Wednesday, September 21, 2011

9.21.11 - medications used in the treatment of multiple sclerosis

Following the idea of my previous posts, I am going to share information from different websites that discuss aspects of MS and include my personal experiences.

Comparing Drugs for Multiple Sclerosis

Laura Dean, MD.
Created: February 11, 2011.

Multiple sclerosis (MS) is an autoimmune disease of the central nervous system. MS affects the myelin coating of nerves, interrupting nerve conduction and leaving lesions that can be seen on brain scans.

Symptoms of MS can be unpredictable, and include changes in sensation, muscle weakness, and problems with balance and coordination. Symptoms may gradually develop and worsen over time, or more commonly, occur in acute attacks (relapses) followed by symptom-free periods (remissions). About 85% of patients have the relapsing-remitting form of MS (RRMS), and most cases eventually develop into a secondary progressive form (SPMS).

The management of MS includes treating symptoms (e.g. muscle relaxants for muscle spasms) and acute flare-ups (e.g. high dose steroids for sudden loss of vision). Disease-modifying drugs are used to slow the progression of MS. These drugs modify the immune response and include the β interferons (Avonex, Rebif, Betaseron, and Extavia), glatiramer acetate (Copaxone), mitoxantrone (Novantrone) and natalizumab (Tysabri).

The "Drug Class Review on Disease-modifying drugs for Multiple Sclerosis" compares the safety and effectiveness of seven drugs. A summary of the findings is below.

How do disease-modifying drugs compare in multiple sclerosis?

In patients with relapsing-remitting multiple sclerosis, Avonex is less effective than Rebif and Betaseron for preventing relapse. Fair evidence suggests that Rebif is similar to Avonex for slowing disease progression. Evidence comparing Betaseron to Avonex for preventing disease progression was conflicting, with one trial showing Betaseron more effective for slowing disease progression, but no difference between the drugs in measures of disability.
No differences were found between Copaxone and Rebif or Betaseron in either relapse rates or disease progression.
Direct comparisons are lacking in other types of multiple sclerosis. Natalizumab and mitoxantrone have not been directly compared to other disease-modifying drugs. [details]

How do disease-modifying drugs compare in clinically isolated syndrome?

Compared to placebo, the following drugs were more effective at reducing the chances of a clinically isolated syndrome converting into multiple sclerosis: Avonex, Betaseron, Copaxone, and Rebif.
There are no studies of Novantrone or Tysabri in patients with a clinically isolated syndrome. [details]

How do disease-modifying drugs compare in safety?

Interferons appear to share a similar rate of adverse events. Increases in liver enzymes are common, but most are transient and asymptomatic. Avonex had the lowest rate of injection site reactions (9%, compared to ~ 60% for Betaseron and Rebif) but flu-like symptoms were about twice as common.
Data are limited for other adverse events, such as for depression, but suggest a lower rate of depression in patients taking Rebif compared with other interferons. Mitoxantrone has been linked with acute leukemia (2 in 1620 patients) and cardiotoxicity (incidence 0.15%), and natalizumb has been linked with progressive multifocal leukoencephalopathy (incidence 0.001%). [details]

How do patient factors affect the safety and effectiveness of disease-modifying drugs?

Observational studies of women taking beta interferons or glatiramer in pregnancy did not find an increase in risk of adverse events, but there is not enough evidence to determine the safety of multiple sclerosis drugs in pregnancy.
One analysis found that African-American patients were more likely to experience exacerbations with Avonex and Rebif compared to white patients.
There is some evidence that response to beta interferons and glatiramer differs in men and women, but there is no evidence that this difference favors one product over another. [details]

Drugs included in this review

Generic Name        Trade Names
Glatiramer Acetate                   Copaxone

Glatiramer Injection(gla tir' a mer)

Last reviewed: February 1, 2009.

Why is this medication prescribed?

Glatiramer is used to reduce episodes of symptoms in patients with relapsing-remitting multiple sclerosis. Glatiramer is in a class of medications called immunomodulators. It works by stopping the body from damaging its own nerve cells (myelin).

How should this medicine be used?

