vonoprazan

REMS

Erosive esophagitis and relief of heartburn associated with erosive esophagitis.
Maintenance of healed erosive esophagitis and relief of heartburn associated with erosive esophagitis.
Relief of heartburn associated with nonerosive gastroesophageal reflux disease.
Helicobacter pylori infection (in combination with amoxicillin or with amoxicillin and clarithromycin).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Concurrent use of rilpivirine-containing products;
Severe renal impairment (for treatment of Helicobacter pylori infection);
Moderate or severe hepatic impairment (for treatment of Helicobacter pylori infection);
Lactation: Lactation.

Use Cautiously in:

Patients using high doses for >1 yr (↑ risk of hip, wrist, or spine fractures and fundic gland polyps);
Severe renal impairment (↓ dose recommended for treatment of erosive esophagitis);
Moderate or severe hepatic impairment (↓ dose recommended for treatment of erosive esophagitis);
OB: Safety not established in pregnancy;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension

Derm: STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN)

F and E: hypocalcemia(especially if treatment duration ≥3 mo), hypokalemia(especially if treatment duration ≥3 mo), hypomagnesemia(especially if treatment duration ≥3 mo)

GI: abdominal distension, abdominal pain, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, dyspepsia, fundic gland polyps, gastritis, nausea

GU: acute tubulointerstitial nephritis, urinary tract infection

Hemat: vitamin B₁₂ deficiency

MS: bone fracture

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

May ↓ rilpivirine levels and ↑ risk of resistance; concurrent use contraindicated.
May ↓ absorption of drugs requiring acid pH, including ketoconazole, itraconazole, atazanavir, nelfinavir, iron salts, dasatinib, erlotinib, nilotinib, and mycophenolate mofetil; avoid concurrent use with atazanavir and nelfinavir.
Hypomagnesemia and hypokalemia ↑ risk of digoxin toxicity.
Diuretics may ↑ risk of hypomagnesemia and hypokalemia.
May ↑ levels and risk of toxicity of CYP3A substrates, including midazolam.
May ↓ antiplatelet effects of clopidogrel; avoid concurrent use.
May ↑ levels and risk of toxicity of CYP2C19 substrates, including citalopram and cilostazol.
Strong CYP3A inducers, including rifampin, and moderate CYP3A inducers, including efavirenz, may ↓ levels and effectiveness; avoid concurrent use.

Availability ⬆ ⬇

Tablets: 10 mg; 20 mg
In combination with: amoxicillin (Voquezna Dual Pak); amoxicillin and clarithromycin (Voquezna Triple Pak). See Appendix [not included in this PDA edition].

Route/Dosage ⬆ ⬇

Erosive Esophagitis and Relief of Heartburn Associated with Erosive Esophagitis

PO (Adults ): 20 mg once daily for 8 wk.

Renal Impairment

PO (Adults ): CCr <30 mL/min: 10 mg once daily for 8 wk.

Hepatic Impairment

PO (Adults ): Moderate or severe hepatic impairment: 10 mg once daily for 8 wk.

Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Associated with Erosive Esophagitis

PO (Adults ): 10 mg once daily for up to 6 mo.

Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease

PO (Adults ): 10 mg once daily for 4 wk.

Helicobacter pylori Infection

PO (Adults ): In combination with amoxicillin (dual therapy) or amoxicillin and clarithromycin (triple therapy): 20 mg twice daily for 14 days.

Renal Impairment

PO (Adults ): CCr <30 mL/min: Not recommended.

Hepatic Impairment

PO (Adults ): Moderate or severe hepatic impairment: Not recommended.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a potassium-competitive acid blocker that suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H⁺, K⁺-ATPase enzyme system in a potassium competitive manner.

Therapeutic effects:

Healing and maintenance of healing of erosive esophagitis.
Relief of heartburn associated with erosive esophagitis and nonerosive gastroesophageal reflux disease.
Resolution of Helicobacter pylori infection.

Classifications ⬆ ⬇

Therapeutic Classification: antiulcer agents

Pharmacologic Classification:

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following oral administration unknown.

Distribution: Extensively distributed to extravascular tissues.

Metabolism/Excretion: Metabolized in the liver to inactive compounds via the CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 isoenzymes as well as sulfo- and glucuronosyl-transferases. Primarily excreted in the urine (67%; 8% as unchanged drug), with 31% excreted in the feces (<2% as unchanged drug).

Half-Life: 6.8–7.9 hr.

Time/Action Profile ⬆ ⬇

(antisecretory effects)

ROUTE	ONSET	PEAK	DURATION
PO	2–3 hr	unknown	24 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of vonoprazan. Advise to take as directed with food and swallow tablets whole; do not crush or chew. Missed dose for H pylori infection:take the next dose if missed ≤4 hr. If >4 hr have passed, skip the missed dose and take the next dose at the regularly scheduled time.Missed dose for healed erosive esophagitis or nonerosive gastroesophageal reflux disease:take the next dose if missed ≤12 hr. If >12 hr have passed, skip the missed dose and take the next dose at the regularly scheduled time. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Advise patient to report and immediately seek treatment for any unusual progressive rashes, fever, flu-like symptoms, mouth sores, or swollen lymph nodes.
Instruct patient to report signs/symptoms of hypomagnesemia, hypocalcemia, or hypokalemia such as muscle cramps and spasms, twitching, numbness and tingling in the hands and feet, palpitations, or weakness.
Advise patient to report persistent diarrhea especially if watery diarrhea with mucus or blood, fever, abdominal pain or cramping, nausea; urinary symptoms such as frequent urination, urinary pain, or flank pain.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications. Avoid use with St. John's Wort or rifampin.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected, and to avoid breastfeeding during therapy. Report pregnancies to the Phathom Pharmaceutical, Inc Adverse Event reporting line at 1-888-775-7428.

section name header

Indications ⬇