Medication info

Akigajeong 50/500 mg

Prescription medicationTablet
Ingredient · strength
Niraparib Tosylate Monohydrate›79.7mg / 1 tabletAbiraterone Acetate Micronized›500mg / 1 tablet
Manufacturer / importer
(주)한국얀센
Appearance
Oval film-coated tablets ranging from orange-yellow to brownish-yellow.
Packaging
56 tablets/box [28 tablets/PTP x 2]
Approval status
Active

MFDS item code 202302816 · Approved 2023.09.25

Summary

Main use
Efficacy in the treatment of metastatic castration-resistant prostate cancer with BRCA mutation.
Who uses it
Adults
Adult dosage
The recommended dose is Niraparib 200 mg / Abiraterone acetate 1000 mg (2 tablets of 100 mg/500 mg) taken once daily at the same time. This medication should be taken on an empty stomach. It should be administered at least 2 hours after a meal and no food should be consumed for at least 1 hour after taking it. This medication must be swallowed whole with water and should not be chewed or crushed.

Ingredients

Importer
(주)한국얀센

Efficacy & effects

Efficacy in the treatment of metastatic castration-resistant prostate cancer with BRCA mutation.

View approved original text

This medication is used in patients with metastatic castration-resistant prostate cancer who have BRCA gene mutations and is administered in conjunction with prednisone for adult patients who have not received chemotherapy. This treatment helps suppress the growth of cancer cells and slows the progression of prostate cancer. It provides customized treatment based on the patient’s condition and contributes to improving the overall effectiveness of cancer treatment. Therefore, it is effectively used for BRCA mutation metastatic castration-resistant prostate cancer.

Dosage and Administration

Adult dosage

The recommended dose is Niraparib 200 mg / Abiraterone acetate 1000 mg (2 tablets of 100 mg/500 mg) taken once daily at the same time. This medication should be taken on an empty stomach. It should be administered at least 2 hours after a meal and no food should be consumed for at least 1 hour after taking it. This medication must be swallowed whole with water and should not be chewed or crushed.

Precautions

This medication may cause severe hematological malignancies such as myelodysplastic syndrome or acute myeloid leukemia, so additional evaluation by a specialist is necessary if there are symptoms suggestive of blood cancer or if hematological toxicity persists for an extended period. It should not be used in individuals allergic to this medication's ingredients or excipients, in pregnant or breastfeeding women, or in patients with moderate to severe liver impairment. Patients with hereditary metabolism disorders such as galactose intolerance or lactose enzyme deficiency should also not take this medication. The use of radium-223 dichloride in conjunction is not recommended, as this combination may increase the risk of fractures and mortality and requires caution. Patients with hypertension, hypokalemia, fluid retention, or cardiovascular disease should be carefully administered this medication, as it can increase mineralocorticoid levels, worsening these symptoms. Caution is also required for patients with severe renal impairment when using this medication. Common side effects associated with this medication include anemia, constipation, hypertension, nausea, fatigue, thrombocytopenia, weakness, pain, loss of appetite, vomiting, neutropenia, arthralgia, urinary tract infections, insomnia, headaches, dyspnea, abdominal pain, peripheral edema, hypokalemia, dizziness, nasopharyngitis, bronchitis, conjunctivitis, leukopenia, hypertriglyceridemia, depression, anxiety, confusion, palpitations, atrial fibrillation, tachycardia, heart failure, myocardial infarction, pneumonitis, and dyspepsia. Hematological adverse reactions, such as anemia, thrombocytopenia, and neutropenia, mainly occur early in treatment and may require regular blood tests for monitoring and dosage adjustments or treatment discontinuation if necessary. Blood pressure should be adequately controlled before administration and monitored regularly during treatment. Patients with a history of heart disease should carefully manage cardiac function and monitor for symptoms, considering drug discontinuation if severe cardiac abnormalities arise. Since there is a risk of liver function abnormalities or hepatotoxicity, frequent liver function tests should be conducted before and during treatment, and treatment should be suspended if liver levels rise significantly. There may be an increased risk of infection, so careful observation for symptoms of infection is essential, and symptoms of pulmonary embolism should also be promptly evaluated and treated. Rarely, this medication may cause a reversible posterior leukoencephalopathy syndrome that can affect brain function; if symptoms such as seizures, headache, or visual disturbances occur, immediate consultation with healthcare professionals is necessary. Diabetic patients should closely monitor blood glucose changes, and monitoring for adrenal function impairment is essential upon discontinuation of corticosteroids. Women who are pregnant or may become pregnant should take care to avoid exposure to this medication and should use effective contraception during the treatment period and for four months after the last dose. The safety and efficacy of this medication in children have not been established, and for elderly patients, special dose adjustments are not required. There is no specific antidote for overdose, so symptomatic treatment will be provided according to symptoms. This medication may require caution when operating vehicles or machinery, so one should act carefully during such activities. Keep this medication out of the reach of children and store it in the original container to prevent misuse or degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, labored breathing or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, consciousness confusion, vision abnormalities, paralysis, urination.

Mild side effects

  • Anemia
  • constipation
  • nausea
  • fatigue
  • thrombocytopenia
  • weakness
  • back pain
  • loss of appetite
  • vomiting
  • neutropenia
Show 24 more
  • arthralgia
  • lymphocytopenia
  • urinary tract infections
  • insomnia
  • headache
  • cough
  • abdominal pain
  • hypokalemia
  • dizziness
  • nasopharyngitis
  • bronchitis
  • conjunctivitis
  • leukopenia
  • hypertriglyceridemia
  • depression
  • anxiety
  • confusion
  • palpitations
  • atrial fibrillation
  • tachycardia
  • heart failure
  • myocardial infarction
  • pneumonitis
  • dyspepsia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to preserve its effectiveness over time.

Appearance and packaging

Appearance

Oval film-coated tablets ranging from orange-yellow to brownish-yellow.

Package unit

56 tablets/box [28 tablets/PTP x 2]

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.

Questions about this medicine

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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.