• IV: Active hairy cell leukemia manifested as anemia, leukopenia, thrombocytopenia, or clinical symptoms.
• PO: Relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive disease in patients who have had an inadequate response to or have not tolerated other medications indicated for the treatment of MS.

Contraindicated in:

• Hypersensitivity
• Current malignancy (oral)
• Patients with HIV (oral)
• Active infection (oral)
• Diluent contains benzyl alcohol and should be avoided in patients with known intolerance
• Moderate to severe renal impairment (oral)
• Moderate to severe hepatic impairment (oral)
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Active infection (IV)
• ↓ bone marrow reserve
• Hepatic or renal impairment (IV)
• Rep: Women and men of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: HF, edema, hypertension, tachycardia.

Derm: rash, alopecia, erythema, petechiae, pruritus, STEVENS-JOHNSON SYNDROME, sweating, TOXIC EPIDERMAL NECROLYSIS.

EENT: epistaxis.

GI: anorexia, diarrhea, nausea, vomiting, abdominal pain, constipation, HEPATOTOXICITY.

Hemat: anemia, lymphopenia, neutropenia, thrombocytopenia.

Local: injection site reactions, phlebitis, thrombosis.

MS: arthralgia, myalgia.

Neuro: fatigue, headache, depression, dizziness, insomnia, malaise, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML), SEIZURES, weakness.

Resp: abnormal breath sounds, cough, dyspnea.

Misc: fever, hypersensitivity reactions (including angioedema), infection, chills, MALIGNANCY.

Drug-Drug:

• Additive bone marrow depression may occur with other antineoplastics or radiation therapy.
• Cilostazol, cyclosporine, dipyridamole, eltrombopag, nifedipine, nimodipine, ritonavir, and sulindac may ↑ levels; avoid concurrent use.
• Corticosteroids and rifampin may ↓ levels; avoid concurrent use.
• May ↓ the effectiveness of hormonal contraceptives; recommend additional use of barrier contraceptive during therapy and for ≥4 wk after last dose in each treatment course.

Drug-Natural Products:

• St. John's wort may ↓ levels; avoid concurrent use.

(Generic available)

• Solution for injection: 1 mg/mL;
• Tablets: 10 mg;

Hairy Cell Leukemia

• IV (Adults): 0.09 mg/kg/day for 7 days.

Multiple Sclerosis

The cumulative dose is 3.5 mg/kg over 2-yr treatment course, administered as 1.75 mg/kg in each yr. During each yr, the treatment course is divided into 2 treatment cycles.

• PO (Adults ≥110 kg): 1st treatment course (Year 1): 1st cycle: 100 mg (10 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 1st treatment course/1st cycle): 100 mg (10 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd treatment course (Year 2): 1st cycle (to be started ≥43 wk after last dose of 1st treatment course/2nd cycle): 100 mg (10 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 2nd treatment course/1st cycle): 100 mg (10 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days.
• PO (Adults 100–<110 kg): 1st treatment course (Year 1): 1st cycle: 100 mg (10 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 1st treatment course/1st cycle): 90 mg (9 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd treatment course (Year 2): 1st cycle (to be started ≥43 wk after last dose of 1st treatment course/2nd cycle): 100 mg (10 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 2nd treatment course/1st cycle): 90 mg (9 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days.
• PO (Adults 90–<100 kg): 1st treatment course (Year 1): 1st cycle: 90 mg (9 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 1st treatment course/1st cycle): 80 mg (8 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd treatment course (Year 2): 1st cycle (to be started ≥43 wk after last dose of 1st treatment course/2nd cycle): 90 mg (9 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 2nd treatment course/1st cycle): 80 mg (8 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days.
• PO (Adults 80–<90 kg): 1st treatment course (Year 1): 1st cycle: 80 mg (8 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 1st treatment course/1st cycle): 70 mg (7 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd treatment course (Year 2): 1st cycle (to be started ≥43 wk after last dose of 1st treatment course/2nd cycle): 80 mg (8 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 2nd treatment course/1st cycle): 70 mg (7 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days.
• PO (Adults 70–<80 kg): 1st treatment course (Year 1): 1st cycle: 70 mg (7 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 1st treatment course/1st cycle): 70 mg (7 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd treatment course (Year 2): 1st cycle (to be started ≥43 wk after last dose of 1st treatment course/2nd cycle): 70 mg (7 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 2nd treatment course/1st cycle): 70 mg (7 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days.
• PO (Adults 60–<70 kg): 1st treatment course (Year 1): 1st cycle: 60 mg (6 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 1st treatment course/1st cycle): 60 mg (6 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd treatment course (Year 2): 1st cycle (to be started ≥43 wk after last dose of 1st treatment course/2nd cycle): 60 mg (6 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 2nd treatment course/1st cycle): 60 mg (6 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days.
• PO (Adults 50–<60 kg): 1st treatment course (Year 1): 1st cycle: 50 mg (5 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 1st treatment course/1st cycle): 50 mg (5 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd treatment course (Year 2): 1st cycle (to be started ≥43 wk after last dose of 1st treatment course/2nd cycle): 50 mg (5 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 2nd treatment course/1st cycle): 50 mg (5 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days.
• PO (Adults 40–<50 kg): 1st treatment course (Year 1): 1st cycle: 40 mg (4 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 1st treatment course/1st cycle): 40 mg (4 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd treatment course (Year 2): 1st cycle (to be started ≥43 wk after last dose of 1st treatment course/2nd cycle): 40 mg (4 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days. 2nd cycle (to be started 23–27 days after last dose of 2nd treatment course/1st cycle): 40 mg (4 tablets) administered as 1–2 tablets once daily for 4–5 consecutive days.

