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Cladribine

Generic Name: cladribine (oral) (KLAD ri been)
Brand Name: Mavenclad
Physician reviewed cladribine (oral) patient information - includes cladribine description, dosage and directions.
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Drug Information:
Cladribine is used to treat relapsing multiple sclerosis (MS) in adults. Cladribine will not cure MS, it will only decrease the frequency of relapse symptoms. Cladribine is usually given after other treatments have failed. Cladribine may also be used for purposes not listed in this medication guide. Do not take Cladribine if you are pregnant. Both men and women should use effective birth control to prevent pregnancy while taking Cladribine, and for 6 months after the last dose. If you use birth control pills or other hormonal forms (implants, skin patches, vaginal rings), also use a barrier form of birth control (condom, diaphragm, cervical cap, contraceptive sponge) to prevent pregnancy while taking Cladribine and for at least 4 weeks after your treatment course ends. Learn more

Cladribine Side Effects

Cladribine Side Effects

In Summary

Commonly reported side effects of cladribine include: infection, anuria, severe neutropenia, neurotoxicity, neutropenia, thrombocytopenia, acidosis, fever, increased serum creatinine, and renal insufficiency. Other side effects include: pruritus. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to cladribine: intravenous solution

Warning

Intravenous route (Solution)

Suppression of bone marrow function, which is usually reversible and appears to be dose dependent, should be anticipated with cladribine. Serious neurological toxicity (including irreversible paraparesis and quadriparesis) has been reported in patients who received cladribine injection 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. 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.

Along with its needed effects, cladribine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.

Also, because of the way cancer medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking cladribine:

More common

  • Black, tarry stools
  • blood in urine
  • cough or hoarseness, accompanied by fever or chills
  • fever
  • lower back or side pain, accompanied by fever or chills
  • painful or difficult urination, accompanied by fever or chills
  • pinpoint red spots on skin
  • unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur while taking cladribine:

More common

  • Skin rash

Less common

  • Pain or redness at place of injection
  • shortness of breath
  • stomach pain
  • swelling of feet or lower legs
  • unusually fast heartbeat

This medicine may also cause the following side effects that your doctor will watch out for:

More common

  • Anemia
  • low white cell counts in blood

Some side effects of cladribine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Headache
  • loss of appetite
  • nausea
  • unusual tiredness
  • vomiting

Less common

  • Constipation
  • diarrhea
  • dizziness
  • general feeling of discomfort or illness
  • itching
  • muscle or joint pain
  • sweating
  • trouble in sleeping
  • weakness

For Healthcare Professionals

Applies to cladribine: intravenous solution, oral tablet

Hematologic

Very common (10% or more): Neutropenia, thrombocytopenia, anemia, purpura

Common (1% to 10%): Febrile neutropenia

Uncommon (0.1% to 1%): Bone marrow suppression with prolonged pancytopenia, aplastic anemia, hypereosinophilia, myelodysplastic syndrome

Postmarketing reports: Hemolytic anemia, febrile neutropenia

Renal

Common (1% to 10%): Renal impairment, renal failure

Gastrointestinal

Very common (10% or more): Nausea (28%), anorexia (17%), vomiting (13%), diarrhea (10%)

Common (1% to 10%): Constipation, abdominal pain, flatulence

Uncommon (0.1% to 1%): Mucositis

Dermatologic

Very common (10% or more): Rash (28%), diaphoresis, pruritus

Common (1% to 10%): Hyperhidrosis, petechiae, ecchymosis, urticaria

Uncommon (0.1% to 1%): Stevens-Johnson syndrome, toxic skin eruption, toxic epidermal necrolysis

Rare (less than 0.1%): Alopecia

Nervous system

Very common (10% or more): Headache

Common (1% to 10%): Dizziness, somnolence

Uncommon (0.1% to 1%): Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy (paralysis), polyneuropathy, paraparesis)

Local

Very common (10% or more): Administration site reaction

Metabolic

Common (1% to 10%): Weight loss

Uncommon (0.1% to 1%): Tumor lysis syndrome, metabolic acidosis

Cardiovascular

Common (1% to 10%): Edema, tachycardia, myocardial ischemia, peripheral edema

Rare (less than 0.1%): Heart failure, arrhythmia, heart murmur, hypotension, thrombosis

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia

Uncommon (0.1% to 1%): Muscular weakness, paraparesis

Respiratory

Very common (10% or more): Cough

Common (1% to 10%): Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis), abnormal breath sounds, abnormal chest sounds, dyspnea, rales

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Hepatic

Uncommon (0.1% to 1%): Increases in bilirubin, increases in transaminases, jaundice

Immunologic

Very common (10% or more): Infection (unspecified) (up to 28%)

Common (1% to 10%): Bacteremia, cellulitis, localized infection, pneumonia, septic shock, serious infection, opportunistic infection

Ocular

Postmarketing reports: Conjunctivitis

Other

Very common (10% or more): Fatigue, pyrexia, pain

Common (1% to 10%): Asthenia, chills, malaise, localized edema, chills

Oncologic

Postmarketing reports: Secondary malignancies

Psychiatric

Common (1% to 10%): Confusion, anxiety, insomnia

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Cladribine (www.drugs.com/mtm/cladribine.html).