ALKERAN 50 MG ( MELPHALAN ) VIAL

WHAT IS MELPHALAN (ALKERAN, ALKERAN I.V., EVOMELA)?
Melphalan is used as a "palliative" treatment to relieve symptoms of multiple myeloma (a type of blood cancer) or a certain type of ovarian cancer.

Melphalan injection is used as a "conditioning" treatment for multiple myeloma before you receive a stem cell transplant.

Melphalan may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF MELPHALAN (ALKERAN, ALKERAN I.V., EVOMELA)?
Get emergency medical help if you have signs of an allergic reaction: hives, itching, skin redness; blurred vision, feeling light-headed; fast heartbeats; trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

low white blood cell counts--fever, chills, cough, pain or burning when you urinate.
low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
easy bruising, unusual bleeding, purple or red spots under your skin;
sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
severe ongoing nausea, vomiting, or diarrhea;
new or worsening cough, fever, trouble breathing;
unusual lumps or masses;
missed menstrual periods;
inflammation of your blood vessels--warmth or tingling, skin rash, fever, headache, body aches, night sweats, weight loss, feeling or weak or tired;
liver problems--loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.
Common side effects may include:

low blood cell counts;
mouth sores;
tiredness;
low potassium levels; or
hair loss.
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 THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT MELPHALAN (ALKERAN, ALKERAN I.V., EVOMELA)?
While using melphalan, you may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough, mouth sores, unusual bleeding or bruising, or pain or burning when you urinate.

Alkeran Injection Patient Information including How Should I Take

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE USING MELPHALAN (ALKERAN, ALKERAN I.V., EVOMELA)?
You should not use melphalan if you are allergic to it, or if you received this medicine in the past and it did not work.

Tell your doctor if you now have or have ever had:

nausea, vomiting, or diarrhea;
an infection or weak immune system (caused by disease or by using certain medicine);
liver or kidney disease; or
chemotherapy or radiation.
Using melphalan may increase your risk of developing other cancers, such as leukemia. Ask your doctor about this risk.

Both men and women using this medicine should use effective birth control to prevent pregnancy during and shortly after treatment. Melphalan can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Ask your doctor how long you should keep using birth control after your last dose of melphalan. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using melphalan.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because melphalan can harm an unborn baby.

You should not breastfeed while using melphalan.

HOW IS MELPHALAN GIVEN (ALKERAN, ALKERAN I.V., EVOMELA)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Melphalan oral is taken by mouth.

Melphalan injection is given as an infusion through a central intravenous (IV) line placed into a large vein. A healthcare provider will give you this injection. This medicine must be given slowly, and the infusion can take up to 30 minutes to complete. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when melphalan is injected.

As a palliative treatment for multiple myeloma: Melphalan injection is usually given every 2 to 4 weeks. Melphalan oral is usually taken daily and your doctor may occasionally ask you to stop taking it for a short time.

As a conditioning treatment stem cell transplant: Melphalan injection is usually given for 2 days in a row before stem cell transplant.

As a palliative treatment for ovarian cancer: Melphalan oral is usually taken for 5 days in a row every 4 to 5 weeks.

Follow your doctor's dosing instructions very carefully.

You may be given another medication to help prevent nausea. Keep using this medicine and tell your doctor if you have severe nausea, vomiting, or diarrhea.

Your blood will need to be tested often. This will help your doctor determine the correct dose for you. Your cancer treatments may be delayed based on the results of your blood tests.

You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

It may take several months before your body responds to melphalan. Your doctor will determine how long to treat you with this medicine. For best results, keep using melphalan as directed. You may not get the full benefit of this medicine if you stop using it too soon.

Store melphalan tablets in the refrigerator and protect them from light.

Alkeran Injection Patient Information including If I Miss a Dose

WHAT HAPPENS IF I MISS A DOSE (ALKERAN, ALKERAN I.V., EVOMELA)?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if you miss an appointment for your melphalan injection.

WHAT HAPPENS IF I OVERDOSE (ALKERAN, ALKERAN I.V., EVOMELA)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme weakness, vision problems, severe mouth sores, increased salivation or sweating, cough with mucus, shortness of breath, severe nausea and vomiting, diarrhea, bloody or tarry stools, severe stomach pain, loss of muscle movement, or seizure.

WHAT SHOULD I AVOID WHILE USING MELPHALAN (ALKERAN, ALKERAN I.V., EVOMELA)?
Do not receive a "live" vaccine while using melphalan. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

WHAT OTHER DRUGS WILL AFFECT MELPHALAN (ALKERAN, ALKERAN I.V., EVOMELA)?
Other drugs may affect melphalan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

WHERE CAN I GET MORE INFORMATION (ALKERAN, ALKERAN I.V., EVOMELA)?
Your pharmacist can provide more information about melphalan.

REMEMBER, KEEP THIS AND ALL OTHER MEDICINES OUT OF THE REACH OF CHILDREN, NEVER SHARE YOUR MEDICINES WITH OTHERS, AND USE THIS MEDICATION ONLY FOR THE INDICATION PRESCRIBED.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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