Medication info
Zeposia Capsule Starter Pack 0.23 mg/0.46 mg (Ozanimod Hydrochloride)

Zeposia Capsule Starter Pack 0.23 mg/0.46 mg (Ozanimod Hydrochloride)

Prescription medicationHard capsuleOral
Ingredient · strength
Ozanimod Hydrochloride›0.5mg / 1 capsule
Manufacturer / importer
BMS Pharmaceutical Korea Ltd.
Appearance
0.23 mg: A gray opaque capsule containing a white to light yellow powder 0.46 mg: An opaque capsule with an orange upper part and a gray lower part containing a white to light yellow powder
Packaging
Starter Pack - 4 capsules/blister [0.23 mg], Starter Pack - 3 capsules/blister [0.46 mg]
Approval status
Active

MFDS item code 202300676 · Approved 2023.02.23 · Insurance code 658700770

Summary

Main use
Treatment of moderately to severely active ulcerative colitis in adults
Who takes it
Adults · Children
Adult dose
The recommended dose of this drug is 0.92 mg orally once daily. From day 1 through day 7 of treatment with this drug, administer 0.23mg once daily on days 1–4 and 0.46mg once daily on days 5–7, according to the dose-escalation regimen. From day 8 onward, administer the recommended dose of 0.92 mg orally once daily. Swallow the capsules whole; they may be taken with or without food.
Child dose
The safety and efficacy of this drug have not been established in children under 18 years of age.

Ingredients

Importer
BMS Pharmaceutical Korea Ltd.

Efficacy & effects

Treatment of moderately to severely active ulcerative colitis in adults

  • Moderate to severe active ulcerative colitis
View approved original text

This medication is used for the treatment of moderate to severe active ulcerative colitis in adults who do not adequately respond to or have become intolerant to conventional therapies such as corticosteroids or immunosuppressive agents, or biological products. Patients may use this drug to control inflammation and relieve symptoms when previous treatments have been ineffective. It helps to reduce the activity of ulcerative colitis and improve the quality of life through specialized therapy.

How to take

Adult dose

The recommended dose of this drug is 0.92 mg orally once daily. From day 1 through day 7 of treatment with this drug, administer 0.23mg once daily on days 1–4 and 0.46mg once daily on days 5–7, according to the dose-escalation regimen. From day 8 onward, administer the recommended dose of 0.92 mg orally once daily. Swallow the capsules whole; they may be taken with or without food.

Child dose

The safety and efficacy of this drug have not been established in children under 18 years of age.

Precautions

This medication should not be administered to certain patients. For example, patients with an allergy to this medication or its ingredients, patients who have had serious cardiovascular issues such as heart disease or stroke within the last 6 months, patients with cardiac conduction disorders without a pacemaker, patients with untreated severe sleep apnea, patients taking monoamine oxidase inhibitors, females who are pregnant or potentially pregnant without using effective contraception, etc. This medication may affect liver function and can cause elevated liver enzyme levels. Symptoms of liver dysfunction may include nausea, vomiting, abdominal pain, fatigue, loss of appetite, and jaundice, so if these symptoms occur, contact your doctor immediately. Moreover, this medication may temporarily lower heart rate, so caution is advised for patients with heart disease or heart rate issues. Blood pressure may increase while taking this medication, so regular monitoring and management of blood pressure is required. A decrease in lymphocyte count may make patients more susceptible to infections, so it's important to check immune status with a blood test before treatment, and treatment should start only after any infections have been resolved. During the use of this medication, patients should immediately inform healthcare providers if any symptoms of infection develop; treatment may need to be discontinued. This medication may cause edema in the retina, so if there are changes in vision, an ophthalmic examination should be performed. It is especially advised for patients with a history of diabetes or retinal disease to undergo an ophthalmic examination prior to treatment. This medication carries a risk of progressive multifocal leukoencephalopathy (PML), a specific brain condition, so if neurological symptoms arise, inform your doctor immediately. Women who are pregnant or planning to become pregnant should not take this medication and should use effective contraception while on it. Additionally, this medication may interact with other drugs, so patients should inform healthcare providers of any medications they are currently taking. There is no specific antidote for overdose; appropriate treatment should be provided according to symptoms.

Side effects

  • Peripheral edema
  • nasopharyngitis
  • herpes zoster
  • herpes labialis
  • increased ALT
  • increased GGT
  • headache
  • hypertension
  • elevated liver aminotransferases
  • bradycardia
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  • elevated blood pressure
  • decreased blood lymphocytes
  • infection
  • macular edema
  • acute liver failure

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering and should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

0.23 mg: A gray opaque capsule containing a white to light yellow powder 0.46 mg: An opaque capsule with an orange upper part and a gray lower part containing a white to light yellow powder

Package unit

Starter Pack - 4 capsules/blister [0.23 mg], Starter Pack - 3 capsules/blister [0.46 mg]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.