Glatiramer comes as a solution to inject in the fatty layer just under the skin (subcutaneously). It is usually injected once a day. To help you remember to inject glatiramer, inject it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use glatiramer exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
You will receive your first dose of glatiramer in your doctor's office. After that, you can inject glatiramer yourself or have a friend or relative perform the injections. Before you use glatiramer yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it.
Glatiramer comes in prefilled syringes. Use each syringe only once and inject all the solution in the syringe. Even if there is still some solution left in the syringe after you inject, do not inject again. Dispose of used syringes in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.
You can inject glatiramer into seven parts of your body: right and left arms, thighs, and hips; and lower stomach. There are specific spots on each of these body parts where you can inject glatiramer. Refer to the diagram in the manufacturer's patient information for the exact places you can inject. You should inject in each of the body parts once a week, and you should pick a different place on the body part each time. Keep a list of the places where you have given injections so that you will not inject in these places again until some time has passed.
To inject glatiramer, follow these steps:
  1. Remove one blister pack from the carton of glatiramer syringes and place it on a clean flat surface. Wait 20 minutes to allow the medication to warm to room temperature.
  2. Wash your hands thoroughly with soap and water and dry them with a clean towel.
  3. Peel back the paper label and remove the syringe from the blister pack. Check your pre-filled syringe to be sure it is safe to use. It should be labeled with the correct name of the medication and should contain a clear colorless solution. Do not use the syringe if it is expired, is cloudy, or contains any particles. Small air bubbles in the syringe will not cause any problems and you should not try to remove them.
  4. Wipe the place on your skin where you will inject glatiramer with a fresh alcohol pad and wait several seconds to allow it to dry.
  5. Pick up the syringe like a pencil and remove the needle cover.
  6. Use your other hand to pinch a 2-inch (5-centimeter) fold of skin between your thumb and index finger.
  7. Hold the syringe at a 90-degree angle to your body and push the needle straight into your skin. When the needle is all the way in, let go of the pinched fold of skin.
  8. Hold the syringe steady while slowly pushing down the plunger until the syringe is empty.
  9. Pull the needle straight out.
  10. Press a dry cotton ball on the injection site for a few minutes, but do not rub it.

Glatiramer controls multiple sclerosis but does not cure it. Continue to use glatiramer even if you feel well. Do not stop using glatiramer without talking to your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking glatiramer,
  • tell your doctor and pharmacist if you are allergic to glatiramer, mannitol, or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using glatiramer, call your doctor.
  • you should know that you may have a reaction immediately after you inject glatiramer. You may experience the following symptoms: flushing, chest pain, pounding heartbeat, anxiety, trouble breathing, closing of the throat, and hives. This reaction is most likely to occur several months into your treatment, but may happen at any time. These symptoms will usually go away without treatment in a short time. Get emergency medical care if these symptoms become severe or last longer than a few minutes. It is important to tell your doctor if this happens.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What side effects can this medication cause?

Glatiramer may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • pain, redness, swelling, itching, or lump in the place where you injected glatiramer
  • weakness
  • flushing
  • depression
  • abnormal dreams
  • pain in the back, neck, or any other part of the body
  • severe headache
  • loss of appetite
  • diarrhea
  • nausea
  • vomiting
  • weight gain
  • swelling of the hands, feet, ankles, or lower legs
  • purple patches on skin
  • joint pain
  • confusion
  • nervousness
  • crossed eyes
  • difficulty speaking
  • shaking hands that you cannot control
  • sweating
  • ear pain
  • painful or changed menstrual periods
  • vaginal itching and discharge
  • urgent need to urinate or defecate
  • tightness in muscles
  • white patches in the mouth

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately. In some cases, your doctor may tell you to stop using glatiramer:
  • dizziness
  • excessive sweating
  • chest pain
  • sore throat, fever, chills, and other signs of infection
  • runny nose
  • coughing
  • fast heartbeat
  • fainting
  • skin rash
  • hives
  • itching
  • difficulty breathing or swallowing
  • very severe pain at the injection site

Glatiramer affects your immune system, so it may increase your risk of developing cancer or a serious infection. Talk to your doctor about the risks of using this medication.
Glatiramer may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in a refrigerator but do not freeze it. If you will not have access to a refrigerator, you can store glatiramer at room temperature for up to 7 days, but do not expose it to bright light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Other names

  • copolymer-1

American Society of Health-System Pharmacists, Disclaimer

                                                                                    
Interferon β 1a                          Avonex
                                                       Avonex PS
Once-A-Week AVONEX (interferon beta-1a) multiple sclerosis treatment    Interferon beta-1a Subcutaneous Injection(in ter feer' on) 
Last reviewed: September 1, 2008.

