cladribine


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cladribine

 [kla´drĭ-bēn]
a purine antimetaboliteantineoplastic agent administered intravenously in the treatment of hairy cell leukemia.

cladribine

(klad-ri-been) ,

Leustatin

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: antimetabolites
Pregnancy Category: D

Indications

Management of active hairy cell leukemia manifested as anemia, leukopenia, thrombocytopenia, or clinical symptoms.chronic lymphocytic leukemia, chronic myelogenous leukemia, non-Hodgkin's lymphomas, progressive multiple sclerosis.

Action

Inhibits DNA synthesis.

Therapeutic effects

Death of rapidly replicating cells, particularly malignant ones.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Extensively distributed to body tissues; penetrates into cerebrospinal fluid.
Metabolism and Excretion: Unknown.
Half-life: 3–22 hr.

Time/action profile (noted as effect on peripheral counts)

ROUTEONSETPEAKDURATION†
Plateletsunknownunknown12 days
Absolute neutrophil countunknownunknown5 wk
Hemoglobinunknownunknown8 wk
†Time to normalization of counts

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Diluent contains benzyl alcohol and should be avoided in patients with known intolerance; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Active infection;↓ bone marrow reserve;Hepatic or renal impairment; Obstetric: Patients with childbearing potential; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue (most frequent)
  • headache (most frequent)
  • dizziness
  • insomnia
  • malaise
  • weakness

Ear, Eye, Nose, Throat

  • epistaxis

Respiratory

  • abnormal breath sounds (most frequent)
  • cough (most frequent)
  • dyspnea

Cardiovascular

  • edema
  • tachycardia

Gastrointestinal

  • anorexia (most frequent)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)
  • abdominal pain
  • constipation

Dermatologic

  • rash (most frequent)
  • erythema
  • petechiae
  • pruritis
  • sweating

Hematologic

  • neutropenia
  • anemia (most frequent)
  • thrombocytopenia (most frequent)

Local

  • injection site reactions
  • phlebitis
  • thrombosis

Musculoskeletal

  • arthralgia
  • myalgia

Miscellaneous

  • chills
  • fever (most frequent)
  • infection (most frequent)
  • trunk pain

Interactions

Drug-Drug interaction

Additive bone marrow depression may occur with other antineoplastics or radiation therapy.

Route/Dosage

Intravenous (Adults) Hairy cell leukemia–0.09 mg/kg/day for 7 days.

Availability (generic available)

Injection: 1 mg/mL

Nursing implications

Nursing assessment

  • Monitor for bone marrow depression. Assess for fever, chills, sore throat, and signs of infection. Monitor platelet count throughout therapy. Assess for bleeding (bleeding gums, bruising, petechiae; test stool, urine, and emesis for blood). Avoid administering IM injections and taking rectal temperatures. Apply pressure to venipuncture site for 10 min. Anemia may occur. Monitor for increased fatigue and dyspnea.
  • Monitor IV site for phlebitis.
  • Monitor intake and output. Development of uric acid nephropathy in patients with leukemia and lymphoma may be prevented with adequate oral hydration and allopurinol, if needed.
  • Lab Test Considerations: Monitor CD4 T-lymphocyte count and CD8 T-lymphocyte count before initiation of therapy and periodically during and after therapy. Cladribine causes prolonged depression of CD4 and CD8 lymphocyte subset counts, with recovery taking at least 6–12 mo.
    • Monitor hemoglobin, hematocrit, leukocyte, and platelet counts before and periodically throughout therapy, especially during the first 4–8 wk after treatment. During the first 2 wk after therapy, platelet counts, absolute neutrophil count (ANC), and hemoglobin decrease. Transfusions of platelets and red blood cells may be required. Platelet count, ANC, and hemoglobin usually return to normal levels by day 12, week 5, and week 8, respectively.
    • Monitor renal and hepatic function before and periodically during therapy. May cause nephrotoxicity, resulting in elevated serum creatinine, anuria, and acidosis.
    • Monitor serum uric acid concentrations before and periodically during therapy, especially in patients with high tumor burden. May cause elevated serum and uric acid concentrations. May require alkalinization of the urine.
  • May cause irreversible neurologic toxicity, resulting in motor weakness progressing to paraparesis or quadriparesis with high doses. If symptoms occur, discontinue cladribine. There is no known antidote.

