Drug Information Center

Highlights of FDA Activities – 12/1/2020 – 12/31/2020

FDA Drug Safety Communications & Drug Information Updates:

Tranexamic Acid Injection: Drug Safety Communication – Inadvertent Intrathecal Injection 12/3/20 The FDA alerted health care professionals that intrathecal administration of tranexamic acid injection may cause serious‐life threatening injuries such as seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. Container and carton labeling for tranexamic acid injection are being updated to reflect the recommended intravenous route of administration. Warnings within the tranexamic acid prescribing information will include the risk of medication errors due to incorrect route of administration.

Januvia, Janumet, and Janumet XR Show No Improvement in Pediatric Patients: Drug Safety 12/4/20 Communication The FDA approved changes to the labeling for Januvia, Janumet, and Janumet XR stating that these drugs have not shown improvement in glycemic control in pediatric patients 10 to 17 years with type 2 diabetes. Three double‐ blind, placebo‐controlled studies found no difference in HbA1c results in uncontrolled type 2 diabetes patients receiving sitagliptin compared to placebo over 54 weeks. Although the common during these trials were similar in pediatric patients to those reported in adults, pediatric patients had an increased risk of hypoglycemia episodes when they received sitagliptin with insulin therapy compared to placebo. The efficacy and safety of sitagliptin has not been studied in pediatric patients with type 2 diabetes younger than 10 years.

Pfizer‐BioNTech COVID‐19 Vaccine – Emergency Use Authorization 12/11/20 The FDA issued the first EUA for a COVID‐19 vaccine. Information on the EUA and vaccine can be found on the FDA ‐BioNTech COVID‐19 vaccine site.

Moderna COVID‐19 Vaccine – Emergency Use Authorization 12/18/20 The FDA issued a second EUA for a COVID‐19 vaccine. Information on the EUA and vaccine can be found on the FDA COVID‐19 vaccine site.

Transmucosal Immediate‐Release Fentanyl ‐Updated Risk Evaluation and Mitigation Strategy (REMS) 12/23/20 The FDA strengthened the REMS program for transmucosal immediate‐release fentanyl (TIRF) products including requiring prescribers document a patient’s opioid tolerance with each TIRF prescription for outpatient use, require outpatient pharmacies dispensing TIRF medicines document and verify the patient’s opioid tolerance, require inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients requiring TIRF medicines while hospitalized, and require a new patient registry to monitor for accidental exposure, misuse, abuse, addiction, and overdose.

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

Baxter SIGMA Spectrum Infusion Pumps and Spectrum IQ Infusion Systems: Recall – Unplanned 12/1/20 Shutdown Issues Baxter Healthcare recalled the Baxter Healthcare Sigma Spectrum Infusion Pumps with Master Drug Library (V6, V8) and the Baxter Spectrum IQ Infusion Systems with Dose IQ Safety Software (V9) because improper cleaning of the devices can result in residue build‐up or corrosion which can lead to unplanned shutdown without alarm or alert.

Regenecare HA Hydrogel by MPM Medical: Recall – Microbial Contamination 12/2/20 MPM Medical recalled one lot of Regenecare HA Hydrogel to the consumer level (NDC 66977‐107‐03, lot 41262, date 2021‐01). Following two complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepacia.

FDA Activity Newsletter WSU Drug Information December 2020 Page | 2

Anagrelide Capsules, USP by Torrent Pharmaceuticals Limited: Recall – Dissolution Test Failure 12/9/20 Torrent Pharmaceuticals Limited recalled one lot of anagrelide capsule (NDC 13668‐462‐01, lot BFD1G001, exp. 12/2021) due to dissolution test failure detected during routine quality testing.

Sildenafil Tablets and Trazodone Tablets by AvKARE: Recall – Product Mix‐Up 12/9/20 AvKare recalled one lot of sildenafil 100 mg tablets (NDC 42291‐748‐01, lot 36884) and one lot of trazodone 100 mg tablets (NDC 42291‐834‐10) to the consumer level due to a product mix‐up resulting in these products being inadvertently packaged together during bottling.