Why is this medication prescribed?

Interferon beta-1a is used to prevent episodes of symptoms and slow the development of disability in patients with relapsing-remitting multiple sclerosis (MS, a disease in which the nerves do not function properly and patients may experience weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control). Interferon beta-1a has not been shown to help patients with chronic progressive MS. Interferon beta-1a is in a class of medications called immunomodulators. It is not known how interferon beta-1a works to treat MS.

How should this medicine be used?

Interferon beta-1a subcutaneous injection comes as a solution to inject subcutaneously (under the skin) three times a week. You should inject this medication on the same 3 days every week, for example, every Monday, Wednesday, and Friday. The injections should be spaced at least 48 hours apart, so it is best to inject your medication around the same time of day on each of your injection days. The best time to inject this medication is in the late afternoon or evening. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use interferon beta-1a exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Your doctor may start you on a low dose of interferon beta-1a and gradually increase your dose, not more than once every 2 weeks.
Interferon beta-1a controls symptoms of MS, but does not cure it. Continue to use interferon beta-1a even if you feel well. Do not stop using interferon beta-1a without talking to your doctor.
You will receive your first dose of interferon beta-1a in your doctor's office. After that, you can inject interferon beta-1a yourself or have a friend or relative perform the injections. Before you use interferon beta-1a yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it.
Interferon beta-1a comes in prefilled syringes. Use each syringe and needle only once and inject all the solution in the syringe. Even if there is still some solution left in the syringe after you inject, do not inject again. Throw away used syringes and needles in a puncture-resistant container kept out of reach of children. Talk to your doctor or pharmacist about how to throw away the puncture-resistant container.
You can inject interferon beta-1a in areas of your body with a layer of fat between the skin and muscle, such as your thigh, the outer surface of your upper arms, your stomach, or your buttocks. If you are very thin, only inject in your thigh or the outer surface of your arm for injection. Use a different spot for each injection. Keep a record of the date and spot of each injection. Do not use the same spot two times in a row. Do not inject near your navel (belly button) or waistline or into an area where the skin is sore, red, bruised, scarred, infected, or abnormal in any way.
To inject interferon beta-1a, follow these steps:
  1. Remove the prefilled syringe from the refrigerator and allow it to warm to room temperature for about 30 minutes before using. Do not use a heat source such as hot water or a microwave to warm the syringe.
  2. Check the syringe to be sure it is safe to use. The syringe should be labeled with the correct name of the medication and an expiration date that has not passed and should contain a clear to slightly yellow solution. If the syringe is expired, or the solution is cloudy, discolored, or contains particles, do not use it and call your pharmacist.
  3. Set up a clean, well-lit, flat work surface, like a table, to collect all the supplies you will need to inject interferon beta-1a. Assemble these supplies: alcohol wipes, gauze pad, small adhesive bandage, and puncture-resistant container for disposal of used syringes and needles.
  4. Wash your hands well with antibacterial soap.
  5. Choose a spot to inject interferon beta-1a and clean it with an alcohol wipe, using a circular motion. Let the skin air dry.
  6. Remove the cap from the syringe needle.
  7. The syringe should be filled with interferon beta-1a to the 0.5-mL mark. This is a full dose. If your doctor has told you to use less than the full dose, slowly push the syringe plunger in until the amount of medication left in the syringe is the amount your doctor told you to use.
  8. Use your thumb and forefinger to pinch up a pad of skin around the spot where you will inject interferon beta-1a. Hold the syringe like a pencil with your other hand.
  9. Hold the syringe at a 90-degree angle (straight up and down), and push the needle straight into your skin, stopping just underneath the skin.
  10. When the needle is in, let go of the pinched skin and slowly push down on the syringe plunger until the syringe is empty.
  11. Hold a gauze pad near the needle and pull the needle straight out of the skin. Use the gauze pad to apply pressure to the spot for a few seconds. You may cover the spot with a bandage.
  12. Throw away the used syringe, needle, and gauze pad properly.
  13. Apply a cold compress or ice pack to the injection spot to help reduce redness, swelling, or tenderness that may occur.
  14. After 2 hours, check the injection spot for redness, swelling, or tenderness. If you have redness, swelling, or tenderness that does not go away in a few days or is severe, call your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using interferon beta-1a,
  • tell your doctor and pharmacist if you are allergic to interferon beta-1a, any other interferon product, any other medications, or human albumin.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: acetaminophen (Tylenol, others); antidepressants; azathioprine (Imuran); cancer chemotherapy medications; carbamazepine (Tegretol); chloramphenicol (Chloromycetin); cholesterol-lowering medications (statins); cyclosporine (Neoral, Sandimmune); gold compounds such as auranofin (Ridaura) and aurothioglucose (Solganol); heparin; iron products; isoniazid (INH, Nydrazid); medications for acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV); methotrexate (Rheumatrex); niacin (nicotinic acid); penicillamine (Cuprimine, Depen); phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane); sirolimus (Rapamune); sulfa antibiotics such as sulfamethoxazole (Bactrim, Septra) and sulfisoxazole (Gantrisin); thyroid medications; and tacrolimus (Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had AIDS or HIV; an autoimmune disease (a disease in which the body attacks its own cells; ask your doctor if you are not sure if you have this type of disease); blood problems such as anemia (low red blood cells) or easy bruising or bleeding; anxiety, depression, or mental illness; cancer; seizures; or kidney, liver, or thyroid disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using interferon beta-1a, call your doctor immediately.
  • if you are having surgery, including dental surgery, tell the doctor or dentist you are using interferon beta-1a.
  • ask your doctor about the safe use of alcoholic beverages while you are using interferon beta-1a. Alcohol can make the side effects of interferon beta-1a worse.
  • you should know that you may have flu-like symptoms such as headache, fever, chills, sweating, muscle aches, back pain, and tiredness that last for a day after your injection. Your doctor may tell you to take an over-the-counter pain and fever medication to help with these symptoms. These symptoms usually improve or go away over time. Talk to your doctor if these symptoms last longer than the first few months of therapy, or if they are difficult to manage or become severe.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Inject the missed dose as soon as you remember it. If you are scheduled for a dose the following day, skip that dose. Do not inject interferon beta-1a 2 days in a row. Do not inject a double dose to make up for a missed dose. You should return to your regular dosing schedule the following week. Call your doctor if you miss a dose and have questions about what to do.

