• Refractory or relapsed acute lymphoblastic leukemia after ≥2 previous regimens.

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Hepatic or renal impairment
• Concurrent use of nephrotoxic or hepatotoxic drugs
• Infection, sepsis or tumor lysis syndrome (↑ risk of acute renal failure).

CV: pericardial effusion, tachycardia, edema.

Derm: STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

F and E: dehydration.

GI: diarrhea, nausea, abdominal pain, constipation, ENTEROCOLITIS, HEPATOTOXICITY, mucositis, vomiting.

GU: hematuria, acute renal failure.

Hemat: bleeding, neutropenia, anemia, thrombocytopenia.

Local: injection site pain.

Neuro: fatigue.

Resp: pharyngitis.

Misc: infection, chills, fever, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, TUMOR LYSIS SYNDROME.

Drug-Drug:

• Concurrent use of hepatotoxic or nephrotoxic drugs ↑ risk of hepatotoxicity and nephrotoxicity and should be avoided for the 5-day treatment period.

(Generic available)

• Solution for injection: 1 mg/mL;

• IV (Children 1–21 yr): 52 mg/m² daily for 5 days; cycle may be repeated every 2–6 wk.

Clolar

• Converted intracellularly to the active 5'-triphosphate metabolite which acts as a purine nucleoside antimetabolite; net result is inhibition of DNA synthesis.
• Produces a rapid reduction of peripheral leukemia cells.

• Death of rapidly replicating cells, particularly malignant ones.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimetabolites

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: 46–60% excreted unchanged in urine.

Half-life: 5.2 hr.

(effect on WBCs)

• Explain purpose of clofarabine to patient.
• Advise patient to notify health care professional if signs and symptoms of hematologic toxicity (weakness, fatigue, pallor, shortness of breath, easy bruising, petechiae, purpura, fever), infection (fever), systemic inflammatory response syndrome/capillary leak syndrome (fever, tachycardia, tachypnea, dyspnea, hypotension), and rash occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 6 mo after last dose and to avoid breastfeeding during and for at least 2 wk after last dose of therapy. Advise males with female partners of reproductive potential to use effective contraception during and for at least 3 mo after last dose of therapy. May impair female and male fertility.

klo-FAR-a-been

NDC Code^*

• 0024- Sanofi-Aventis U.S. LLC
  • 0024-5860- Clolar
    • 0024-5860-01- 1 VIAL, SINGLE-USE in 1 BOX (0024-5860-01) > 20 mL in 1 VIAL, SINGLE-USE

• 0024- Sanofi-Aventis U.S. LLC
  • 0024-5917- Clolar
    • 0024-5917-01- 1 VIAL, SINGLE-USE in 1 BOX (0024-5917-01) > 20 mL in 1 VIAL, SINGLE-USE

• 0955- Winthrop U.S.
  • 0955-1746- clofarabine
    • 0955-1746-01- 1 VIAL, SINGLE-USE in 1 BOX (0955-1746-01) > 20 mL in 1 VIAL, SINGLE-USE

• 43598- Dr.Reddy's Laboratories Inc
  • 43598-309- Clofarabine
    • 43598-309-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-309-20) > 20 mL in 1 VIAL, SINGLE-DOSE

• 50742- Ingenus Pharmaceuticals, LLC
  • 50742-512- CLOFARABINE
    • 50742-512-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-512-20) > 20 mL in 1 VIAL, SINGLE-DOSE

• 60505- Apotex Corp.
  • 60505-6166- Clofarabine
    • 60505-6166-0- 1 VIAL, SINGLE-USE in 1 CARTON (60505-6166-0) > 20 mL in 1 VIAL, SINGLE-USE

• 63323- Fresenius-Kabi
  • 63323-572- CLOFARABINE
    • 63323-572-70- 1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70) > 20 mL in 1 VIAL, SINGLE-USE

• 67457- Mylan Institutional LLC
  • 67457-546- clofarabine
    • 67457-546-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-546-20) > 20 mL in 1 VIAL, SINGLE-DOSE

• 68083- Gland Pharma Limited
  • 68083-386- Clofarabine
    • 68083-386-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) > 20 mL in 1 VIAL, SINGLE-DOSE

• 70121- Amneal Biosciences LLC
  • 70121-1236- Clofarabine
    • 70121-1236-1- 1 VIAL, SINGLE-DOSE in 1 BOX (70121-1236-1) > 20 mL in 1 VIAL, SINGLE-DOSE

• 72266- Fosun Pharma USA Inc.
  • 72266-108- CLOFARABINE
    • 72266-108-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (72266-108-01) > 20 mL in 1 VIAL, SINGLE-DOSE