Medical Editor: John P. Cunha, DO, FACOEP
What Is Myleran?
What Are Side Effects of Myleran?
Myleran may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- sore throat,
- burning eyes,
- skin pain,
- red or purple skin rash with blistering and peeling,
- easy bruising,
- unusual bleeding,
- purple or red sports under your skin,
- sore throat,
- chest pain,
- coughing with bloody mucus,
- pale skin,
- cold hands and feet,
- vision problems,
- persistent cough,
- breathing problems that occur several months or years after using the medication,
- loss of appetite,
- weight loss,
- severe weakness,
- stomach pain,
- sharp chest pain,
- weight gain,
- stomach swelling or tenderness,
- yellowing of the skin or eyes,
- muscle contractions,
- muscle weakness,
- leg cramps,
- irregular heartbeats,
- fluttering in your chest,
- increased thirst or urination, and
- numbness or tingling
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Myleran include:
- darkening skin
- dry mouth
- upset stomach
- flushing (warmth, redness, or tingly feeling)
- swelling or irritation around the IV needle
- missed menstrual periods
- hair loss
- loss of appetite
- weight loss
- weakness, or
Tell your doctor if you have serious side effects of Myleran including:
- signs of liver disease (such as persistent nausea or vomiting, severe stomach or abdominal pain, yellowing skin/eyes, dark urine),
- unusual or extreme tiredness,
- painful urination,
- toe or joint pain,
- fast or pounding heartbeat, or
- cloudy or blurred vision.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Myleran
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.
What Drugs, Substances, or Supplements Interact with Myleran?
Myleran During Pregnancy or Breastfeeding
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.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if you have:
- easy bruising, unusual bleeding, purple or red spots under your skin;
- fever, chills, tiredness, sore throat;
- cough, trouble breathing, chest pain, wheezing;
- coughing with bloody mucus;
- pale skin, cold hands and feet;
- vision problems;
- persistent cough, congestion, or breathing problems that occur several months or years after using busulfan;
- a seizure;
- adrenal gland problems--nausea, vomiting, loss of appetite, weight loss and severe weakness or tired feeling;
- signs of a heart problem--stomach pain, vomiting, sharp chest pain, trouble breathing;
- signs of liver problems--weight gain, stomach swelling or tenderness, jaundice (yellowing of the skin or eyes); o
- signs of an electrolyte imbalance--muscle contractions, muscle weakness, leg cramps, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling.
Common side effects may include:
- fever, chills, headache, weakness;
- nausea, vomiting, stomach pain, diarrhea;
- fast heartbeats;
- changes in your menstrual periods;
- blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
- dry mouth, nose, or throat;
- dry or thinning skin, darkened skin color;
- breast swelling;
- sleep problems (insomnia); or
To report SUSPECTED ADVERSE REACTIONS, contact As pen Global Inc. Toll-Free at 1-855- 800-8165 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
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 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.
Busulfan is capable of inducing cataracts in rats and there have been several reports indicating that this is a rare complication in humans.
Hyperpigmentation is the most common adverse skin reaction and occurs in 5% to 10% of patients, particularly those with a dark complexion.
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.
Esophageal varices have been reported in patients receiving continuous busulfan and thioguanine therapy for treatment of chronic myelogenous leukemia (see DRUG INTERACTIONS). Hepatic veno-occlusive disease has been observed in patients receiving busulfan (see WARNINGS).
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.
Read the entire FDA prescribing information for Myleran (Busulfan Tablets)
© Myleran Patient Information is supplied by Cerner Multum, Inc. and Myleran Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
Health Solutions From Our Sponsors