Wash‐Free Hand Sanitizer, Innovative Marketing Consultants: Recall – Undeclared Methanol 12/24/20 Shane Erickson, doing business as Innovative Marketing Consultants, recalled imc Wash‐Free Hand Sanitizer (lot 2020/05/11 and MFG: 2020/05/10 L/N: 20200510‐3) and Thrifty White Pharmacy Wash‐Free Hand Sanitizer (lot 2020/05/11) due to the potential presence of methanol.

Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Sunstar Americas – Microbial Contamination 12/28/20 Sunstar Americas recalled all lots of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% (exp 12/31/2020 – 09/20/2022) due to potential microbial contamination with Burkholderia lata.

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 3 KO Gold XT Sexual enhancement Vardenafil 69MODE Blue 69 Sexual enhancement Sildenafil and tadalafil Black Stallion 9000 Sexual enhancement Tadalafil Blue Panther Extreme 75k Sexual enhancement Sildenafil and tadalafil Burn 7 Weight loss Phenolphthalein1 Burro en Primavera 60000 Sexual enhancement Tadalafil Cord Care and Goldenseal Powder, Dry umbilical cords Microbial contamination with Cronobacter WishGarden Herbs Inc* sakazakii Fruta Bio Weight loss Phenolphthalein1 and sibutramine2 Fruta Planta Weight loss Sibutramine2 Ginseng Power 5000 Sexual enhancement Tadalafil Gold Lion Sexual enhancement Sildenafil Happy Ducts Compress by Wish Garden Compress Microbial contamination with Cronobacter Herbs* sakazakii Hot Rod Sexual enhancement Tadalafil1 Imperial Extreme 2000 Sexual enhancement Sildenafil and tadalafil Imperial Gold 2000 Sexual enhancement Sildenafil and tadalafil Imperial Platinum 2000 Sexual enhancement Tadalafil Imperla Elita Vitaccino Weight loss Sibutramine2 and fluoxetine Kopi Jantan Tradisional Natural Herbs Coffee Sexual enhancement Sildenafil Krazy Night Sexual enhancement Tadalafil Li Da Daidaihua Plus Weight loss Phenolphthalein1 Lishou Slimming Coffee Weight loss Sibutramine and desmethylsibutramine2 Mero Macho Sexual enhancement Tadalafil Original White Dragon Sexual enhancement Sildenafil and tadalafil Poseidon Platinum 10000 Sexual enhancement Vardenafil Poseidon Platinum 3500 Sexual enhancement Sildenafil and tadalafil Premier maxxzen Platinum 12000 Sexual enhancement Sildenafil and tadalafil Premier Platinum 5000 Sexual enhancement Tadalafil PremierZen Black 5000 Sexual enhancement Sildenafil and tadalafil

FDA Activity Newsletter WSU Drug Information Center December 2020 Page | 3

Product (continued…) Promoted Use Undeclared Ingredient(s) or Contaminants PremierZen Extreme 3000 Sexual enhancement Tadalafil PremierZen Gold 7000 Sexual enhancement Sildenafil and tadalafil PremierZen Platinum 8000 Sexual enhancement Sildenafil and tadalafil Premium OrgaZen 7000 Sexual enhancement Sildenafil and tadalafil Red Spartan 3000 Sexual enhancement Sildenafil and tadalafil Rock Steady 72 Hours Sexual enhancement Sildenafil and tadalafil Royal Honey Sexual enhancement Tadalafil Shogun‐X Black Sexual enhancement Tadalafil Shogun‐X Platinum 7000 Sexual enhancement Sildenafil and tadalafil Super Slim Weight loss Sibutramine and desmethylsibutramine2 The Super Panther 77k Sexual enhancement Sildenafil and tadalafil Thumbs Up 7 Black 25K Sexual enhancement Tadalafil 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 vardenafil Triple SupremeZen Extreme 3500 Sexual enhancement Sildenafil and tadalafil Triple SupremeZen Gold 3500 Sexual enhancement Sildenafil and tadalafil Triple SupremeZen Plus 3500 Sexual enhancement Tadalafil Triple Wicked Platinum Sexual enhancement Sildenafil and tadalafil White Panther Sexual enhancement Sildenafil and tadalafil *recalled 1Phenolphthalein was an over‐the‐counter laxative that is no longer marketed in the US due to carcinogenicity concerns 2Sibutramine has been associated with increased cardiovascular events; removed from market for safety reasons in 2010FDA; N‐desmethylsibutramine is an active metabolite of sibutramine

