Idamycin - Cap 10mg: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

IDAMYCIN (idarubicin hydrochloride for Injection, house) and IDAMYCIN PFS (idarubicin hydrochloride injection) are chemotherapy agents used to treat two different types of leukemia (blood cancer):

$ Acute non-lymphocytic leukemia (ANLL) in adults and $ Acute lymphocytic leukemia (ALL) in adults and children.

IDAMYCIN Capsule is used to treat one type of blood cancer: $ Acute non-lymphocytic leukemia (ANLL) in adults, whenever

the intravenous route is not considered suitable.

IDAMYCIN (idarubicin hydrochloride capsules) may be used in combination with other chemotherapy agents.

What it does:

IDAMYCIN and IDAMYCIN PFS are chemotherapy drugs, often used in combination with other drugs to kill cancer cells. In people with Leukemia, the bone marrow produces abnormal white blood cells. The abnormal cells are leukemia cells (cancer cells). Most chemotherapy agents (including IDAMYCIN and IDAMYCIN PFS) work by killing rapidly dividing cells, such as cancer cells. This action can affect normal cells as well.

When it should not be used:

• If you are allergic to idarubicin or any of the ingredients of the

  drug or its container (see What the important nonmedicinal ingredients are),

• If you are allergic to other anthracyclines or anthracediones

  such as epirubicin, daunorubicin, mitoxanthrone or mitomycin.

• If you have:

  • Persistent low blood count (myelosuppression)
  • Severe liver, renal or heart disease
  • Recent heart attack

  • Severe irregular heartbeat

    • History of severe cardiac disease
    • Uncontrolled infections
    • If you have been treated with a maximum dose of idarubicin, doxorubicin, daunorubicin, epirubicin or other anthracyclines or anthracenediones.

What the medicinal ingredient is:

Idarubicin hydrochloride is the active ingredient.

What the important non-medicinal ingredients are: IDAMYCIN PFS 1mg/mL (idarubicin hydrochloride injection):

Glycerol USP/Ph.Eur.

Hydrochloric acid

Water for Injection USP

IDAMYCIN (idarubicin hydrochloride for injection, house):

Lactose NF

IDAMYCIN (idarubicin hydrochloride capsules):

Glyceryl Palmito-stearate

Microcrystalline cellulose

Each capsule is composed of gelatin and contains as inactive ingredients red iron oxide, titanium dioxide and edible white ink or red ink.

What dosage forms it comes in:

IDAMYCIN PFS 1mg/mL (idarubicin hydrochloride injection) is a clear red-orange sterile solution to be given intravenously.

IDAMYCIN (idarubicin hydrochloride for injection, house) is a red-orange sterile powder to be given intravenously after reconstitution with sterile water for injection.

IDAMYCIN (idarubicin hydrochloride capsule)

WARNINGS AND PRECAUTIONS

BEFORE you use IDAMYCIN or IDAMYCIN PFS talk to your doctor if you have:

• Low blood cell counts;
• Heart disease, recent heart attack or irregular heartbeat;
• Infection;
• Had radiotherapy to chest area;
• If you are taking calcium channel blockers, such as amlodipine, diltiazem, verapamil;

• if you are taking any other medications (see

  INTERACTIONS WITH THIS MEDICATION) ;

• You are pregnant, breast-feeding or planning to become pregnant

As IDAMYCIN and IDAMYCIN PFS may be harmful to an unborm child, women should be advised to avoid becoming pregnant. Effective contraceptive 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 IDAMYCIN or IDAMYCIN PFS. Ask your baby’s doctor to recommend a formula that would be best for your baby.

As IDAMYCIN and IDAMYCIN PFS may cause fertility impairment and damage chromosomes in sperm. Men undergoing treatment with IDAMYCIN or IDAMYCIN PFS, should use effective contraceptive methods.

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 to make sure the cancer has not returned.

INTERACTIONS WITH THIS MEDICATION

Drug that may interact with IDAMYCIN or IDAMYCIN PFS include: cytarabine, other anthracyclines, anthracenediones and calcium channel blockers such amlodipine, diltiazem or verapamil.

Other drugs that may be used in therapy with IDAMYCIN or IDAMYCIN PFS may increase the chance of toxic effects include: cyclophosphamide, fludarabine, etoposide, paclitaxel.

Previous or concomitant radiotherapy of chest area may also lead to additive toxicity especially with regard to blood cell count and cardiac effects. (see WARNINGS AND PRECAUTIONS).

PROPER USE OF THIS MEDICATION

How are IDAMYCIN and IDAMYCIN PFS given? You may receive IDAMYCIN or IDAMYCIN PFS through a vein in the arm (“intravenously” or “IV”) by your doctor or nurse, usually 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.

Is treatment with IDAMYCIN or IDAMYCIN PFS painful? It is unusual to feel pain during the injection, however, if you do feel pain or burning, you should immediately tell your nurse or doctor.

How much time does it take to get a treatment with IDAMYCIN?

It usually takes about 5-10 minutes to inject IDAMYCIN or IDAMYCIN PFS. However, you may get other medicines before or after IDAMYCIN or IDAMYCIN PFS, so your entire treatment may last an hour or longer.

How long will I need treatment?

Your doctor will determine the length of your treatment based on your treatment goals, the medicines you receive, and how your body responds to those medicines.

Your treatment cycle will depend on your medical condition and the other chemotherapy medicines you are getting. IDAMYCIN and IDAMYCIN PFS are usually given once a day for 3 consecutive days.

