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Cladribine

Pronunciation

(KLA dri been)

Index Terms

  • 2-CdA
  • 2-Chlorodeoxyadenosine
  • Leustatin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Generic: 10 mg/10 mL (10 mL)

Pharmacologic Category

  • Antineoplastic Agent, Antimetabolite
  • Antineoplastic Agent, Antimetabolite (Purine Analog)
  • Immunosuppressant Agent

Pharmacology

Cladribine is a purine nucleoside analogue; it is a prodrug which is activated via phosphorylation by deoxycytidine kinase to a 5'-triphosphate derivative (2-CaAMP). This active form incorporates into DNA to result in the breakage of DNA strand and shutdown of DNA synthesis and repair. This also results in a depletion of nicotinamide adenine dinucleotide and adenosine triphosphate (ATP). Cladribine is cell-cycle nonspecific.

Distribution

Vd: Children 8 months to 18 years: 12.7 ± 8.5 L/kg; penetrates CSF (CSF concentrations are ~18% of plasma concentration) (Kearns 1994); Adults: ~9 L/kg; penetrates CSF (CSF concentrations are ~25% of plasma concentrations)

Excretion

Urine (18%)

Half-Life Elimination

Children 8 months to 18 years: 19.7 ± 3.4 hours (Kearns 1994); Adults: After a 2-hour infusion (with normal renal function): 5.4 hours

Protein Binding

~20%

Use: Labeled Indications

Hairy cell leukemia: Treatment of active hairy cell leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.

Multiple sclerosis (oral tablet [Canadian product]): Treatment of relapsed-remitting multiple sclerosis (RRMS) to reduce the frequency of exacerbations and to delay the progression of disability in adults who have had inadequate response or are intolerant to one or more other therapies. Note: Not an approved use in the US; dosage form (oral tablet) is not available in the US.

Off Label Uses

Acute myeloid leukemia (AML) (adults)

Data from a large multicenter randomized phase III trial supports the use of cladribine (in combination with daunorubicin and cytarabine) as induction therapy in newly diagnosed adult patients with acute myeloid leukemia (AML) [Holowiecki 2012]. In addition, data from studies in adult patients with relapsed or refractory AML supports the use of cladribine (in combination with cytarabine and G-CSF [CLAG regimen] or with cytarabine, mitoxantrone, and G-CSF [CLAG-M regimen]) in the treatment of refractory or relapsed AML in adults [Robak 2000], [Wierzbowska 2008], [Wrzesien-Kus 2003].

Acute myeloid leukemia (AML) (children/adolescents)

Data from studies in children and adolescents (0 to 21 years of age) supports the use of cladribine (alone or in combination with cytarabine) in the treatment of newly diagnosed acute myeloid leukemia (AML) in pediatric patients [Crews 2002], [Krance 2001], [Rubnitz 2009].

Langerhans cell histiocytosis (refractory) (children)

Data from a nonrandomized phase II study in children (median age range of 1.6 to 43 months) with varying degrees of refractory Langerhans cell histiocytosis (LCH) suggest that cladribine may be beneficial for the treatment of refractory LCH [Weitzman 2009]. Additional data may be necessary to further define the role of cladribine in this condition.

Mantle cell lymphoma

Data from 2 prospective, open label studies in patients with either untreated or relapsed mantle cell lymphoma supports the use of cladribine in the treatment of mantle cell lymphoma [Rummel 1999], [Inwards 2008].

T-cell large granular lymphocytic leukemia (refractory)

Data from a single case report suggests that cladribine may have efficacy in the management of T-cell large granular lymphocytic leukemia [Edelman 1997]. Additional trials are necessary to further define the role of cladribine in this condition.

Waldenström macroglobulinemia

Data from one single-center nonrandomized clinical trial and one multi-center phase II clinical trial in patients with Waldenström macroglobulinemia support the use of cladribine (either alone or in combination with rituximab) for the treatment of Waldenström macroglobulinemia [Dimopoulos 1994], [Laszlo 2010].