Potential Nursing Diagnoses

Risk for infection (Indications)
Risk for injury (Adverse Reactions)

Implementation

  • high alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double-check single, daily, and course-of-therapy dose limits; have second practitioner independently double-check original order, calculations, and infusion pump settings.
  • Prepare solution in a biologic cabinet. Wear gloves, gown, and mask while handling IV medication. Discard IV equipment in specially designated containers (see ).
  • Intravenous Administration
  • pH: 5.5–8.0.
  • Continuous Infusion: Diluent: Add the daily dose to 500 mL of 0.9% NaCl for injection. Solution is stable for 24 hr at room temperature or 8 days if refrigerated.
    • May also be prepared as a 7-day solution with bacteriostatic 0.9% NaCl for infusion via Pharmacia Deltec medication cassettes.
  • Rate: Administer as a continuous infusion over 24 hr.
  • Y-Site Compatibility: aminophylline, bumetanide, buprenorphine, butorphanol, calcium gluconate, carboplatin, chlorpromazine, cisplatin, cyclophosphamide, cytarabine, dexamethasone, diphenhydramine, dobutamine, dopamine, doxorubicin hydrochloride, droperidol, enalaprilat, etoposide, famotidine, furosemide, granisetron, haloperidol, heparin, hydrocortisone, hydromorphone, idarubicin, leucovorin, lorazepam, mannitol, meperidine, mesna, methylprednisolone, metoclopramide, mitoxantrone, morphine, nalbuphine, ondansetron, paclitaxel, potassium chloride, prochlorperazine, promethazine, ranitidine, sodium bicarbonate, teniposide, vincristine
  • Additive Incompatiblity: D5W. Do not admix with other medications or solutions.

Patient/Family Teaching

  • Instruct patient to notify health care professional promptly in the event of fever; sore throat; signs of infection; bleeding gums; bruising; petechiae; blood in urine, stool, or emesis; unusual swelling; joint pain; shortness of breath; or confusion. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to be especially careful to avoid falls. Patients should also be cautioned not to drink alcoholic beverages or to take products containing aspirin or NSAIDs because these may precipitate GI hemorrhage.
  • Advise patient to use nonhormonal contraceptive measures during and for at least 4 mo after completion of therapy and to avoid breastfeeding.
  • Instruct patient not to receive any vaccinations without advice of health care professional.

Evaluation/Desired Outcomes

  • Improvement in hematologic status in patients with leukemia.

cladribine

/clad·ri·bine/ (kla´drĭ-bēn) a purine antimetabolite used as an antineoplastic in the treatment of hairy cell leukemia.

cladribine

An anticancer drug used to treat hairy cell LEUKAEMIA and B cell chronic lymphocytic leukaemia. A brand name is Leustat.
References in periodicals archive ?
The patient underwent orthopedic stabilization and has received a course of cladribine therapy.
The benefit/risk profile of Cladribine Tablets is unchanged - Ongoing clinical trials will continue
Cladribine has been approved for MS treatment in Russia and Australia, but was disapproved by the European Medicines Agency.
Cladribine (Leustatin), which is currently marketed as chemotherapy for certain leukemias and lymphomas, initially was rejected by the FDA when it was submitted for approval as an oral therapy for multiple sclerosis.
Cladribine (2-CdA, commonly known by its brand name Leustatin) is also already in use to treat hairy-cell leukemia.
The Anticipated High Cost of Gilenya and Oral Cladribine Will Not Be a Significant Hurdle to Their Reimbursement in Europe, According to a New Report from Decision Resources
Cladribine is a preferential lymphocyte-depleting therapy.
In November, the FDA rebuffed its application for the experimental multiple sclerosis therapy cladribine, leaving the company lagging Novartis AG in the race to get the first pill for the disease to patients.
The CLARITY study of oral cladribine in 1326 patients showed relative reductions in relapse rates of ~ 55% and in disability progression of ~ 30% with supportive improvement also in MR measures.
Current status: Submission for registration of cladribine tablets planned for mid-2009