cladribine (Rx)

Brand and Other Names:Leustatin DSC, Mavenclad
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution (generic formulation)

  • 1mg/mL (10 mL single-use vial)

tablets

  • 10mg (Mavenclad)

Hairy Cell Leukemia

Cladribine (parenteral only)

  • 0.09 mg/kg/day IV continuous infusion for 7 days  

Dosing considerations

  • Monitor CBC with differential
  • Monitor for signs/symptoms of neurotoxicity and infection; if infection present, treat as appropriate prior to therapy; if not possible, consider alternative therapy if possible

Relapsing Forms of Multiple Sclerosis

Mavenclad only

  • Include relapsing-remitting disease and active secondary progressive disease
  • Use is generally recommended for patients with inadequate response to, or unable to tolerate, alternate indicated drug
  • 2 yearly treatment courses: 1.75 mg/kg/course PO; each course divided into 2 treatment cycles; not to exceed 3.5 mg/kg cumulative dosage (see oral administration)
  • Oral dose per cycle by weight in each treatment course
    • Also see Administration for timing of each treatment course and cycles
    • <40 kg: Safety and efficacy not established
    • 40 kg to <50 kg: 40 mg first cycle; 40 mg second cycle
    • 50 kg to <60 kg: 50 mg first cycle; 50 mg second cycle
    • 60 kg to <70 kg: 60 mg first cycle; 60 mg second cycle
    • 70 kg to <80 kg: 70 mg first cycle; 70 mg second cycle
    • 80 kg to <90 kg: 80 mg first cycle; 70 mg second cycle
    • 90 kg to <100 kg: 90 mg first cycle; 80 mg second cycle
    • 100 kg to <110 kg: 100 mg first cycle; 90 mg second cycle
    • ≥110 kg: 100 mg first cycle; 100 mg second cycle
    • Do not administer >2 tablets daily; administer 1-2 tablets/day PO over 4-5 consecutive days

Dosage Modifications

Mavenclad only

  • Renal impairment
    • Mild (CrCl 60-89 mL/min): No dosage adjustment recommended
    • Moderate to severe (CrCl <60 mL/min): Not recommended
  • Hepatic impairment
    • Mild: No dosage adjustment recommended
    • Moderate to severe (Child-Pugh >6): Not recommended

Dosing Considerations

Mavenclad only

  • Limitations of use: Treatment is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile
  • Prior to administration
    • Follow standard cancer screening guidelines because of risk of malignancies
    • Exclude pregnancy in females of reproductive potential
    • Exclude HIV infection
    • Perform tuberculosis screening
    • Screen for hepatitis B and C
    • Evaluate acute infection; consider delaying treatment until any acute infection is fully controlled
    • Vaccination recommended for patients who are antibody-negative for varicella zoster virus
    • Administer all immunizations according to immunization guidelines; administer live-attenuated or live vaccines 4-6 weeks prior to therapy; avoid vaccination with live-attenuated or live vaccines during and after therapy while the patient’s white blood cell counts are not within normal limits
    • Obtain a baseline (within 3 months) magnetic resonance imaging prior to first treatment course because of risk of progressive multifocal leukoencephalopathy (PML); at first sign or symptom suggestive of PML, withhold therapy and perform an appropriate diagnostic evaluation
    • Evaluate for liver injury; obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels
  • Complete blood count
    • Lymphocytes must be within normal limits before initiating first treatment course and at least 800 cells/mcL before initiating second treatment course
    • May delay second treatment course for up to 6 months to allow for recovery of lymphocytes to at least 800 cells per microliter; if recovery takes >6 months, patient should not receive further treatment
    • Obtain CBC with differential including lymphocyte count before initiating first treatment course and before initiating second course
    • Obtain CBC with differential including lymphocyte count 2 and 6 months after start of treatment course; if lymphocyte count at month 2 <200 cells/mcL, monitor monthly until month 6 and periodically thereafter and when clinically indicated
    • Hold therapy if lymphocyte count <200 cells/mcL
    • Administer antiherpes prophylaxis in patients with lymphocyte counts <200 cells/mcL