Contraindications

Hypersensitivity to cladribine or any component of the formulation

Oral tablet [Canadian product]: Hypersensitivity to cladribine or any component of the formulation; patients at increased risk of opportunistic infections (including those immunocompromised due to therapy [immunosuppressive or immunomodulating, antineoplastic or myelosuppressive therapies; total lymphoid irradiation; bone marrow transplantation] or disease [immunodeficiency syndrome]); latent or active infections (including active chronic bacterial, fungal or viral infections [eg, hepatitis, tuberculosis]); history of progressive multifocal leukoencephalopathy; active malignancy; moderate or severe renal impairment (CrCL <60 mL/minute); pregnancy; breastfeeding.

Dosing: Adult

Note: If active infection is present, manage as appropriate prior to cladribine administration. If it is not possible to control infection, consider an alternative agent if possible (Grever 2017).

Hairy cell leukemia:

IV: 0.14 mg/kg/day over 2 hours for 5 days (Grever 2017) or 0.1 mg/kg/day continuous infusion for 7 days for 1 cycle (Goodman 2003; Saven 1998) or 0.09 mg/kg/day continuous infusion for 7 days for 1 cycle (Cladribine labeling [Fresenius] August 2016)

SubQ (off-label route): 0.1 to 0.14 mg/kg/day for 5 days (Grever 2017)

Acute myeloid leukemia (newly diagnosed), induction (off-label use): DAC regimen: IV: 5 mg/m2 over 3 hours on days 1 to 5 (in combination with daunorubicin and cytarabine); a second induction cycle may be administered if needed (Holowiecki 2012)

Acute myeloid leukemia (relapsed/refractory), induction (off-label use): CLAG or CLAG-M regimen: IV: 5 mg/m2/day over 2 hours for 5 days (in combination with cytarabine and filgrastim ± mitoxantrone); a second induction cycle may be administered if needed (Robak 2000; Wierzbowska 2008; Wrzesień-Kuś 2003)

Mantle cell lymphoma (off-label use): IV: 5 mg/m2/day over 2 hours for 5 days every 4 weeks for 2 to 6 cycles (Inwards 2008) or 5 mg/m2/day over 2 hours for 5 days every 4 to 5 weeks for a maximum of 6 cycles (Rummel 1999) or 5 mg/m2/day over 2 hours for 5 days every 4 weeks for 2 to 6 cycles (in combination with rituximab) (Inwards 2008)

Multiple sclerosis: Mavenclad [Canadian product; not available in the US]: Oral: 3.5 mg/kg over 2 years, administered as 1.75 mg/kg in each year (divided over 4 to 5 days in each of 2 treatment weeks per year; Usual dose: 10 or 20 mg once daily for 4 to 5 days in weeks 1 and 2 each year for 2 years); refer to manufacturer's labeling for additional dosing details, including dosing tables.

T-cell large granular lymphocytic leukemia, refractory (off-label use): IV: 0.1 mg/kg/day continuous infusion for 7 days for 2 cycles (Edelman 1997). Additional trials are necessary to further define the role of cladribine in this condition.

Waldenström macroglobulinemia (off-label use):

IV: 0.1 mg/kg/day continuous infusion for 7 days every 4 weeks for 2 cycles (Dimopoulos 1994)

SubQ: 0.1 mg/kg/day for 5 consecutive days every month for 4 cycles (in combination with rituximab) (Laszlo 2010)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acute myeloid leukemia (off-label use): IV: 8.9 mg/m2/day continuous infusion for 5 days for 1 or 2 courses (Krance, 2001) or 9 mg/m2/day over 30 minutes for 5 days for 1 course (in combination with cytarabine) (Crews 2002; Rubnitz 2009)

Langerhans cell histiocytosis, refractory (off-label use): IV: 5 mg/m2/day over 2 hours for 5 days every 21 days for up to 6 cycles (Weitzman 2009)

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling (due to inadequate data); use with caution. The following adjustments have been used (Aronoff 2007):

Adults: IV:

CrCl 10 to 50 mL/minute: Administer 75% of dose

CrCl <10 mL/minute: Administer 50% of dose

Continuous ambulatory peritoneal dialysis (CAPD): Administer 50% of dose

Children: IV:

CrCl 10 to 50 mL/minute: Administer 50% of dose

CrCl <10 mL/minute: Administer 30% of dose

Hemodialysis: Administer 30% of dose

Continuous renal replacement therapy (CRRT): Administer 50% of dose

Oral tablet [Canadian product]:

CrCl ≥60 mL/minute: No dosage adjustment necessary.

