Alkeran

DRUG DESCRIPTION

ALKERAN (melphalan), also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent which is active against selective human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine. The molecular formula is C13H18Cl2N2O2 and the molecular weight is 305.20. The structural formula is:

ALKERAN® (melphalan) Structural Formula Illustration

Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL–) form is known as merphalan or sarcolysin.

Melphalan is practically insoluble in water and has a pKa1 of ~2.5.

ALKERAN (melphalan) is available in tablet form for oral administration. Each film-coated tablet contains 2 mg melphalan and the inactive ingredients colloidal silicon dioxide, crospovidone, hypromellose, macrogol/PEG 400, magnesium stearate, microcrystalline cellulose, and titanium dioxide.

What are the possible side effects of melphalan (Alkeran, Alkeran I.V.)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • missed menstrual periods;
  • ...

Read All Potential Side Effects and See Pictures of Alkeran »

What are the precautions when taking melphalan (Alkeran)?

Before taking melphalan, tell your doctor or pharmacist if you are allergic to it; or to chlorambucil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., bone marrow depression), previous cancer chemotherapy, kidney problems, radiation treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects...

Read All Potential Precautions of Alkeran »


Alkeran Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, lip/mouth sores, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that 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. Follow your doctor's orders and keep all medical/lab appointments to lower your risk of serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, bloody/black/tarry stools, lower back or side pain, decreased or missed menstrual periods, decreased sexual function, pinkish urine, painful/difficult urination, unusual weight loss, vomit that looks like coffee grounds.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Tell your doctor immediately if any of these rare but very serious side effects occur: painful/difficult breathing, chest pain, coughing up blood, persistent cough, unusual lumps/masses under the skin, pain/redness/swelling of the arms/legs, stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

PRECAUTIONS: Before taking melphalan, tell your doctor or pharmacist if you are allergic to it; or to chlorambucil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., bone marrow depression), previous cancer chemotherapy, kidney problems, radiation treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Wash your hands well to prevent the spread of infection.

This drug should not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Talk with your doctor about effective forms of birth control.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Alkeran Patient Information Including Side Effects

Brand Names: Alkeran, Alkeran I.V.

Generic Name: melphalan (Pronunciation: MEL fa lan)

  • What is melphalan (Alkeran)?
  • What are the possible side effects of melphalan (Alkeran)?
  • What is the most important information I should know about melphalan (Alkeran)?
  • What should I discuss with my healthcare provider before using melphalan (Alkeran)?
  • How should I take melphalan (Alkeran)?
  • What happens if I miss a dose (Alkeran)?
  • What happens if I overdose (Alkeran)?
  • What should I avoid while taking melphalan (Alkeran)?
  • What other drugs will affect melphalan (Alkeran)?
  • Where can I get more information?

What is melphalan (Alkeran)?

Melphalan is a cancer medication. Melphalan interferes with the growth of cancer cells and slows their growth and spread in the body.

Melphalan is used to treat multiple myeloma (a type of blood cancer), cancer of the ovary, and breast cancer.

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

What are the possible side effects of melphalan (Alkeran)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • missed menstrual periods;
  • unusual lumps or masses;
  • red skin rash, rapid pulse, pain, weight loss;
  • breathing problems or a cough that won't go away; or
  • pale or yellowed skin, dark colored urine, confusion and weakness.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea;
  • white patches or sores inside your mouth or on your lips;
  • temporary hair loss; or
  • mild skin itching and rash.

In some cases, second cancers have been reported to occur during and after treatment with melphalan. Talk to your doctor about your individual risk and benefit in using 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 the most important information I should know about melphalan (Alkeran)?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Melphalan can cause serious side effects, including: decreased bone marrow function and blood problems (easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms, bloody or black stools, pale or yellowed skin, confusion or weakness); breathing problems; or liver damage (nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice [yellowing of the skin or eyes]). Call your doctor at once if you have any of these side effects.

In some cases, second cancers have been reported to occur during and after treatment with melphalan. Talk to your doctor about your individual risk and benefit of this medication.

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