Description
Melphalan injection is used to treat multiple myeloma (bone marrow cancer) before receiving a stem cell transplant (conditioning treatment). Melphalan belongs to the group of medicines called alkylating agents (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by melphalan, other unwanted effects will also occur. Before you begin treatment with melphalan, talk to your doctor about the benefits as well as the risks of using it.
Melphalan injection is also used to treat uveal melanoma (eye cancer) that has spread to the liver and cannot be removed by surgery (unresectable liver metastases).
Evomela®, Alkeran®, and Melphalan injection are to be given only by or under the direct supervision of your doctor. Hepzato® injection is available only under a restricted distribution program called Hepzato® Kit REMS (Risk Evaluation and Mitigation Strategy) Program.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of melphalan injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of melphalan injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Varicella Virus Vaccine, Live
- Zoster Vaccine, Live
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abciximab
- Aceclofenac
- Acemetacin
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfuzosin
- Amlodipine
- Amtolmetin Guacil
- Anagrelide
- Apixaban
- Aranidipine
- Aspirin
- Bacillus of Calmette and Guerin Vaccine, Live
- Benazepril
- Bepridil
- Bromfenac
- Bufexamac
- Bunazosin
- Captopril
- Celecoxib
- Cholera Vaccine, Live
- Choline Salicylate
- Cilnidipine
- Cilostazol
- Clevidipine
- Clonixin
- Clopidogrel
- Cyclosporine
- Dabigatran Etexilate
- Dapiprazole
- Dengue Tetravalent Vaccine, Live
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Diltiazem
- Dipyridamole
- Dipyrone
- Doxazosin
- Droxicam
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Buthionine Sulfoximine
- Nalidixic Acid
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to heparin, history of or
- Allergy to iodinated contrast agents not controlled by allergy medicine or steroids, history of or
- Allergy to latex, history of or
- Angina (chest pain) or
- Bleeding problems or
- Blood clotting problems (eg, uncorrectable coagulopathy) or
- Brain cancer, active or
- Heart attack or
- Heart disease or
- Heart failure, new or worsening or
- Heart rhythm problems or
- Liver failure or
- Liver treatment or surgery within the past 4 weeks or
- Portal hypertension (high blood pressure in the liver portal vein) or
- Thrombocytopenia (low number of platelets), heparin-induced—Should not be used in patients with these conditions.
- Anemia or
- Bone marrow suppression or
- Leukopenia (low white blood cells) or
- Liver disease or
- Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
- Infection—May decrease your ability to fight an infection.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Evomela® and Alkeran®: A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the IV tube will need to stay in place for at least 30 minutes. It is usually given for 2 days before receiving a stem cell transplant.
Melphalan injection: A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the IV tube will need to stay in place for at least 15 to 20 minutes.
Hepzato®: A doctor or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into an artery of the liver every 6 to 8 weeks.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control while you are receiving this medicine and for at least 6 months after the last dose to keep from getting pregnant. Males who are receiving this medicine, with female partners who can become pregnant, must use effective birth control during and for at least 3 months after the last dose of this medicine. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, hoarseness, lightheadedness or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.
This medicine may cause bleeding problems. Check with your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools.
Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, severe headache, slurred speech, sudden, unexplained trouble breathing, sudden loss of coordination, sudden, severe weakness or numbness in the arm or leg, or vision changes. These may be symptoms of blood clots (eg, thromboembolism).
Melphalan can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
While you are being treated with melphalan, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Melphalan may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Melphalan can cause diarrhea, nausea or vomiting, or sores or ulcers in the mouth, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about ways to control these symptoms.
Using this medicine may increase your risk of getting other types of cancer (eg, myeloproliferative syndrome, acute leukemia, and carcinoma). Talk to your doctor if you have concerns about this risk.
Tell your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Some men and women using this medicine have become infertile (unable to have children). This medicine might make a woman stop having menstrual periods temporarily. Talk with your doctor if this is a concern.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Bleeding gums
- blurred vision
- chest pain
- chills
- confusion
- cough or hoarseness
- coughing up blood
- difficulty in swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- headache
- increased menstrual flow or vaginal bleeding
- lower back or side pain
- nosebleeds
- painful or difficult urination
- paralysis
- pinpoint red spots on skin
- prolonged bleeding from cuts
- red or dark brown urine
- red or black, tarry stools
- sores, ulcers, or white spots on the lips or in the mouth
- sweating
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Blue lips and fingernails
- coughing that sometimes produces a pink frothy sputum
- dark-colored urine
- fast heartbeat
- increased sweating
- light-colored stools
- no blood pressure or pulse
- pain, redness, or swelling in the arm or leg
- pale skin
- stomach pain
- stopping of the heart
- swelling in the legs and ankles
- unconsciousness
- vomiting
- yellow eyes or skin
Incidence not known
- Absent, missed, or irregular menstrual periods
- back or leg pains
- bloated stomach
- chest tightness
- clay-colored stools
- confusion
- fast, pounding, or irregular heartbeat or pulse
- general body swelling
- hives, itching, rash
- indigestion
- light-colored stools
- loss of appetite
- nausea
- noisy breathing
- pain and fullness in the right upper abdomen or stomach
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- reddening of the skin, especially around the ears
- sore throat
- swelling of the eyes, face, hands, ankles, feet, or lower legs
- unpleasant breath odor
- unusual lumps or masses
- vomiting of blood
- weight gain or loss
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Indigestion
- passing of gas
- stomach fullness
Incidence not known
- Blue-green to black skin discoloration
- hair loss or thinning of the hair
- pain, redness, soreness, or sloughing of the skin at the injection site
- sores, welting, or blisters
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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