Drug Information Center

Highlights of FDA Activities – 3/1/21 – 3/31/21

FDA Drug Safety Communications & Drug Information Updates:

Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch.

COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency.

Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab).

Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device. Propylhexedrine should only be used via inhalation, any other route can cause serious harm. Immediate medical attention is needed in people who experience severe anxiety or agitation, confusion, hallucinations, paranoia, rapid heartbeat or abnormal heart rhythm, chest pain or tightness. Serious complications from abuse/misuse can lead to death. There is no specific reversal agent in cases of acute intoxication, symptomatic and supportive care should be provided.

Lamotrigine (Lamictal) Safety Communication: Increased Risk of Arrhythmias 3/31/21 FDA study review finds a potential increased risk of arrhythmias in patients with heart disease while taking lamotrigine. Safety studies are now being required on medications in the same drug class. Reports of abnormal electrocardiographic findings, chest pain, loss of consciousness, and cardiac arrest prompted further investigation into lamotrigine’s effect on the heart. The public will be updated when additional information becomes available. Providers should assess risks and benefits in patients taking lamotrigine who also have clinically important structural and functional heart disorders, including heart failure, valvular heart disease, congenital heart disease, conduction system disease, ventricular arrhythmias, Brugada syndrome or risk factors for coronary artery disease.

Major Medication/Drug‐Related Product Recalls Announced Through MedWatch:

Spironolactone 25 mg & 50 mg Tablets, Bryant Ranch Prepack: Recall – Mislabeled, Incorrect Strength 3/10/21 Bryant Ranch Prepack recalled 4 lots of spironolactone tablets because the products have been mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain 25 mg tablets and vice versa. The recalled products include spironolactone 25 mg tablets (NDC 63629106401 [lot 148969], NDCs 63629106402 & 63629106403 [lot 148791] and 50 mg tablets (NDC 63629106701 [lot 148992]), all with an expiration date of 7/31/2022.

FDA Activity Newsletter WSU Drug Information Center March 2021 Page | 2

Phenylephrine HCl Injection 10 mg/mL, Sagent Pharmaceuticals: Compromised Vial Seal 3/12/21 Three lots of Phenylephrine hydrochloride injection, USP 10 mg/mL vials (NDC 25021‐315‐01) manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals, were recalled due to potentially loose crimped vial over‐seals which could result in non‐sterile product. Lot numbers involved are PHT8IB2, PHT9IB2, and PHT1JB2.

Heal the World Hand Sanitizer 9.6 oz, PNHC: Recall – Resemble Water Bottles 3/17/21 PNHC, LLC, doing business as Heal the World, recalled all lots of Heal the World hand sanitizer packaged in 9.6 oz bottles because they resemble water bottles. No other package sizes were recalled.

ChloraPrep 3 mL applicators by BD: Recall ‐ Microbial Contamination Risks 3/25/21 The FDA advised health care providers not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company) and labeled with “CareFusion, El Paso, TX” following a recall expansion to include the applicators in all U.S. states. The product is prone to microbial contamination due to product lid failure when exposed to high temperature and humidity, including the growth of Aspergillus penicillioides within the packaging. The drug is used to sanitize skin prior to surgery or catheter procedures.

Telmisartan Tablets 20 mg, Alembic Pharmaceuticals: Recall ‐ Mislabeling and Incorrect Strength 3/25/21 One lot of telmisartan 20 mg, USP tablets packaged in 30‐count bottles (lot 1905005661) was recalled due to incorrect product strength in the package (40 mg). FDA advises to check tablets for shape and imprint; the 20 mg tablets should be round with an L202 imprint.

Acyclovir Sodium Injection 50 mg/mL, Zydus: Recall ‐ Crystallization 3/25/21 Four lots of acyclovir sodium injection 50 mg/mL in 10 mL and 20 mL vials were recalled after complaints of crystallization in vials. Lots being recalled are L000155, L000156, L000126 and L000127.

