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Oforta

Last reviewed on RxList: 6/13/2017
Oforta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/13/2017

Oforta (fludarabine phosphate) is a cancer medication used to treat B-cell chronic lymphocytic leukemia (CLL). Oforta is usually given after other cancer medications have been tried without successful response to treatment. The brand name Oforta is discontinued, but generic versions may be available. Common side effects of Oforta (fludarabine phosphate) include:

  • nausea or vomiting (may be severe)
  • stomach pain
  • diarrhea
  • tiredness
  • pain or sores in the mouth and throat
  • loss of appetite
  • muscle pain
  • swelling in your legs
  • cold symptoms (runny or stuffy nose, sneezing)
  • sweating, or mild itching or
  • skin rash

The recommended adult dose of Oforta is 40 mg/m administered by mouth daily for five consecutive days. Each 5-day course of treatment should commence every 28 days. Oforta may interact with other drugs. Tell your doctor all medications and supplements you use. Oforta is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Both males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment and for 6 months after treatment has ended. Consult your doctor to discuss birth control. It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Breastfeeding while using this medication is not recommended.

Our Oforta (fludarabine phosphate) 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.

Oforta Consumer Information

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

Call your doctor at once if you have a serious side effect such as:

  • pale or yellowed skin, dark colored urine;
  • fast or slow heart rate, weak pulse, trouble concentrating, feeling tired or short of breath;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat, nausea, vomiting, loss of appetite;
  • vision problems, confusion, agitation, changes in behavior, or feeling like you might pass out;
  • cough with yellow or green mucus, stabbing chest pain, trouble breathing;
  • black or bloody stools, coughing up blood;
  • lower back pain, blood in your urine, pain or burning when you urinate;
  • urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth; or
  • muscle weakness, tightness, or contraction, overactive reflexes.

Less serious side effects may include:

  • muscle pain;
  • swelling in your legs;
  • mild nausea, diarrhea, stomach pain;
  • cold symptoms such as runny or stuffy nose, sneezing;
  • sweating; or
  • mild itching or skin rash.

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 Oforta (Fludarabine Phosphate Tablets)

Oforta Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Oforta™ (fludarabine phosphate tablets) in 159 patients exposed to the drug. Oforta™ (fludarabine phosphate tablets) was studied primarily in Study 1 in 78 patients with CLL who received prior therapy and in Study 2 in 81 patients with CLL who had not received prior therapy.

Based on experience with the intravenous and oral use of fludarabine phosphate, the most common adverse reactions include myelosuppression (neutropenia, thrombocytopenia and anemia), fever and chills, infection, and nausea and vomiting. Other commonly reported events include malaise, fatigue, anorexia, and weakness. Serious opportunistic infections have occurred in patients with CLL treated with fludarabine phosphate. The most frequently reported adverse reactions and those reactions which are more clearly related to the drug, as reported in clinical studies conducted with intravenous and oral fludarabine phosphate, are arranged below according to body system.

Hematopoietic Systems

Hematologic events (neutropenia, thrombocytopenia, and/or anemia) were reported in the majority of patients with CLL treated with fludarabine phosphate. During intravenous fludarabine phosphate treatment of 133 patients with CLL, the absolute neutrophil count decreased to less than 500/mm in 59% of patients, hemoglobin decreased from pretreatment values by at least 2 grams percent in 60%, and platelet count decreased from pretreatment values by at least 50% in 55%. Among 78 patients with B-CLL who were treated with Oforta™ (fludarabine phosphate tablets) , the absolute neutrophil count decreased to less than 500/mm in 37% of patients, hemoglobin decreased from pretreatment values by at least 2 grams percent in 14%, and platelet count decreased from pretreatment values by at least 50% in 17% of patients. Myelosuppression may be severe, cumulative, and may affect multiple cell lines. Bone marrow fibrosis occurred in one CLL patient treated with fludarabine phosphate intravenously. In the pivotal oral fludarabine phosphate study (Study 1), there was one report of a non-fatal case of pancytopenia. Similarly, there was one case of non-fatal pancytopenia reported among the 133 patients with CLL treated with intravenous fludarabine phosphate.

Life-threatening and sometimes fatal autoimmune hemolytic anemias have been reported to occur in patients receiving fludarabine phosphate. [See WARNINGS AND PRECAUTIONS] The majority of patients rechallenged with fludarabine phosphate developed a recurrence in the hemolytic process.

Metabolic

Tumor lysis syndrome has been reported in patients with CLL treated with fludarabine phosphate for injection. This complication may include hyperuricemia, hyperphosphatemia, hypocalcemia, metabolic acidosis, hyperkalemia, hematuria, urate crystalluria, and renal failure. The onset of this syndrome may be heralded by flank pain and hematuria.

