Perbon Injection 50 mg (Polinotate Calcium)

Adult administration

1. Methotrexate conventional therapy: As polinotate, administer 6-12 mg intramuscularly every 6 hours, four times a day. 2. Methotrexate-Polinotate rescue therapy: Starting 3 hours after the end of administration, administer 15 mg of polinotate as an intravenous injection every 3 hours for 9 doses, then follow with 8 doses every 6 hours, either intravenously or intramuscularly. 3. Combination therapy with 5-Fluorouracil (5-FU) in progressive colorectal cancer:

This drug is not suitable for the treatment of pernicious anemia due to vitamin B12 deficiency or other megaloblastic anemias. Neurological symptoms may improve while hematological status may still be unfavorable, so caution is needed. Care must be taken to avoid the risk of glass fragments when cutting the ampoule, especially when used on children and the elderly. Pregnant or breastfeeding women should preferably avoid using this drug unless specific cases warrant it. Consideration should be given when administering to pregnant and breastfeeding women, particularly when used in combination with folate antagonists. Allergic reactions may present with symptoms such as anaphylaxis or hives; any unusual symptoms should be reported to medical professionals immediately. There may be pain or temporary discomfort at the injection site. Rarely, fever or central nervous system symptoms, such as paralysis, agitation, or depression may occur, so caution is warranted. When used in conjunction with 5-FU, side effects such as diarrhea, skin reactions, and stomatitis may occur, and severe diarrhea may necessitate adjustments in the dose of 5-FU. This drug should be administered in accordance with the directives of a physician experienced in chemotherapy alongside methotrexate, and blood concentration levels must be monitored during treatment. In cases of renal impairment or fluid abnormalities, dosing adjustments may be necessary due to delayed drug excretion. This drug and methotrexate use the same carrier, so if resistance develops, the effects of this drug may also decrease. For patients at risk of vomiting, injection is preferred over oral administration. For patients with central nervous system tumors, overdosage of this drug may reduce its anticancer effects, therefore doses should be adjusted. This drug is not used for the treatment of anemia caused by certain DNA synthesis inhibitors. This drug does not mitigate some side effects associated with methotrexate-induced nephrotoxicity. When used alongside 5-FU, regular blood tests and liver function tests should be conducted before and after treatment, and the dose of 5-FU should be adjusted based on adverse reactions. This drug may lower the concentration of other drugs that are metabolized in the liver, increasing the risk of seizures; therefore, blood concentration monitoring is essential. Caution should be taken during combination with 5-FU as it may enhance both the efficacy and side effects. When used alongside methotrexate and other folate-inhibiting anticancer agents, the anticancer effect may be diminished or lost. Administration to pregnant women should consider fetal risk, and it should not be used in combination with 5-FU. Breastfeeding women should also exercise caution as this drug may be excreted in breast milk and should not be used in conjunction with 5-FU. Elderly patients may be at higher risk for gastrointestinal toxicity and should be particularly cautious; generally, older adults have decreased physiological function, necessitating careful drug use. This drug is contraindicated for intrathecal administration, and since it contains calcium, careful attention should be paid not to exceed 160 mg per minute during intravenous infusion. It should be stored out of reach of children and sealed in its original container to prevent drug misuse and deterioration of quality.

Serious side effects

• Hives
• anaphylactic reactions
• paralytic disorders

Mild side effects

• Vascular pain
• transient pain
• fever
• agitation
• depression
• diarrhea
• skin dryness
• stomatitis
• conjunctivitis
• mucositis

This drug may be sensitive to light, therefore it should be stored in a container that is not light-permeable. Additionally, it should be stored at room temperature and kept away from excessively hot or cold places.

Appearance

A colorless to pale yellow transparent injection solution contained in a brown ampoule.

Package unit

5mL - 10 ampoules per box