Durisan Antimicrobial Solutions Hand Sanitizer: Recall – Microbial Contamination 3/25/21 Sanit Technologies LLC, doing business as Durisan, recalled Durisan Antimicrobial Solutions Hand Sanitizer due to microbial contamination with Burkholderia cepacia complex and Ralstonia pickettii. A complete list of the recalled lots can be found on the FDA site and the product has been added to the FDA do‐not‐use list of hand sanitizers.

Dietary Supplement Recalls & Public Notifications Notifications were issued regarding undeclared active ingredients or contaminants in the following products. Patients are advised not to purchase or use these products. Product Promoted Use Undeclared Ingredient(s) or Contaminants 2 Own The Knight Sexual enhancement Sildenafil and tadalafil 69MODE Blue 69* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Furious X 1350 Sexual enhancement Sildenafil and tadalafil Imperial Extreme 2000 mg* Sexual enhancement Sildenafil and tadalafil Krazy Night* Sexual enhancement Sildenafil, tadalafil and vardenafil PremierZen Black 5000* Sexual enhancement Sildenafil and tadalafil Rhino SE7EN2 Sexual enhancement Sildenafil and tadalafil Shogun‐X 15000mg* Sexual enhancement Sildenafil, tadalafil and vardenafil Shogun‐X 7000* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Stiff Rox Sexual enhancement Sildenafil and tadalafil Titanium 18K Sexual enhancement Sildenafil and tadalafil Thumbs Up 7 Black 25K* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Thumbs Up 7 Blue 69K* Sexual enhancement Sildenafil and tadalafil Thumbs Up 7 Red 70K* Sexual enhancement Sildenafil, tadalafil and vardenafil Thumbs Up 7 White 11K* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Yin‐Yang Essence Men Power Sexual enhancement Sildenafil and tadalafil Zing Plus Sexual enhancement Sildenafil *recalled

FDA Activity Newsletter WSU Drug Information Center March 2021 Page | 3

New Product Shortages Date Initially Posted Desmopressin Acetate (Stimate) Nasal Spray 3/12/21 Disopyramide phosphate capsules 3/19/21 Cortisone acetate tablets 3/26/21 Chlordiazepoxide hydrochloride USP capsules 3/30/21

Brand Name or Sole Source Product Discontinuations/Withdrawals Date Posted Neomycin sulfate, polymyxin b sulfate, bacitracin zinc, and hydrocortisone ointment (Cortisporin, Pfizer) 3/9/21 – alternative corticosteroid and antibiotic combinations remain available Neomycin sulfate, polymyxin b sulfate, and hydrocortisone cream (Cortisporin, Pfizer) ‐– alternative 3/9/21 corticosteroid and antibiotic combinations remain available Estradiol patch (Alora, Allergan) – alternative estradiol transdermal products remain available 3/24/21 Norethindrone acetate, ethinyl estradiol tablets (Femhrt, Allergan) – generics remain available 3/24/21 Norethindrone acetate, ethinyl estradiol, ferrous fumarate kit (Tilia Fe, Allergan) – generics remain 3/24/21 available Norethindrone acetate, ethinyl estradiol, ferrous fumarate kit (Estrostep Fe, Allergan) – generics remain 3/24/21 available

New Drug Approvals: Description (See Attached Drug Summaries) Date Approved Serdexmethylphenidate and Central nervous system stimulant for the treatment of attention 3/2/21 dexmethylphenidate / Azstarys / deficit hyperactivity disorder in patients 6 years or older Corium, Inc Tivozanib / Fotivda / Aveo Kinase inhibitor for the treatment of relapsed or refractory 3/10/21 Pharmaceuticals, Inc advanced renal cell carcinoma in patients who have received two or more prior systemic therapies Ponesimod / Ponvory / Janssen Sphingosine 1‐phosphate receptor modulator for the treatment 3/18/21 Pharmaceuticals, Inc of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‐remitting disease, and active secondary progressive disease in adult patients. Dasiglucagon / Zegalogue / Zealand Antihypoglycemic agent for the treatment of severe 3/22/21 Pharma hypoglycemia in pediatric and adult patients with diabetes 6 years and older. Idecabtagene vicleucel / Abecma / B‐cell maturation antigen‐directed genetically modified 3/27/21 Celgene autologous chimeric antigen receptor (CAR) T‐cell therapy for treatment of adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least 4 prior lines of therapy.