What side effects can this medication cause?

Interferon beta-1a may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • dry eyes
  • dry mouth
  • nausea
  • vomiting
  • stomach pain
  • tight muscles
  • bruising, pain, redness, swelling, or tenderness in the place where you injected interferon beta-1a
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
  • depression
  • thoughts of hurting yourself or others
  • anxiety
  • hives
  • skin rash
  • itching
  • flushing
  • difficulty breathing or swallowing
  • lightheadedness
  • fainting
  • seizures
  • loss of coordination
  • vision problems
  • extreme tiredness
  • lack of energy
  • loss of appetite
  • pain in the upper right part of the stomach
  • yellowing of the skin or eyes
  • pale skin
  • chest pain
  • fast heartbeat
  • difficulty sleeping
  • unusual bruising or bleeding
  • swollen glands in your neck
  • sore throat, cough, fever, chills, or other signs of infection
  • unexplained weight gain or loss
  • feeling cold or hot all the time
  • blackening of skin or drainage in the place where you injected interferon beta-1a
Interferon beta-1a may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator, but do not freeze it. If a refrigerator is not available, you can store the medication at room temperature away from heat and light for up to 30 days. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Logo of American Society of Health-System Pharmacists
American Society of Health-System Pharmacists, Disclaimer
                                                                                    
 
Interferon β 1b                          Betaseron

Interferon Beta-1b Injection(in ter feer' on)

Last reviewed: September 1, 2008.