CrCl <60 mL/minute: Use is contraindicated.

Dosing: Hepatic Impairment

IV: There are no dosage adjustments provided in the manufacturer's labeling (due to inadequate data); use with caution.

Oral tablet [Canadian product]:

Mild impairment (Child-Pugh class A): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Moderate to severe impairment (Child-Pugh classes B and C): Use is not recommended (has not been studied).

Dosing: Obesity

ASCO Guidelines for appropriate chemotherapy dosing in obese adults with cancer (excluding leukemias): Utilize patient's actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; manage regimen-related toxicities in the same manner as for nonobese patients; if a dose reduction is utilized due to toxicity, consider resumption of full weight-based dosing with subsequent cycles, especially if cause of toxicity (eg, hepatic or renal impairment) is resolved (Griggs 2012).

Reconstitution

A precipitate may develop at low temperatures and may be resolubilized at room temperature or by shaking the solution vigorously. Inadvertent freezing does not affect the solution; if freezing occurs prior to dilution, allow to thaw naturally; do not heat or microwave; do not refreeze.

Do not use D5W as a diluent due to increased degradation of cladribine. Prepare cladribine infusions with NS.

To prepare a 24-hour continuous infusion: Dilute in 500 mL NS. The manufacturer recommends filtering with a 0.22 micron hydrophilic syringe filter prior to adding to infusion bag.

To prepare a 7-day continuous infusion: Dilute to a total volume of 100 mL in a CADD medication cassette reservoir using bacteriostatic NS. Filter diluent and cladribine with a 0.22 micron hydrophilic filter prior to adding to cassette/reservoir.

Administration

IV: Usually administered as a continuous infusion or over 2 hours; infusions over 30 minutes or over 3 hours have also been reported; refer to specific reference for infusion rate.

SubQ (off-label route): May also be administered SubQ (Grever 2017; Laszlo 2010)

Oral tablet [Canadian product]: Administer with water (with or without food); swallow whole immediately after removing from packaging; do not chew or allow to dissolve in mouth. Patients should use dry hands for handling; wash hands thoroughly afterwards. Refer to manufacturer's labeling for additional administration detail.

Storage

Store intact vials refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. A precipitate may develop at low temperatures and may be resolubilized at room temperature or by shaking the solution vigorously. Inadvertent freezing does not affect the solution; if freezing occurs prior to dilution, allow to thaw naturally prior to reconstitution; do not heat or microwave; do not refreeze.

Solutions for infusion diluted in NS in PVC containers are stable for 24 hours at room temperature and normal lighting conditions.

24-hour continuous infusion: Dilutions in NS for infusion should be used promptly; if not used promptly, the 24-hour infusion may be stored refrigerated for up to 8 hours prior to administration.

7-day continuous infusion: Dilutions in NS for infusion should be used promptly; if not used promptly, the 7-day infusion may be stored refrigerated for up to 8 hours prior to administration. Reconstituted solution is stable for 7 days (when diluted in bacteriostatic NS) in a CADD medication cassette reservoir. For patients weighing >85 kg, the effectiveness of the preservative in the bacteriostatic diluent may be reduced (due to dilution).

Oral tablet [Canadian product]: Store at 15°C to 30°C (59°F to 86°F). Protect from moisture. Store in original packing until immediately before use.

