Monday, October 24, 2016

Imatinib


i-ma-TIN-ib


Commonly used brand name(s)

In the U.S.


  • Gleevec

Available Dosage Forms:


  • Tablet

  • Capsule

Therapeutic Class: Antineoplastic Agent


Pharmacologic Class: Tyrosine Kinase Inhibitor


Uses For imatinib


Imatinib is used to prevent and stop the growth of cancer cells. It helps your body fight against a type of cancer called gastrointestinal stromal tumors (GIST) or Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or chronic phase (CP) after other treatments, such as interferon-alpha, have failed, in adult patients. CML is a disease in which your body makes too many abnormal white blood cells, which can cause you to become sick more often and to feel weak or tired. Imatinib helps your body stop making these abnormal white blood cells. GIST is a group of cancer cells that start growing in the wall of the stomach, intestines, or rectum. Imatinib helps your body stop making these abnormal cells. Imatinib is also used as an additional treatment in adult patients that have their GIST tumors completely removed.


Imatinib is also used to treat other conditions in adult patients such as Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), myelodysplastic syndrome (MDS) or myeloproliferative diseases (MPD), aggressive systemic mastocytosis (ASM), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), and dermatofibrosarcoma protuberans (DFSP).


imatinib is also used to treat a newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase in adult and pediatric patients.


Before you begin treatment with imatinib, you and your doctor should talk about the benefits imatinib will do as well as the possible risks of using it.


imatinib is available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, imatinib is used in certain patients with the following medical condition:


  • Acute lymphoblastic leukemia, Philadelphia chromosome-positive, newly diagnosed, as part of combination chemotherapy.

Before Using imatinib


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 imatinib, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to imatinib 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 imatinib in children younger than 2 years of age. 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 imatinib in the elderly. However, serious side effects (e.g., swelling of the face, hands, fingers, feet, and/or lower legs, and unusual weight gain) may be more likely to occur in elderly patients, who may be more sensitive than younger adults to the effects of imatinib.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


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.


Interactions with Medicines


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 taking imatinib, 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 imatinib 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.


  • Aprepitant

  • Carbamazepine

  • Clozapine

  • Dexamethasone

  • Dihydroergotamine

  • Ergotamine

  • Fentanyl

  • Fosaprepitant

  • Ginseng

  • Phenobarbital

  • Phenytoin

  • Pimozide

  • Rifampin

  • St John's Wort

  • Warfarin

Using imatinib 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.


  • Amlodipine

  • Ketoconazole

  • Levothyroxine

  • Rifabutin

  • Simvastatin

Interactions with Food/Tobacco/Alcohol


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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using imatinib with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use imatinib, or give you special instructions about the use of food, alcohol, or tobacco.


  • Grapefruit Juice

Other Medical Problems


The presence of other medical problems may affect the use of imatinib. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia or

  • Neutropenia (low white blood cells) or

  • Thrombocytopenia (low platelets in the blood)—May worsen these conditions and affect the decision to continue therapy.

  • Ascites (fluid in the abdomen) or

  • Bleeding problems or

  • Cardiogenic shock (shock caused by heart attack) or

  • Congestive heart failure or

  • Hypothyroidism (underactive thyroid) or

  • Liver disease or

  • Pericardial effusion (fluid around the heart) or

  • Pleural effusion (fluid around your lungs) or

  • Pulmonary edema (fluid inside the lungs) or

  • Stomach or intestinal problems (e.g., bleeding, perforation)—Use with caution. May make these conditions worse.

  • Heart disease—Patients with this condition should be monitored closely when using imatinib.

  • Infection—May decrease your body's ability to fight infection.

  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of imatinib


Take imatinib only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition. Do not change the dose or stop using imatinib without checking first with your doctor.


imatinib should be taken with a tall glass of water and a meal to help prevent stomach irritation.


