Cladribine
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What is Cladribine?[edit | edit source]
- Cladribine is a synthetic antineoplastic agent used primarily in the therapy of hairy cell leukemia.
What are the uses of this medicine?[edit | edit source]
- Cladribine is used for the treatment of active Hairy Cell Leukemia as defined by anemia, neutropenia, thrombocytopenia or disease-related symptoms.
How does this medicine work?[edit | edit source]
- Cladribine (klad' ri been) is a purine analogue (2-chlorodeoxyadeosine) that is used predominantly in the treatment of hairy cell leukemia.
- Cladribine is a chlorodinated derivative of adenine which is converted intracellularly to the cladribine triphosphate, which is believed to compete with adenine triphosphate in DNA synthesis.
- Cladribine was found to have marked activity against hairy leukemia and was approved for this use in the United States in 1993.
- Cladribine has been used off-label to treat low grade lymphomas and other hematologic malignancies, but its current formal indications are limited to therapy of active hairy cell leukemia.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients:
- who are hypersensitive to this drug or any of its components.
What drug interactions can this medicine cause?[edit | edit source]
- There are no known drug interactions with cladribine injection.
- Caution should be exercised if cladribine injection is administered before, after, or in conjunction with other drugs known to cause immunosuppression or myelosuppression.
Is this medicine FDA approved?[edit | edit source]
- Cladribine was approved by the FDA in 1993 for hairy cell leukemia as an orphan drug, and was approved in Europe later that year.
How should this medicine be used?[edit | edit source]
Recommended dosage:
- The recommended dose and schedule of cladribine injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for seven consecutive days at a dose of 0.09 mg/kg/day.
Administration:
- Cladribine is typically given intravenously daily for 7 days.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As injection, USP is available in single-dose vials containing 10 mg (1 mg/mL) of cladribine
This medicine is available in fallowing brand namesː
- CLADRIBINE
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- vomiting
- nausea
- stomach pain
- diarrhea
- constipation
- headache
- loss of appetite
- excessive sweating
- skin rash
- pain, redness, swelling, or sores in the place where the medication was injected
cladribine can cause some serious side effects include:
- pale skin
- excessive tiredness
- shortness of breath
- dizziness
- fast heartbeat
What special precautions should I follow?[edit | edit source]
- Cladribine injection is a potent antineoplastic agent with potentially significant toxic side effects. It should be administered only under the supervision of a physician experienced with the use of cancer chemotherapeutic agents.
- Serious neurological toxicity (including irreversible paraparesis and quadraparesis) has been reported in patients who received cladribine injection by continuous infusion at high doses.
- Acute nephrotoxicity has been observed with high doses of cladribine injection (four to nine times the recommended dose for Hairy Cell Leukemia), especially when given concomitantly with other nephrotoxic agents/therapies.
- Cladribine has not been associated with serum enzyme elevations during therapy or with instances of clinically apparent acute liver injury with jaundice.
- Due to increased risk of infection in the setting of immunosuppression with chemotherapy including cladribine, it is recommended not to administer live attenuated vaccines to patients receiving cladribine injection.
- Severe bone marrow suppression, including neutropenia, anemia and thrombocytopenia, has been commonly observed in patients treated with cladribine injection, especially at high doses.
- Serious (e.g. respiratory infection, pneumonia and viral skin infections), including fatal infections (e.g., sepsis) were reported.
What to do in case of emergency/overdose?[edit | edit source]
Symptoms of overdosage may include:
- irreversible neurologic toxicity (paraparesis/quadriparesis), acute nephrotoxicity, and severe bone marrow suppression resulting in neutropenia, anemia and thrombocytopenia
Management of overdosage:
- There is no known specific antidote to overdosage.
- Treatment of overdosage consists of discontinuation of cladribine, careful observation, and appropriate supportive measures.
- It is not known whether the drug can be removed from the circulation by dialysis or hemofiltration.
Can this medicine be used in pregnancy?[edit | edit source]
- Cladribine can cause fetal harm when administered to a pregnant woman.
- Advise females of reproductive potential to use highly effective contraception during treatment with cladribine.
Can this medicine be used in children?[edit | edit source]
- Safety and effectiveness in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredients include:
- CLADRIBINE
Inactive ingredients include:
- SODIUM CHLORIDE
- PHOSPHORIC ACID
- SODIUM PHOSPHATE, DIBASIC
Who manufactures and distributes this medicine?[edit | edit source]
- Packager: Fresenius Kabi USA, LLC
What should I know about storage and disposal of this medication?[edit | edit source]
- Store refrigerated 2° to 8°C (36° to 46°F).
- Protect from light (keep in outer carton until time of use).
Alphabetic list of antineoplastic agents - 0-9 - A1 - A2 - A3 - A4 - A5 -A6 - B - C - D - E - F - G - H - I - JK - L - M - NO - PQ - R - S - T - UVW - XYZ
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