New Product Shortages Date Initially Posted Acetazolamide injection 12/2/20 Amino acids injection 12/8/20 Zinc acetate capsules 12/15/20 Azacitidine for injection 12/18/20 Teprotumumab‐trbw 12/23/20 Misoprostol tablets 12/28/20 Valproate sodium injection 12/30/20

Product Discontinuations/Withdrawals Date Posted Fluoxetine tablets (Sarafem, ); fluoxetine tablets and capsules remain available as generics 12/22/20

New Drug Approvals: Description Date Approved PSMA‐11 Ga 68/ Gallium GA 68 PSMA‐ Injection for PET imaging of PSMA lesions/ Indicated for 12/1/20 11 / Univ California Los Angeles patients with suspected prostate metastasis who are curable by surgery or radiation Berotralstat / Orladeyo / BioCryst Prophylaxis to prevent attacks of hereditary angioedema in 12/3/20 Pharmaceuticals, Inc adult and pediatric patients (See Attached Drug Summary) Tirbanibulin / Klisyri / Almirall, LLC Topical treatment of actinic keratosis of the face or scalp (See 12/14/20 Attached Drug Summary) Margetuximab‐cmkb / Margenza / Treatment of metastatic HER2‐positive breast cancer (See 12/16/20 MacroGenics Inc. Attached Drug Summary)

FDA Activity Newsletter WSU Drug Information Center December 2020 Page | 4

New Drug Approvals: (continued…) Description Date Approved Relugolix / Orgovyx / Myovant Treatment of adults with advanced prostate cancer (See 12/18/20 Sciences, Inc. Attached Drug Summary) Ansuvimab‐zykl / Ebanga / Ridgeback Treatment of Zaire ebolavirus infection in adults and children 12/21/20 Biotherapeutics Vibegron / Gemtesa / Urovant Treatment of adults with overactive bladder with symptoms 12/23/20 Sciences, Inc. of urge incontinence, urgency, and urinary frequency (See Attached Drug Summary)

New Indications: Description Date Approved Pralsetinib / Gavreto / Blueprint Treatment of advanced or metastatic RET‐mutant medullary 12/1/20 Medicines Corporation thyroid cancer or with advanced or metastatic RET fusion‐ positive thyroid cancer in those who require systemic therapy and who are refractory to radioactive iodine (if radioactive iodine is appropriate) in adults and pediatric patients 12 year and older Tasimelteon / Hetlioz / Vanda Treatment of nighttime sleep disturbances in Smith‐Magenis 12/1/20 Pharmaceuticals Inc. Syndrome in patients 16 years and older Liraglutide / Saxenda / Novo Nordisk, Adjunct to a reduced calorie diet and increased physical 12/4/20 Inc activity for chronic weight management in pediatric patients 12 years and older with a body weight above 60 kg and an initial BMI corresponding to 30 kg/m2 for adults (obese) by international cut‐offs Belimumab / Benlysta / Treatment of adult patients with active lupus nephritis who 12/16/20 GlaxoSmithKline are receiving standard therapy Selinexor / Xpovio / Karyopharm Use in combination with bortezomib and dexamethasone for 12/18/20 Therapeutics Inc. the treatment of adult patients with multiple myeloma who have received at least one prior therapy Osimertinib / Tagrisso / AstraZeneca Adjuvant therapy after tumor resection in adult patients with 12/18/20 non‐small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutation Ponatinib / Iclusig / Ariad Treatment of chronic phase chronic myeloid leukemia with 12/18/20 Pharmaceuticals resistance or intolerance to at least two prior kinase inhibitors IncomotulinumtoxinA / Xeomin / Merz Indication for treatment of chronic sialorrhea expanded to 12/18/20 Pharmaceuticals include patients 2 years of age and older