If you cannot swallow the tablet, you may dissolve the tablet in a glass of water or apple juice. If you are taking the 100 mg tablet, dissolve it in 2 ounces (1/4 cup) of water or juice. If you are taking the 400 mg tablet, dissolve it in 7 ounces (about 1 cup) of water or juice. Stir with a spoon and drink immediately after the tablet has dissolved.


Dosing


The dose of imatinib will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of imatinib. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For the treatment of Ph+ CML-CP, CML-AP, CML-BC after failure of Interferon-alpha therapy:
      • Adults—400 or 600 milligrams (mg) once a day, as determined by your doctor. Your doctor may increase your dose as needed.

      • Children—Use and dose must be determined by your doctor.


    • For the treatment of newly diagnosed Ph+ CML-CP:
      • Adults—400 milligrams (mg) once a day. Your doctor may increase your dose as needed.

      • Children 2 years of age and older—Dose is based on body size and must be determined by your doctor. The dose is usually 340 milligrams per square meter (mg/m[2]) per day. The dose may be taken once a day or the dose may be divided into two small doses (once in the morning and once in the evening).

      • Children younger than 2 years of age—Use and dose must be determined by your doctor.


    • For the treatment of relapsed or refractory Ph+ ALL:
      • Adults—600 milligrams (mg) once a day.

      • Children—Use and dose must be determined by your doctor.


    • For the treatment of ASM:
      • Adults—400 milligrams (mg) once a day. Your doctor may adjust your dose as needed.

      • Children—Use and dose must be determined by your doctor.


    • For the treatment of DFSP:
      • Adults—800 milligrams (mg) per day.

      • Children—Use and dose must be determined by your doctor.


    • For the treatment of GIST:
      • Adults—400 milligrams (mg) once a day. Your doctor may increase your dose as needed.

      • Children—Use and dose must be determined by your doctor.


    • For the additional treatment after complete removal of GIST:
      • Adults—400 milligrams (mg) once a day. Your doctor may adjust your dose as needed.

      • Children—Use and dose must be determined by your doctor.


    • For the treatment of HES or CEL:
      • Adults—400 milligrams (mg) once a day. Your doctor may start you at a lower dose and adjust your dose as needed.

      • Children—Use and dose must be determined by your doctor.


    • For the treatment of MDS or MPD:
      • Adults—400 milligrams (mg) once a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of imatinib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using imatinib


It is very important that your doctor check your progress at regular visits to make sure that imatinib is working properly. Blood tests may be needed to check for unwanted effects. Be sure to keep all appointments.


Using imatinib while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


Serious skin reactions can occur during treatment with imatinib. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using imatinib.


Some serious side effects such as black, tarry stools; severe stomach pain; or vomiting of blood or material that looks like coffee grounds can occur during treatment with imatinib.


While you are being treated with imatinib, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Imatinib may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.


Imatinib 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.

If you are rapidly gaining weight; having shortness of breath; chest pain or discomfort; extreme tiredness or weakness; difficulty with breathing; uneven heartbeat; or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.


Check with your doctor right away if you have if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.


imatinib may cause slow growth. If your child is using imatinib, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.


imatinib may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.


Do not eat grapefruit or drink grapefruit juice while you are using imatinib. Grapefruit and grapefruit juice may change the amount of imatinib that is absorbed in the body.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.


imatinib 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 immediately if any of the following side effects occur:


