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Leustatin

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Leustatin

Leustatin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Leustatin (cladribine) Injection is used to treat hairy cell leukemia (a type of blood cancer). It is an antineoplastic (anticancer) medication. This medication is available in generic form. Common side effects include nausea, vomiting, headache, cough, weakness, or pain/swelling/redness at injection site.

The recommended dose and schedule of Leustatin Injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day. Leustatin may interact with other cancer medications, cyclosporine, sirolimus, tacrolimus, basiliximab, efalizumab, muromonab-CD3, mycophenolate mofetil, azathioprine, leflunomide, etanercept, or steroids. Tell your doctor all medications and supplements you use. Leustatin is not recommended for use during pregnancy. It may harm a fetus. Consult your doctor to discuss using at least 2 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. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Leustatin (cladribine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Leustatin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • numbness, tingling, weakness, or burning pain in your fingers or toes;
  • numbness or tingly feeling around your mouth;
  • feeling like you might pass out;
  • redness, swelling, or itching under your skin;
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • fast or slow heart rate, weak pulse, feeling short of breath;
  • pale or yellowed skin, dark colored urine, fever, confusion;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
  • signs of infection such as fever, chills, sore throat, flu symptoms, cough with yellow or green mucus, loss of appetite, mouth sores, unusual weakness.

Less serious side effects may include:

  • headache, tired feeling;
  • nausea, diarrhea, constipation;
  • mild itching or skin rash;
  • cough; or
  • pain, swelling, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Leustatin (Cladribine Injection For Intravenous Infusion Only) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Leustatin Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, dizziness, headache, cough, weakness, 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, mental/mood changes, seizures, 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Leustatin (Cladribine Injection For Intravenous Infusion Only)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Leustatin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Adverse drug reactions reported by ≥ 1% of LEUSTATIN-treated patients with HCL noted in the HCL clinical dataset (studies K90-091 and L91-048, n=576) are shown in the table below.

Adverse Drug Reactions in ≥ 1% of Patients Treated With LEUSTATIN in HCL Clinical Trials

System Organ Class Preferred Term LEUSTATIN
(n=576) %
Blood and Lymphatic System Disorder (see also sections WARNINGS and PRECAUTIONS)
  Anemia 1
  Febrile neutropenia 8
Psychiatric Disorders
  Anxiety 1
  Insomnia 3
Nervous System Disorders
  Dizziness 6
  Headache 14
Cardiac Disorders
  Tachycardia 2
Respiratory, Thoracic and Mediastinal Disorders
  Breath sounds abnormal 4
  Cough 7
  Dyspnea* 5
  Rales 1
Gastrointestinal Disorders
  Abdominal pain** 4
  Constipation 4
  Diarrhea 7
  Flatulence 1
  Nausea 22
  Vomiting 9
Skin and Subcutaneous Tissue Disorders
  Ecchymosis 2
  Hyperhidrosis 3
  Petechiae 2
  Pruritus 2
  Rash*** 16
Musculoskeletal, Connective Tissue, and Bone Disorders
  Arthralgia 3
  Myalgia 6
  Pain**** 6
General Disorders and Administration Site Conditions (see also sections WARNINGS and PRECAUTIONS)
  Administration site reaction***** 11
  Asthenia 6
  Chills 2
  Decreased appetite 8
  Fatigue 31
  Malaise 5
  Muscular weakness 1
  Edema peripheral 2
  Pyrexia 33
Injury, Poisoning and Procedural Complications
  Contusion 1
* Dyspnea includes dyspnea, dyspnea exertional, and wheezing
** Abdominal pain includes abdominal discomfort, abdominal pain, and abdominal pain (lower and upper)
*** Rash includes erythema, rash, and rash (macular, macula-papular, papular, pruritic, pustular and erythematous)
**** Pain includes pain, back pain, chest pain, arthritis pain, bone pain, and pain in extremity
***** Administration site reaction includes administration site reaction, catheter site (cellulitis, erythema, hemorrhage, and pain), and infusion site reaction(erythema, edema, and pain)

The following safety data are based on 196 patients with Hairy Cell Leukemia: the original cohort of 124 patients plus an additional 72 patients enrolled at the same two centers after the original enrollment cutoff. In Month 1 of the Hairy Cell Leukemia clinical trials, severe neutropenia was noted in 70% of patients, fever in 69%, and infection was documented in 28%. Most non-hematologic adverse experiences were mild to moderate in severity.

