bendamustine

(redirected from Treanda)

bendamustine

(ben-da-muss-teen) ,

Treanda

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: benzimidazoles
Pregnancy Category: D

Indications

Chronic lymphocytic leukemia.Indolent B-cell non-Hodgkin's lymphoma that has progressed during or within 6 mo of receiving rituximab or a rituximab-containing regimen.

Action

Damages DNA resulting in death of rapidly replicating cells.

Therapeutic effects

Decreased proliferation of leukemic cells.
Death of lymphoma cells.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Distributes freely into red blood cells.
Protein Binding: 94–96%.
Metabolism and Excretion: Mostly metabolized (partially by the CYP1A2 enzyme system); 90% excreted in feces; some renal elimination. Although metabolites have antineoplastic activity, levels are extremely low.
Half-life: 40 min.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IVrapidend of infusionunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to bendamustine or mannitol;Moderate-to-severe renal impairment (CCr <40 mL/min;Moderate or severe hepatic impairment; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Patients at risk for tumor lysis syndrome (concurrent allopurinol recommended);Mild hepatic impairment;Mild to moderate renal impairment;Patients with child-bearing potential; Geriatric: May be more susceptible to adverse reactions; Pediatric: Effectiveness not established.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue
  • weakness

Respiratory

  • cough

Gastrointestinal

  • nausea (most frequent)
  • vomiting (most frequent)
  • diarrhea

Dermatologic

  • toxic epidermal necrolysis
  • stevens-johnson syndrome
  • skin reactions

Hematologic

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

Metabolic

  • hyperuricemia

Miscellaneous

  • malignancy (life-threatening)
  • tumor lysis syndrome (life-threatening)
  • allergic reactions including anaphylaxis
  • fever (most frequent)
  • infusion reactions

Interactions

Drug-Drug interaction

CYP1A2 inhibitors, including fluvoxamine and ciprofloxacin may ↑ levels of bendamustine and ↓ levels of active metabolites; consider alternative treatments.CYP1A2 inducers, including omeprazole and smoking may ↓ levels of bendamustine and ↑ levels of its active metabolites; consider alternative treatments.

Route/Dosage

Chronic Lymphocytic Leukemia
Intravenous (Adults) 100 mg/m2 on days 1 and 2 of a 28-day cycle, up to 6 cycles; dose modification required for toxicity.
Non-Hodgkin's Lymphoma
Intravenous (Adults) 120 mg/m2 on days 1 and 2 of a 21-day cycle, up to 8 cycles; dose modification required for toxicity.

Availability

Solution for injection: 45 mg/0.5 mL, 180 mg/2 mL

Nursing implications

Nursing assessment

  • Monitor for bone marrow depression. Assess for bleeding (bleeding gums, bruising, petechiae, guaiac stools, urine, and emesis) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia; anemia may occur; monitor for increased fatigue, dyspnea, and orthostatic hypotension.
  • Monitor for symptoms of infusion reactions (fever, chills, pruritus, rash). May rarely cause severe allergic and anaphylactic reactions, especially in second and subsequent cycles. Discontinue therapy if severe reactions occur. Ask patient about symptoms suggestive of infusion reactions after first cycle of therapy. Consider using antihistamines, antipyretics, and corticosteroids in patients who previously experienced Grade 1 or 2 reactions. Consider discontinuation of therapy in patients with Grade 3 or 4 reactions.
  • Assess for tumor lysis syndrome. Usually occurs during first cycle of bendamustine. May lead to acute renal failure and death. Maintain adequate volume status, close monitoring of blood chemistry, especially potassium and uric acid levels, and use allopurinol during first 1–2 wk of therapy in high risk patients.
  • Assess for skin reactions (rash, toxic skin reactions, bullous exanthema). Withhold or discontinue therapy if reactions are progressive or severe. If non-hematologic toxicity is ≥ Grade 3, reduce dose to 50 mg/m2 on Days 1 and 2 of each cycle.
  • Monitor intake and output, appetite, and nutritional intake. Assess for nausea and vomiting. Administration of an antiemetic before and during therapy and adjusting diet as tolerated may help maintain fluid and electrolyte balance and nutritional status.
  • Monitor IV site for redness, swelling, pain, infection, and necrosis frequently during an after infusion. Extravasation may cause erythema, marked swelling, and pain.
  • Lab Test Considerations: Monitor CBC with differential and platelet count before and during therapy. The hematologic nadirs occur wk 3. Recovery usually occurs in 28 days. Withhold dose and notify physician if ANC is ≥1 × 109/L and platelet count is ≥75,000 × 109/L.For patients treated for chronic lymphocytic leukemia: If hemotologic toxicity ≥Grade 3, reduce dose to 50 mg/m2 on Days 1 and 2. If Grade 3 or greater toxicity recurs, reduce dose to 25 mg/m2 on Days 1 and 2. For patients treated for non-Hodgkin's lymphoma: If hematologic toxicity ≥Grade 4, reduce dose to 90 mg/m2 on Days 1 and 2. If Grade 4 or greater toxicity recurs, reduce dose to 60 mg/m2 on Days 1 and 2.
    • Monitor blood chemistry, especially serum potassium and uric acid before and periodically during therapy. Allopurinol may be used during first wk of therapy to prevent tumor lysis syndrome.

