Vocinti^® (Tablets) Instructions for Use

Marketing Authorization Holder

Takeda Pharmaceutical Company Limited (Japan)

Manufactured By

Takeda Pharmaceutical Company Limited (Japan)

Labeled By

KOKANDO, Co. Ltd. (Japan)

Or

TAKEDA PHARMACEUTICALS, LLC (Russia)

Quality Control Release

TAKEDA PHARMACEUTICAL COMPANY, Limited (Japan)

Or

TAKEDA PHARMACEUTICALS, LLC (Russia)

ATC Code

A02BC08 (Vonoprazan)

Active Substance

Vonoprazan (Rec.INN registered by WHO)

Dosage Forms

	Vocinti®	Film-coated tablets, 10 mg: 30 pcs.
		Film-coated tablets, 20 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pale yellow, oval, with the inscription “B217” on one side ( – Takeda company logo).

Excipients: D-mannitol, microcrystalline cellulose, hydroxypropylcellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide, yellow iron oxide dye, gray F1 marking ink.

10 pcs. – blisters (3) – cardboard packs.

Film-coated tablets pink, oval, with a score on both sides and with the inscription “B218” on one side ( – Takeda company logo).

Excipients: D-mannitol, microcrystalline cellulose, hydroxypropylcellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide, red iron oxide dye, gray F1 marking ink.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor. Antiulcer drug

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antiulcer agents and agents for the treatment of gastroesophageal reflux disease (GERD); proton pump inhibitors

Pharmacological Action

Potassium-competitive acid blocker. Reduces the amount of acid produced in the stomach.

Indications

Treatment of gastric and duodenal ulcers; treatment of reflux esophagitis (erosive esophagitis).

Maintenance therapy for reflux esophagitis (erosive esophagitis) in patients with recurrent disease.

Prevention of recurrence of gastric and duodenal ulcers when using low-dose acetylsalicylic acid, when using NSAIDs.

As an adjuvant in the therapy of Helicobacter pylori infection in gastric and duodenal lesions, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, gastric condition after endoscopic resection for early-stage cancer, or Helicobacter pylori-associated gastritis.

ICD codes

Dosage Regimen

Take orally, once daily.

For gastric and duodenal ulcers and erosive esophagitis, the usual adult dose is 20 mg once daily.

For maintenance therapy of healed erosive esophagitis, the usual adult dose is 10 mg once daily.

For prevention of ulcer recurrence with NSAIDs or low-dose aspirin, the usual adult dose is 10 mg once daily.

For Helicobacter pylori eradication, use a dose of 20 mg twice daily as part of a combination regimen with antibiotics.

Administer the tablet with or without food.

Swallow the tablet whole; do not crush or chew.

The duration of treatment varies by indication: typically 4-8 weeks for ulcer healing, 4 weeks for initial esophagitis treatment, and 7 days for H. pylori eradication.

For long-term maintenance therapy, use the lowest effective dose.

Do not use in patients with severe hepatic impairment.

Adjust dosing frequency with caution in patients with renal impairment.

Regularly monitor liver function during prolonged therapy exceeding one year.

Adverse Reactions

Allergic reactions: urticaria, skin edema, chest tightness, feeling of shortness of breath, darkening of the eyes, dizziness, arterial hypotension (anaphylactic reaction and anaphylactic shock).

Skin and subcutaneous tissue disorders severe skin reactions, including severe skin rash, urticaria, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme).

Digestive system disorders abdominal pain, diarrhea (pseudomembranous colitis), jaundice, impaired liver function; infrequently – nausea, abdominal bloating; abnormal liver function tests, incl. increased GGT, AST activity.

Contraindications

Hypersensitivity to vonoprazan, impaired liver function, simultaneous use with atazanavir or rilpivirine, children and adolescents under 18 years of age.

With caution

Liver diseases, kidney diseases, elderly patients.

Use in Pregnancy and Lactation

As a precaution, Vonoprazan should not be used in probable or existing pregnancy unless the expected therapeutic benefit to the mother outweighs any possible risk to the fetus.

It has not been established whether Vonoprazan is excreted in human breast milk. Use during breastfeeding is contraindicated.

Use in Hepatic Impairment

Contraindicated in cases of impaired liver function. Use with caution in liver diseases.

Use in Renal Impairment

Use with caution in kidney diseases.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Use with caution in elderly patients. Kidney and liver function should be monitored.

Special Precautions

It is recommended to discontinue vonoprazan in patients with confirmed liver dysfunction or if they develop signs or symptoms indicating liver dysfunction.

Use of vonoprazan leads to an increase in the pH of gastric contents and therefore it is not recommended to take it with drugs whose absorption depends on the acidic pH of gastric contents.

Before using vonoprazan, the presence of a malignant stomach tumor should be ruled out, because taking vonoprazan may mask the symptoms of stomach cancer.

Use of drugs that increase the pH of gastric contents may be associated with an increased risk of gastrointestinal infection with Clostridium difficile. Pseudomembranous colitis may be due to the use of antibiotics for H. pylori eradication in combination with vonoprazan. In case of abdominal pain and frequent episodes of diarrhea, appropriate measures should be taken, including immediate discontinuation of the drug and seeking medical attention from a doctor.

It has been reported that the likelihood of bone fractures (hip, wrist, or spine) may increase when taking vonoprazan together with other drugs that reduce stomach acidity. This is especially likely with treatment lasting one year or more.

When using vonoprazan for a long time (more than 1 year), the patient’s condition should be regularly monitored, especially the state of liver and kidney function.

Drug Interactions

Concomitant use of vonoprazan may affect the absorption of drugs whose bioavailability depends on gastric pH.

When used concomitantly with vonoprazan, the effects of atazanavir and rilpivirine may be reduced (concomitant use is contraindicated).

Use with caution with the following drugs: CYP3A4 inhibitors (incl. clarithromycin) – when used concomitantly with clarithromycin, the plasma concentration of vonoprazan may increase.

Concomitant use may enhance the effect of cardiac glycosides.

Concomitant use may reduce the effectiveness of itraconazole, anticancer drugs that are tyrosine kinase inhibitors (gefitinib, nilotinib, erlotinib), and the antiviral drug nelfinavir.

Concomitant use with corticosteroids may increase the risk of osteoporosis.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.