More common
  • Abdominal or stomach pain, cramping, burning, or tenderness

  • bleeding from wound after surgery

  • bleeding gums

  • bleeding problems

  • bloating or swelling of the face, hands, lower legs, or feet

  • blood in the urine

  • bloody eye

  • bloody nose

  • blue lips and fingernails

  • blurred vision

  • body aches or pain

  • chest pain or discomfort

  • chills

  • clay-colored stools

  • cough

  • coughing that sometimes produces a pink frothy sputum

  • coughing up blood

  • decrease in the amount of urine

  • decreased appetite

  • decreased urination

  • diarrhea

  • difficult or labored breathing

  • difficulty with swallowing

  • dizziness

  • dry mouth

  • ear congestion

  • fever

  • general feeling of discomfort or illness

  • headache

  • inability to speak

  • increased menstrual flow or vaginal bleeding

  • increased thirst

  • irregular heartbeat

  • itching

  • joint pain

  • large, flat, blue, or purplish patches on the skin

  • loss of appetite

  • loss of voice

  • mood changes

  • muscle aches and pain

  • muscle cramps

  • nasal congestion

  • nausea and vomiting

  • noisy, rattling breathing

  • nosebleed

  • numbness or tingling in the hands, feet, or lips

  • pain or tenderness around the eyes and cheekbones

  • painful or difficult urination

  • pale skin

  • prolonged bleeding from cuts

  • rapid weight gain

  • red, black, bloody, or tarry stools

  • red or dark brown urine

  • redness of the eye

  • seizures

  • shivering

  • shortness of breath

  • skin rash

  • slurred speech

  • small red or purple spots on the skin

  • sneezing

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • stuffy or runny nose

  • sweating

  • swelling in the legs and ankles

  • swollen glands

  • temporary blindness

  • tightness in the chest

  • trouble sleeping

  • troubled breathing at rest

  • troubled breathing when moving or walking

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • vomiting of blood or material that looks like coffee grounds

  • weakness in the arm or leg on one side of the body, sudden and severe

  • wheezing

  • yellow eyes or skin

Incidence not known
  • Anxiety

  • blistering, peeling, or loosening of the skin

  • change in vision not present before treatment

  • chest pain, possibly moving to the left arm, neck, or shoulder

  • confusion

  • delayed or slow growth in children

  • irregular, fast or slow, or shallow breathing

  • nausea, heartburn, or indigestion, severe and continuing

  • pain in the bones

  • red, irritated eyes

  • red skin lesions, often with a purple center

  • seeing floaters, veil, or curtain appearing across part of vision

  • severe abdominal or stomach pain, cramping, or burning

  • severe constipation

  • severe vomiting

  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

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:


More common
  • Acid or sour stomach

  • belching

  • difficulty having a bowel movement (stool)

  • difficulty with moving

  • discouragement

  • excess air or gas in the stomach or intestines

  • fear or nervousness

  • feeling sad or empty

  • feeling unusually cold

  • full or bloated feeling

  • increased bowel movements

  • irritability

  • lack or loss of strength

  • loose stools

  • loss of interest or pleasure

  • muscle stiffness

  • night sweats

  • passing gas

  • sleeplessness

  • stomach discomfort, upset, or pain

  • swollen joints

  • trouble concentrating

  • unable to sleep

  • weight loss

Less common
  • Back pain

  • bad, unusual, or unpleasant (after) taste

  • change in taste

  • watering of the eyes

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.

See also: imatinib side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More imatinib resources


  • Imatinib Side Effects (in more detail)
  • Imatinib Dosage
  • Imatinib Use in Pregnancy & Breastfeeding
  • Imatinib Drug Interactions
  • Imatinib Support Group
  • 12 Reviews for Imatinib - Add your own review/rating


  • Imatinib Professional Patient Advice (Wolters Kluwer)

  • Imatinib MedFacts Consumer Leaflet (Wolters Kluwer)

  • Gleevec Prescribing Information (FDA)

  • Gleevec Monograph (AHFS DI)

  • Gleevec Consumer Overview



Compare imatinib with other medications


  • Acute Lymphoblastic Leukemia
  • Chronic Eosinophilic Leukemia
  • Chronic Myelogenous Leukemia
  • Dermatofibrosarcoma Protuberans
  • Gastrointestinal Stromal Tumor
  • Hypereosinophilic Syndrome
  • Myelodysplastic Diseases
  • Myeloproliferative Disorders
  • Systemic Mastocytosis


No comments:

Post a Comment