Drug Interactions

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Monitor therapy

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

Adverse Reactions

>10%:

Central nervous system: Fatigue (11% to 45%), headache (7% to 22%)

Dermatologic: Skin rash (10% to 27%)

Gastrointestinal: Nausea (22% to 28%), decreased appetite (8% to 17%), vomiting (9% to 13%)

Hematologic & oncologic: Neutropenia (grade 4: 70%; recovery by week 5), febrile neutropenia (8% to 47%; severe: 32%), anemia (1% to 37%; recovery by week 8), bone marrow depression (34%; prolonged), thrombocytopenia (grade 4: 12%; recovery by day 12)

Infection: Infection (month 1: 28% [serious: 6%]; month 2: 6%)

Local: Injection site reaction (9% to 19%)

Respiratory: Abnormal breath sounds (4% to 11%)

Miscellaneous: Fever (33% to 69%; ≥100°F: 67%; ≥104°F: 11%)

1% to 10%:

Cardiovascular: Edema (2% to 6%), tachycardia (2% to 6%), phlebitis (2%), thrombosis (2%)

Central nervous system: Dizziness (6% to 9%), chills (2% to 9%), malaise (5% to 7%), insomnia (3% to 7%), pain (6%), anxiety (1%), myasthenia (1%)

Dermatologic: Diaphoresis (9%), erythema (6%), pruritus (2% to 6%), hyperhidrosis (3%)

Gastrointestinal: Diarrhea (7% to 10%), constipation (4% to 9%), abdominal pain (4% to 6%), flatulence (1%)

Hematologic & oncologic: Purpura (10%), petechia (2% to 8%), bruise (1% to 2%)

Neuromuscular & skeletal: Weakness (6% to 9%), myalgia (6% to 7%), arthralgia (3% to 5%)

Respiratory: Cough (7% to 10%), dyspnea (5% to 7%), epistaxis (5%), rales (1%)

<1%, postmarketing, and/or case reports: Aplastic anemia, bacteremia, cellulitis, cerebrovascular accident, confusion, conjunctivitis, decreased CD-4 cell count (nadir: 4 to 6 months), eosinophilia (hypereosinophilia or persistent), hemolytic anemia, hypersensitivity reaction, impaired consciousness, increased serum bilirubin, increased serum transaminases, lower extremity weakness, myelodysplastic syndrome, opportunistic infection (cytomegalovirus disease, fungal infection, herpes virus infection, listeriosis, Pneumocystis jirovecii), pancytopenia (prolonged), paresis (at high doses; paraparesis/quadriparesis), pneumonia, polyneuropathy (with high doses), progressive multifocal leukoencephalopathy, pulmonary infiltrates (interstitial), reactivated tuberculosis, renal failure, renal insufficiency (with high doses), septic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis, tumor lysis syndrome, urticaria

ALERT: U.S. Boxed Warning

Experienced physician:

Cladribine should be administered under the supervision of a qualified health care provider experienced in the use of antineoplastic therapy.

Bone marrow suppression:

Suppression of bone marrow function should be anticipated. This is usually reversible and appears to be dose dependent.

Neurotoxicity:

Serious neurological toxicity (including irreversible paraparesis and quadriparesis) has been reported in patients who received cladribine by continuous infusion at high doses (4 to 9 times the recommended dose for hairy cell leukemia). Neurologic toxicity appears to demonstrate a dose relationship; however, severe neurological toxicity has been reported rarely following treatment with standard cladribine dosing regimens.

Renal toxicity:

Acute nephrotoxicity has been observed with high doses of cladribine (4 to 9 times the recommended dose for hairy cell leukemia), especially when given concomitantly with other nephrotoxic agents/therapies.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: [US Boxed Warning]: Dose-dependent myelosuppression (neutropenia, anemia, and thrombocytopenia) is common and generally reversible. Use with caution in patients with preexisting hematologic or immunologic abnormalities. Monitor blood counts, especially during the first 4 to 8 weeks after treatment.

• Fever: Treatment is associated with fever (≥100°F), with or without neutropenia, and is observed more commonly in the first month of treatment.

• Infection: Infections (bacterial, viral, and fungal) were reported more commonly in the first month after treatment (generally mild or moderate in severity, although serious infections including sepsis have been reported); the incidence is reduced in the second month. Due to neutropenia and T-cell depletion, risk versus benefit of treatment should be evaluated in patients with active infections. If active infection is present, manage appropriately prior to administering cladribine (Grever 2017).

