Drugs

A BIT OF INFORMATION ABOUT THE DRUGS I AM HAVING TO TREAT MY ITP

DAPSONE

Dapsone (also called Diphenylsulfone, DDS, or Avlosulfon) is an anti-infective sulfone drug, commonly used to treat a form of dermatitis (herpetiformis) and susceptible cases of leprosy (Hansen’s disease). In recent years Dapsone has also proved useful in treating lupus, rheumatoid arthritis and as a second-line treatment for ITP. The exact mechanism by which Dapsone assists in ITP is unclear, however, limited studies report successful increases in platelet counts of around 40-50% of patients taking the drug.

Dosage

Dapsone is usually prescribed at between 25mg to 100mg per day. It takes an average of 3-4 weeks to effect platelet count. Regular blood counts should be performed to monitor potential hemolysis (red blood cell destruction and anemia). Liver function tests are also recommended.

Side Effects

Dapsone is generally well-tolerated despite its effects on red blood cells. Most side effects are dose-related and reversible.

Common: Hemolytic anemia (reduction in red blood cells), lowered hemoglobin (~1-2g), agranulocytosis (reduction in white blood cells), pale skin, fatigue.

Uncommon / rare: GI upset, headache, dizziness, tachycardia, nervousness, insomnia, skin disorders, muscle weakness, hypersensitivity phenomena (sulfone syndrome), mood changes, peripheral neuritis, male infertility.

Precautions

Dapsone is not recommended for people with a glucose-6-phosphate dehydrogenase (G6PD) deficiency, severe anemia, methemoglobin reductase deficiency, or an allergy or sensitivity to sulfonamides. It is also unsuitable for those with liver or kidney problems, as well as pregnant women and nursing mothers.

The above came from here… http://www.itppeople.com/dapsone.htm

 

MABTHERA AND ITP STUDY

Basel, 8 December 2008

New phase III data suggest MabThera is a highly effective treatment for patients with idiopathic thrombocytopenic purpura

MabThera significantly reduces risk of serious bleeding for people with rare life-threatening autoimmune disorder

New data presented at the 50^th Annual Meeting of the American Society of Hematology (ASH) today show that people living with previously untreated idiopathic thrombocytopenic purpura (ITP), a bleeding disorder, who received MabThera (rituximab) in combination with standard management, experience much better outcomes than those receiving standard treatment alone. MabThera lessens the ability of the immune system to reduce the platelet count, thereby maintaining  a patient’s platelet count for longer, avoiding potentially life-threatening bleeding in vital organs such as the brain.

Data from a phase III study, which is the first randomised study to evaluate the use of MabThera in treating platelet disorders, demonstrate that patients with ITP who were given MabThera and standard treatment were able to maintain their blood platelet count for longer than those who are given standard treatment alone (intent-to-treat analysis: 63% vs 36%, p=0.004; per-protocol analysis: 85% vs 39%, p<0.001).

“People with chronic ITP and very low platelet counts live with the threat of bleeding. The aim of treatment is to stop blood platelet counts falling to help prevent this from happening. These data show that patients receiving MabThera experience an immediate benefit,” said Francesco Zaja from the University of Udine, Italy, and principle investigator for the study.

ITP is an autoimmune disease in which the body attacks its own blood cells (platelets) or does not produce enough blood cells to protect itself.  This means the blood does not clot properly, resulting in easy bruising, nose bleeds, bleeding from the gums, gut, and bleeding in the brain. ITP is either an acute condition in children or a chronic condition in adults.  Chronic ITP predominantly affects adults (median age around 50 years) and is more common in women. It is relatively rare with 5.8-6.6 per 100,000 adults affected by the chronic form of the disorder.

“The long period of time without the disease recurring shows that in some patients MabThera offers the potential for cure,” said Francesco Zaja. “This is extremely good news for people with this potentially life-threatening condition as current forms of treatment only aim to relieve symptoms rather than cure the condition itself.”

Based on these important new results, Roche will evaluate a potential regulatory filing of MabThera for use in ITP.

About the study

The study is a randomized phase III study designed to assess the monoclonal antibody MabThera in combination with oral corticosteroid dexamethasone in adult patients with first-line ITP.  165 patients previously untreated for ITP with a blood platelet count of ≤ 20 x 109/L were involved in the study, which was conducted between July 2005 and June 2007.  Of these, 75 patients received MabThera in combination with dexamethasone and 90 patients received dexamethasone alone.  The primary endpoint was sustained response rate, i.e. a blood platelet count of ³50 x 109/L after six months.  The results were analysed by an intent-to-treat (ITT) and by a per-protocol (PP) analysis.