Nervous System

Objective weakness, agitation, confusion, visual disturbances, and coma< have occurred in patients with CLL treated with fludarabine phosphate at the recommended dose. Peripheral neuropathy and one case of wrist-drop have been observed with intravenous administration of fludarabine phosphate. In Study 1 for Oforta™ (fludarabine phosphate tablets) , there was one report of severe impairment of consciousness that presented concurrent with hemolytic anemia. This patient had enrolled in the study with pre-existing peripheral neurotoxicity. [See WARNINGS AND PRECAUTIONS]

Pulmonary System

Pneumonia, a frequent manifestation of infection in patients with CLL, was observed in two clinical trials conducted with intravenous fludarabine phosphate (16% and 22%) and in two clinical trials with Oforta (fludarabine phosphate tablets) ™ (8% and 3%). Pulmonary hypersensitivity reactions to fludarabine phosphate characterized by dyspnea, cough and interstitial pulmonary infiltrate have been observed. In Study 1 conducted with Oforta™ (fludarabine phosphate tablets) , severe pulmonary toxicity was reported in 5 of 78 patients, often in conjunction with respiratory or pulmonary infections and hence not regarded as isolated drug related pulmonary toxicity.

Gastrointestinal System

Gastrointestinal disturbances such as nausea and vomiting, anorexia, diarrhea, stomatitis and gastrointestinal bleeding have been reported in patients treated with fludarabine phosphate. Nausea and vomiting occurred in up to 38% of patients following treatment with Oforta™ (fludarabine phosphate tablets) in the clinical trials.

Cardiovascular

Edema has been frequently reported. One patient developed a pericardial effusion possibly related to treatment with Oforta™ (fludarabine phosphate tablets) . No other severe cardiovascular events were considered to be drug related.

Genitourinary System

Hemorrhagic cystitis has been reported in patients treated intravenously with fludarabine phosphate.

Skin

Skin toxicity, consisting primarily of skin rashes, has been reported in patients treated with oral and intravenous fludarabine phosphate.

Data in Table 2 are derived from the 159 patients with CLL who received Oforta™ (fludarabine phosphate tablets) in Study 1 and Study 2.

TABLE 2: Incidence (≥ 5%) of Non-Hematologic Adverse Reactions in Patients with CLL Treated with Oforta™ (fludarabine phosphate tablets)

ADVERSE REACTIONS Study 1 Study 2
(N=78) (N=81)
% %
ANY ADVERSE REACTION 82 89
BODY AS A WHOLE 59 77
FEVER 26 11
INFECTION 12 17
PAIN 5 19
FLU SYNDROME 8 5
DIAPHORESIS 8 0
NEUROLOGICAL 19 41
WEAKNESS/FATIGUE (ASTHENIA) 13 31
SWEATING INCREASED 0 14
HEADACHE 9 9
PULMONARY 37 53
COUGH 21 0
COUGH INCREASED 0 6
PNEUMONIA 8 3
DYSPNEA 1 5
SINUSITIS 1 5
UPPER RESPIRATORY INFECTION 9 14
RHINITIS 3 11
BRONCHITIS 6 9
METABOLIC AND NUTRITIONAL 3 31
WEIGHT DECREASED 1 6
LACTIC DEHYDROGENASE INCREASED 0 6
PERIPHERAL EDEMA 0 7
GASTROINTESTINAL 41 28
NAUSEA 5 1
DIARRHEA 6 5
ANOREXIA 19 0
ABDOMINAL PAIN 8 10
CUTANEOUS 22 25
RASH 5 4
SKIN DISORDER 0 6
HERPES SIMPLEX 8 7
GENITOURINARY 8 14
URINARY TRACT INFECTION 4 5
CARDIOVASCULAR 14 17
CHEST PAIN 0 5
MUSCULOSKELETAL 10 19
BACK PAIN 4 9

Post Marketing Experience

The following adverse reactions have been identified during post approval use of Oforta™ (fludarabine phosphate tablets) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possibly to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematopoietic Systems

Several instances of trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia, sometimes resulting in death, have been reported in post-marketing surveillance. The duration of clinically significant cytopenia in the reported cases has ranged from approximately 2 months to approximately 1 year. These episodes have occurred both in previously treated or untreated patients.

Nervous System

In post-marketing experience, cases of progressive multifocal leukoencephalopathy have been reported. Most cases had a fatal outcome. Many of these cases were confounded by prior and/or concurrent chemotherapy. The median time to onset was approximately one year.

Pulmonary System

In post-marketing experience, cases of severe pulmonary toxicity have been observed with fludarabine phosphate use which resulted in acute respiratory distress syndrome, respiratory distress, pulmonary hemorrhage, pulmonary fibrosis, and respiratory failure. After exclusion of an infectious origin, some patients experienced symptom improvement with corticosteroids.

Read the entire FDA prescribing information for Oforta (Fludarabine Phosphate Tablets)

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© Oforta Patient Information is supplied by Cerner Multum, Inc. and Oforta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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