About your treatment

Your doctor has ordered interferon beta-1b, a biologic response modifier. This medication is used to treat patients with multiple sclerosis (MS), a disease in which the nerves do not function properly and patients may experience weakness; numbness; loss of muscle coordination; and problems with vision, speech, and bladder control. This medication will be injected subcutaneously (under the skin) every other day. Your healthcare provider will show you how to prepare and give the injection.
Interferon beta-1b is a man-made version of a naturally occurring protein. It is used to treat patients with relapsing forms of MS (course of disease where symptoms flare up for a short time, then go away). Interferon beta-1b does not cure MS but may reduce the number of disease flare-ups. Interferon beta-1b may be prescribed for other uses; ask your doctor or pharmacist for more information.
Your healthcare provider (doctor, nurse, or pharmacist) may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations. It is important to keep all appointments with your doctor and the laboratory. The length of treatment depends on how you respond to the medication.

What special precautions should I follow?

Before using interferon beta-1b,
  • tell your doctor and pharmacist if you are allergic to interferon beta-1b, or any other medications, or human albumin.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you drink or have ever drunk large amounts of alcohol, if you have or have ever had anemia (low red blood cells) or low white blood cells, blood problems such as bruising easily or bleeding, diabetes, anxiety, depression, mental illness, thoughts of hurting yourself, seizures, trouble falling asleep or staying asleep, or prostate, skin, thyroid, blood, heart, or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using interferon beta-1b, stop using interferon beta-1b immediately and call your doctor.

Administering your medication

Before you administer interferon beta-1b, look at the solution closely. It should be clear and free of floating material. Observe the solution container to make sure there are no leaks and check the expiration date. Do not use the solution if it is discolored, if it contains particles, or if the container leaks or it is expired. Use a new solution, but show the damaged or expired one to your healthcare provider.
It is important that you use your medication exactly as directed. Your healthcare provider may start you on a low dose of interferon beta-1b and gradually increase your dose. Do not change your dosing schedule without talking to your healthcare provider. Your injections should be approximately 48 hours (2 days) apart, so it is best to give them at the same time, preferably in the evening just before bedtime.
Do not inject interferon beta-1b into an area of skin that is irritated, sore, red, bruised, infected, damaged, or abnormal in any way. It is important that you change your injection area each time interferon beta-1b is injected; keeping a record will help you to remember to rotate injection sites. Do not use the same injection area two times in a row. Do not inject interferon beta-1b near the navel (bellybutton) or waistline.
If you miss a dose of interferon beta-1b, inject your next dose as soon as you remember or are able to give it. Your next injection should then be given 48 hours (2 days) after that dose. Do not use interferon beta-1b on 2 days in a row. If you accidentally use more than your prescribed dose, or give it on 2 days in a row, call your healthcare provider right away.

What side effects can this medication cause?

Side effects from interferon beta-1b can occur. Interferon beta-1b sometimes causes a flu-like illness with headache, fever, chills, sweating, muscle aches, tiredness, and general discomfort. Tell your healthcare provider if any of these problems continue or worsen. You should talk with your healthcare provider about whether to take an over-the-counter medication for pain or fever before or after using your dose of interferon beta-1b.
Tell your healthcare provider if any of these symptoms are severe or do not go away:
  • nausea
  • indigestion
  • diarrhea
  • constipation
  • weight gain or weight loss
  • feeling cold or hot much of the time
  • dizziness
  • increased urinary frequency
  • incontinence
  • flushing
  • hair loss
  • joint or muscle weakness or pain
  • leg cramps
  • difficulty falling asleep or staying asleep
  • changes in sex drive or ability (in men)
  • increased menstrual pain

