Medication info

Ribavirin Injection (Cladribine)

Prescription medicationSolutionInjection
Ingredient · strength
Cladribine›1mg / 1mL
Manufacturer / importer
ZP Therapeutics Korea Co., Ltd.
Appearance
A clear, colorless solution in a vial
Packaging
10mL/vial/box
Approval status
Active

MFDS item code 199704348 · Approved 1997.02.03 · Insurance code 057200101

Summary

Main use
Treatment of active hairy cell leukemia
Who receives it
Adults
Adult administration
For active hairy cell leukemia, administer cladribine 0.09 mg/kg/day by continuous intravenous infusion for 7 consecutive days (one treatment cycle per week). It is preferable not to change this dose. If neurotoxicity or nephrotoxicity develops, delaying or discontinuing treatment should be considered. For preparation of each daily dose, pass the Leustatin injection through a single-use, sterile 0.22 μm hydrophilic syringe filter before adding it to the infusion container. Add the calculated amount of drug (0.09 mg/kg or 0.09 mL/kg) through a sterile filter to an infusion container containing 500 mL of 0.9% sodium chloride injection, and administer this diluted solution by continuous intravenous infusion over 24 hours. Repeat this procedure daily for a total of 7 days. Do not use 5% glucose solution as a diluent because it increases the degradation of cladribine. The diluted solution of this drug is physically and chemically stable for at least 24 hours in a Baxter Viaflex PVC infusion container at room temperature under normal indoor fluorescent lighting. 24-hour infusion regimen: daily dose 0.09 mg/kg, recommended diluent 0.9% sodium chloride injection, diluent volume 500 mL

Ingredients

Importer
ZP Therapeutics Korea Co., Ltd.

Efficacy & effects

Treatment of active hairy cell leukemia

  • Hairy cell leukemia
View approved original text

Active hairy cell leukemia is a rare blood cancer characterized by the abnormal proliferation of specific white blood cells in the blood. This medication is used to effectively treat hairy cell leukemia.

How it is given

Adult administration

For active hairy cell leukemia, administer cladribine 0.09 mg/kg/day by continuous intravenous infusion for 7 consecutive days (one treatment cycle per week). It is preferable not to change this dose. If neurotoxicity or nephrotoxicity develops, delaying or discontinuing treatment should be considered. For preparation of each daily dose, pass the Leustatin injection through a single-use, sterile 0.22 μm hydrophilic syringe filter before adding it to the infusion container. Add the calculated amount of drug (0.09 mg/kg or 0.09 mL/kg) through a sterile filter to an infusion container containing 500 mL of 0.9% sodium chloride injection, and administer this diluted solution by continuous intravenous infusion over 24 hours. Repeat this procedure daily for a total of 7 days. Do not use 5% glucose solution as a diluent because it increases the degradation of cladribine. The diluted solution of this drug is physically and chemically stable for at least 24 hours in a Baxter Viaflex PVC infusion container at room temperature under normal indoor fluorescent lighting. 24-hour infusion regimen: daily dose 0.09 mg/kg, recommended diluent 0.9% sodium chloride injection, diluent volume 500 mL

Precautions

This drug should only be used under the supervision of a specialist experienced in cancer treatment. Bone marrow function may be suppressed, which is usually temporary and varies with dosage. High-dose administration may lead to severe adverse effects such as serious neurological damage or acute renal failure. Some patients using this drug have reported serious brain diseases called progressive multifocal leukoencephalopathy, which can occur months to years after use. Therefore, if any new or worsening neurological symptoms arise, immediate consultation with a specialist is required. Patients with hypersensitivity to this drug should not use it, and those with poor kidney or liver function require careful evaluation before administration. Fever and neutropenia are common in the early stages of administration, increasing the risk of infection; hence, patients should be closely monitored, and antibiotics should be administered as necessary. This drug can suppress immune function, making patients more susceptible to infections; thus, it should be administered after treating any active infections. Patients with high white blood cell counts may require adequate hydration and medication to prevent tumor lysis syndrome. Fatal infections have also been reported, so healthcare personnel should be informed immediately if any symptoms of infection occur. As a potent anticancer agent, this drug can cause various serious adverse reactions, and regular blood tests and health status checks are necessary during treatment. It must not be used during pregnancy, and effective contraception is required during treatment and for six months after discontinuation. It is safe for breastfeeding women to discontinue breastfeeding while receiving this medication. Safety in children has not been established, and in case of overdose, administration should be stopped immediately and appropriate treatment initiated. When administering, do not mix with other medications, and if the drug comes into contact with skin or mucous membranes, wash thoroughly immediately. Store in a sealed container to protect from air and light, and keep refrigerated at temperatures between 2°C and 8°C. Proper storage maintains the drug's efficacy and allows for safe use.

Side effects

Bone marrow suppression, severe irreversible neurotoxicity, acute renal failure, progressive multifocal leukoencephalopathy, hypersensitivity reactions, fever, severe neutropenia, infections, fatal infections, tumor lysis syndrome, death, renal failure symptoms, neurotoxicity, gastrointestinal symptoms, acidosis, anuria, elevated serum creatinine levels, ataxia, paresthesia, dizziness, anemia, febrile neutropenia, anxiety, insomnia, vertigo, headache, tachycardia, abnormal breath sounds, cough, dyspnea, crackles, abdominal pain, constipation, diarrhea, gastric distension, nausea, vomiting, petechiae, hyperhidrosis, purpura, pruritus, rash, arthralgia, myalgia, pain, injection site reactions, weakness, chills, appetite loss, fatigue, malaise, muscle weakness, peripheral edema, bruising, aplastic anemia, delayed pancytopenia, hemolytic anemia, eosinophilia, myelodysplastic syndrome, confusion, lowered level of consciousness, peripheral sensory neuropathy, motor neuron disease, polyneuropathy, paraplegia, conjunctivitis, interstitial lung infiltration, elevated bilirubin, elevated transaminases, urticaria, Stevens-Johnson syndrome, renal failure, septic shock, opportunistic infections

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

Storage

This drug should be stored in a sealed container to protect from air and light, and it must be kept at refrigerated temperatures between 2°C and 8°C. Proper storage maintains the drug's efficacy and ensures safe use.

Appearance and packaging

Appearance

A clear, colorless solution in a vial

Package unit

10mL/vial/box

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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.