Generic Name: Methylprednisolone (meth-el-pred-ni-ZOE-lone), 6-Methylprednisolone, Methylprednisolone Acetate, Methylprednisolone Sodium Succinate
Trade Name: Duralone®, Medralone®, Medrol®, Solu-Medrol®
For which conditions is Duralone approved for? Duralone is FDA approved for the palliative treatment of leukemia or non-Hodgkin’s lymphoma in adults and for childhood acute leukemia. It is also indicated for the treatment of hypercalcemia (high levels of calcium in the blood) associated with cancer. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Duralone is classified as a glucocorticoid. It is a derivative of prednisolone. Duralone produces its anti-cancer effects by interfering with inflammatory processes that may be associated with the growth of cancer, or may be associated with pain or other side effects caused by cancer.
How is Duralone typically given (administered)? Duralone may be administered orally, in the form of a pill, or injected into a muscle (intramuscular) or into a vein (intravenous). The dose and method of administration depend on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Duralone. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Patients may also have blood tests to measure levels of electrolytes or blood sugar levels.
What are the common (may occur in 30% or more of patients) side effects of treatment with Duralone?
• Irritability, nervousness
• Stomach ulcers
• Impaired wound healing
• Increase in appetite
• Elevated levels of sugar in the blood
• Fluid retention resulting in swelling
• Weight gain, especially around abdomen and shoulders. Round, moon shaped face.
What are the less common (may occur in 10% to 29% of patients) side effects of treatment with Duralone?
• Mood swings, changes in emotions
• Increase in blood pressure
• Potassium loss
• Thin, fragile skin
What are the possible late side effects of treatment with Duralone? Patients who are treated with Duralone for long periods of time are at an increased risk of developing cataracts, glaucoma, or a reduction in bone density (osteoporosis).
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
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What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Eat small meals frequently to help alleviate nausea.
• Take Duralone with food or milk to help alleviate stomach upset.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should not abruptly stop taking Duralone, unless instructed by their physician, as this may lead to serious side effects.
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Duralone may cause high blood sugar levels – patients with diabetes may be required to check their blood sugar levels frequently.
When should patients notify their physician?
• Signs of infection: redness, swelling, pus, tenderness
• Slow wound healing
• Prolonged or severe fatigue and weakness
• Chest or jaw pain, difficulty breathing, a noticeable change in heart rate or rhythm
• Severe depression or mood swings
• Severe heartburn
• Abdominal or stomach pain
• Prolonged nausea that interferes with eating
• Sudden weight gain
• Signs of high blood sugar (frequent urination or severe thirst, confusion, drowsiness, decreased or blurred vision, dry mouth)
• Severe headache
• Unusual bleeding or bruising – (nosebleeds, blood in urine, black tarry stools, etc.)
• Dizziness or faintness
• Severe pain
• Bone pain
• Muscle weakness, cramps or pain
• Changes in vision, or eye abnormalities
• Changes in skin (rashes, red spots), thin skin, unusual bruising, acne
• Swelling of feet or ankles
• Swelling, pain or redness in one extremity and not the other
• Menstrual irregularities
• Shortness or breath or difficulty breathing
• Rash, hives, itching
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.