If you experience any of the following symptoms, call your healthcare provider immediately:
  • extreme tiredness
  • lack of energy
  • unusual bruising or bleeding
  • loss of appetite
  • pain in the upper right part of the stomach
  • yellowing of the skin or eyes
  • hives
  • rash
  • itching
  • difficulty breathing or swallowing
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, abdomen (stomach), or lower legs
  • hoarseness
  • vaginal bleeding or spotting between menstrual periods
  • change in coordination
  • heart palpitations or rapid heart rate
  • chest pain
  • nervousness
  • depression
  • anxiety
  • thoughts of hurting yourself
  • swollen lymph nodes

Interferon beta-1b affects your immune system so it may increase your risk of developing a serious infection. Talk to your healthcare provider about the risks of using this medication.
Interferon beta-1b may cause other side effects. Call your healthcare provider if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Signs of infection

If you are receiving interferon beta-1b under your skin, you need to know the signs of an injection area infection (an infection at the area where you have given your medication subcutaneously). If you experience any of these signs near an injection area, call your healthcare provider as soon as possible:
  • swelling
  • lump
  • pain
  • irritation
  • redness
  • bruising
  • drainage
  • dark discoloration
  • other skin problems

American Society of Health-System Pharmacists, Disclaimer

Interferon β 1b                          Extavia
                                                                                   
Mitoxantrone                            Novantrone

Mitoxantrone Injection(mye toe zan' trone)

Last Revision: July 1, 2009.

Warning

Mitoxantrone should be given only under the supervision of a doctor with experience in the use of chemotherapy medications.
Mitoxantrone may cause a decrease in the number of white blood cells in the blood. Your doctor will order laboratory tests regularly before and during your treatment to check whether the number of white blood cells in your body has decreased. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, cough, frequent or painful urination, or other signs of infection.
Mitoxantrone injection may cause damage to your heart at any time during your treatment or months to years after your treatment has ended. This heart damage can be serious and may cause death and can occur even in people without any risks for heart disease. Your doctor will examine you and perform certain tests to check how well your heart is working before beginning treatment with mitoxantrone and if you show any signs of heart problems. If you are using mitoxantrone injection for multiple sclerosis (MS; a condition in which the nerves do not function properly, causing symptoms such as weakness; numbness; loss of muscle coordination; and problems with vision, speech, and bladder control), your doctor will also perform certain tests before each dose of mitoxantrone injection and yearly after you have completed your treatment. These tests may include an electrocardiogram (ECG; test that records the electrical activity of the heart) and an echocardiogram (test that uses sound waves to measure your heart's ability to pump blood). Your doctor may tell you that you should not receive this medication if the tests show your heart's ability to pump blood has decreased. Tell your doctor if you have or have ever had any type of heart disease or radiation (x-ray) therapy to the chest area. Tell your doctor and pharmacist if you are taking or have ever received certain cancer chemotherapy medications such as daunorubicin (Cerubidine), doxorubicin (Doxil), epirubicin (Ellence), or idarubicin (Idamycin), or if you have ever been treated with mitoxantrone in the past. The risk of heart damage may depend on the total amount of mitoxantrone given to a person over a lifetime, so your doctor will probably limit the total number of doses you receive if you are using this medication for MS. If you experience any of the following symptoms, call your doctor immediately: difficulty breathing, chest pain, swelling of the legs or ankles, or irregular or fast heartbeat.
Mitoxantrone may increase your risk for developing leukemia (cancer of the white blood cells), especially when it is given in high doses or together with certain other chemotherapy medications.
Talk to your doctor about the risks of using mitoxantrone injection.
Show full warning

Why is this medication prescribed?

Mitoxantrone injection is used to decrease the number of symptom episodes and slow the development of disability in patients with certain forms of MS. Mitoxantrone injection is also used together with steroid medications to relieve pain in people with advanced prostate cancer who did not respond to other medications. Mitoxantrone injection is also used together with other medications to treat certain types of leukemia. Mitoxantrone injection is in a class of medications called anthracenediones. Mitoxantrone treats MS by stopping certain cells of the immune system from reaching the brain and spinal cord and causing damage. Mitoxantrone treats cancer by stopping the growth and spread of cancer cells.

How should this medicine be used?

