Ornova (Vonoprazan): A Potassium Competitive Acid Blocker (P-CAB)

Ornova contains Vonoprazan, a potassium competitive acid blocker (P-CAB). It is indicated for the treatment and prevention of various acid-related gastrointestinal conditions, and as an adjunct in Helicobacter pylori eradication regimens. It is classified as a Potassium competitive acid blocker.

How Ornova Works (Pharmacology)

Vonoprazan is a novel type of acid-suppressing drug that works differently from proton pump inhibitors (PPIs).

• Potassium Competitive Acid Blocker (P-CAB): Unlike PPIs, Vonoprazan directly and reversibly inhibits the H+, K+-ATPase (proton pump) in gastric parietal cells by competing with potassium ions.
• No Acid Activation Required: It does not require activation by acid, allowing it to exert its inhibitory effect immediately upon administration.
• Strong Basicity and Prolonged Residence: Vonoprazan has a strong basicity, causing it to accumulate and reside on the acid production site of gastric parietal cells for a prolonged period. This leads to sustained inhibition of gastric acid production.
• Mucosal Protection: It exerts a strong inhibitory effect on the formation of mucosal damage in the upper gastrointestinal tract.

Key Indications & Benefits

Ornova is indicated for:

• Gastric ulcer
• Duodenal ulcer
• Reflux esophagitis
• Prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin administration.
• Prevention of recurrence of gastric or duodenal ulcer during NSAID (non-steroidal anti-inflammatory drug) administration.
• Adjunct to Helicobacter pylori eradication in the following conditions:
  • Gastric ulcer
  • Duodenal ulcer
  • Gastric mucosa-associated lymphatic tissue (MALT) lymphoma
  • Idiopathic thrombocytopenic purpura
  • The stomach after endoscopic resection of early-stage gastric cancer
  • Helicobacter pylori gastritis

Dosage & Administration

Vonoprazan can be taken without regard to food or timing of food. Always consult a registered physician for medication use.

• Gastric ulcer: Usual adult dose is 20 mg once daily for an 8-week treatment.
• Duodenal ulcer: Usual adult dose is 20 mg once daily for a 6-week treatment.
• Reflux esophagitis:
  • Initial: 20 mg once daily for 4 weeks. If insufficient, extend up to 8 weeks.
  • Maintenance therapy (for recurrence/recrudescence): 10 mg once daily. If efficacy is inadequate, may increase to 20 mg once daily.
• Prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin administration: 10 mg once daily.
• Prevention of recurrence of gastric or duodenal ulcer during NSAID administration: 10 mg once daily.
• Adjunct to Helicobacter pylori eradication (Adults):
  • First-line regimen: 20 mg Vonoprazan, 750 mg amoxicillin hydrate, and 200 mg clarithromycin, all administered orally twice daily for seven days. (Clarithromycin dose may increase up to 400 mg twice daily as clinically warranted).
  • Alternative regimen (if first-line unsuccessful): 20 mg Vonoprazan, 750 mg amoxicillin hydrate, and 250 mg metronidazole, all administered orally twice daily for seven days.

Important Considerations & Warnings

It is crucial to discuss your full medical history with your doctor before taking Ornova.

Contraindications:

• Patients with hypersensitivity to Vonoprazan or any excipient of the product.
• Patients receiving atazanavir sulfate, nelfinavir, or rilpivirine hydrochloride.

Side Effects:

• Common: Diarrhea, constipation, nausea, abdominal distension.
• Hypersensitivity reactions: Drug hypersensitivity (including anaphylactic shock), drug eruption, urticaria, rash.
• Hepatic effects: Hepatotoxicity, jaundice, increased gamma-glutamyl transferase, increased AST, abnormal liver function test, increased ALT, increased ALP, increased LDH, increased y-GPT.
• Other: Edema, eosinophilia.

Pregnancy & Lactation:

• Pregnancy: Should be used in pregnant women or women with possibility of pregnancy only if the expected therapeutic benefit outweighs any possible risk.
• Lactation: It is advisable to avoid administration to nursing mothers. If administration is indispensable, nursing should be discontinued.

Precautions & Warnings:

• Close Observation: During treatment, closely observe the course of the disease and use the minimum therapeutically necessary dose.
• Long-term Treatment: For long-term treatment with Ornova, close observation (e.g., by endoscopy) should be made.
• Maintenance of Reflux Esophagitis: Administer only to patients who experience repeated recurrence and recrudescence of the condition. Avoid administration to patients who do not necessitate maintenance healing.
• Dose Reduction/Suspension: When healing is maintained for a long period and there is no risk of recurrence, consider dose reduction (from 20 mg to 10 mg) or suspension of administration.

Use in Special Populations:

• Elderly: Administer carefully, as physiological functions (hepatic/renal) are generally decreased.
• Children less than 18 years of age: Safety and efficacy have not been established. Administration is not recommended.
• Renal impairment:
  • Mild to moderate (eGFR 30 to 89 mL/min): No dose adjustment recommended.
  • Severe (eGFR < 30 mL/min):Avoid use.
• Hepatic impairment:
  • Mild (Child-Pugh A): No dose adjustment recommended.
  • Moderate to severe (Child-Pugh B or C):Avoid use.

Overdose Effects

• There is no experience of overdose with Ornova.
• Ornova is not removed from circulation by hemodialysis.
• If overdose occurs, treatment should be symptomatic and supportive.

Storage Conditions

Store below 30°C, in a cool and dry place. Keep away from light. Keep all medicines out of the reach of children.