New Dosage Forms or Formulation: Description Date Approved Tasimelteon / Hetlioz LQ / Vanda Oral suspension, 4 mg/ml; for treatment of nighttime sleep 12/1/20 Pharmaceuticals Inc disturbances in Smith‐Magenis Syndrome in pediatric patients 3 years to 15 years of age

Compiled by: Terri Levien, Pharm.D. Drug Information Center Brittany Craft, Pharm.D., PGY2 Drug Information Resident College of Pharmacy and Pharmaceutical Sciences Jing Wang, Doctor of Pharmacy Candidate 2021 Washington State University Lee Roy Esposo, Doctor of Pharmacy Candidate 2021 412 E. Spokane Falls Blvd. Spokane, WA 99202‐2131 (509) 358‐7662 [email protected]

FDA Activity Newsletter WSU Drug Information Center December 2020 Page | 5

Berotralstat / Orladeyo / BioCryst Pharmaceuticals, Inc Generic Name / Brand Name / Company Berotralstat / Orladeyo / BioCryst Pharmaceuticals, Inc Date of approval 12/3/20 Drug Class (Mechanism of Action if novel agent) Kallikrein Inhibitor Indication Prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. Comparative agent – Therapeutic interchange? Ecallantide, lanadelumab Dosage forms/strengths Capsules: 110 mg, 150 mg Common Dose/sig 150 mg by mouth once daily with food For patients with persistent gastrointestinal reactions, consider reducing the dose to 110 mg by mouth once daily with food DEA Schedule None Date of market availability Available Similar Medication Names Osilodrostat, orlistat Clinical Use Evaluation Common Adverse Effects ≥10%: abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease Severe Adverse Effects None reported Severe Drug‐Drug Interactions P‐gp or BCRP inhibitors: with chronic administration of P‐gp or BCRP inhibitors (e.g., cyclosporine), berotralstat 110 mg is recommended. P‐gp Inducers: Coadministration with P‐gp inducers (e.g., rifampin, St. John’s wort) may decrease berotralstat plasma concentrations and efficacy. Avoid concurrent use of P‐gp inducers with berotralstat. CYP2D6 and CYP3A4 Substrates: Berotralstat at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. Monitoring and dose titrations are recommended with concurrent narrow therapeutic index medications predominantly metabolized by CYP2D6 (e.g., thioridazine, pimozide) or CYP3A4 (e.g., cyclosporine, fentanyl). P‐gp Substrates: Berotralstat at a dose of 300 mg is a P‐gp inhibitor. Monitoring and dose titration recommended for P‐gp substrates (e.g., digoxin) co‐administered with berotralstat. Severe Drug‐Food Interactions None known Important Labs Values to assess prior to order entry None required or at point of clinical follow up. Used in Pediatric Areas Evaluated in pediatric patients 12 years and older as prophylaxis to prevent attacks of hereditary angioedema; safety profile and attack rate between pediatric patients 12 years and older was like those observed in adults. Safety and efficacy have not evaluated in pediatric patients less than 12 years. Renal or Hepatic Dosing Renal impairment: No dosage modifications are recommended for patients with mild, moderate, or severe renal impairment. Berotralstat has not been studied in patients with end‐stage renal disease (CrCl < 15 mL/min or eGFR < 15 mL/min/1.73m2 or in patients requiring hemodialysis; use is not recommended in these patient populations. Hepatic impairment: No dosage modifications are recommended in patients with mild hepatic impairment. The recommended dose is 110 mg once daily with food in patients with moderate to 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

FDA Activity Newsletter WSU Drug Information Center December 2020 Page | 6

or suspected hypersensitivity to berotralstat or any of its inactive ingredients. Warnings/Precautions: Risk of QT prolongation with higher‐than‐ recommended dosages. Additional doses or doses higher than 150 mg once daily are not recommended. Special administration technique or considerations Capsules should be taken with food. Prepared by Brittany Craft Source Orladeyo (berotralstat) [prescribing information]. Durham, NC: BioCryst Pharmaceuticals, Inc; December 2020.