Orphan Designations

Non-Hodgkin Lymphoma

Acute Myeloid Leukemia

Chronic Lymphocytic Leukemia

Orphan sponsor

  • Ortho Biotech Oncology Research & Development, Unit of J & J Pharmaceutical Research & Dev., LLC; 920 Route 202 South, P.O. Box 300; Raritan, NJ 08869-0602

Other Uses

Off-label: Cutaneous T-cell lymphoma, AML, CLL, NHL, autoimmune hemolytic anemia, mycosis fungoides, Sezary syndrome

Safety and efficacy not established

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Interactions

Interaction Checker

and cladribine

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • adenovirus types 4 and 7 live, oral

                cladribine decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • palifermin

                palifermin increases toxicity of cladribine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • tofacitinib

                cladribine, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (14)

              • acalabrutinib

                acalabrutinib, cladribine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • belatacept

                belatacept and cladribine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • cholera vaccine

                cladribine decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • dengue vaccine

                cladribine decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                cladribine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • fingolimod

                cladribine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • hydroxyurea

                cladribine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • influenza A (H5N1) vaccine

                cladribine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • influenza virus vaccine (H5N1), adjuvanted

                cladribine decreases effects of influenza virus vaccine (H5N1), adjuvanted by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • ofatumumab SC

                ofatumumab SC, cladribine. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • siponimod

                siponimod and cladribine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                cladribine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • trastuzumab

                trastuzumab, cladribine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, cladribine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              Minor (4)

              • maitake

                maitake increases effects of cladribine by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).

              • taurine

                cladribine decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.

              • vitamin A

                vitamin A, cladribine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

              • vitamin E

                vitamin E, cladribine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

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              Adverse Effects

              >10%

              Cladribine (parenteral)

              • Fever (69%)
              • Fatigue (45%)
              • Nausea (28%)
              • Rash (27%)
              • Headache (22%)
              • Appetite decreased (17%)
              • Vomiting (13%)

              Mavenclad

              • Upper respiratory tract infection (38%)
              • Headache (25%)
              • Lymphopenia (24%)
              • Nausea (10%)
              • Hypersensitivity (11%)

              1-10%

              Cladribine (parenteral)

              • Diarrhea (10%)
              • Purpura (10%)
              • Asthenia (9%)
              • Chills (9%)
              • Constipation (9%)
              • Dizziness (9%)
              • Petechiae (8%)
              • Insomnia (7%)
              • Malaise (7%)
              • Abdominal pain (6%)
              • Edema (6%)
              • Erythema (6%)
              • Pruritus (6%)

              Mavenclad

              • Back pain (8%)
              • Arthralgia and arthritis (7%)
              • Insomnia (6%)
              • Bronchitis (5%)
              • Hypertension (5%)
              • Fever (5%)
              • Depression (5%)
              • Alopecia (3%)

              <1%

              Cladribine (parenteral)

              • Aplastic anemia
              • Cellulitis
              • Eosinophilia
              • Hemolytic anemia
              • Melodysplastic syndrome
              • Fungal infection
              • Pneumonia
              • Pancytopenia

              Mavenclad

              • Seizures
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              Warnings

              Black Box Warnings

              Cladribine (parenteral)

              • The drug should be administered under the supervision of an experienced cancer chemotherapy physician
              • Bone marrow suppression may occur but is usually reversible and appears to be dose dependent
              • Continuous infusion of high doses of 4 to 9 times the recommended dose for hairy cell leukemia has been associated with serious acute nephrotoxicity and neurological toxicity resulting in irreversible paraparesis and quadriparesis; standard cladribine dosing regimens have also been associated with severe neurological toxicity
              • Acute nephrotoxicity reported with high doses (4-9 times recommended dose for hairy cell leukemia), especially when used concomitantly with nephrotoxic agents

              Mavenclad

              • Malignancies
                • Therapy may increase risk of malignancy
                • Contraindicated in patients with current malignancy
                • Evaluate on an individual patient basis the benefits and risks therapy in patients with prior malignancy or with increased risk of malignancy; follow standard cancer screening guidelines in patients receiving therapy
              • Risk of teratogenicity
                • Contraindicated for use in pregnant women and women and men of reproductive potential who do not plan to use effective contraception because of potential for fetal harm
                • Malformations and embryolethality shown in animals
                • Exclude pregnancy before start of treatment in females of reproductive potential
                • Advise females and males of reproductive potential to use effective contraception during therapy and for 6 months after last dose in each treatment course
                • Stop therapy if patient becomes pregnant

