Vonoprazan/Amoxicillin/Clarithromycin

DEA Class; Rx

Common Brand Names; Voquezna Triple Pak

Indicated for treatment of Helicobacter pylori (H pylori) infection

Known hypersensitivity to any component – vonoprazan, amoxicillin (or other beta-lactam antibacterials [eg, penicillins, cephalosporins]), or clarithromycin (or other macrolide antibacterial drugs [eg, erythromycin])

Rilpivirine-containing products, owing to inhibition of gastric pH by vonoprazan

• Dysgeusia (4.6%)
• Diarrhea (4%)
• Vulvovaginal candidiasis (3.2%)
• Headache (2.6%)
• Abdominal pain (2.3%)
• Hypertension (2%)
• Blood and lymphatic system disorders: Anemia, leukocytosis, leukopenia, neutropenia
• Cardiac disorders: QT prolongation, tachycardia
• Eye disorders: Orbital edema
• Gastrointestinal disorders: Abdominal distention, constipation, dry mouth, duodenal polyp, duodenal ulcer, dyspepsia, flatulence, gastric ulcer, gastroesophageal reflux disease, hematochezia, large intestine polyp, nausea, rectal polyp, stomatitis, tongue discomfort, vomiting
• General disorders and administration site conditions: Fatigue, pyrexia
• Immune system disorders: Drug hypersensitivity
• Infections and infestations: Anal fungal infection, gastrointestinal viral infection, oral fungal infection, pneumonia, tongue fungal infection, upper respiratory tract infection, urinary tract infection, viral infection
• Investigations: Liver function test abnormal
• Metabolism and nutrition disorders: Decreased appetite
• Musculoskeletal system: Bone fracture
• Nervous system disorders: Ageusia, dizziness, tension headache
• Psychiatric disorders: Anxiety, depression, insomnia
• Renal and urinary disorders: Renal hypertrophy, tubulointerstitial nephritis
• Reproductive system and breast disorders: Vaginal discharge
• Respiratory, thoracic, and mediastinal disorders: Cough, nasal polyps, oropharyngeal pain
• Skin and subcutaneous tissue disorders: Dermatitis, dry skin, rash
• Nasopharyngitis (0.3%)

Serious and occasionally fatal hypersensitivity reactions (eg, anaphylaxis, anaphylactic shock, rash, erythema multiforme, and Henoch-Schonlein purpura) reported with components; discontinue immediately and institute appropriate treatment if hypersensitivity occurs

Severe cutaneous adverse reactions (SCAR), including SJS and TEN reported with all components; additionally, DRESS and AGEP have been reported with amoxicillin and clarithromycin; discontinue at first signs of SCAR

Clostridioides difficile–associated diarrhea (CDAD) reported with acid-suppressing therapies and nearly all antibacterial agents; CDAD must be considered in all patients who present with diarrhea following antibacterial use; careful medical history necessary since CDAD reported to occur over 2 months after administration of antibacterial agents; if CDAD confirmed, discontinue, and implement appropriate management

High percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash; avoid in patients with mononucleosis

Prescribing this regimen in absence of proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit, and increases risk for drug-resistant bacteria

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity; increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors; assess CgA levels at least 14 days after treatment, and consider repeating test if initial CgA levels are high

Glucose tests: High urine concentrations of amoxicillin may cause false-positive results when using glucose tests based on the Benedict copper reduction reaction that determines the amount of reducing substances, like glucose, in the urine; use enzymatic glucose oxidase reactions instead while taking amoxicillin

On the basis of animal studies and observational studies in pregnant females with use of clarithromycin, use is not recommended in pregnant females, except in clinical circumstances where no alternative therapy is appropriate

Vonoprazan

• There are no data regarding the presence of vonoprazan in human milk, the effects on the breastfed infant or the effects on milk production

• Vonoprazan and its metabolites are present in rat milk; liver injury occurred in offspring from pregnant and lactating rats administered oral vonoprazan at AUC exposures approximately equal to and greater than the MRHD

Amoxicillin

• Data from published clinical lactation study indicate that amoxicillin is present in human milk

• There are no data on the effects of amoxicillin on milk production

Clarithromycin

• Observational study of lactating women exposed to clarithromycin, reported adverse effects on breastfed children (rash, diarrhea, loss of appetite, somnolence) that were comparable with amoxicillin