About MabThera

MabThera is a therapeutic antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and malignant B-cells.  It then recruits the body’s natural defences to attack and kill the marked B-cells.  Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

The above is from… http://www.roche.com/investors/ir_update/inv-update-2008-12-08.htm

MORE ON MABTHERA

MabThera is indicated for the treatment of patients with stage III and IV follicular non-Hodgkin’s Lymphoma and patients with CD20-positive diffuse large B cell non-Hodgkin’s lymphoma.  MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.  MabThera is known as Rituxan in the United States, Japan and Canada.  To date, patients have received more than 1 million treatments with MabThera worldwide.

About MabThera in idiopathic thrombocytopenic purpura (ITP)

ITP is a disease of the immune system leading to a dramatic decrease in the platelet count in the bloodstream. This puts patients at increased risk for bleeding into organs such as the brain or the GI tract, and it can cause severe disease. Associated with the development of ITP are abnormal lymphocytes. MabThera targets those specific abnormal lymphocytes in the bloodstream and in the bone marrow and thereby has the potential to eradicate lymphocytes that are responsible for causing the disease.

Genentech and Biogen Idec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Mabthera infusion contains the active ingredient rituximab, which is a type of medicine known as a monoclonal antibody. It works by attacking white blood cells called B cells. This action means it can be used to treat two different diseases: cancers of the lymphatic system known as non-Hodgkins lymphomas, and the inflammatory disease of the joints known as rheumatoid arthritis.

Lymphomas are cancers involving white blood cells called lymphocytes. Cancer occurs when these lymphocytes, for some reason, begin to multiply in an uncontrolled way. This can cause a lump or tumour in the lymph nodes. Lymphocytes are normally involved in fighting infection and they travel around the lymphatic system and the bloodstream to do this. If abnormal cancerous lymphocytes travel, the cancer can spread to other lymph nodes and other areas of the body.

Rituximab is used to treat non-Hodgkins lymphomas that involve a sub-group of lymphocytes called B lymphocytes. It works by attacking the abnormal B lymphocytes.

Rituximab works in a similar way to the natural antibodies produced by our immune system. Our natural antibodies recognise foreign invadors and bind to them, helping our immune systems to attack them and protect us from infections. Monoclonal antibodies like rituximab are made in laboratories. They are designed to attack particular body cells.

Rituximab specifically recognises and binds to a protein called CD20, which is found on the surface of cancerous B lymphocyte cells. This triggers the immune system to attack the cancerous cells, and can also sometimes cause the cells to destroy themselves. This is how how rituximab works in treating lymphoma.

This medicine will either be given on its own to treat lymphoma, or in combination with other chemotherapy medicines. If used on its own, it will usually be given once a week for four weeks. If used in combination with other chemotherapy, it will be given on the same day as the other medicines, which are usually given eight times at three week intervals. Courses may be repeated. If the cancer responds to the intial treatment, maintenance treatment may be given once every three months for up to two years.

Rituximab can also be used to treat severe forms of rheumatoid arthritis. This disease is known as an autoimmune disease, because the inflammation and damage to the joints results from overactivity in the immune system. B lymphocytes seem to play a key role in this process. Rituximab works in rheumatoid arthritis by attacking the B lymphoctyes in the same way as described above. This interrupts the process of inflammation and damage in the joints.

Rituximab will be given as two doses, two weeks apart for rheumatoid arthritis. This course may be repeated after six to twelve months if your doctor feels it is necessary to control your symptoms.

Rituximab is given by a drip into a vein (intravenous infusion). Some people can have a severe allergic reaction to rituximab, so to reduce the chance of this the first drip will usually be given over a period of a few hours. You will also usually be given some painkillers, antihistamine and possibly steroids before the drip to help prevent a reaction.

What is it used for?

• A type of cancer of the lymphatic system called follicular non-Hodgkins lymphoma (as a first-line treatment in combination with chemotherapy).
• Follicular non-Hodgkins lymphoma that is resistant to chemotherapy or has relapsed following chemotherapy.
• A type of cancer of the lymphatic system called CD20 positive diffuse large B cell non-Hodgkin’s lymphoma (in combination with CHOP chemotherapy).
• Severe active rheumatoid arthritis, in combination with another medicine called methotrexate, in adults whose arthritis has not responded well enough to treatment with disease modifiying antirheumatic drugs (DMARDs, including infliximab, etanercept or adalimumab), or who cannot take these medicines due to side effects.

Warning!

