Mustargen: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MUSTARGEN (mechlorethamine hydrochloride for injection) is used in the palliative treatment of Hodgkin’s disease (a cancer of lymph tissue) in combination with other drugs (vincristine, procarbamine and prednisone).

What it does:

MUSTARGEN is a chemotherapy drug, often used in combination with other drugs to kill cancer cells. Most chemotherapy agents (including MUSTARGEN) work by killing rapidly dividing cells, such as cancer cells. This action can affect normal cells as well.

When it should not be used:

MUSTARGEN should not be used if you:

• have had a previous allergic reaction to

  mechlorethamine hydrochloride or any other ingredients in MUSTARGEN

• have an infection.

What the medicinal ingredient is:

Mechlorethamine hydrochloride is the active ingredient.

What the nonmedicinal ingredients are:

• Sodium chloride (90 mg)

What dosage forms it comes in:

Each vial of MUSTARGEN has 10 mg of mechlorethamine hydrochloride with 90 mg of sodium chloride that are ground together. The powder for injection is light yellow-brown in color.

WARNINGS AND PRECAUTIONS

SERIOUS WARNINGS AND PRECAUTIONS

MUSTARGEN is highly toxic and should not be handled by pregnant women. MUSTARGEN must be given by a doctor experienced in the used of anti-cancer drugs. Serious side effects with the use of MUSTARGEN include:

• decrease in the production of blood cells

  (myelosuppression)

• severe allergic reaction including anaphylaxis
• increased risk of having s second cancer
• severe blistering (MUSTARGEN is a powerful vesicant)

BEFORE you use MUSTARGEN, talk to your doctor if you:

• have any infections
• had radiation therapy to the chest area
• are taking steroid medications by mouth such as prednisone, dexamethasome or hydrocortisone

• are pregnant or plan to get pregnant.

  MUSTARGEN is harmful to an unborn child. While receiving treatment with MUSTARGEN, women must use effective birth control methods to avoid getting pregnant

• are breast feeding. Breast feeding should be stopped before treatment with MUSTARGEN

As MUSTARGEN may be harmful to an unborn child, women should be advised to avoid becoming pregnant. Effective birth control methods should be used. Tell your doctor right away if you become pregnant during treatment. If you have been nursing, you should stop before starting treatment with MUSTARGEN. Ask your baby’s doctor to recommend a formula that would be best for your baby.

As MUSTARGEN may damage the chromosomes found in sperm, men getting treated with MUSTARGEN should use effective birth control.

INTERACTIONS WITH THIS MEDICATION

MUSTARGEN has been reported to suppress your immune system. The use of this drug may make you more susceptible to bacterial, viral or fungal infections. If you use this drug in combination with steroid therapy such as prednisone, dexamethasone or hydrocortisone, it is more likely that you may get a bacterial, viral or fungal infection.

If radiation therapy is given before or after treatment with MUSTARGEN, there is a greater risk of a decrease in your blood count.

Tell your doctor or pharmacist about any medication that you are taking or plan to take including any medicine obtained without a prescription, vitamin or mineral supplement, and natural health products.

PROPER USE OF THIS MEDICATION

How is MUSTARGEN given?

MUSTARGEN is given through a vein in the arm (intravenously). MUSTARGEN may also be injected directly into the cavity around your lungs (“intrapleurally”), into the cavity in your abdomen (“intraperitoneally”), or into the cavity around your heart (“intrapericardially”). It is given in the hospital, outpatient department or clinic.

If you are getting many injections, for your convenience, your doctor may insert a catheter (thin tube) or port into a large vein in your body that is placed there as long as it is needed.

Medicines get injected through the catheter or port rather than directly into a vein.

What is the dose of MUSTARGEN I will receive?

The dose of MUSTARGEN will be calculated based on how much you weigh and other factors your doctor will consider, such as your blood count. MUSTARGEN can either be given as a single dose or divided into two or four daily doses.

What happens if I receive too much MUSTARGEN?

If you are given too large a dose of MUSTARGEN, your white blood cell count, red blood cell count or platelet count could get dangerously low. This could lead to bleeding or even death.

Is treatment with MUSTARGEN painful?

MUSTARGEN is usually given through a vein. If the drug leaks into the area outside the vein, painful swelling will result. If this should happen, or if MUSTARGEN should leak out of the IV and contact your skin, tell your doctor or nurse right away.

Will I be able to work?

Some people work full time while others work part time or wait until their chemotherapy treatments are finished. It depends on the type of job you have and the side effects you experience.

What happens after treatment?

After you have completed all your chemotherapy treatments, your doctor will check you regularly.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Why do side effects occur?

Most chemotherapy medicines work by killing the fastest growing cells in the body, which include cancer cells and some normal cells. Normal cells that grow very rapidly are in your bone marrow, lining of the mouth, stomach and hair follicles. These fast-growing cells can be affected by the chemotherapy medicines too, sometimes causing side effects such as low white blood cell count, low red blood cell count (anemia), nausea and vomiting, rash and hair loss. These side effects usually disappear after treatment ends. Before your next cycle of chemotherapy, your white blood cell count normally increases and new cells grow back. After your chemotherapy is completely finished, your hair will begin to grow back.

