Risk Of Bias In Included Studies
The methodological quality of the studies was unsatisfactory in four of seven studies . Four studies , described adequate methods for sequence generation and were rated as low risk for this item. Three studies were rated as unclear risk because the methods used for randomization were not described. Appropriate methods for allocation concealment were reported or supplied by the authors for two of the seven studies , and these studies were rated as low risk of bias for this item. The other five studies , were rated as unclear for allocation concealment. Two of the three studies using active comparators were open label , and therefore at high risk of bias for lack of blinding. Paraskeva 2000 did not describe blinding in the abstract. The study by Sood 2000 was single blind and was rated as high risk of bias for blinding. Six studies were rated as low risk for incomplete outcome data . Three of the studies were rated at an unclear risk of bias for selective reporting because of missing outcomes , or potential post hoc outcomes . The other four studies were rated as low risk for this item. Furthermore, it is of note that all studies were small ).
Duration Of Treatment And Tapering
No study has been conducted to show the necessary or optimal period of AZA or 6MP treatment in quiescent disease, but a retrospective survey of long-term treatment showed that two-thirds of Crohns disease patients remained in remission after 5years. In this study, it was suggested that relapse was more likely in females and younger patients, whereas the disease site did not influence the relapse rate. Candy etal. reported that AZA offers therapeutic advantage over placebo in the maintenance of remission in Crohns disease over a period of only 15months. Sixty-three patients were randomized to receive either 2.5mg/kg AZA or placebo, in addition to tapering of an initial dose of prednisolone , over a period of 3months. After this period, there was no significant difference in remission rates but, after 15months of treatment, 42% of those receiving AZA and only 7% of those receiving placebo were in remission .
A disadvantage of AZA or 6MP treatment of both ulcerative colitis and Crohns disease is the risk of relapse after stopping these drugs. The chances of relapse are 37% at 1year and 66% at 3years after discontinuation. The percentage of relapse in ulcerative colitis is higher than that reported in Crohns disease patients treated with AZA, but the ulcerative colitis patients treated with AZA included troublesome cases .
Eliminating The Biological Or Immunosuppressive After Remission With Both
To be considered preferably only after 1 full year of maintenance therapy and full dose of both after remission achieved first reduce dose of the immunosuppressives eventually eliminate the 6-MP/AZA or the biological the authors preference is to eliminate the 6-MP/AZA and continue the biological later reduce the dose of the biological as well.
Once remission of the IBD has been maintained for at least a year, there are many considerations. While some patients do not wish to change the therapeutic program because of its success, others are fearful of complications of either or both drugs and are anxious to eliminate or reduce. In some cases the specific indication for starting the program remains tolerable but not eliminated, in which case I encourage the patient to persist. In other cases where the indication for starting one or both drugs is gone and indeed mucosal healing has been accomplished as well , I undertake a dose reduction.
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What Should I Know About Storage And Disposal Of This Medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture . Mercaptopurine suspension can be kept at room temperature for up to 6 weeks after the bottle is opened for the first time. Then, dispose of any suspension that is left over after 6 weeks.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.
Prednisone Prednisolone And Methylprednisolone
Prednisone is taken by mouth and is available as:
- an immediate-release tablet
- a delayed-release tablet
- a liquid solution
Its available as a generic drug and as the brand-name drugs Prednisone Intensol and Rayos .
The forms of prednisolone that are FDA approved for UC are:
- immediate-release tablet
- liquid solution
You can take any of these forms by mouth. Prednisolone is available as a generic drug and as the brand-name drugs Millipred and Prelone .
Methylprednisolone comes in two forms:
- injectable medication
Its available as a generic drug and as the brand-name drugs Medrol and Depo-Medrol .
Side effects, complications, and interactions
When given in high doses, the side effects of these drugs are similar. The more common side effects can include:
- increased blood sugar levels
Immunomodulators are drugs that decrease the bodys response to its own immune system. The result is lowered inflammation throughout your body.
Immunomodulators may reduce the number of UC flare-ups you have and help you stay symptom-free longer.
Theyre generally prescribed to people whose symptoms havent been managed with 5-ASA drugs and corticosteroids. However, these drugs may take several months to start working.
The FDA has not approved immunomodulators for the treatment of UC.