Tirbanibulin / Klisyri / Almirall, LLC Generic Name / Brand Name / Company Tirbanibulin / Klisyri / Almirall, LLC Date of approval 12/14/20 Drug Class (Mechanism of Action if novel agent) Microtubule Inhibitor Indication Topical treatment of actinic keratosis on the face or scalp Comparative agent – Therapeutic interchange? 5‐fluorouracil/diclofenac/imiquimod Dosage forms/strengths 1% topical ointment in single‐dose packets Common Dose/sig Apply contents of one packet to evenly cover up to 25 cm2 on the face or scalp once daily for 5 consecutive days. DEA Schedule None Date of market availability First quarter 2021 Similar Medication Names None Clinical Use Evaluation Common Adverse Effects >2%: local skin reactions (erythema, flaking/scaling, crusting, swelling), application site pruritus, application site pain Severe Adverse Effects Severe local skin reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) Severe Drug‐Drug Interactions None 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 effectiveness not established Renal or Hepatic Dosing None Critical Issues (i.e., contraindications, warnings, etc) May cause eye irritation and local skin irritation including severe reactions that should be emphasized like vesiculation/pustulation or erosion/ulceration Special administration technique or considerations Wash hands well after application. Avoid transfer of medication to other areas or persons; avoid application near eyes, mouth and lips. Do not touch or wash treated area for 8 hours after treatment. Prepared by Lee Roy Esposo Source Klisyri (tirbanibulin) [prescribing information]. Exton, PA: Almirall, LLC, December 2020.

Margetuximab‐cmkb / Margenza / MacroGenics Inc. Generic Name / Brand Name / Company Margetuximab‐cmkb / Margenza / MacroGenics Inc. Date of approval 12/16/20 Drug Class (Mechanism of Action if novel agent) HER2/neu receptor antagonist Indication In combination with chemotherapy for the treatment of metastatic HER2‐positive breast cancer in patients who have received two or more prior anti‐HER2 regimens, at least one of which was for metastatic disease Comparative agent – Therapeutic interchange? Fam‐trastuzumab Dosage forms/strengths Injection: 250 mg/10 mL (25 mg/mL) in a single‐dose vial FDA Activity Newsletter WSU Drug Information Center December 2020 Page | 7

Common Dose/sig 15 mg/kg IV infusion at over 120 minutes for the initial dose, then over a minimum of 30 minutes every 3 weeks for all subsequent doses DEA Schedule None Date of market availability March 2021 Similar Medication Names None identified Clinical Use Evaluation Common Adverse Effects > 10%: fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, infusion‐related reactions, palmar‐plantar erythrodysesthesia, and extremity pain. Severe Adverse Effects Infusion reaction, left ventricular dysfunction, embryo‐fetal toxicity Severe Drug‐Drug Interactions Anthracyclines: avoid anthracycline‐based therapy for up to 4 months after stopping margetuximab‐cmkb Severe Drug‐Food Interactions None Important Labs Values to assess prior to order entry Left ventricular ejection fraction before initiation and regularly during or at point of clinical follow up. treatment; pregnancy test if reproductive potential Used in Pediatric Areas Safety and effectiveness have not been established Renal or Hepatic Dosing No dosage adjustment required; impact of severe renal impairment or moderate to severe hepatic impairment is unknown Critical Issues (i.e., contraindications, warnings, etc) Warnings and precautions: that should be emphasized Monitor for left ventricular dysfunction; may require withholding or discontinuation of therapy Monitor for infusion‐related reactions; consider premedication Verify pregnancy status prior to initiation Special administration technique or considerations Swirl the vial gently, do not shake the vial or the IV bag Do not administer as IV push or IV bolus On days administered with chemotherapy, may be administered immediately after chemotherapy completion Prepared by Jing Wang Source Margenza (margetuximab) [prescribing information]. Rockville, MD: MacroGenics Inc; December 2020.