              Contraindications

              Cladribine (parenteral)

              • Hypersensitivity

              Mavenclad

              • Patients with current malignancy
              • Pregnant women and women and men of reproductive potential who do not plan to use effective contraception during therapy and for 6 months after last dose in each treatment course
              • Patients with infected HIV
              • Active chronic infections (eg, hepatitis, tuberculosis)
              • History of hypersensitivity to drug or excipients
              • Women intending to breastfeed on a treatment day and for 10 days after last dose

              Cautions

              Cladribine (parenteral)

              • As with other potent chemotherapeutic agents, monitoring of renal and hepatic function is also recommended, especially in patients with underlying kidney or liver dysfunction
              • Allopurinol and IV hydration recommended for patients with high tumor burden to prevent tumor lysis syndrome
              • May impair fertility; shown to suppress rapidly generating cells, including testicular cells
              • Fever with or without neutropenia is frequently observed during first month of treatment; given known myelosuppressive effects of therapy, practitioners should carefully evaluate risks and benefits of administering this drug to patients with active infections
              • Nephrotoxicity reported with high doses (4-9 times approved dose), especially when coadministered with other nephrotoxic drugs; manufacturer reports no nephrotoxicity at doses approved for hairy cell leukemia
              • Periodic assessment of peripheral blood counts, particularly during first 4-8 weeks post-treatment, recommended to detect development of anemia, neutropenia and thrombocytopenia and for early detection of any potential sequelae (eg, infection or bleeding)

              Mavenclad

              • Treatment may increase risk of malignancies, including metastatic pancreatic carcinoma, malignant melanoma, and ovarian cancer
              • Serious cases of thrombocytopenia, neutropenia, and pancytopenia (some with documented bone marrow hypoplasia) requiring transfusion and granulocyte-colony stimulating factor treatment reported; monitor CBC
              • Advise women of potential risk to a fetus during therapy and for 6 months after last dose in each treatment course
              • Latent tuberculosis infections may be activated with therapy; in patients with tuberculosis infection, delay initiation of treatment until infection adequately treated
              • Patients who are carriers of hepatitis B or C virus may be at risk of irreversible liver damage caused by virus reactivation; in patients with hepatitis infection, delay initiation of therapy until infection adequately treated
              • Incidence of herpes zoster reported to be higher during period of absolute lymphocyte count <500 cells/mcL per microliter; monitor for signs and symptoms suggestive of infections, including herpes infections in patients with lymphocyte counts <500 cells/mcL; if such signs and symptoms occur, initiate treatment as clinically indicated; consider interruption or delay of therapy until there is resolution of infection
              • In patients treated with parenteral cladribine for oncologic indications, cases of PML reported in the postmarketing setting; no cases reported in clinical studies of receiving therapy for MS
              • In patients who require blood transfusion, irradiation of cellular blood components recommended prior to administration to decrease risk of transfusion-related graft versus host disease; consultation with hematologist advised
              • Liver injury may occur; if a patient develops clinical signs, including unexplained liver enzyme elevations or symptoms suggestive of hepatic dysfunction, including unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice, and/or dark urine, promptly measure serum transaminases and total bilirubin and interrupt or discontinue treatment as appropriate
              • Not for use in patients with history of hypersensitivity; discontinue therapy if hypersensitivity reaction suspected
              • Cardiac failure with myocarditis reported with parenteral cladribine for indications other than MS; patients should seek medical advice if they experience symptoms of cardiac failure, including shortness of breath, rapid or irregular heartbeat, or swelling