However, theyre well supported in medical literature as useful options, and your doctor may still prescribe them. This is known as off-label drug use.
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Management Of Ulcerative Colitis
Management of ulcerative colitis involves first treating the acute symptoms of the disease, then maintaining remission. Ulcerative colitis is a form of colitis, a disease of the intestine, specifically the large intestine or colon, that includes characteristic ulcers, or open sores, in the colon. The main symptom of active disease is usually diarrhea mixed with blood, of gradual onset which often leads to anaemia. Ulcerative colitis is, however, a systemic disease that affects many parts of the body outside the intestine.
What Is This Medication
MERCAPTOPURINE, 6-MP is a chemotherapy drug. It interferes with the growth of cancer cells and can reduce immune system activity. It is used to treat certain types of acute leukemia.
This medicine may be used for other purposes ask your health care provider or pharmacist if you have questions.
COMMON BRAND NAME: Purinethol
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Side Effects And Interactions
The more common side effects of biologics can include:
Biologic drugs may interact with other drugs and biologic agents, including:
- natalizumab , which can be used to treat Crohns disease or multiple sclerosis
- tocilizumab , anakinra , abatacept , which are primarily used to treat arthritis
- theophylline , an asthma medication
- live vaccines such as the varicella zoster vaccine
What Side Effects May I Notice From Receiving This Medication
Side effects that you should report to your doctor or health care professional as soon as possible:
- allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
- breathing problems
- low blood counts – this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding
- signs of decreased platelets or bleeding – bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
- signs of decreased red blood cells – unusually weak or tired, feeling faint or lightheaded, falls
- signs of infection – fever or chills, cough, sore throat, pain or difficulty passing urine
- signs and symptoms of liver injury like dark yellow or brown urine general ill feeling or flu-like symptoms light-colored stools loss of appetite nausea right upper belly pain unusually weak or tired yellowing of the eyes or skin
- swelling of the stomach
Side effects that usually do not require medical attention :
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Note For Carers And Schools
Thiopurines are considered cytotoxic with a very small increased risk of cancers in those taking them. Caution is needed when touching the tablets and with all bodily fluids: stool, urine, vomit, sputum from patients taking them. Any spill should be cleaned with soap and water and the toilet always flushed with the lid down. The chances of any harm to another person from contact with the drug or with body fluids from someone on the drug are extremely rare but caution is required as these drugs have no known minimum safe exposure.
How To Take Purinethol
This medication is usually taken once a day, around the same time. No specific time of day is recommended in the prescription label for taking Purinethol however, studies have demonstrated better outcomes with an evening schedule versus a morning schedule for children treated for ALL.
For both the tablet and suspension form, you can take it with or without food, but you should consistently take it the same way.
Although there is no specific time of day recommended in the prescribing label for Purinethol
If you are taking the suspension form , make sure to use the provided syringes that come with the medication so that you administer the correct dose. Shake the suspension well for 30 seconds before each dose. After using, wash the syringe in warm, soapy water and allow it to fully dry before using it again. Make sure to discard the suspension within eight weeks of opening the bottle.
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What Is My Medicine
Both Azathioprine and 6-Mercaptopurine belong to a group of drugs called thiopurines which are immunosuppressants. Thiopurines work by suppressing inflammation and slowing down the bodys immune response. They are also used to avoid rejection following organ transplantation. They are given once daily in tablet form, sometimes twice daily if drug blood levels indicate twice daily to be better. The dose is calculated according to weight and modified according to drug blood levels.
Both Azathioprine and 6-MP have the same active ingredient, 6-TG, but 6-MP has fewer potential side effects. Patients on Azathioprine need not change. The information below applies to both drugs which are used to help maintain remission in patients with moderate to severe Crohns and Colitis, minimising the need for corticosteroids.
The proper name of your medicine is Azathioprine but the label on your medicine may sometimes say Imuran, Azamun, Azahexal, or Azapin. For 6-Mercaptopurine the label on your medicine may say Puri-nethol. These are brand names. They are available in tablet form, Azathioprine has two strengths, 25mg and 50mg, whereas 6-MP is only available as 50mg tablet.
Do not stop taking your medicine unless advised by your doctor. Azathioprine and 6-MP are generally well tolerated and it is important to remember that most patients do not experience any adverse side effects.