New Indications: Description Date Approved Tocilizumab / Actemra / Genentech Slowing the rate of decline in pulmonary function in adults with 3/4/21 systemic sclerosis‐associated interstitial lung disease Blinatumomab / Blincyto / Amgen Revision of indication to include relapsed or refractory CD19‐ 3/11/21 positive B‐cell precursor acute lymphoblastic leukemia (ALL) Pembrolizumab / Ketruda / Merck FDA approved for treatment of locally advanced or metastatic 3/16/21 Sharp & Dohme Corp. esophageal or gastroesophageal junction carcinoma that is not amendable to surgical resection or definitive chemoradiation, in combination with platinum‐ and fluoropyrimidine‐based chemotherapy. FDA Activity Newsletter WSU Drug Information Center March 2021 Page | 4

New Indications continued: Description Date Approved Rilonacept / Arcalyst / Kiniksa Treatment of recurrent pericarditis for adults and children 12 3/18/21 Pharmaceuticals Ltd years and older. Bupivacaine liposome injectable Indication for postsurgical local analgesia expanded to include 3/22/21 suspension / Exparel / Pacira patients 6 to 17 years. Pharm. Isatuximab‐irfc / Sarclisa / Sanofi In combination with carfilzomib and dexamethasone for the 3/31/21 Aventis treatment of adult patients with relapsed or refractor multiple myeloma who have received 1 to 3 prior lines of therapy Treprostinil inhalation solution / Treatment of pulmonary hypertension associated with 3/31/21 Tyvaso / United Therapeutics interstitial lung disease to improve exercise ability

New Dosage Forms or Formulation: Description Date Approved Rosuvastatin and ezetimibe / Roszet / Combination oral tablet: rosuvastatin/ezetimibe 5 mg/10 mg, 3/23/21 Althera Life Sciences, LLC 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg; for reduction of LDL‐C as adjunct to diet in patients with primary non‐familial hyperlipidemia and alone or as adjunct to other therapies in patients with homozygous familial hypercholesterolemia. Mirabegron / Myrbetriq /Astellas Granules for extended‐release oral suspension: 8 mg/mL, for 3/25/21 Pharma US, Inc the treatment of neurogenic detrusor overactivity in pediatric patients 3 years and older

Compiled by: Terri Levien, Pharm.D. Drug Information Center Brittany Craft, Pharm.D., PGY2 Drug Information Resident College of Pharmacy and Pharmaceutical Sciences Melinda Tiegs, Doctor of Pharmacy Candidate 2021 Washington State University Kevin Penney, Doctor of Pharmacy Candidate 2021 412 E. Spokane Falls Blvd. Manasvi Karia, Doctor of Pharmacy Student, class of 2023 Spokane, WA 99202‐2131 (509) 358‐7662 [email protected]

Serdexmethylphenidate and dexmethylphenidate / Azstarys / Corium, Inc Generic Name / Brand Name / Company Serdexmethylphenidate and dexmethylphenidate / Azstarys / Corium, Inc Date of approval 3/2/21 Drug Class (Mechanism of Action if novel agent) Serdexmethylphenidate is a prodrug of dexmethylphenidate. Dexmethyl‐ phenidate HCl is a central nervous system stimulant and is the more pharmacologically active d‐enantiomer of racemic d,l‐methylphenidate. Methylphenidate is a norepinephrine and dopamine reuptake inhibitor. Indication Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older Comparative agent – Therapeutic interchange? Dexmethylphenidate‐ and methylphenidate‐containing products; do not substitute mg‐per‐mg for other products Dosage forms/strengths. Oral Capsules: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg Common Dose/sig Starting dose: 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate by mouth once daily in the morning DEA Schedule CII [pending controlled substance scheduling] Date of market availability Summer 2021 Similar Medication Names Dexmedetomidine, dexamethasone, Seradex FDA Activity Newsletter WSU Drug Information Center March 2021 Page | 5

