Gleevec

What is Gleevec?

Gleevec, a cancer-targeted treatment, is used for certain types of leukaemia (blood cancer), bone-marrow disorders, and skin cancers.Gleevec is an oral tablet (imatinib). It is usually taken twice or once a day.Gleevec is a cancer treatment that works by blocking specific proteins, which help tumours grow and spread throughout the body. They are part of a family called BCR-ABL Tyrosine Kinase Inhibitors. Gleevec, when first approved by the FDA on May 10, 2011, was an innovative cancer treatment.Gleevec can be used to treat certain types of cancer.

• Chronic myeloid leukaemia
• Acute lymphoblastic leukaemia
• Myelodysplastic/myeloproliferative diseases
• ASM (Aggressive Systemic Mastocytosis)
• Hypereosinophilic syndrome (HES) or Chronic Eosinophilic Leukaemia
• Dermatofibrosarcoma protuberans (DFSP)
• Gastrointestinal Stromal Tumours (GIST)

Now Gleevec is available in generic form.

Warnings

Gleevec lowers blood cells, which help the body fight infections and clot blood. It may be easier to get infected or bleed. If you notice unusual bleeding or bruising or signs that an infection is present (fever chills the body), call your doctor.Gleevec can increase your risk for liver disease. If you experience upper stomach pain or loss of appetite, or if your urine is dark or your stools are clay-coloured, tell your doctor.Gleevec can increase your risk of fluid retention and heart issues. Swelling or rapid weight loss, shortness or breathlessness, a slow or fast heartbeat, a weak pulse, or fainting should be reported to your doctor.

Before you take this drug

Gleevec should be avoided if imatinib is an allergen.

If you've ever:

• Hepatitis B is a liver disorder.
• Kidney disease
• Thyroid underactivity; recent or forthcoming thyroid surgery
• Heart disease, hypertension, and congestive failure of the heart.
• An ulcer on the stomach;
• Diabetes
• Chemotherapy.

Before starting the treatment, you may be required to take a pregnancy test.Avoid using Gleevec while pregnant. This medication could cause birth defects or harm to the baby. You should use effective birth control during the time you take this medication and at least for 14 days following your last dose.You should not breastfeed your baby if you use Gleevec. This is true for at least one month following the last dose.

How to take Gleevec?

Follow your doctor's instructions and take Gleevec only as directed. Read all the instructions on the prescription label.Gleevec should be taken with food and water. Never take Gleevec without eating.You can dissolve a tablet in water or juice if you are unable to swallow it whole. For each tablet weighing 100 milligrammes, use approximately 2 ounces of liquid. Use 7 ounces of liquid per 400 milligramme tablet. Mix the ingredients and consume them all immediately.Don't use a tablet that has been broken. A broken tablet can contain dangerous medicine if you accidentally get it in your nose, mouth, or eyes. Wash your hands with soap and warm water, then rinse your eyes. Your pharmacist can tell you how to properly dispose of broken pills.Gleevec lowers blood cells, which help the body fight infection and clot your blood. You will have to test your blood often. These tests could delay cancer treatments.Your liver will need to be tested frequently.Stop using Gleevec only on your doctor's recommendation.Avoid heat and moisture at room temperature.

Details on dosage

Adult dose of Gleevec for chronic myelogenous leukaemia:

Phase chronic: 400mg orally, once daily
Rapid phase, or blast crises: 600mg orally, one time per day.
In the absence of severe drug reactions and non-leukaemia-related severe neutropenia, or thrombocytopenia, a dose increase can be considered if the following conditions are met: progression of the disease (at any point), failure to obtain a satisfactory response hematologically after 3 to 6 months of therapy, failure to attain a response cytogenetically after 6–12 months of therapy, or the loss of an already achieved response hematologically or cytogenically:
-Chronic phase of disease progression: 600 mg once daily orally
Blast crisis or accelerated disease progression: Take 400mg orally twice a day.
Uses:
Patients newly diagnosed with chronic myeloid lymphoma (Ph+CML) are in the chronic phase.
Patients with Philadelphia chromosome-positive chronic myeloid lymphoma (Ph+CML), in blast crises (BC), accelerated phases (AP), and chronic phases after interferon alpha treatment

Adult dose of Gleevec used for acute lymphoblastic leukaemia:

Take 600mg orally every day.
Use for relapsed and refractory Philadelphia-chromosome-positive acute lymphoblastic leukaemia (Ph+ALL)

Adult dose of Gleevec in myeloproliferative disorder:

Take 400mg orally every day.
Comments:
Determine the status of PDGFRb rearrangements prior to starting therapy.
Use: For patients with myelodysplastic/myeloproliferative (MDS/MPD) diseases associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements

Adult dose of Gleevec in Myelodysplastic Disorder:

Take 400mg orally every day.
Comments:
Determine the status of PDGFRb rearrangements prior to starting therapy.
Utilisation: These treatments may benefit patients suffering from myelodysplastic/myeloproliferative (MDS/MPD) diseases that involve PDGFR gene rearrangements.