Potential Nursing Diagnoses

Risk for infection (Side Effects)

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.
  • Intravenous Administration
  • pH: 2.5–3.5.
  • Prepare solution in a biologic cabinet. Wear gloves and safety glasses while handling medication. Discard equipment in designated containers.
  • Intermittent Infusion: Diluent: Withdraw volume needed and transfer to 500 mL of 0.9% NaCl or 2.5% dextrose/0.45% NaCl. Mix thoroughly. Solution should be clear, colorless to pale yellow. Do not administer solutions that are discolored or contain a precipitate. Concentration: 0.2–0.7 mg/mL.
    • Diluted solution is stable for 24 hr when refrigerated or 2 hr at room temperature; administration must be completed within this period. Solution contains no preservatives; discard unused solution.
  • Rate: Chronic Lymphocytic Leukemia—Administer 100 mg/m2 over 30 min. Non-Hodgkin's lymphoma—Administer 120 mg/m2 over 60 min.
  • Additive Incompatibility: Do not admix or dilute with other solutions or medication.

Patient/Family Teaching

  • Instruct patient to notify health care professional if fever; chills; sore throat; signs of infection; lower back or side pain; difficult or painful urination; shortness of breath; fatigue; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Caution patients to avoid alcoholic beverages and products containing aspirin or NSAIDs; may precipitate gastric bleeding.
  • Instruct patient to notify health care professional immediately if symptoms of allergic reactions (rash, facial swelling, or difficulty breathing) or nausea, vomiting or diarrhea occur.
  • May cause tiredness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
  • Instruct patient not to receive any vaccinations without advice of health care professional.
  • Advise patient this medication may have teratogenic effects. Contraception should be used by both men and women during and for at least 3 mo following completion of therapy. Advise women not to breast feed during therapy.
  • Emphasize need for periodic lab tests to monitor for side effects.

Evaluation/Desired Outcomes

  • Improvement in hematologic parameters.
References in periodicals archive ?
Food and Drug Administration (FDA) has updated its March 2015 Safety Alert based on Teva Pharmaceuticals (Teva) findings which include that the BD PhaSeal System is the only closed system drug transfer device (CSTD) compatible with the chemotherapy drug, Treanda Injection (bendamustine HCl) based on the testing performed by Teva from February through June 2015.
She has worked on numerous media teams for advisory committee meetings and drug approvals for INVOKANA, ZYTIGA, LATUDA, PROCRIT, LAP-BAND, Aranesp, Avelox, BOTOX, Cipro, Diovan, Elidel, Kineret, Abatacept, Rimonabant, Novolog, Treanda, Viracept and Zoloft, among others.
Products discussed in this research report include Rituxan/Mabthera (rituximab) - Roche, Adcetris (Brentuximab vedotin) - Seattle Genetics/Millennium, Zevalin (ibritumomab tiuxetan) - Spectrum Pharmaceuticals, Revlimid (lenalidomide) - Celgene, Velcade (bortezomib) - Millennium/Johnson-Johnson, Istodax (romidepsin) - Celgene, Zolinza (vorinostat) - Merck, Zydelig (idelalisib/GS-1101) - Gilead Sciences, Imbruvica (ibrutinib) - Pharmacyclics/Janssen Biotech, Beleodaq (belinostat) - Spectrum Pharmaceuticals, Poteligeo (mogamulizumab) - Kyowa Hakko Kirin, Pixuvri (pixantrone dimaleate) - CTI BioPharma, Treanda (bendamustine) + Rituxan (rituximab), CHOP/R-CHOP and CVP/R-CVP.
The company's proprietary products in the United States include: AMRIX (cyclobenzaprine hydrochloride extended-release capsules), TREANDA (bendamustine hydrochloride) for Injection, FENTORA (fentanyl buccal tablet) (C-II), PROVIGIL (modafinil) Tablets (C-IV), TRISENOX (arsenic trioxide) injection, GABITRIL (tiagabine hydrochloride), NUVIGIL (armodafinil) Tablets (C-IV) and ACTIQ (oral transmucosal fentanyl citrate) (C-II).
The data supporting the FDA approval show that TREANDA is effective, has a tolerable side effect profile in patients with indolent NHL and that treatment results in a high durable response rate.
The FDA's letter to Cephalon makes similar complaints about missing risk information in the company's promotional cards for Treanda, a lymphoma treatment.
Cancer treatment sales jumped 86%, thanks in part to the April launch of Treanda, which treats chronic lymphocytic leukemia.
The company's proprietary products in the United States include: TREANDA (bendamustine hydrochloride) for injection, AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules), PROVIGIL (modafinil) Tablets (C-IV), FENTORA, TRISENOX (arsenic trioxide) injection, VIVITROL (naltrexone for extended-release injectable suspension), GABITRIL (tiagabine hydrochloride), NUVIGIL (armodafinil) Tablets (C-IV) and ACTIQ (oral transmucosal fentanyl citrate) (C-II).
Cephalon Inc's (Frazer PA) experimental cancer drug Treanda was significantly more effective than a common chemotherapy agent in helping patients with chronic lymphocytic leukemia (CLL) who had not received prior treatment achieve remission, according to a late-stage study.
announced today that it has filed an ANDA with a Paragraph IV certification for bendamustine hydrochloride powder for IV (infusion), 25 mg/vial and 100 mg/vial, a generic version of Treanda by Cephalon, Inc.