              Drug interaction overview

              • Therapy causes dose-dependent reduction in lymphocyte count; additive hematological adverse reactions may be expected if therapy administered prior to or concomitantly with other drugs that affect the hematological profile
              • Initiation of therapy in patients currently receiving immunosuppressive or myelosuppressive therapy not recommended; concomitant use may increase risk of myelosuppression; acute short-term therapy with corticosteroids may be administered
              • Do not administer live virus vaccines; risk of infection in setting of immunosuppression
              • Lymphopenia risk may be increased when therapy coadministered with interferon-beta
              • Avoid coadministration of potent ENT1, CNT3, or BCRP transporter inhibitors (eg, ritonavir, eltrombopag, curcumin, cyclosporine, diltiazem, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4- to 5-day treatment cycle; the bioavailability, intracellular distribution, and renal elimination of the drug may be altered
              • Consider a possible decrease in efficacy if potent BCRP (eg, corticosteroids) or P-gp (eg, rifampicin, St. John's wort) transporter inducers are coadministered
              • Women using systemically acting hormonal contraceptives should add a barrier method during therapy and for at least 4 weeks after last dose in each treatment course
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              Pregnancy & Lactation

              Pregnancy

              Contraindicated in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception; there are no adequate data on the developmental risk associated with therapy in pregnant women

              Reproductive potential

              • Females of reproductive potential should prevent pregnancy by use of effective contraception during therapy and for at least 6 months after last dose in each treatment course; add also a barrier method during therapy and for at least 4 weeks after last dose in each treatment course
              • As cladribine interferes with DNA synthesis, adverse effects on human gametogenesis could be expected; male patients of reproductive potential should take precautions to prevent pregnancy of their partner during therapy and for at least 6 months after last dose in each treatment course

              Animal data

              • Cladribine was embryolethal when administered to pregnant mice and produced malformations in mice and rabbits; the observed developmental effects are consistent with the effects of cladribine on DNA

              Lactation

              Therapy is contraindicated in breastfeeding women because of potential for serious adverse reactions in breastfed infants; advise women not to breastfeed during therapy and for 10 days after last dose

              There are no data on presence of cladribine in human milk, effects on breastfed infant, or on milk production

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Purine analog, impairs DNA repair; cladribine is a prodrug; in the treatment of hairy cell leukemia, the active form incorporates into DNA, resulting in breakage of DNA strand and shutdown of DNA synthesis and repair, which in turn inhibits cell replication

              Cladribine is a prodrug of the active moiety Cd-ATP; mechanism in multiple sclerosis not fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes

              Pharmacokinetics

              Parenteral

              • Half-Life: 5.4 hr
              • Protein bound: 20%
              • Vd: 4.5 L/kg
              • Clearance: 978 mL/hr/kg
              • Excretion: urine

              Oral

              • Absorption
                • Bioavailability: 40%
                • Peak plasma time: 0.5 hr (0.5-1.5 hr range)
                • Peak plasma concentration: 22-29 ng/mL
                • Mean AUC: 80-101 ng.h/mL
              • Distribution
                • Protein bound: 20%
                • Vd: 480-490 L
              • Metabolism
                • Prodrug is phosphorylated to active moiety Cd-ATP by deoxycytidine kinase and deoxyguanosine kinase in the mitochondria; dephosphorylation and deactivation of Cd-AMP is catalyzed by cytoplasmic 5”-nucleotidase
              • Elimination
                • Half-life: 1 day
                • Renal clearance: 22.2 L/hr
                • Excretion: Urine (28.5%)
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              Administration

              IV Incompatibilities (Cladribine Parenteral)

              Solution: D5W

              Y-site: none reported

              IV Compatibilities (Cladribine Parenteral)

              Y-site (partial list): carboplatin, cisplatin, cyclophosphamide, cytarabine, diphenhydramine, dopamine, etoposide, heparin, lorazepam, metoclopramide, morphine, ondansetron, paclitaxel, KCl, prochlorperazine, promethazine, NaHCO3, teniposide, vincristine

              IV Preparation (Cladribine Parenteral)

              Single-use vials

              Prepare with bacteriostatic NS

              Both cladribine and diluent should be passed through a sterile 0.22 micron hydrophilic filter as they are being introduced into infusion reservoir

              The calculated dose of cladribine (7 days x 0.09 mg/kg) should first be added to the infusion reservoir through a filter, then the bacteriostatic NS should be added to the reservoir to obtain a total volume of 100 mL

              Standard IV 24 hr infusion dilution: 24 hr dose/500 mL NS

              Standard IV 7 day infusion dilution: 7 day dose/QS to 100 mL with bacteriostatic NS