Serdexmethylphenidate and dexmethylphenidate continued… Clinical Use Evaluation Common Adverse Effects >5%: decreased appetite, insomnia, nausea, dyspepsia, vomiting, abdominal pain, weight loss, anxiety, dizziness, irritability, affect lability, tachycardia, increased blood pressure Severe Adverse Effects With this class: sudden death, stroke and myocardial infarction; priapism; peripheral vasculopathy; long‐term suppression of growth Severe Drug‐Drug Interactions Use of monoamine oxidase inhibitors (MAOI) in preceding 14 days. Halogenated anesthetics: avoid use of serdexmethylphenidate/ dexmethylphenidate on the day of surgery. Antihypertensive drugs: adjust dose of antihypertensive drug as needed. Risperidone: alterations in dose of either drug may precipitate extrapyramidal symptoms. Severe Drug‐Food Interactions None Important Labs Values to assess prior to order entry None or at point of clinical follow up. Used in Pediatric Areas Safety and efficacy have not been established in pediatric patients less than 6 years of age. Renal or Hepatic Dosing No experience in patients with renal or hepatic impairment. Neither serdexmethylphenidate nor methylphenidate are renally eliminated. Critical Issues (i.e., contraindications, warnings, etc) Contraindicated: patients with known hypersensitivity to that should be emphasized. serdexmethylphenidate, methylphenidate, or product ingredients, and with concurrent monoamine oxidase inhibitor (MAOI) or use of an MAOI within 14 days. Boxed Warning: CNS stimulants have a high potential for abuse and dependence. Assess risk of abuse prior to use. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias or coronary artery disease. May increase heart rate and blood pressure; monitor May cause or exacerbate symptoms of psychiatric illness. Evaluate for bipolar disorder prior to use. Other warnings: priapism, peripheral vasculopathy/Raynaud’s phenomenon, long‐term suppression of growth Special administration technique or considerations Administered once daily in the morning; may be taken with or without food. Capsules may be opened and contents sprinkled into 50 mL of water or 2 tablespoons of applesauce. Consume complete mixture within 10 minutes. Not comparable to other methylphenidate products on a milligram‐ per‐milligram basis. Therapy should always be started with a titration schedule. Prepared by Melinda Tiegs Source Azstarys (serdexmethylphenidate and dexmethylphenidate) [prescribing information]. Grand Rapids, MI: Corium, Inc; March 2021.