Myelosuppression was frequently observed during the first month after starting treatment. Neutropenia (ANC < 500 x 106/L) was noted in 70% of patients, compared with 26% in whom it was present initially. Severe anemia (Hemoglobin < 8.5 g/dL) developed in 37% of patients, compared with 10% initially and thrombocytopenia (Platelets < 20 x 109/L) developed in 12% of patients, compared to 4% in whom it was noted initially.

During the first month, 54 of 196 patients (28%) exhibited documented evidence of infection. Serious infections (e.g., septicemia, pneumonia) were reported in 6% of all patients; the remainder were mild or moderate. Several deaths were attributable to infection and/or complications related to the underlying disease. During the second month, the overall rate of documented infection was 6%; these infections were mild to moderate and no severe systemic infections were seen. After the third month, the monthly incidence of infection was either less than or equal to that of the months immediately preceding LEUSTATIN therapy.

During the first month, 11% of patients experienced severe fever (i.e., ≥ 104°F). Documented infections were noted in fewer than one-third of febrile episodes. Of the 196 patients studied, 19 were noted to have a documented infection in the month prior to treatment. In the month following treatment, there were 54 episodes of documented infection: 23 (42%) were bacterial, 11 (20%) were viral and 11 (20%) were fungal. Seven (7) of 8 documented episodes of herpes zoster occurred during the month following treatment. Fourteen (14) of 16 episodes of documented fungal infections occurred in the first two months following treatment. Virtually all of these patients were treated empirically with antibiotics. (see WARNINGS and PRECAUTIONS)

Analysis of lymphocyte subsets indicates that treatment with cladribine is associated with prolonged depression of the CD4 counts. Prior to treatment, the mean CD4 count was 766/μL. The mean CD4 count nadir, which occurred 4 to 6 months following treatment, was 272/μL. Fifteen (15) months after treatment, mean CD4 counts remained below 500/μL. CD8 counts behaved similarly, though increasing counts were observed after 9 months. The clinical significance of the prolonged CD4 lymphopenia is unclear.

Another event of unknown clinical significance includes the observation of prolonged bone marrow hypocellularity. Bone marrow cellularity of < 35% was noted after 4 months in 42 of 124 patients (34%) treated in the two pivotal trials. This hypocellularity was noted as late as day 1010. It is not known whether the hypocellularity is the result of disease related marrow fibrosis or if it is the result of cladribine toxicity. There was no apparent clinical effect on the peripheral blood counts.

The vast majority of rashes were mild. Most episodes of nausea were mild, not accompanied by vomiting, and did not require treatment with antiemetics. In patients requiring antiemetics, nausea was easily controlled, most frequently with chlorpromazine.

When used in other clinical settings the following ADRs were reported: bacteremia, cellulitis, localized infection, pneumonia, anemia, thrombocytopenia (with bleeding or petechiae), phlebitis, purpura, crepitations, localized edema and edema.

For a description of adverse reactions associated with use of high doses in non-Hairy Cell Leukemia patients, see WARNINGS.

Postmarketing Experience

The following additional adverse reactions have been reported since the drug became commercially available. These adverse reactions have been reported primarily in patients who received multiple courses of LEUSTATIN Injection:

Infections and infestations: Septic shock. Opportunistic infections have occurred in the acute phase of treatment.

Blood and lymphatic system disorders: Bone marrow suppression with prolonged pancytopenia, including some reports of aplastic anemia; hemolytic anemia (including autoimmune hemolytic anemia), which was reported in patients with lymphoid malignancies, occurring within the first few weeks following treatment. Rare cases of myelodysplastic syndrome have been reported.

Immune system disorders: Hypersensitivity.

Metabolism and nutrition disorders: Tumor lysis syndrome.

Psychiatric disorders: Confusion (including disorientation).

Hepatobiliary disorders: Reversible, generally mild increases in bilirubin (uncommon) and transaminases.

Nervous System disorders: Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy (paralysis), polyneuropathy, paraparesis); however, severe neurotoxicity has been reported rarely following treatment with standard cladribine dosing regimens.

Eye disorders: Conjunctivitis.

Respiratory, thoracic and mediastinal disorders: Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis); in most cases, an infectious etiology was identified.

Skin and tissue disorders: Urticaria, hypereosinophilia; Stevens-Johnson. In isolated cases toxic epidermal necrolysis has been reported in patients who were receiving or had recently been treated with other medications (e.g., allopurinol or antibiotics) known to cause these syndromes.

Renal and urinary disorders: Renal failure (including renal failure acute, renal impairment).

Read the entire FDA prescribing information for Leustatin (Cladribine Injection For Intravenous Infusion Only) »

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