              Do not dilute in D5W

              IV Administration (Cladribine Parenteral)

              Single daily infusion: administer diluted in an infusion bag containing 500 mL of NS and repeated for a total of 7 consecutive days

              7 day infusion: administer via ambulatory infusion pump into central line; use 0.22 micron filter to infuse

              Oral Administration (Mavenclad)

              Administer tablets with water, swallowed whole without chewing; may take with or without food

              Administration of other drugs should be separated by at least 3 hr during 4-5 day of treatment cycle

              First course

              • First cycle: Start anytime
              • Second cycle: Administer 23-27 days after last dose of first course/first cycle

              Second course

              • First cycle: Administer at least 43 weeks after last dose of first course/second cycle
              • Second cycle: Administer 23-27 days after last dose of second course/first cycle
              • Following administration of 2 treatment courses, do not administer additional treatment during next 2 years; it may further increase risk of malignancy
              • Safety and efficacy of reinitiating therapy more than 2 years after completing 2 treatment courses not studied

              Missed dose

              • If a dose missed, do not take double or extra doses
              • If dose not taken on scheduled day, patient must take missed dose on following day and extend number of days in that treatment cycle; if two consecutive doses missed, extend treatment cycle by 2 days

              Cytotoxic handling

              • Drug is cytotoxic; follow applicable special handling and disposal procedures; patients hand must be dry when handling drug; tablet is uncoated and must be swallowed immediately once removed from blister
              • If tablet left on surface, or if broken or fragmented tablet released from blister, area must be washed with water; avoid prolonged contact with skin

              Storage

              Cladribine (parenteral)

              • Store intact vials under refrigeration

              Mavenclad

              • Store in original package in order to protect from moisture
              • Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              cladribine intravenous
              -
              10 mg/10 mL vial
              cladribine intravenous
              -
              10 mg/10 mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              cladribine intravenous

              CLADRIBINE - INJECTION

              (KLAD-rib-een)

              COMMON BRAND NAME(S): Leustatin

              WARNING: This medication may cause very serious blood disorders (decreased bone marrow function leading to low number of blood cells such as white cells, red cells, and platelets). This effect can weaken the immune system/increase the risk of infection, cause anemia, or cause your body to bruise or bleed easier. Tell your doctor right away if you develop any of the following: signs of infection (fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.When used in high doses, cladribine may cause very serious kidney or nerve problems. Nerve problems may also rarely occur in patients taking the normal dose of cladribine. Get medical help right away if you develop any of the following: change in the amount of urine, weakness/numbness/tingling in your hands/feet, or inability to move your arms/legs.Cladribine may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking, seizures, or sudden vision changes. See also Side Effects section.

              USES: Cladribine is used to treat a certain type of cancer (hairy cell leukemia). It works by stopping the growth of cancer cells.

              HOW TO USE: This medication is given by injection into a vein by a health care professional. Dosage is based on your weight and response to treatment. This medication is usually given continuously for 7 days in a row or as directed by your doctor.Avoid getting the medication on the skin or in the eyes, mouth, or nose. If you do get the medication in those areas, flush with plenty of water and tell your doctor right away.

              SIDE EFFECTS: See also Warning section.Nausea, vomiting, dizziness, headache, cough, diarrhea, joint/muscle pain, trouble sleeping, stomach/abdominal pain, constipation, or pain/swelling/redness at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: pain/swelling/redness of arms or legs, shortness of breath.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.Cladribine can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using cladribine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, nerve/muscle disorder, blood/bone marrow disorder, recent/current infections.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist that you are using this medication.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as oral polio vaccine or flu vaccine inhaled through the nose).Wash your hands well to prevent the spread of infections.To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as cyclosporine, natalizumab, rituximab, drugs to treat cancer like irinotecan), other drugs that worsen kidney problems (including NSAIDs such as ibuprofen).

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: weakness/numbness/tingling in your hands/feet, inability to move your arms/legs, change in the amount of urine, signs of infection (fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

              NOTES: Laboratory and/or medical tests (e.g., complete blood count, hemoglobin, platelets, kidney/liver function) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised October 2020. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
              Additional Offers
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.