FDA Activity Newsletter WSU Drug Information Center March 2021 Page | 6

Tivozanib / Fotivda / Aveo Pharmaceuticals, Inc Generic Name / Brand Name / Company Tivozanib / Fotivda / Aveo Pharmaceuticals, Inc Date of approval 3/10/21 Drug Class (Mechanism of Action if novel agent) Tyrosine kinase inhibitor Indication Treatment of adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. Comparative agent – Therapeutic interchange? Sorafenib Dosage forms/strengths. Capsules: 1.34 mg and 0.89 mg Common Dose/sig 1.34 mg once daily for 21 days on treatment followed by 7 days off treatment (in 28‐day cycles). Dose modifications for adverse reactions. DEA Schedule None Date of market availability Available Similar Medication Names Tivicay, Fosamax, Foscarnet Clinical Use Evaluation Common Adverse Effects >20%: fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis. Severe Adverse Effects Hypertension, cardiac failure, arterial thromboembolic events, hemorrhagic events, proteinuria, decreased appetite/weight loss, decreased sodium, increased lipase, decreased phosphate. Severe Drug‐Drug Interactions CYP3A Inducers – avoid concomitant use of strong CYP3A inducers. Severe Drug‐Food Interactions None Important Labs Values to assess prior to order entry Thyroid function and proteinuria before initiation and periodically or at point of clinical follow up. throughout treatment; Used in Pediatric Areas Safety and effectiveness have not been established in pediatric patients. Renal or Hepatic Dosing No dosage modification is recommended for mild‐severe renal impairment; dosage for patients with end‐stage renal disease has not been established. Discontinue if develop nephrotic syndrome For patients with moderate hepatic impairment, reduce the dose to 0.89 mg for 21 days on treatment followed by 7 days off treatment (28‐day cycle). Avoid use in patients with severe hepatic impairment. Critical Issues (i.e., contraindications, warnings, etc.) Contraindications: While no contraindications are listed in the prescribing that should be emphasized. information, this medication should be avoided in patients with known or suspected hypersensitivity to tivozanib or any component of its formulation. Warnings: Hypertension and hypertensive crisis: control blood pressure prior to starting and monitor periodically throughout treatment. Cardiac failure: Monitor for signs/symptoms of cardiac failure. Cardiac ischemia: can cause serious cardiac ischemia and stroke Venous thromboembolic events: can cause serious VTE events Hemorrhagic events: can cause serious hemorrhagic events Proteinuria: monitor for proteinuria and acute kidney injury Thyroid dysfunction: monitor, treat as needed to maintain euthyroid state Risk of impaired wound healing Reversible posterior leukoencephalopathy syndrome Embryo‐fetal toxicity Special administration technique or considerations Can be taken with or without food. Swallow capsule whole with a glass of water, do not open or break. Prepared by Manasvi Karia Source Fotivda (tivozanib) [prescribing information]. Boston, MA: Aveo Pharmaceuticals, Inc; March 2021.

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Ponesimod / Ponvory / Janssen Pharmaceuticals, Inc Generic Name / Brand Name / Company Ponesimod / Ponvory / Janssen Pharmaceuticals, Inc Date of approval 3/18/21 Drug Class (Mechanism of Action if novel agent) Sphingosine 1‐phosphate receptor modulator Indication Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing‐remitting disease, and active secondary progressive disease, in adults. Comparative agent – Therapeutic interchange? Fingolimod, siponimod, ozanimod Dosage forms/strengths. Tablets: 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 20 mg Common Dose/sig The recommended maintenance dosage is 20 mg taken orally once daily. Initiated with starter pack and 2 mg daily dose. DEA Schedule None Date of market availability April 2021 Similar Medication Names Fingolimod, siponimod, ozanimod, ponatinib Clinical Use Evaluation Common Adverse Effects >10%: upper respiratory tract infection, hepatic transaminase elevation, and hypertension Severe Adverse Effects Infections, bradyarrhythmias, AV conduction delays, respiratory effects, liver injury, increased blood pressure, cutaneous malignancies, macular edema, posterior reversible encephalopathy syndrome Severe Drug‐Drug Interactions Screen for prior or current medications with immune system, anti‐ arrhythmic, beta‐blocker, or QT prolonging effects prior to initiation. Avoid live attenuated vaccines during and for up to 1‐2 weeks after treatment with ponesimod. Coadministration of strong CYP3A4 and UGT1A1 Inducers with ponesimod is not recommended. Severe Drug‐Food Interactions None Important Labs Values to assess prior to order entry Complete blood count, including lymphocyte count, transaminase and or at point of clinical follow up. bilirubin levels, antibodies to varicella zoster virus, prior to initiation. Used in Pediatric Areas Safety and effectiveness in pediatric patients have not been established. Renal or Hepatic Dosing No dosage adjustment in renal impairment or in mild hepatic impairment; use not recommended in moderate or severe hepatic impairment. Critical Issues (i.e., contraindications, warnings, etc.) Contraindications: myocardial infarction (MI), unstable angina, stroke, that should be emphasized. transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure in last 6 months, or presence of Mobitz type II second‐degree, third‐degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker Warnings: CV Monitoring: Obtain ECG prior to initiation. In patients with bradycardia, AV conduction delays or history of MI or heart failure more than 6 months prior, monitor pulse and blood pressure for 4 hours after the first dose, plus ECG prior to dosing and after 4 hours. Monitor for infection risk, respiratory effects, liver injury, increased blood pressure, cutaneous malignancies, macular edema (conduct ophthalmic evaluation prior to initiation), posterior reversible encephalopathy. Fetal risk Special administration technique or considerations Take with or without food. Swallow the tablet whole. If 4 or more consecutive doses are missed, reinitiate with titration regimen. Prepared by Manasvi Karia Source Ponvory (ponesimod) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2021.