• Molecules called cytokines may be released into the body when the B lymphocytes are destroyed by this medicine. This can lead to severe infusion-related reactions such as fever, chills, breathing difficulties, itching, blisters, throat or tongue swelling, nausea and vomiting, headache, flushing or palpitations. People whose lung function is compromised or who have cancer that has invaded the lungs, or who have a high number of cancer cells circulating in the blood or a high tumour burden are at greater risk of this syndrome. All patients must be very closely monitored, particularly those with a history of heart disease or a history of breathing problems. Your doctor may need to interrupt your infusion if you develop these symptoms. These reactions are less likely to happen after your second infusion.
• You should have regular blood tests to check the levels of your blood cells, while you are having treatment with this medicine, particularly if you are also receiving chemotherapy treatment.
• This medicine can increase your risk of infections. You should tell your doctor immediately if you get any signs of infection following any of your infusions, for example, a high temperature (fever), sore throat, mouth ulcers or swollen glands.
• Very rarely, some people treated with this medicine have had a serious brain infection called Progressive Multifocal Leukoencephalopathy (PML). This usually causes severe disability and can be fatal. As a result, you should tell your doctor immediately if you experience possible symptoms of this disorder, which include memory loss, trouble thinking, changes in behaviour, difficulty with walking, trouble moving one side of your body, pins and needles sensations or loss of vision.
• It is not known if rituximab can affect reproductive ability, or if it can harm a developing baby when given during pregnancy. However, because it could potentially cross the placenta and attack the B cells of a developing foetus, women who could get pregnant must use an effective method of contraception to avoid pregnancy both during treatment and for 12 months after stopping treatment with this medicine.

Use with caution in

• People who have a high number of cancer cells circulating in the blood or a high tumour burden.
• People with cancer that has invaded the lungs.
• History of lung disease.
• History of heart disease.
• People who have previously been treated with chemotherapy that can have side effects on the heart.
• People with low numbers of blood cells called neutrophils and platelets in their blood.
• People whose immune systems have a decreased ability to fight infection and disease.
• History of recurrent or chronic infections.
• History of hepatitis B.

Not to be used in

• Allergy to mouse protein.
• The safety and efficacy of MabThera in children have not been established by the manufactuer. It is not recommended for children.
• When treating rheumatoid arthritis, this medicine should not be given to people with active infections, a very underactive immune system (eg due to HIV infection or hypogammaglobulinaemia), severe heart failure, or other severe uncontrolled heart disease.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• It is not known if rituximab can affect reproductive ability, or if it can harm a foetus when given during pregnancy. However, because it could potentially cross the placenta and attack the B cells of a developing foetus, it should not be given to pregnant women unlesss the potential benefit outweighs the possible risk. Women who could get pregnant must use an effective method of contraception to prevent pregnancy, both during treatment and for 12 months after their last drip. Seek further medical advice from your doctor.
• It is not known if this medicine passes into breast milk. However, because it may pass into breast milk and harm a nursing infant, it should not be given to women who are breastfeeding. Women who have been treated with Mabthera should not breastfeed for 12 months after their last drip. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect. Side effects are less likely if you are being treated with this medicine for rheumatoid arthritis.

• Fever (pyrexia) or chills.
• Weakness or loss of strength (asthenia).
• Headache.
• Decreased numer of white blood cells, platelets or red blood cells in the blood.
• Increased susceptibility to infections – see warning section above.
• Rash or itching.
• Hair loss.
• Sweating.
• Disturbances of the gut such as nausea and vomiting, diarrhoea, constipation, abdominal pain or swelling, indigestion.
• Runny or itchy nose.
• Severe swelling of lips, face or tongue (angioedema).
• Decrease or increase in blood pressure.
• Dizziness.
• Flushing.
• Pins and needles or numb sensations.
• Difficulty sleeping (insomnia).
• Anxiety, agitation, nervousness or depression.
• Sensation of ringing or other noise in the ears (tinnitus).
• Breathing difficulties due to a narrowing of the airways (bronchospasm) or other lung problems.
• Throat irritation.
• Pain in the muscles, joints, back or neck.
• Increased blood sugar level (hyperglycaemia).
• Swollen ankles due to fluid retention.
• Tumour pain.
• Heart problems, such as abnormal heart beats (arrhythmias), heart failure, chest pain or heart attack.

The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

Always tell your doctor if you are taking any other medicines, including over-the-counter and herbal medicines, before starting treatment with rituximab. Similarly, always seek advice from your doctor or pharmacist before taking any new medicines while you are receiving treatment with rituximab, so they can check that the combination is safe.

Rituximab may cause low blood pressure and enhance the effect of blood pressure lowering medicines. For this reason, if you are taking medicines for high blood pressure your doctor may want you to stop taking them 12 hours before your Mabthera drip.

If you are having this medicine for rheumatoid arthritis, you should tell your doctor if you are likely to need any vaccinations, for example travel vaccinations, before you have your drip. As this medicine attacks your B cells, which are part of your immune system, it can make it hard for your body to produce antibodies. This means that vaccines may potentially be less effective if given during treatment, and live vaccines may cause serious infections. For this reason, if you need to have any vaccinations, these should be completed at least four weeks before your first MabThera drip. Live vaccines are not recommended while your B cells are depleted (for a few months after your drip). Live vaccines include measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever.