Relugolix / Orgovyx / Myovant Sciences, Inc. Generic Name / Brand Name / Company Relugolix / Orgovyx / Myovant Sciences, Inc. Date of approval 12/18/20 Drug Class (Mechanism of Action if novel agent) Gonadotropin‐releasing hormone (GnRH) receptor antagonist Indication Advanced prostate cancer Comparative agent – Therapeutic interchange? leuprolide Dosage forms/strengths Tablet: 120mg Common Dose/sig A loading dose of 360 mg on the first day of treatment followed by 120 mg taken orally once daily, at approximately the same time each day DEA Schedule None Date of market availability January 2021 Similar Medication Names Degarelix, elagolix Clinical Use Evaluation Common Adverse Effects >10%: hot flush, musculoskeletal pain, fatigue, constipation, and diarrhea >15%: glucose increased, triglycerides increased, hemoglobin decreased, increased ALT and AST Severe Adverse Effects Hot flush, musculoskeletal pain, fatigue, diarrhea, increased glucose, increased triglycerides, increased ALT, decreased hemoglobin

FDA Activity Newsletter WSU Drug Information Center December 2020 Page | 8

Severe Drug‐Drug Interactions P‐gp inhibitors: avoid co‐administration with oral P‐gp inhibitors. If co‐ administration is unavoidable, take relugolix first and separate dosing by at least 6 hours. Combined P‐gp and strong CYP3A inducers: avoid co‐administration with relugolix. If unavoidable, increase relugolix dose to 240 mg once daily. Severe Drug‐Food Interactions None Important Labs Values to assess prior to order entry PSA level, if PSA increases measure serum testosterone or at point of clinical follow up. Used in Pediatric Areas Safety and efficacy in pediatric patients have not been established Renal or Hepatic Dosing Renal or hepatic dosing have not been established; pharmacokinetics were not altered in mild to severe renal impairment or mild to moderate hepatic impairment. There is no data in severe hepatic impairment. Critical Issues (i.e., contraindications, warnings, etc) No contraindications in labeling that should be emphasized Warnings and precautions: QT prolongation may occur with androgen deprivation therapy; consider risks, correct electrolyte abnormalities, monitor Embryo‐fetal toxicity; advise males with female partners of reproductive potential to use effective contraception Special administration technique or considerations Take with or without food, swallow tablets whole If treatment is interrupted for more than 7 days, restart with loading dose Prepared by Jing Wang Source Orgovyx (relugolix) [prescribing information]. Brisbane, CA: Myovant Sciences Inc; December 2020.

Vibegron / Gemtesa / Urovant Sciences, Inc. Generic Name / Brand Name / Company Vibegron / Gemtesa / Urovant Sciences, Inc. Date of approval 12/23/20 Drug Class (Mechanism of Action if novel agent) Beta‐3 adrenergic agonist Indication Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. Comparative agent – Therapeutic interchange? Mirabegron Dosage forms/strengths Tablet: 75 mg Common Dose/sig One 75 mg tablet orally, once daily with or without food DEA Schedule None Date of market availability First quarter 2021 Similar Medication Names None identified Clinical Use Evaluation Common Adverse Effects >2%: headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, upper respiratory tract infection Severe Adverse Effects None reported Severe Drug‐Drug Interactions Concomitant with digoxin may increase digoxin concentrations 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 effectiveness not established Renal or Hepatic Dosing No dosage adjustment with mild to severe renal impairment or mild to moderate hepatic impairment. Has not been studied in patients with severe hepatic or end‐stage renal disease and is not recommended in these populations

FDA Activity Newsletter WSU Drug Information Center December 2020 Page | 9

Critical Issues (i.e., contraindications, warnings, etc) Contraindicated in patients with known hypersensitivity to vibegron or any that should be emphasized tablet ingredients. Monitor for urinary retention, especially in patients with bladder outlet obstruction and in patients with taking muscarinic antagonists. If urinary retention develops, discontinue use. Special administration technique or considerations Swallow tablet whole with a glass of water. May be crushed and mixed with applesauce and taken immediately with a glass of water. Prepared by Lee Roy Esposo Source Gemtesa (vibegron) [prescribing information]. Irvine, CA: Urovant Sciences Inc., December 2020.

FDA Activity Newsletter WSU Drug Information Center December 2020