Leustatin

Leustatin

 [loo-sta´tin]
trademark for a preparation of cladribine, an antineoplastic agent.

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.
References in periodicals archive ?
Drugs that have reached the market with no listed patents, but only regulatory exclusivity, include: Mefloquine HCl (mefloquine hydrochloride), Clozaril (clozapine), Hexalen (altretamine), Leustatin (cladribine), Trasylol (aprotinin bovine), Sclerosol (talc), and Ellence (epirubicin hydrochloride).
Piro, Adjunct Faculty Member at JWCI, has achieved worldwide recognition for working on the development of cutting-edge cancer drugs including Leustatin and Rituxan.
It is marketed under the name Leustatin and distributed by Ortho Biotech, a Johnson & Johnson subsidiary.
PROCRIT was introduced for patients undergoing chemotherapy, LEUSTATIN for hairy cell leukemia, and PROPULSID for nighttime heartburn associated with gastrointestinal esophageal reflux disease.
In addition, sales growth was aided by new products introduced within the last twelve months such as: ORTHO-CYCLEN, ORTHO TRI-CYCLEN AND ORTHO-CEPT oral contraceptives; LEUSTATIN, for treatment of hairy cell leukemia; SPORANOX, an antifungal; expanded indication for OKT-3 for treatment of organ transplant rejection; and PROCRIT, which received approval earlier this year for expanded use to treat anemia associated with chemotherapy.
8 percent due to sales gains in PROCRIT, LEUSTATIN, SPORANOX, oral contraceptive products, FLOXIN, an antibiotic, DURAGESIC, the transdermal patch for chronic cancer pain, and the introduction of PROPULSID.
New product introductions continued this year including the gastrointestinal drug PROPULSID and the leukemia drug LEUSTATIN.
5 percent led by the introduction of PROCRIT for treating anemia associated with cancer patients on chemotherapy, LEUSTATIN, introduced late in the first quarter of 1993 for the treatment of hairy cell leukemia, SPORANOX, an antifungal, DURAGESIC, the transdermal patch for chronic cancer pain, and growth in the oral contraceptive business.
The increase in revenue can be attributed to products recently introduced such as ORTHO-CEPT, an oral contraceptive; SPORANOX, an antifungal; and LEUSTATIN, a drug that treats hairy cell leukemia, which was approved by the Food and Drug Administration (FDA) in the first quarter.
Leading the way for the domestic pharmaceutical sales gain were ORTHO- CEPT, DURAGESIC, SPORANOX, PROCRIT, NIZORAL Shampoo, OKT-3, an organ transplant rejection drug, and LEUSTATIN.
Ortho Biotech recently introduced LEUSTATIN (cladribine) Injection.
The drug, cladribine, with the trade name of Leustatin, is given to patients in one continuous treatment over a seven-day period rather than in several separate treatments over a period of months, as required for other cancer drugs.