PharmaFacts September 2025

PharmaFacts for Case Managers September 2025

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Dawnzera Injection

Papzimeos Injection

• Generic Name: Donidalorsen.

• Generic Name: Zopapogene imadenovec-drba.

• Company: Ionis Pharmaceuticals, Inc.

• Company: Precigen, Inc.

• Treatment For: Prophylaxis to prevent attacks of hereditary angioedema in adult and pediatric patients 12 years of age and older.

• Treatment For: Recurrent respiratory papillomatosis in adults.

• Description: A prekallikrein-directed antisense oligonucleotide (ASO) covalently linked to a ligand containing three N-acetylgalactosamine residues to facilitate delivery of the ASO to hepatocytes.

• Drug Class: Antisense oligonucleotide.

• Dosing Information: Dawnzera 80 mg administered subcutaneously every 4 weeks (80 mg every 8 weeks may be considered).

• Side Effects: Injection-site reactions, upper respiratory tract infections, urinary tract infection, and abdominal discomfort.

• Full Prescribing Information: https://ionis.com/medicines/ DAWNZERA/DAWNZERA-FPI.pdf

Tonmya • Generic Name: Cyclobenzaprine hydrochloride.

• Company: Tonix Pharmaceuticals Holding Corp.

• Treatment For: Fibromyalgia in adults.

• Description: Tonmya is a white to off-white crystalline tricyclic amine salt powder.

• Dosing Information: Tonmya is administered 5.6 mg sublingually once daily at bedtime.

• Side Effects: Embryofetal toxicity, serotonin syndrome, CNS depression, oral mucosal reactions, atropine-like adverse reactions, tricyclic antidepressant-like reactions.

• Full Prescribing Information: https://www.tonixpharma. com/wp-content/uploads/2025/08/Tonmya-PrescribingInformation.pdf

• Description: Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen of selected regions of human papillomavirus problems expressed in HPV-6 and HPV-11 infected cells.

• Drug Class: Immunotherapy.

• Dosing Information: Papzimeos is administered in 5 x 1011 particle units per subcutaneous injection four times over a 12-week interval.

• Side Effects: Injection-site reaction, thrombotic events, oral paresthesia and pain, fatigue, chills, pyrexia, myalgia, and nausea.

• Full Prescribing Information: https://precigen.com/papzimeos-prescribing-information.pdf

Brinsupri Tablets • Generic Name: Brensocatib.

• Company: Ismed Incorporated.

• Treatment For: Non-cystic fibrosis bronchiectasis in adults and pediatric patients 12 years and older.

• Description: Brinsupri is a competitive, reversible inhibitor of dipeptidyl peptidase that activates pro-inflammatory neutrophil serine proteases during neutrophil maturation in the bone marrow.

• Drug Class: Immunotherapy.

• Dosing Information: 10 mg or 25 mg orally once a day.

• Side Effects: Dermatologic reactions, upper respiratory tract infections, headache, and hypertension.

• Full Prescribing Information: https://insmed.com/pdf/brinsupri_full_prescribing_information.pdf PharmaFacts | September 2025 1

PharmaFacts for Case Managers

Hernexeos Tablets

Modeyso Capsules

• Generic Name: Zongertinib tablets.

• Generic Name: Dordaviprone.

• Company: Boehringer Ingelheim Pharmaceuticals, Inc.

• Company: Jazz Pharmaceuticals, Inc.

• Treatment For: Adults with unresectable or metastatic, non-squamous non-small cell lung cancer tyrosine kinase domain-activating mutations and who have received prior systemic therapy.

• Treatment For: Adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

• Description: Hernexeos is a kinase inhibitor of human epidermal growth factor receptor 2 (HER2).

• Description: Modeyso is a protease activator.

• Drug Class: Chemotherapy.

• Dosing Information: Dosing is based on weight: < 90 kg: 120 mg; > 90 kg: 180 mg taken once a day until disease progression or unacceptable toxicity.

• Side Effects: Hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, gastrointestinal disorders, skin disorders.

• Full Prescribing Information: https://pro.boehringer-ingelheim.com/us/products/hernexeos/bipdf/ hernexeos-prescribing-information

2 PharmaFacts | September 2025

• Dosing Information: Recommended dose for adults is 625 mg orally once a week. The recommended dose for pediatric patients ³ 10 kg is based on weight. Continue dosing until disease progression or until unacceptable toxicity.

• Side Effects: Hypersensitivity, QTc internal prolongation, fatigue, nervous system disorders, gastrointestinal disorders.

• Full Prescribing Information: https://pp.jazzpharma.com/ pi/modeyso.en.USPI.pdf.