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Myleran

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Myleran Tablets

Myleran Tablets

Myleran Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Myleran (busulfan) is a cancer (antineoplastic) medication used to treat the symptoms of chronic myelogenous leukemia (a type of blood cancer). It is not a cure for leukemia. Common side effects include darkening skin or dry mouth.

The usual adult dose range of Myleran for remission induction is 4 to 8 mg, total dose, daily. Dosing on a weight basis is the same for both children and adults, approximately 60 mcg/kg of body weight or 1.8 mg/m2 of body surface, daily. Myleran may interact with acetaminophen (Tylenol), itraconazole, or phenytoin. Tell your doctor all medications and supplements you use. Myleran is not recommended for use during pregnancy. It may harm a fetus. Discuss the use of 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 Myleran (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.

Myleran 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 Myleran (Busulfan Tablets) »

What is Patient Information Overview?

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

Myleran Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Darkening skin or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 immediately if any of these unlikely but serious side effects occur: signs of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, yellowing skin/eyes, dark urine), missed menstrual periods, shrinking testicles, seizures, unusual/extreme tiredness, painful urination, toe/joint pain.

Tell your doctor immediately if any of these rare but serious side effects occur: fainting, fast/pounding heartbeat, cloudy/blurred vision.

Busulfan has rarely caused very serious (possibly fatal) lung disease. This may occur after months to years of using busulfan. 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.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 Myleran (Busulfan Tablets)»

What is Prescribing information?

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

Myleran FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Hematological Effects: The most frequent, serious, toxic effect of busulfan is dose-related myelosuppression resulting in leukopenia, thrombocytopenia, and anemia. Myelosuppression is most frequently the result of a failure to discontinue dosage in the face of an undetected decrease in leukocyte or platelet counts.

Aplastic anemia (sometimes irreversible) has been reported rarely, often following long-term conventional doses and also high doses of MYLERAN.

Pulmonary:Interstitial pulmonary fibrosis has been reported rarely, but it is a clinically significant adverse effect when observed and calls for immediate discontinuation of further administration of the drug. The role of corticosteroids in arresting or reversing the fibrosis has been reported to be beneficial in some cases and without effect in others.

Cardiac: Cardiac tamponade has been reported in a small number of patients with thalassemia who received busulfan and cyclophosphamide as the preparatory regimen for bone marrow transplantation (see WARNINGS).

One case of endocardial fibrosis has been reported in a 79-year-old woman who received a total dose of 7,200 mg of busulfan over a period of 9 years for the management of chronic myelogenous leukemia. At autopsy, she was found to have endocardial fibrosis of the left ventricle in addition to interstitial pulmonary fibrosis.

Ocular: Busulfan is capable of inducing cataracts in rats and there have been several reports indicating that this is a rare complication in humans.

Dermatologic:Hyperpigmentation is the most common adverse skin reaction and occurs in 5% to 10% of patients, particularly those with a dark complexion.

Metabolic:In a few cases, a clinical syndrome closely resembling adrenal insufficiency and characterized by weakness, severe fatigue, anorexia, weight loss, nausea and vomiting, and melanoderma has developed after prolonged busulfan therapy. The symptoms have sometimes been reversible when busulfan was withdrawn. Adrenal responsiveness to exogenously administered ACTH has usually been normal. However, pituitary function testing with metyrapone revealed a blunted urinary 17-hydroxycorticosteroid excretion in 2 patients. Following the discontinuation of busulfan (which was associated with clinical improvement), rechallenge with metyrapone revealed normal pituitary-adrenal function.

Hyperuricemia and/or hyperuricosuria are not uncommon in patients with chronic myelogenous leukemia. Additional rapid destruction of granulocytes may accompany the initiation of chemotherapy and increase the urate pool. Adverse effects can be minimized by increased hydration, urine alkalinization, and the prophylactic administration of a xanthine oxidase inhibitor such as allopurinol.

Hepatic Effects: Esophageal varices have been reported in patients receiving continuous busulfan and thioguanine therapy for treatment of chronic myelogenous leukemia (see PRECAUTIONS: DRUG INTERACTIONS). Hepatic veno-occlusive disease has been observed in patients receiving busulfan (see WARNINGS).

Miscellaneous: Other reported adverse reactions include: urticaria, erythema multiforme, erythema nodosum, alopecia, porphyria cutanea tarda, excessive dryness and fragility of the skin with anhidrosis, dryness of the oral mucous membranes and cheilosis, gynecomastia, cholestatic jaundice, and myasthenia gravis. Most of these are single case reports, and in many, a clear cause-and-effect relationship with busulfan has not been demonstrated.

Seizures (see PRECAUTIONS: General) have been observed in patients receiving higher than recommended doses of busulfan.

Observed During Clinical Practice: The following events have been identified during post-approval use of busulfan. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to busulfan.

Blood and Lymphatic: Aplastic anemia.

Eye: Cataracts, corneal thinning, lens changes.

Hepatobiliary Tract and Pancreas: Centrilobular sinusoidal fibrosis, hepatic veno-occlusive disease, hepatocellular atrophy, hepatocellular necrosis, hyperbilirubinemia (see WARNINGS).

Non-site Specific: Infection, mucositis, sepsis.

Respiratory: Pneumonia.

Skin: Rash. An increased local cutaneous reaction has been observed in patients receiving radiotherapy soon after busulfan.

Read the entire FDA prescribing information for Myleran (Busulfan Tablets) »

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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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