Pernobon Injection 1% (Polininate Calcium)

Adult administration

1. Methotrexate standard therapy: Administer 6-12mg of polininate as an intramuscular injection every 6 hours for a total of 4 times a day. 2. Methotrexate-polininate rescue therapy: Administer 15mg intravenously every 3 hours for a total of 9 times, followed by 8 intravenous or intramuscular injections every 6 hours. 3. Co-administration with 5-Fluorouracil (5-FU) in advanced colon cancer: 1) 200mg of polininate calcium per day

This drug is not suitable for the treatment of pernicious anemia due to vitamin B12 deficiency or other macrocytic anemias. Even if neurological symptoms continue to progress, blood status may improve temporarily, so caution is advised. Women who are pregnant or breastfeeding should not receive this drug, especially in combination with 5-FU. However, it should be used with caution in pregnant or lactating women when administered to mitigate the toxicity of folate antagonists. This drug can cause hypersensitivity reactions such as anaphylaxis or allergic reactions like urticaria, and pain or discomfort at the injection site may occur. Additionally, fever or central nervous system symptoms, such as paralysis, excitement, and depression, may also occur. When used with 5-FU, diarrhea, skin problems, mucositis, conjunctivitis, and blood abnormalities may occur, requiring dosage adjustments of 5-FU if symptoms are severe. This medication should be used in conjunction with methotrexate under the guidance of a physician experienced in chemotherapy, and it should be administered promptly in case of folate antagonist overdose for better efficacy. Proper dosages and treatment duration should be determined while monitoring the methotrexate concentration in the blood. In particular, in cases with impaired kidney function or fluid retention in the body, the excretion of methotrexate may be delayed, allowing for high doses of this drug to be administered intravenously. This drug uses transporters like methotrexate, so patients who are resistant to methotrexate may be resistant to this drug as well. If there is a possibility of vomiting, it is recommended to administer this drug via injection rather than orally. In patients with central nervous system tumors, repeated administration of this drug may accumulate in the body and reduce the anticancer effect of methotrexate, so overdose should be avoided. This drug is not used for the treatment of macrocytic anemia caused by DNA synthesis inhibitors, and it is ineffective for other adverse reactions aside from blood toxicity due to methotrexate. When used in combination with 5-FU, regular blood tests and liver function tests should be conducted before and during treatment, and if adverse reactions occur, the dosage of 5-FU should be adjusted. This drug may increase liver metabolism, lowering the blood concentration of some anticonvulsants and increasing the risk of seizures, thus requiring blood concentration monitoring during administration. For pregnant women, the risk to the fetus should be carefully considered before administering this drug, and caution should be exercised in nursing women as well. In elderly patients, especially when used with 5-FU, the risk of gastrointestinal toxicity is increased, so care should be taken, and generally, elderly individuals should be cautious with medication use due to decreased physical function. This drug is contraindicated for intrathecal administration and has a calcium component; therefore, intravenous administration should be limited to a rate of 160mg per minute.

Serious side effects

Urticaria, anaphylactic reactions, central nervous system disorders (paralytic disorders)

Mild side effects

Vein pain (during intravenous injection), transient pain (during intramuscular injection), fever, depression, diarrhea, skin reactions, dry skin, mucositis, conjunctivitis, mild blood toxicity, leukopenia

This drug is sensitive to light and should be stored away from direct sunlight. Additionally, it should be stored in a sealed container to prevent exposure to air, and the appropriate storage temperature is refrigeration between 2 degrees and 8 degrees Celsius. Therefore, it is safe to store it inside the refrigerator.

Appearance

A colorless to pale yellow transparent solution in a brown glass vial

Package unit

10 vials/box [5mL/vial], 10 vials/box [10mL/vial], 5 vials/box [20mL/vial], 1 vial/box [30mL/vial], 1 vial/box [50mL/vial]