Cladribine Novaplus Side Effects

Generic Name: cladribine

Note: This page contains information about the side effects of cladribine. Some of the dosage forms included on this document may not apply to the brand name Cladribine Novaplus.

Not all side effects for Cladribine Novaplus may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to cladribine: intravenous solution

Along with its needed effects, cladribine (the active ingredient contained in Cladribine Novaplus) 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.

You should check with your doctor immediately if any of these side effects occur when 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

If any of the following side effects occur while taking cladribine, check with your doctor or nurse as soon as possible:

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 of the side effects that can occur with cladribine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Hematologic

Very common (10% or more): Neutropenia (up to 70%), anemia (up to 37%), thrombocytopenia (up to 12%)
Common (1% to 10%): Febrile neutropenia (8%)
Postmarketing reports: Bone marrow suppression with pancytopenia, aplastic anemia, hemolytic anemia, myelodysplastic syndrome[Ref]

Renal

Postmarketing reports: Acute renal failure, renal impairment[Ref]

Gastrointestinal

Very common (10% or more): Nausea (22%)
Common (1% to 10%): Vomiting (9%), diarrhea (7%), constipation (4%), abdominal pain (4%), flatulence (1%)[Ref]

Dermatologic

Very common (10% or more): Rash (16%)
Common (1% to 10%): Hyperhidrosis (3%), petechiae (2%), pruritus (2%), ecchymosis (2%)
Postmarketing reports: Urticaria, hypereosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]

Nervous system

Very common (10% or more): Headache (14%)
Common (1% to 10%): Dizziness (6%)
Postmarketing reports: Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy, polyneuropathy, paraparesis)[Ref]

Profound (proximal > distal) extremity motor weakness has been described in some patients who received relatively large doses of 0.45 to 0.52 mg/kg per day. Some affected patients were unable to walk and experienced numbness, paresthesia, and hyperesthesia. Nerve conduction velocity studies in affected patients showed markedly decreased compound muscle action potential amplitude, absent or delayed F-wave and H-reflex responses, and (per EMG) polyphasic potentials without evidence of myopathic changes. Overall, the findings were consistent with a symmetric axonal peripheral polyneuropathy with prominent motor involvement.[Ref]

Local

Very common (10% or more): Administration site reaction (11%)[Ref]

Metabolic

Postmarketing reports: Tumor lysis syndrome[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia (2%)[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia (6%), pain (6%), arthralgia (6%), muscular weakness (1%)[Ref]

Respiratory

Common (1% to 10%): Cough (7%), dyspnea (5%), abnormal breath sounds (4%), rales (1%)
Postmarketing reports: Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis)[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity[Ref]

Hepatic

Postmarketing reports: Increased bilirubin, increased transaminases[Ref]

Immunologic

Very common (10% or more): Infection (up to 28%)
Common (1% to 10%): Serious infection (up to 6%)
Postmarketing reports: Septic shock, opportunistic infections

Ocular

Postmarketing reports: Conjunctivitis

Other

Very common (10% or more): Pyrexia (33%), fatigue (31%),
Common (1% to 10%): Decreased appetite (8%), asthenia (6%), malaise (5%), chills (2%), peripheral edema (2%), contusion (1%)

References

1. Franco V, Florena AM, Quintini G, Musso M "Bone marrow granulomas in hairy cell leukaemia following 2- chlorodeoxyadenosine therapy." Histopathology 24 (1994): 271-3

2. Kobayashi K, Vogelzang NJ, O'Brien SM, Schilsky RL, Vokes EE, Ratain MJ "A phase I study of intermittent infusion cladribine in patients with solid tumors." Cancer 74 (1994): 168-73

3. Juliusson G, Liliemark J "Rapid recovery from cytopenia in hairy cell leukemia after treatment with 2-chloro-2'-deoxyadenosine (CdA): relation to opportunistic infections." Blood 79 (1992): 888-94

4. Marks RS, Letendre L, Reid JM, Bagniewski PG, Ames MM "A Phase I and pharmacologic study of 2-chlorodeoxyadenosine in patients with chronic myelomonocytic or chronic granulocytic leukemias (Meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 13 (1994): a4151994