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Dasiglucagon / Zegalogue / Zealand Pharma Generic Name / Brand Name / Company Dasiglucagon / Zegalogue / Zealand Pharma Date of approval 3/22/21 Drug Class (Mechanism of Action if novel agent) Glucagon receptor agonist. Blood glucose concentration is increased when dasiglucagon activates hepatic glucagon receptors, stimulating glycogenolysis. Glycogen stores in the liver are required for dasiglucagon to exert its effect. Indication Severe hypoglycemia in adults and children 6 years and older with diabetes Comparative agent – Therapeutic interchange? GlucaGen (glucagon hydrochloride reconstitution injection), Baqsimi (glucagon nasal powder), Gvoke (subcutaneous glucagon injection) Dosage forms/strengths. Autoinjector or prefilled syringe: 0.6 mg/0.6 mL single dose Common Dose/sig 0.6 mg subcutaneous injection. May repeat in 15 minutes with an additional dose of 0.6 mg from a new device if no response. DEA Schedule Not scheduled Date of market availability June 2021 Similar Medication Names Glucagon Clinical Use Evaluation Common Adverse Effects >2%: nausea, vomiting, headache, diarrhea, injection site pain Severe Adverse Effects Allergic reactions have been reported with glucagon, including anaphylactic shock. Severe Drug‐Drug Interactions Beta‐blockers: dasiglucagon may cause a transient increase in pulse and blood pressure when given to patients on beta‐blockers. Indomethacin: dasiglucagon may lose ability to raise blood glucose or produce hypoglycemia. Warfarin: dasiglucagon may increase the anticoagulant effect of warfarin. Severe Drug‐Food Interactions Dasiglucagon may not be effective if the patient is in a state of starvation and without food for a long period of time. Important Labs Values to assess prior to order entry None at order entry; blood glucose as clinically indicated or at point of clinical follow up. Used in Pediatric Areas Safety and effectiveness have not been established in pediatric patients younger than 6 years of age. Renal or Hepatic Dosing Dasiglucagon is cleared like native glucagon through proteolytic pathways in blood, liver and kidneys. No renal or hepatic dose adjustments required. Critical Issues (i.e., contraindications, warnings, etc) Contraindicated in pheochromocytoma: dasiglucagon may stimulate that should be emphasized catecholamine release from the tumor. Contraindicated in insulinoma: glucagon products may produce exaggerated insulin release from an insulinoma. Sufficient glycogen must be present for dasiglucagon efficacy: patients with adrenal insufficiency, in a state of starvation or with chronic hypoglycemia should be treated with glucose instead. Special administration technique or considerations Administer subcutaneously into lower abdomen, buttocks, thigh or outer upper arm. Monitor for response to treatment. If a patient develops symptoms of hypoglycemia after a dose of dasiglucagon, give glucose orally or intravenously. Administer oral carbohydrates after treatment response. Prepared by Melinda Tiegs Source Zegalogue (dasiglucagon) [prescribing information]. Soborg, Denmark: Zealand Pharma A/S; March 2021.

FDA Activity Newsletter WSU Drug Information Center March 2021