The use of this medicine in combination with other medicines for rheumatoid arthritis has not been studied (with the exception of methotrexate). If you are prescribed any other disease modifiying antirheumatic drugs (DMARDs, eg infliximab, etanercept, adalimumab, gold, penicillamine, chloroquine, sulfasalazine) after your Mabthera drip, you should let your doctor know if you experience any side effects, particularly any signs of infection such as fever.

The above is from http://www.netdoctor.co.uk/medicines/100001561.html

 

PREDNISONE

Prednisone is a corticosteroid hormone (glucocorticoid). It decreases your immune system’s response to various diseases to reduce symptoms such as swelling and allergic-type reactions. It is used to treat conditions such as arthritis, blood disorders, breathing problems, certain cancers, eye problems, immune system diseases, and skin diseases.

Side Effects

Stomach upset, headache, dizziness, trouble sleeping, increased sweating, mood swings or weight gain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: black stools, bone pain (fracture), “coffee-ground” vomit, easy bruising/bleeding, heartburn, increased thirst and urination, irregular/fast/pounding heartbeat, menstrual period changes, mental/mood changes, muscle weakness/pain, persistent weight gain, puffy face, seizures, signs of infection (e.g., fever, persistent sore throat), slow-healing wounds, stomach/abdominal pain, swelling of the feet/ankles, thinning skin, trouble breathing, unusual hair growth, unusual skin growths, vision changes.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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.

Precautions

Before taking prednisone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: untreated active fungal infections.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, history of blood clots, bone loss (osteoporosis), diabetes, eye diseases (e.g., ocular herpes infection, cataracts, glaucoma), heart problems (congestive heart failure), high blood pressure, kidney disease, mental/mood conditions, other infections (e.g., tuberculosis, threadworm), severe liver disease (cirrhosis), stomach/intestinal problems (e.g., ulcer, ulcerative colitis, diverticulitis), underactive thyroid.

Make sure your doctors know that you are taking this medication or have used it in the past.

This medication may mask signs of infection or put you at greater risk of developing very serious (rarely fatal) infections. Report any injuries or signs of infection (e.g., persistent sore throat/fever/cough, pain during urination, muscle aches) that occur during treatment.

If your body is under severe stress due to major infection, surgery, or injury, your dose may need to be adjusted upward if you are using a very low dose of prednisone for a long time. Your body may not be able to make enough natural steroids. If you have stopped taking this drug within the past 12 months, consult your doctor. You may need to start taking it again if your body is under severe stress. Tell your doctor immediately if any of the following side effects occur when your body is under severe stress: unusual weakness, sudden weight loss, dizziness. Tell your doctor if you are scheduling surgery.

Avoid exposure to chickenpox or measles infection while taking this medication. If you are exposed to these infections, seek immediate medical attention.

If you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit alcoholic beverages while taking this drug. Alcohol may increase the risk of stomach/intestinal bleeding.

If you have diabetes, this drug may increase your blood sugar levels. Check your blood (or urine) glucose level frequently, as directed by your doctor. Promptly report any abnormal results as directed. Your medicine, exercise plan, or diet may need to be adjusted.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially osteoporosis. Talk with your doctor about ways to prevent bone loss.

Caution is advised when using this drug in children. It may slow down a child’s growth rate if given for prolonged periods. Monitor your child’s height and growth rate regularly. Consult your doctor or pharmacist for more details.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to an unborn baby when it is used during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: aldesleukin, natalizumab.

If you are currently using any of these medications, tell your doctor or pharmacist before starting prednisone.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: large doses of aspirin and aspirin-like drugs (salicylates), birth control pills, “blood thinners” (e.g., warfarin), estrogens, mifepristone, nonsteroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ibuprofen), drugs which decrease blood potassium levels (e.g., amphotericin B, “water pills” such as hydrochlorothiazide and furosemide), drugs which affect certain liver enzymes (CYP 3A4 substrates, inhibitors and inducers such as azole antifungals, macrolide antibiotics, rifamycins, certain anti-seizure medications).

Do not have any vaccinations, immunizations or skin tests while you are using this drug unless specifically directed by your doctor. Live vaccines may cause serious complications (e.g., infection) if given while you are taking this medication. Consult your doctor for details.

Low-dose aspirin, as prescribed by your doctor for heart attack or stroke prevention (usually these dosages are 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

This medication may interfere with certain laboratory tests (including skin tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

The above is from http://www.webmd.com/drugs/mono-9383-PREDNISONE+-+ORAL.aspx?drugid=6007&drugname=Prednisone+Oral