5. Marks RS, Richardson RL, Reid JM, Bagniewski PG, Ames MM "A Phase I and pharmacologic study of 2-chlorodeoxyadenosine in patients with advanced solid tumors (Meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 13 (1994): a4161994

6. Saven A, Carrera CJ, Carson DA, Beutler E, Piro LD "2-Chlorodeoxyadenosine: an active agent in the treatment of cutaneous T-cell lymphoma." Blood 80 (1992): 587-92

7. Jaiyesimi IA, Kantarjian HM, Estey EH "Advances in therapy for hairy cell leukemia. A review." Cancer 72 (1993): 5-16

8. Weiss GR, Kuhn JG, Rizzo J, Smith LS, Rodriguez GI, Eckardt JR, Burris HA 3rd, Fields S, VanDenBerg K, von Hoff DD, Burris HA rd "A phase I and pharmacokinetics study of 2-chlorodeoxyadenosine in patients with solid tumors." Cancer Chemother Pharmacol 35 (1995): 397-402

9. Hickish T, Serafinowski P, Oza A, Dorland P, Millar B, Roldan A, Judson I, Lister A, Harrap K, Cunningham D "2-Chlorodeoxyadenosine: evaluation of a novel lymphocyte-selective agent in lymphoid malignancies (Meeting abstract)." Br J Cancer 65 Suppl (1992): 91992

10. "Pentostatin and 2-chlorodeoxyadenosine for hairy-cell leukemia." Med Lett Drugs Ther 34 (1992): 89-90

11. Tallman MS, Hakimian D, Zanzig C, Hogan DK, Rademaker A, Rose E, Variakojis D "Cladribine in the treatment of relapsed or refractory chronic lymphocytic leukemia." J Clin Oncol 13 (1995): 983-8

12. Hickish T, Serafinowski P, Cunningham D, Oza A, Dorland E, Judson I, Millar BC, Lister TA, Roldan A "2'-Chlorodeoxyadenosine: evaluation of a novel predominantly lymphocyte selective agent in lymphoid malignancies." Br J Cancer 67 (1993): 139-43

13. Beutler E "Cladribine (2-chlorodeoxyadenosine)." Lancet 340 (1992): 952-6

14. Bryson HM, Sorkin EM "Cladribine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in haematological malignancies." Drugs 46 (1993): 872-94

15. Betticher DC, Fey MF, Rabaglio M, Cerny T, Hess U, Meier V, Stalder M, Zulian G "Cladribine and severe myelotoxicity." Lancet 342 (1993): 1369

16. Estey EH, Kurzrock R, Kantarjian HM, O'Brien SM, McCredie KB, Beran M, Koller C, Keating MJ, Hirsch-Ginsberg C, Huh YO, et al "Treatment of hairy cell leukemia with 2-chlorodeoxyadenosine (2-CdA)." Blood 79 (1992): 882-7

17. Fleischman RA, Croy D "Acute onset of severe autoimmune hemolytic anemia after treatment with 2-chlorodeoxyadenosine for chronic lymphocytic leukemia." Am J Hematol 48 (1995): 293

18. "New drug bulletin. Cladribine injection(leustatin)." RN 57 (1994): 41-2

19. "Product Information. Leustatin (cladribine)." Ortho Biotech Inc, Raritan, NJ.

20. Wong ET, Vahdat L, Warrell RP, Nichols GL, Foley KM "Profound motor weakness from high-dose 2-chlorodeoxyadenosine (Meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 13 (1994): a10141994

21. Cheson BD, Vena DA, Foss FM, Sorensen JM "Neurotoxicity of purine analogs: a review." J Clin Oncol 12 (1994): 2216-28

22. Trendle MC, Tefferi A "Tumor lysis syndrome after treatment of chronic lymphocytic leukemia with cladribine." N Engl J Med 330 (1994): 1090

23. Anchisi S, Zulian GB, Dietrich PY, Alberto P "Cladribine and tumour lysis syndrome." Eur J Cancer 31a (1995): 131-2

24. Schirmer M, Vogel W, Thaler J, Grunewald K, Umlauft F, Geisen F, Zilian U, Konwalinka G "Fulminant hepatitis C virus infection." Lancet 343 (1994): 1433

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