• Neurotoxicity: [US Boxed Warning]: Serious, dose-related neurologic toxicity (including irreversible paraparesis and quadriparesis) has been reported with continuous infusions of higher doses (4 to 9 times the approved dose); may also occur at approved doses (rare). Neurotoxicity may be delayed and may present as progressive, irreversible motor weakness of the upper and/or lower extremities; diagnostics with electromyography and nerve conduction studies were consistent with demyelinating disease. Neurotoxicity after high-dose administration was first noted 35 to 84 days after therapy initiation.

• Renal toxicity: [US Boxed Warning]: Acute nephrotoxicity (eg, acidosis, anuria, increased serum creatinine), possibly requiring dialysis, has been reported with high doses (4 to 9 times the approved dose), particularly when administered with other nephrotoxic agents. Per the manufacturer, nephrotoxicity has not occurred when used at the dose approved for hairy cell leukemia.

• Tumor lysis syndrome: With high tumor burden, tumor lysis syndrome and subsequent hyperuricemia may occur (rare); consider antihyperuricemics and hydrate accordingly.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Weekly (7-day) infusion preparation recommends further dilution with bacteriostatic normal saline which contains benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

• Oral tablet [Canadian product]: Multiple sclerosis: Use is contraindicated in patients with active or latent tuberculosis. Complete immunizations at least 6 weeks prior to treatment initiation. Evaluate hepatitis B and C status prior to treatment. Assess varicella zoster virus (VZV) antibody status prior to treatment; if no confirmed history of chicken pox or vaccination and VZV antibody is negative, vaccination is recommended (delay cladribine for 6 weeks after vaccination). Only initiate treatment if lymphocyte counts are normal, Obtain a baseline MRI if patient has previously received MS therapy associated with progressive multifocal leukoencephalopathy (PML); do not initiate or re-initiate therapy until PML has been excluded. May be associated with an increased risk of malignancies.

Other warnings/precautions:

• Experienced physician: [US Boxed Warning]: Should be administered under the supervision of an experienced cancer chemotherapy physician.

• Vaccines: Administration of live vaccines is not recommended during treatment with cladribine (may increase the risk of infection due to immunosuppression).

Monitoring Parameters

IV: CBC with differential (particularly during the first 4 to 8 weeks post-treatment), renal and hepatic function; bone marrow biopsy (after CBC has normalized, to confirm treatment response); monitor for fever; monitor for signs/symptoms of neurotoxicity and infection

Oral tablet [Canadian product]: CBC including lymphocyte count (within 6 months prior to treatment initiation or after discontinuation of prior therapy; assess lymphocyte count prior to initiation in year 1 and year 2 and periodically in between and after treatment); evaluate hepatitis B (HBV) and hepatitis C (HCV) status (prior to treatment); evaluate varicella zoster virus VZV antibody status (prior to treatment); pregnancy test (prior to treatment in females of reproductive potential); MRI (at baseline if received prior MS therapy associated with PML).

Pregnancy Risk Factor

D

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. May cause fetal harm if administered during pregnancy. Women of reproductive potential should use highly effective contraception during treatment.

Oral tablet [Canadian product]: Use is contraindicated in pregnancy. Exclude pregnancy prior to treatment. Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment and for 6 months after the final cladribine dose. Women who become pregnant during therapy should discontinue treatment.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dizziness, headache, muscle pain, or lack of appetite. Have patient report immediately to prescriber signs of infection; signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain); burning, numbness, tingling, or weakness in arms or legs; abnormal heartbeat, signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding); shortness of breath; severe nausea; vomiting; severe diarrhea; severe loss of strength and energy; severe injection site irritation; or signs of tumor lysis syndrome (tachycardia or abnormal heartbeat; any passing out; urinary retention; muscle weakness or cramps; nausea, vomiting, diarrhea or lack of appetite; or feeling sluggish) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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