Your first treatment: what to expect

There will be tests

Before you get your first treatment, your doctor will probably order blood tests to check your blood count (white blood cells, red blood cells, and platelets), heart and liver function tests, X-rays or other tests. These “baseline” tests show your current condition, and will be compared to future test results.

You may get one or more medicines

Before your first treatment, you and your doctor will discuss all of the medicines you will receive during the treatment session. In addition to IDAMYCIN or IDAMYCIN PFS, you may get other intravenous (IV) medicines, such as a medicine to prevent nausea, and other chemotherapy medicines. You can also ask your doctor about possible side effects and what to do if you experience any of these side effects.

Receiving your treatment

Your nurse may insert a very thin plastic tube (IV) into your vein, which allows fluid to drip into your vein from a plastic bag. If you are getting a medicine to prevent nausea, you will probably take that medicine first. Then you will get the rest of your IV medicines - including IDAMYCIN or IDAMYCIN PFS- one at a time.

Capsules:

Handling instructions:

You should swallow the capsules whole with some water and should not suck, bit, or chew them.

Missed dose and overdose:

Please communicate with your doctor, should you miss a dose or take more than the dose prescribed.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Hearing about all of the side effects from chemotherapy may seem overwhelming. But many people go through chemotherapy with very mild or few side effects.

Other people, who are more sensitive to chemotherapy, may have many side effects - but they can usually be controlled. Everyone reacts in a different way to chemotherapy.

Because IDAMYCIN and IDAMYCIN PFS are given with other chemotherapy medicines, it is sometimes hard to know which medicine is causing a particular side effect. If you are having a problem with side effects, call your doctor or nurse. They can suggest medicines or other ways to prevent or relieve your discomfort. Do not skip doses or make changes in your treatment on your own.

Why do side effects occur?

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, mouth sores, rash, itch 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 YOU MAY EXPERIENCE WITH CHEMOTHERAPY

Hair loss

Hair loss is common in chemotherapy with IDAMYCIN and IDAMYCIN PFS. 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

A week or two 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 a 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 a 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 a 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 cut 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.

Nausea and vomiting

The amount of nausea and vomiting varies widely from person to person. Some have mild nausea and vomiting, while others may have severe 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 you 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 odours 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.

Fatigue

Feeling tired - 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 she goes to the supermarket.

• Eat a well-balanced diet.
• Do light exercise regularly.

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 tablets on your own - they may not work for anemia caused by chemotherapy medicines and can make your nausea worse.

Mouth sores

Chemotherapy medicines may cause sores in your mouth and throat about a week or two after a chemotherapy treatment. It’s important to keep your mouth clean during the time you’re having chemotherapy because mouth sores can be a source of infection. Be sure to brush your teeth after each meal with a soft toothbrush. You should also see your dentist before you start chemotherapy to have your teeth cleaned and to take care of any dental work you might need. Mouth sores can be painful, but there are a few things you can do to relieve the pain and prevent further irritation.

• Talk to your doctor about medicines you can use to relieve

  painful mouth sores. There are anesthetic lozenges and sprays you can use to numb the sores before you eat.

• Eat your food cold or at room temperature. Eating warm or

  hot food can irritate your mouth sores.

• Cook your food until it’s soft and tender.

• Eat soft, smooth foods such as applesauce, bananas, cooked

  cereals, scrambled eggs, yogurt, noodles, macaroni and cheese, mashed potatoes, cottage cheese, custards, puddings, milk shakes, and ice cream. You can also make foods smoother and easier to eat by pureeing them in a blender. Some people enjoy eating baby food as the pureed fruits are tasty, easy to store, and ready to eat.

• Cut out spicy or acidic foods (citrus fruits or tomatoes) or

  rough, coarse foods that can irritate mouth sores such as toast and raw vegetables.

• Use a straw to drink liquids. Rinse your mouth with water

  to remove pieces of food that may get stuck in the mouth sore.

• Avoid mouthwashes that contain alcohol, smoking

  cigarettes or drinking alcoholic beverages (beer, wine, and hard liquor).

  Coloration of Urine

  You can expect to see red coloration of your urine for 1 to 2 days after administration during active therapy.

  At site of injection

  Severe adverse events such as local tissue damages due to leakage of IDAMYCIN or IDAMYCIN PFS from your vein into surrounding tissues with intravenous injection might be observed. If you start to have pain, redness, or swelling where the intravenous injection is given tell your doctor or nurse right away.

  Possible long-term cardiac risks after receiving IDAMYCIN or IDAMYCIN PFS

  In a small number of patients, there may be serious side effects after treatment has ended including heart problems, which may include damage to the heart muscle or heart failure. Up to 3.5% of patients may have heart problems, either during treatment or many years later. Few patients treated with IDAMYCIN or IDAMYCIN PFS have had serious heart problems caused by their treatment.

  You may also experience:

  • Sensitivity of irradiated skin
  • Urticaria (hives)
  • Hot flashes
  • Skin and nail changes or colouration, tingling sensation
  • Rash/itch/redness skin allergy
  • Diarrhea with dehydration and symptoms such as skin flushed, dry and pale, less urination

This is not a complete list of side effects. For any unexpected effects while taking IDAMYCIN or IDAMYCIN PFS, contact your doctor or pharmacist.

HOW TO STORE IT

IDAMYCIN PFS (idarubicin hydrochloride injection) should be stored at 2-8°C and protected from light.

IDAMYCIN (idarubicin hydrochloride capsules) should be stored at 15-30°C and protected from light.

IDAMYCIN (idarubicin hydrochloride for injection, house) should be stored at 15-30°C and protected from light.

Keep out of the reach of children.

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, Pfizer Canada Inc. at: 1-800-463-6001.

Last revised: 04 July 2006