged contact with or consumption of large amounts can lead to serious side effects, such as blindness, coma, seizures and death. Not everyone exposed to methanol has symptoms, however. Anyone who thinks they may have signs of methanol poisoning should talk with a doctor right away. Recalled products containing methanol should not be put into the trash or flushed down the drain. Individuals who have them can call the local Poison Control Center or their pharmacy for directions on how to dispose of them. Look here for more information on the latest recall and herefor a list of previously recalled products.

First Generic Approved for Glucagon Emergency Kits

On Dec. 28, 2020, the FDA approved Amphastar Pharmaceuticals’ synthetic glucagon for injection emergency kits as the first generic to Eli Lilly’s Glucagon Emergency Kits for Low Blood Sugar, 1mg (glucagon for injection [rDNA origin]). Injected SC or IM it quickly raises blood sugar levels to reverse severe hypoglycemic episodes for patients who use insulin to manage diabetes. Usually carried by the patient or caregiver, glucagon for emergencies is packaged as a powder that has to be mixed with sterile water contained in a prefilled syringe. The resulting solution then is injected immediately into the affected person’s arm, buttock or thigh. Adults should receive the entire 1mg dose; children who weigh less than 20kg (44 pounds) should get one-half of the syringe contents. Any unused solution should be discarded. Emergency medical responders should be called if an injection is warranted. After 15 minutes, patients who do not recover enough to consume a high-carbohydrate snack, such as fruit juice, honey or hard candy, may need another injection. A nasally administered powder form of glucagon and other glucagon injection kits are available by prescription in the U.S. Also, non-prescription oral glucose tablets and gels are widely available. Injected glucagon also may be used to reduce activity of the GI tract during diagnostic procedures. Amphastar intends to introduce its product to the U.S. market before the end of February 2021. For the 12 months between Oct. 1, 2019 and Sept. 30, 2020, IQVIA estimates that U.S. sales for Eli Lilly’s Glucagon Kits were about $144 million.

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