Leustatin, Mavenclad

• Inhibits DNA synthesis.

• Death of rapidly replicating cells, particularly malignant ones.
• Reduction in MS relapse rate and disability progression.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimetabolites

Absorption: IV administration results in complete bioavailability. 40% absorption of oral tablets.

Distribution: Extensively distributed to body tissues; penetrates into cerebrospinal fluid.

Metabolism/Excretion: Prodrug; activated via phosphorylation in lymphocytes to an active metabolite, Cd-ATP. 29% excreted by the kidneys as unchanged drug.

Half-life: 24 hr.

(plasma concentrations)

• Instruct patient to take cladribine as directed. Take missed dose as soon as remembered on same day. If not until next day, extend the days of the cycle. If 2 doses are missed, extend the cycle by 2 days. Do not take 2 doses the same day.
• Instruct patient to notify health care professional promptly in the event of fever; sore throat; signs of infection (fever; loss of appetite; aching painful muscles; burning, tingling, numbness or itchiness of the skin in affected area; headache; skin blotches, blistered rash and severe pain; feeling of unwell); 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 notify health care professional if signs and symptoms of cardiac failure (shortness of breath, rapid or irregular heartbeat, swelling) PML (weakness on 1 side of body, changes in vision, loss of coordination in arms and legs, changes in thinking or memory, decreased strength, confusion, problems with balance, changes in personality), liver problems (nausea, loss of appetite, vomiting, yellow skin or whites or eyes, stomach pain, dark urine, tiredness) or allergic reaction (rash; swelling or itching of face, lips, tongue or throat; trouble breathing) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
• Instruct patient not to receive any vaccinations without advice of health care professional.
• Inform patients that cladribine may increase their risk of malignancies. Instruct patients to follow standard cancer screening guidelines.
• Rep: May cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during and for at least 6 mo after last dose and to avoid breastfeeding for 10 days after last dose. Women using hormonal contraceptives should also use a barrier method during and for 4 wk after last dose.

KLAD-ri-been

NDC Code^*

• 0143- Hikma Pharmaceuticals USA Inc.
  • 0143-9871- Cladribine
    • 0143-9871-01- 1 VIAL in 1 BOX, UNIT-DOSE (0143-9871-01) > 10 mL in 1 VIAL

• 44087- EMD Serono, Inc.
  • 44087-4000- Mavenclad
    • 44087-4000-0- 5 BLISTER PACK in 1 CARTON (44087-4000-0) > 2 TABLET in 1 BLISTER PACK

• 44087- EMD Serono, Inc.
  • 44087-4000- Mavenclad
    • 44087-4000-4- 4 BLISTER PACK in 1 CARTON (44087-4000-4) > 1 TABLET in 1 BLISTER PACK

• 44087- EMD Serono, Inc.
  • 44087-4000- Mavenclad
    • 44087-4000-5- 5 BLISTER PACK in 1 CARTON (44087-4000-5) > 1 TABLET in 1 BLISTER PACK

• 44087- EMD Serono, Inc.
  • 44087-4000- Mavenclad
    • 44087-4000-6- 6 BLISTER PACK in 1 CARTON (44087-4000-6) > 1 TABLET in 1 BLISTER PACK

• 44087- EMD Serono, Inc.
  • 44087-4000- Mavenclad
    • 44087-4000-7- 7 BLISTER PACK in 1 CARTON (44087-4000-7) > 1 TABLET in 1 BLISTER PACK

• 44087- EMD Serono, Inc.
  • 44087-4000- Mavenclad
    • 44087-4000-8- 8 BLISTER PACK in 1 CARTON (44087-4000-8) > 1 TABLET in 1 BLISTER PACK

• 44087- EMD Serono, Inc.
  • 44087-4000- Mavenclad
    • 44087-4000-9- 9 BLISTER PACK in 1 CARTON (44087-4000-9) > 1 TABLET in 1 BLISTER PACK

• 63323- Fresenius Kabi USA, LLC
  • 63323-140- Cladribine
    • 63323-140-10- 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10) > 10 mL in 1 VIAL, SINGLE-DOSE

• 67457- Mylan Institutional LLC
  • 67457-450- Cladribine
    • 67457-450-10- 1 VIAL in 1 CARTON (67457-450-10) > 10 mL in 1 VIAL