Takecab (Vonoprazan) 10 mg / 20 mg 100 tablets

Takecab (Vonoprazan) tablets 10 mg / 20 mg, 100 tablets — Takeda, Japan

Takecab is a prescription oral acid-suppressing medicine manufactured and marketed in Japan by Takeda Pharmaceutical Company Limited, containing vonoprazan fumarate — a potassium-competitive acid blocker (P-CAB). In Japan it is a 医療用医薬品, i.e. a prescription-only medicine, and treatment is supervised by a physician. Each carton contains 100 film-coated tablets in ten blister strips of 10 tablets. Two strengths are available on this card, 10 mg and 20 mg (タケキャブ錠10mg / 20mg) — choose the strength in the options above. The marketing authorisation holder is Takeda Pharmaceutical Company Limited, Osaka, in co-promotion with Otsuka Pharmaceutical Co., Ltd.

Product overview

• Trade name: Takecab tablets (タケキャブ錠)
• Active ingredient: vonoprazan fumarate (ボノプラザンフマル酸塩)
• Strength: 10 mg or 20 mg of vonoprazan per tablet — choose above
• Pharmacological class: potassium-competitive acid blocker (P-CAB); ATC A02BC
• Dosage form: film-coated tablets
• Pack size: 100 tablets (10 tablets × 10 blister strips)
• Manufacturer: Takeda Pharmaceutical Company Limited, Osaka, Japan
• Country of origin: Japan
• Legal status in Japan: prescription medicine (医療用医薬品)
• Dosages and prices on this card: 10 mg — €136; 20 mg — €177

What vonoprazan is used for

Vonoprazan suppresses gastric acid secretion by blocking the potassium site of the gastric proton pump. The indications approved in Japan are:

• gastric ulcer
• duodenal ulcer
• reflux esophagitis
• maintenance therapy of reflux esophagitis in patients with repeated relapse or re-exacerbation
• prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin therapy
• prevention of recurrence of gastric or duodenal ulcer during non-steroidal anti-inflammatory drug (NSAID) therapy
• as an adjunct to Helicobacter pylori eradication in gastric or duodenal ulcer, gastric MALT lymphoma, H. pylori-associated gastritis, immune thrombocytopenia, and the stomach after endoscopic treatment of early gastric cancer

How to use

The dose and duration are chosen by the attending physician. Approved regimens for adults in Japan:

• Gastric ulcer / duodenal ulcer: 20 mg once daily — up to 8 weeks for gastric ulcer, up to 6 weeks for duodenal ulcer.
• Reflux esophagitis: 20 mg once daily, usually for up to 4 weeks, extended to 8 weeks if the response is insufficient.
• Maintenance of repeatedly relapsing reflux esophagitis: 10 mg once daily, increased to 20 mg once daily if the response is insufficient.
• Prevention of ulcer recurrence during low-dose aspirin therapy or NSAID therapy: 10 mg once daily.
• H. pylori eradication: 20 mg twice daily for 7 days together with amoxicillin 750 mg and clarithromycin 200 mg (up to 400 mg) twice daily; if first-line eradication fails, metronidazole 250 mg replaces clarithromycin.

• Tablets are swallowed whole with water, without crushing or chewing.
• The Japanese label advises periodic endoscopic examination during long-term treatment.
• Do not change the dose, and do not stop or restart treatment, without medical advice.

Possible side effects

The reactions reported most often are diarrhoea, constipation, abdominal bloating, nausea, dysgeusia, stomatitis, abdominal discomfort and oedema. Hypersensitivity reactions, rash, and transient rises in liver enzymes (AST, ALT, ALP, LDH, γ-GTP) occur.

Serious reactions are rare but include shock and anaphylaxis, pancytopenia, agranulocytosis, leukopenia, thrombocytopenia, hepatic dysfunction, toxic epidermal necrolysis and Stevens–Johnson syndrome, erythema multiforme, hypomagnesaemia, QT prolongation, convulsions, numbness, and electrolyte disturbances such as low calcium and low potassium. Stop taking the medicine and seek medical help immediately if you develop a skin rash with blistering, swelling of the face or throat, fainting, palpitations, muscle cramps or convulsions.

Important precautions

• Contraindicated in case of hypersensitivity to any ingredient, and in patients receiving atazanavir sulfate or rilpivirine hydrochloride.
• Use with caution in impaired liver or kidney function, in advanced gastric MALT lymphoma other than the stomach after endoscopic treatment of early gastric cancer, and in elderly patients.
• Relative contraindication in pregnancy; caution is required during breastfeeding; use in children is not established.
• Vonoprazan reduces the absorption of some medicines — atazanavir, rilpivirine, itraconazole, nelfinavir, gefitinib, erlotinib, nilotinib and other tyrosine kinase inhibitors — and can increase the effect of digoxin and methyldigoxin.
• Clarithromycin and other CYP3A4 inhibitors increase vonoprazan blood levels; strong and moderate CYP3A4 inducers such as rifampicin and efavirenz decrease them.
• A prescription is required in Japan; this product is not a substitute for medical advice, and self-treatment of persistent stomach pain, difficulty swallowing, vomiting blood or black stools is unsafe.

Storage

Store below 30 °C in the original carton, protected from light and moisture, keep out of reach of children, leave the tablets in the blister strips, and do not use after the expiry date printed on the pack.

Important notice

The photograph is shown for identification purposes only. The medicine is supplied in its original Japanese packaging. Vonoprazan is a prescription medicine: use it only under medical supervision, keep to the prescribed dose and duration, and check the import rules of your country before ordering. This information summarises the Japanese product labelling and does not replace the advice of your doctor or pharmacist.

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