August 31, 2015
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Busulfex

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Busulfex




Busulfex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Busulfex (busulfan) is used to treat the symptoms of chronic myelogenous leukemia (a type of blood cancer). It is not a cure for leukemia. It is a cancer (antineoplastic) medication. Common side effects include nausea, vomiting, diarrhea, constipation, loss of appetite, mouth sores, stomach/abdominal pain, dizziness, swelling ankles/feet/hand, flushing, headache, or trouble sleeping.

The usual adult dose of Busulfex is 0.8 mg/kg of ideal body weight or actual body weight, whichever is lower, administered every six hours for four days (a total of 16 doses). Busulfex may interact with acetaminophen, itraconazole, or phenytoin. Tell your doctor all medications and supplements you use. Busulfex is not recommended for use during pregnancy. It may harm a fetus. Discuss birth control with your doctor. 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 Busulfex (busulfan) 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.

Busulfex 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.

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

  • pale skin, feeling light-headed or short of breath, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • signs of infection such as fever, chills, sore throat, flu symptoms, loss of appetite, weight loss, unusual weakness, mouth and throat ulcers, rapid and shallow breathing;
  • weight gain, stomach swelling or tenderness, jaundice (yellowing of the skin or eyes);
  • coughing up blood;
  • stomach pain, vomiting, sharp chest pain, trouble breathing;
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • confusion, jerking muscle movements, muscle tightness or contraction, overactive reflexes, muscle weakness or limp feeling, leg discomfort, numbness or tingly feeling around your mouth;
  • fast, slow, or uneven heart rate;
  • weak pulse, feeling short of breath, confusion, fainting;
  • seizure (convulsions); or
  • persistent cough, congestion, low fever, feeling short of breath (these symptoms may occur several months or years after using busulfan).

Less serious side effects may include:

  • headache;
  • diarrhea, constipation, nausea, upset stomach;
  • flushing (warmth, redness, or tingly feeling);
  • swelling or irritation around the IV needle;
  • missed menstrual periods; or
  • hair loss, darkened skin color.

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 Busulfex (Busulfan)

What is Patient Information Overview?

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

Busulfex Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, constipation, loss of appetite, mouth sores, stomach/abdominal pain, dizziness, swelling ankles/feet/hand, flushing, headache, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects.

Many people using this medication develop serious side effects. However, your doctor has prescribed this medication 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: signs of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, yellowing skin/eyes, dark urine), mental/mood changes (such as depression, hallucinations, anxiety, confusion), muscle cramps, increased thirst/urination, fast/irregular heartbeat, coughing up blood, bloody urine, seizures, pain/redness/swelling at injection site, fainting.

Busulfan has rarely caused very serious (possibly fatal) lung disease. Tell your doctor immediately if you develop symptoms of lung disease, including chest pain, shortness of breath, persistent cough.

Busulfan may cause other cancers (such as acute leukemia, tumors). Consult your doctor for more details. Tell your doctor immediately if you notice any symptoms of cancer, including unusual lumps, sudden weight loss.

This medication may affect the ovaries, possibly reducing fertility and causing hormone changes (such as missed menstrual periods). Talk to your doctor for more details.

This medication can decrease sperm production and shrink the testicles, effects that may lower male fertility. Talk to your doctor for more details.

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.

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 Busulfex (Busulfan)

What is Prescribing information?

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

Busulfex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

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.

Adverse reaction information is primarily derived from the clinical study (N=61) of BUSULFEX and the data obtained for high-dose oral busulfan conditioning in the setting of randomized, controlled trials identified through a literature review.

In the BUSULFEX (busulfan) Injection allogeneic stem cell transplantation clinical trial, all patients were treated with BUSULFEX 0.8 mg per kg as a two-hour infusion every six hours for 16 doses over four days, combined with cyclophosphamide 60 mg per kg x2 days. Ninety-three percent (93%) of evaluable patients receiving this dose of BUSULFEX maintained an AUC less than 1,500 μM•min for dose 9, which has generally been considered the level that minimizes the risk of HVOD.

Table 1 lists the non-hematologic adverse reactions events through BMT Day +28 at a rate greater than or equal to 20% in patients treated with BUSULFEX prior to allogeneic hematopoietic cell transplantation.

Table 1: Summary of the Incidence (greater than or equal to 20%) of Non-Hematologic Adverse Reactions through BMT Day +28 in Patients who Received BUSULFEX Prior to Allogeneic Hematopoietic Progenitor Cell Transplantation