Adult dose of Gleevec as usual for systemic mastocytosis:

For patients with ASM who do not have the D816V mutation in c-Kit: 400mg orally every day
If the c-Kit status of the patient is unknown or not available, 400mg orally every day may be recommended for ASM patients who are not responding to other treatments.
For patients with ASM and eosinophilia (a clonal disease related to the fusion kinase FIP1L1-PDGFRA-alpha), a daily dose of 100mg is recommended. If there are no adverse reactions, a dose increase of 100mg to 400mg may be recommended for patients with ASM.
Patients with ASM and eosinophilia, a disease caused by the FIP1L1 fusion protein with the PDGFR alpha gene, take an oral dose of 100mg daily. If there are no adverse reactions to treatment or if the patient's response is insufficient to this therapy, then a 400-mg dosage may be prescribed.
Comments:
Determine the D816V mutation status of c-Kit before initiating treatment.
Use for patients with systemic aggressive mastocytosis who do not have the D816V mutation in c-Kit

Adult dose of Gleevec as usual for hypereosinophilic syndrome:

For patients with HES/CEL, 400mg orally per day
Patients with HES/CEL and FIP1L1 fusion protein with PDGFR alpha: daily 100mg If there are no adverse reactions, the dose can be increased to 400mg.
Use: Patients with chronic eosinophilic lymphoma and/or hypereosinophilic sydrome who do not have a FIP1L1-PDGFR fusion kinase. (FISH, or mutational analysis demonstrating CHIC2 deletion)

Adult dose of Gleevec as usual for chronic eosinophilic leukaemia:

For patients with HES/CEL, 400mg orally per day
Patients with HES/CEL and FIP1L1 fusion protein with PDGFR alpha: daily 100mg If there are no adverse reactions, the dose can be increased to 400mg.
Use: Patients with chronic eosinophilic lymphoma and/or hypereosinophilic syndrome who do not have the FIP1L1-PDGFR fusion kinase. (FISH, or mutational analysis demonstrating CHIC2 deletion)

Adult dose of Gleevec:

Take 100 mg daily.
Patients with DFSP that is unresectable or recurrent, as well as patients who have metastatic DFSP.

Gleevec dosage for chronic myelogenous leukaemia in children:

One year old and older
Orally, 340 mg/m2, once per day. Orally, 170 mg/m2, twice daily
Maximum Dose: 600 mg daily
Comments:
The therapy can be administered as an all-day dose, or it may be divided into two doses. One dose is given in the morning, while the other dose is taken in the evening.
There is no evidence that this drug has been used on infants under one year old.
Use:
Patients newly diagnosed with chronic myeloid lymphoma (Ph+CML) are in the chronic phase.

What happens if I miss the dose?

You should take your medication as soon as possible. Be sure to consume ample meals and liquids each day, and always wait at least an hour after missing a dose to take another. Never more than one at once.

What happens if I overdose?

Call 1-800-222-1222 immediately if you believe someone may have consumed poison, or seek immediate medical assistance.

What should be avoided?

Gleevec can cause blurred or impaired vision, and it may also affect your reaction. You should avoid driving and other hazardous activities until you are sure how the medicine affects you. Drowsiness can lead to accidents or serious injuries.Grapefruit can interact with Gleevec, causing unwanted side effects. Grapefruit is not recommended.Stay away from people with infections or illnesses. If you notice any signs of an infection, tell your doctor immediately.Be careful to avoid activities that may cause injury or bleeding. Take extra precautions to avoid bleeding when shaving or cleaning your teeth.

Side effects of Gleevec 

If you experience symptoms of an allergic response to Gleevec, such as hives, difficulty breathing, or swelling in the face or throat, or severe skin reactions, including fever, sore mouth, eye pain, or red, purple, or blistering skin, seek emergency medical attention.

If you experience:

• Fluid Retention: shortness of breath, swelling, and rapid weight gain (even when lying down);
• Kidney problems: little or no urine; swelling of the feet and ankles.
• Fluid buildup in the lung: pain when breathing, wheezing and gasping for air, foamy coughing;
• Jaundice (yellowing skin or eyes) is a sign of liver disease.
• Low blood counts: fever, flu, or cold symptoms; easy bleeding; sores on the mouth; pale skin and hands; lightheadedness;
• Signs of stomach bleeding include bloody stools or bloody vomit.
• Signs of tumour cell breakdown: confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth;
• Thyroid symptoms include fatigue, dryness of the skin, hair fall, constipation, and depression.

Imatinib may affect the growth of children and adolescents. If your child's growth isn't normal while taking this medication, tell your doctor.

Common Gleevec side effects may include:

• Fluid retention;
• Nausea, vomiting, stomach pain, diarrhoea;
• Joint or muscle pain
• Skin rash;
• Feeling tired?

There may be other side effects. For medical advice on side effects, call your doctor. Report adverse reactions by calling the Food and Drug Administration's Help Line at 1-800-FDA-1088.

Interaction with other drug

It is sometimes not safe to take certain drugs at the same time. Some medications can cause side effects that increase or decrease the effectiveness of another drug you are taking.

Inform your doctor of all medications you are currently taking. Gleevec can interact with many drugs, including:

• Antiviral or antifungal medicine;
• Seizure medicine;
• Warfarin ( Coumadin or Jantoven);
• A vitamin or mineral that contains iron.

Imatinib may be affected by many drugs not listed here. These include prescription drugs, vitamins, and herbs. This list does not encompass all potential drug interactions.