cladribine

High Alert

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)
;
HIV (oral);
Active tuberculosis (TB) (oral);
Active hepatitis (oral);
Active infection (oral);
Diluent contains benzyl alcohol and should be avoided in patients with known intolerance (IV);
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 of reproductive potential and men with female partners of reproductive potential;
Pedi: Safety and effectiveness not established in children.

CV: edema, HF, 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 and risk of toxicity; avoid concurrent use.
Corticosteroids and rifampin may ↓ levels and effectiveness; avoid concurrent use.

Drug-Natural Products:

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

(Generic available)

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

Hairy Cell Leukemia

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

Multiple Sclerosis

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.

Mavenclad

Inhibits DNA synthesis.

Therapeutic effects:

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% absorbed following oral administration.

Distribution: Extensively distributed to body tissues; penetrates into CSF.

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)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown
PO	unknown	30 min	unknown

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 two doses are missed, extend the cycle by 2 days. Do not take two doses on the same day.
Instruct patient to notify health care provider 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 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 provider if signs and symptoms of HF (shortness of breath, rapid or irregular heartbeat, swelling), PML (weakness on one side of body, changes in vision, loss of coordination in arms and legs, changes in thinking or memory, ↓ strength, confusion, problems with balance, changes in personality), liver problems (nausea, loss of appetite, vomiting, yellow skin or whites of 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 provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking any other Rx, OTC, or herbal products.
Instruct patient not to receive any vaccinations without advice of health care provider.
Inform patient that cladribine may ↑ the risk of malignancies. Instruct patients to follow standard cancer-screening guidelines.
Rep:
May cause fetal harm. Advise women of reproductive potential and men with a female partner of reproductive potential to use effective contraception during and for ≥6 mo after last dose. Advise women to avoid breastfeeding for 10 days 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

12502- Cilag AG
- 12502-4912-
  - 12502-4912-0- 10 kg in 1 DRUM (12502-4912-0)

12502- Cilag AG
- 12502-5406-
  - 12502-5406-7- 10 kg in 1 DRUM (12502-5406-7)

42658- Hisun Pharmaceuticals USA, Inc.
- 42658-010- Cladribine
  - 42658-010-01- 1 mL in 1 VIAL, SINGLE-DOSE (42658-010-01)

42658- Hisun Pharmaceuticals USA, Inc.
- 42658-010- Cladribine
  - 42658-010-91- 1 mL in 1 VIAL, SINGLE-DOSE (42658-010-91)

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

54893- MSN Laboratories Private Limited
- 54893-0115-
  - 54893-0115-4- 20 kg in 1 DRUM (54893-0115-4)

58623- Zhejiang Hisun Pharmaceutical Co., Ltd.
- 58623-0037-
  58623-0037-1- 1 kg in 1 DRUM (58623-0037-1)

59605- Reliable Biopharmaceutical LLC
- 59605-3006-
  59605-3006-0- 25 g in 1 BOTTLE, GLASS (59605-3006-0)

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

65129- ScinoPharm Taiwan Ltd.
- 65129-1260-
  - 65129-1260-0- 1000 g in 1 BAG (65129-1260-0)

65129- ScinoPharm Taiwan Ltd.
- 65129-1260-
  65129-1260-1- 1000 g in 1 BAG (65129-1260-1)

76055- SIONC PHARMACEUTICALS PVT LTD
- 76055-0051-
  76055-0051-1- 25 kg in 1 DRUM (76055-0051-1)

76055- SIONC PHARMACEUTICALS PVT LTD
- 76055-0052-
  76055-0052-1- 25 kg in 1 DRUM (76055-0052-1)

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