Side effects with MUSTARGEN include:

Nausea and vomiting

The amount of nausea and vomiting varies widely from person to person. Some have mild nausea and vomiting for a short time after treatment. Nausea and vomiting may start right after a chemotherapy treatment or several hours later. Your doctor can give you medicine to prevent nausea or reduce its severity. If you’ve been treated with a medicine for nausea, but still feel sick to your stomach or vomit, tell your doctor. There are other medicines your doctor can give you that may work better for you. You can also try drinking clear fluids (water, diluted soft drinks, apple juice, and broth) or sucking on popsicles and ice chips. Here are some tips that may help reduce nausea.

• Eat small meals or snacks throughout the

  day instead of 2 or 3 large meals.

• Eat foods that are cold or at room

  temperature.

• Cut out foods that are fried, spicy, fatty or

  sweet.

  • Stay away from odors that may bother you such as cooking smells, cigarette smoke, car exhaust or perfume.
  • Sit upright in a chair after eating – don’t lie flat for at least 2 hours.
  • Wear loose-fitting clothes, especially around the waist.
  • Suck on ice, mints or sour candy (but avoid sour candy if you have mouth sores).
  • Eat something light a few hours before your chemotherapy treatment.

Allergic reactions

Your doctor or nurse will monitor you for signs of allergic reaction during your treatment. These could include symptoms such as itchiness, rash, swelling or shortness of breath.

Fatigue

Feeling weak – or fatigued – is one of the most common side effects of chemotherapy. Many other factors such as stress, diet, sleeping patterns, and your age can also cause fatigue. For some, fatigue may start to improve 2 to 3 months after you complete your chemotherapy treatments. Here’s how you can help reduce fatigue.

• Plan your activities. Allow rest between periods of activity.
• List all of the things you have to do, and number them in order of importance. Only do the things on your list that must get done. Leave the other tasks for another day.
• Ask family and friends to help you with driving, housework or other tasks. For example, ask your friend to pick up a few things for you the next time he/she goes to the supermarket.
• Eat a well-balanced diet.
• Do light exercise regularly.

Hair loss

Hair loss is common in chemotherapy with MUSTARGEN. However, the hair loss is temporary, and your hair usually starts to grow back within 2 or 3 months after you’ve finished your treatments.

Infection

From 24 hours to 3 weeks after a chemotherapy cycle, your white blood cell count may be low. This is the most dangerous time for getting an infection. White blood cells defend your body against infections. When there are very few white blood cells, there may not be enough to fight off an infection. It’s important to know the signs of infection so that you can get treatment before the infection becomes serious. The signs of infection include:

• fever over 38^○ C (100^○ F),
• chills or sweating,
• sore throat or coughing,

• redness or swelling around a cut, wound or

  catheter site,

• a burning feeling when you urinate,
• unusual vaginal itching or discharge.

Your doctor may prescribe oral antibiotics to help prevent infection during chemotherapy. Your doctor may also give you medicine to help increase the number of your white blood cells. If there is evidence of an infection, your doctor may need to admit you to the hospital for a short period of time to receive intravenous antibiotics.

If you have signs of an infection, call your doctor right away. Waiting too long (even a few hours) can lead to serious illness

The following tips can help you prevent infections.

• Wash your hands often. Use lotion

  afterwards to prevent your skin from becoming dry and cracked.

• Bathe or shower every 1 to 2 days.

  • Be careful not to cur yourself when you use a knife, scissors, razor or other sharp objects.
  • Stay away from people who are sick.
  • Have someone else clean cat litter boxes, bird cages or fish tanks.
  • Eat well-balanced meals.

Infertility

MUSTARGEN may interfere with the ability of male or female patients to have children. It may cause a woman’s menses to come less frequently or even to stop permanently. It may cause a reduced sperm count in men which may be permanent.

Injection site reactions

MUSTARGEN may cause reactions at the site where it was given including pain, swelling, blood clots and inflammation of the veins. Your doctor or nurse will attempt to reduce the risks of this side effect. If you start to have pain, redness, or swelling where the intravenous injection is given tell your doctor or nurse right away.

Anemia

Chemotherapy medicines affect the bone marrow, which is where red blood cells are formed. Red blood cells carry oxygen to the muscles and other tissues in your body. When there are too few red blood cells, your muscles, and other body tissues can’t get enough oxygen to do their work, and you feel exhausted. If your red blood cell count drops very low, you may also feel weak or dizzy, or may have shortness of breath. These are all symptoms of anemia. If you have these symptoms, tell your doctor or nurse. Your doctor may give you medicine to treat anemia that is caused by chemotherapy. Do not start taking iron tables on your own – they may not work for anemia caused by chemotherapy medicines and can make your nausea worse.

Kidney or liver damage

Your doctor or nurse will do blood tests to check for problems with your kidneys or liver.

This is not a complete list of side effects. If you experience any unexpected side effects while taking MUSTARGEN, contact your doctor or pharmacist.

HOW TO STORE IT

MUSTARGEN (mechlorethamine HCl for injection) should be stored at 15-30°C (59-86°F) and protected from light and humidity.

Solutions of mechlorethamine HCl decompose on standing; therefore, solutions of the drug should be prepared immediately before use.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness

Information Division

Marketed Health Products Directorate Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals, may be obtained by contacting the sponsor, Lundbeck Inc., at: 1-877-211-3471.

Imported by: McKesson Logistics Solutions, Mississauga, Ontario, Canada

For: Lundbeck Inc., Deerfield, IL 60015, U.S.A.

® Trademark of Lundbeck Inc.

Last Revision: September 11, 2009