 bendamustine hydrochloride |
| Treanda |
Pharmaceutical
company:
Cephalon
www.treanda.com |
Pharmacologic classification: alkylating agent
Therapeutic classification: antineoplastic
Pregnancy risk category: D
AVAILABLE FORMS
Injection: 100-mg single-use vials.
INDICATIONS AND DOSAGES
Chronic lymphocytic leukemia (CLL)--
Adults: 100 mg/m2 I.V. over 30 minutes on days 1 and 2 of a 28-day cycle for up to 6 cycles; dosage may need to be lowered based on patient response and drug toxicity.
CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients hypersensitive to bendamustine or mannitol.
Contraindicated in pregnant or breast-feeding patients.
Contraindicated in those with moderate or severe hepatic impairment or severe renal impairment.
Use cautiously in patients with mild hepatic impairment or with mild or moderate renal impairment.
INTERACTIONS
Drug-drug.
CYP1A2 inhibitors (fluvoxamine, ciprofloxacin) or CYP1A2 inducers (omeprazole, nicotine): May lead to treatment failure or increased toxicity. Avoid using together.
ADVERSE REACTIONS
CNS: asthenia, chills, fever, fatigue.
EENT: mucosal inflammation and stomatitis.
GI: constipation, nausea, vomiting, diarrhea.
Hematologic: anemia, MYELOSUPPRESSION, hyperuricemia, THROMBOCYTOPENIA.
Metabolic: weight loss.
Respiratory: nasopharyngitis, cough.
Skin: rash, pruritus.
Other: hypersensitivity reaction (including anaphylaxis), tumor lysis syndrome, infections.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
|