Importantly:
What Other Medications Interact With Purinethol
You may need to avoid certain medications if taking Purinethol. Taking some medications with Purinethol may also affect how well they work. You may need a dosage change for your Purinethol in some cases.
Medications that can interact with Purinethol include:
- Allopurinol: You may need a reduced dose of Purinethol.
- Warfarin: This combination may decrease the effectiveness of warfarin.
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Before Taking This Medicine
You should not use this medicine if you are allergic to mercaptopurine or thioguanine, or if you have ever used mercaptopurine or thioguanine and they were not effective in treating your condition.
Mercaptopurine may cause a rare type of lymphoma of the liver, spleen, and bone marrow that can be fatal. Talk with your doctor about your own risk.
Using mercaptopurine may also increase your risk of developing other types of cancer. Ask your doctor about your specific risk.
Tell your doctor if you have ever had:
Mercaptopurine may harm an unborn baby, especially when used during the first trimester. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.
You should not breastfeed while taking mercaptopurine.
Report Any Of The Following To Your Doctor As Soon As Possible:
- Fever, chills, diarrhoea or sore throat
- Skin rash or itching or mouth ulcers
- Severe Abdominal pain
- Yellowing of skin or eyes, Dark yellow or brown urine
- Unusual bleeding or bruising or Black, tarry stools
Your childs doctor will arrange regular blood tests to see how their body is responding to the medication, to monitor their blood count and liver function, and intermittently monitor the level of medication in their blood. Initially blood tests will be every few weeks, then, when your doctor is happy you are tolerating the drugs, tests will be less frequent but never less than four monthly.
It is important to tell your doctor before taking any other medications, including those bought over-the-counter from a pharmacy, supermarket or health food shop. Grapefruit should also be avoided as this increases drug levels in the blood unpredictably. Other medicines can affect how your body handles thiopurines which they may impact safety and reduce effectiveness
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What Should I Tell My Care Team Before I Take This Medication
They need to know if you have any of these conditions:
- low blood counts like low white cell, platelet, or red cell counts
- nucleotide diphosphatase deficiency
- recently received or scheduled to receive a vaccine
- thiopurine methyltransferase deficiency
- an unusual or allergic reaction to mercaptopurine, other medicines, foods, dyes, or preservatives
- pregnant or trying to get pregnant
The Role Of Immunosuppressives For Extraintestinal Manifestations
Before the advent of biologicals, treatment of pyoderma gangrenosum, erythema nodosum, arthritic manifestations and uveitis were often successful with the introduction of 6-MP. If however, the extraintestinal manifestation occurs while the patient is already taking an immunosuppressive, the need to introduce a biological is clear.
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Can Mercaptopurine Be Taken With Other Medication
There are some medications which can interact with mercaptopurine. These include:
- Anti bacterials
You should inform your doctor of any medications or supplements you are taking to ensure they do not react with your new medication.
Mercaptopurine is sometimes prescribed at the same time as biologic medications – such as adalimumab or infliximab. This is known as combination therapy.
Before starting your treatment you will receive a number of tests. One of these will look at the level of enzymes in your body. If you have a high level of enzymes then you may be prescribed allopurinol to be taken at the same time as mercaptopurine as these enzymes can cause side effects of the medication.
What Should I Watch For While Using This Medication
This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.
This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.
Do not become pregnant while taking this medicine or for 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.
Do not breast-feed an infant while taking this medicine or for 1 week after stopping it.
This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.
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How Should I Take Mercaptopurine
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Shake the oral suspension before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device .
Use care when handling mercaptopurine tablets or oral suspension. mercaptopurine may be dangerous if it gets in your eyes or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Seek medical attention if you have redness, itching, or swelling even after rinsing off the medicine. Ask your doctor or pharmacist how to dispose of unused medicine no longer needed.
Mercaptopurine can increase your risk of bleeding, infection, or liver problems. You will need frequent medical tests. Your next dose may be delayed based on the results.
Mercaptopurine can affect your kidneys. Drink plenty of liquids to keep your kidneys working properly.
You may be given other medication to help prevent serious side effects on your kidneys. Keep using this medicine for as long as your doctor has prescribed.
Store mercaptopurine at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.