Non-Hematological Adverse Reactions1 Percent Incidence
BODY AS A WHOLE
  Fever 80
  Headache 69
  Asthenia 51
  Chills 46
  Pain 44
  Edema General 28
  Allergic Reaction 26
  Chest Pain 26
  Inflammation at Injection Site 25
  Back Pain 23
CARDIOVASCULAR SYSTEM
  Tachycardia 44
  Hypertension 36
  Thrombosis 33
  Vasodilation 25
DIGESTIVE SYSTEM
  Nausea 98
  Stomatitis (Mucositis) 97
  Vomiting 95
  Anorexia 85
  Diarrhea 84
  Abdominal Pain 72
  Dyspepsia 44
  Constipation 38
  Dry Mouth 26
  Rectal Disorder 25
  Abdominal Enlargement 23
METABOLIC AND NUTRITIONAL SYSTEM
  Hypomagnesemia 77
  Hyperglycemia 66
  Hypokalemia 64
  Hypocalcemia 49
  Hyperbilirubinemia 49
  Edema 36
  SGPT Elevation 31
  Creatinine Increased 21
NERVOUS SYSTEM
  Insomnia 84
  Anxiety 72
  Dizziness 30
  Depression 23
RESPIRATORY SYSTEM
  Rhinitis 44
  Lung Disorder 34
  Cough 28
  Epistaxis 25
  Dyspnea 25
SKIN AND APPENDAGES
  Rash 57
  Pruritus 28
1 Includes all reported adverse reactions regardless of severity (toxicity grades 1-4)]

Additional Adverse Reactions by Body System

Hematologic: Prolonged prothrombin time

Gastrointestinal: Esophagitis, ileus, hematemesis, pancreatitis, rectal discomfort

Hepatic: Alkaline phosphatase increases, jaundice, hepatomegaly

Graft-versus-host disease: Graft-versus-host disease. There were 3 deaths (5%) attributed to GVHD.

Edema: Hypervolemia, or documented weight increase

Infection: Infection, pneumonia (fatal in one patient and life-threatening in 3% of patients)

Cardiovascular: Arrhythmia, atrial fibrillation, ventricular extrasystoles, third degree heart block, thrombosis (all episodes were associated with the central venous catheter), hypotension, flushing and hot flashes, cardiomegaly, ECG abnormality, left-sided heart failure, and pericardial effusion

Pulmonary: Hyperventilation, alveolar hemorrhage (fatal in 3%), pharyngitis, hiccup, asthma, atelectasis, pleural effusion, hypoxia, hemoptysis, sinusitis, and interstitial fibrosis (fatal in a single case)

Neurologic: Cerebral hemorrhage, coma, delirium, agitation, encephalopathy, confusion, hallucinations, lethargy, somnolence Renal: BUN increased, dysuria, oliguria, hematuria, hemorrhagic cystitis

Skin: Alopecia, vesicular rash, maculopapular rash, vesiculo-bullous rash, exfoliative dermatitis, erythema nodosum, acne, skin discoloration

Metabolic: Hypophosphatemia, hyponatremia

Other Events: Injection site pain, myalgia, arthralgia, ear disorder

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure. The following adverse reactions (reported as MedRA terms) have been identified during post-approval use of BUSULFEX (busulfan) Injection:

Blood and Lymphatic System Disorders: febrile neutropenia

Metabolism and Nutrition Disorders: tumor lysis syndrome

Vascular Disorders: thrombotic microangiopathy (TMA)

Infections and Infestations: severe bacterial, viral (e.g., cytomegalovirus viremia) and fungal infections; and sepsis.

Oral Busulfan Literature Review

A literature review identified four randomized controlled trials that evaluated a high-dose oral busulfan-containing conditioning regimen for allogeneic bone marrow transplantation in the setting of CML [see Clinical Studies]. The safety outcomes reported in those trials are summarized in Table 2 below for a mixed population of hematological malignancies (AML, CML, and ALL).

Table 2: Summary of safety analyses from the randomized, controlled trials utilizing a high dose oral busulfancontaining conditioning regimen that were identified in a literature review.

Clift CML Chronic Phase
TRM1 VOD2 GVHD3 Pulmonary Hemorrhagic Cystitis Seizure
Death ≤ 100d =4.1% (3/73) No Report Acute≥Grade 2 =35% Chronic=41% (30/73) 1 death from Idiopathic Interstitial Pneumonitis And 1 death from Pulmonary Fibrosis No Report No Report
Devergie CML Chronic Phase
TRM VOD GVHD Pulmonary Hemorrhagic Cystitis Seizure
38% 7.7% (5/65) Deaths=4.6% (3/65) Acute≥Grade 2 =41% (24/59 at risk) Interstitial Pneumonitis= 16.9% (11/65) 10.8% (7/65) No report
Ringden CML, AML, ALL
TRM VOD GVHD Pulmonary Hemorrhagic Cystitis Seizure
28% 12% Acute≥Grade 2 GVHD=26% Chronic GVHD =45% Interstitial Pneumonitis =14% 24% 6%
Blume CML, AML, ALL
TRM VOD GVHD Pulmonary Hemorrhagic Cystitis Seizure
No Report Deaths =4.9% Acute≥Grade 2 GVHD=22% (13/58 at risk) Chronic GVHD =31% (14/45 at risk) No Report No Report No Report
1 TRM = Transplantation Related Mortality
2 VOD = Veno-Occlusive Disease of the liver
3GVHD = Graft versus Host Disease

Read the entire FDA prescribing information for Busulfex (Busulfan)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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