Mitoxantrone injection comes as a liquid to be given intravenously (into a vein) by a doctor or nurse in a hospital or clinic. When mitoxantrone injection is used to treat MS, it is usually given once every 3 months for about 2 to 3 years (for a total of 8 to 12 doses). When mitoxantrone injection is used to treat prostate cancer, it is usually given once every 21 days. When mitoxantrone injection is used to treat leukemia, you will continue to receive this medication based on your condition and how you respond to the treatment.
If you are using mitoxantrone injection for MS, you should know that it controls MS but does not cure it. Continue to receive treatments even if you feel well. Talk to your doctor if you no longer want to receive treatment with mitoxantrone injection.
If you are using mitoxantrone injection for MS, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

Mitoxantrone injection is also sometimes used to treat non-Hodgkin's lymphoma (NHL; cancer that begins in a type of white blood cell that normally fights infection). Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using mitoxantrone injection,
  • tell your doctor and pharmacist if you are allergic to mitoxantrone injection or any other medications.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had any blood-clotting problems, anemia (decreased amount of red blood cells in the blood), or liver disease.
  • tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using mitoxantrone injection. Talk to your doctor about effective birth control methods that you can use during your treatment. If you become pregnant while using mitoxantrone injection, call your doctor immediately. Mitoxantrone injection may harm the fetus. If you are using mitoxantrone injection to treat MS, even if you are using birth control, your doctor should give you a pregnancy test before each treatment. You must have a negative pregnancy test before the start of each treatment.
  • tell your doctor if you are breastfeeding. Do not breastfeed while you are using mitoxantrone injection.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using mitoxantrone injection.
  • you should know that mitoxantrone injection is dark blue in color and may cause the white parts of your eyes to have a slight blue color for a few days after you receive each dose. It may also change the color of your urine to a blue-green color for about 24 hours after you receive a dose.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Call your doctor right away if you are unable to keep an appointment to receive a dose of mitoxantrone injection.

What side effects can this medication cause?

Mitoxantrone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • heartburn
  • loss of appetite
  • sores on the mouth and tongue
  • runny or stuffed nose
  • thinning or loss of hair
  • changes in the area around or under fingernails and toenails
  • missed or irregular menstrual periods
  • extreme tiredness
  • weakness
  • headache
  • back pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
  • unusual bleeding or bruising
  • small red or purple dots on the skin
  • hives
  • itching
  • rash
  • difficulty swallowing
  • shortness of breath
  • fainting
  • dizziness
  • pale skin
  • yellowing of the skin or eyes
  • seizures
  • redness, pain, swelling, burning, or blue discoloration at the site where the injection was given

Mitoxantrone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to mitoxantrone injection.
Ask your pharmacist any questions you have about mitoxantrone injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

American Society of Health-System Pharmacists, Disclaimer

Natalizumab                             Tysabri

Natalizumab Injection(na ta liz' you mab)

Last Revision: May 10, 2011.

Notice

[UPDATED Posted 04/22/2011] FDA has updated the natalizumab (Tysabri) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of natalizumab for the treatment of multiple sclerosis (MS) and Crohn's disease. The update includes new safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML. Natalizumab, in a class of medications called immunomodulators, has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn's disease since January 2008. The revised label includes a table summarizing rates of PML with natalizumab use according to the number of infusions (how long the drug is taken or duration of exposure) and information on a newly identified PML risk factor. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Warning

Receiving natalizumab injection alone or with other medications that affect the immune system may increase the risk that you will develop progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). The more doses of natalizumab injection you receive, the greater the risk that you will develop PML.
Tell your doctor if you have or have ever had PML, an organ transplant, or another condition that affects your immune system such as human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), leukemia (cancer that causes too many blood cells to be produced and released into the bloodstream), or lymphoma (cancer that develops in the cells of the immune system). Also tell your doctor if you are taking any other medications that affect the immune system such as adalimumab (Humira); azathioprine (Imuran); cyclophosphamide (Cytoxan); cyclosporine (Neoral, Sandimmune); etanercept (Enbrel); glatiramer (Copaxone); infliximab (Remicade); interferon beta (Avonex, Betaseron, Rebif); medications for cancer; mercaptopurine (Purinethol); methotrexate (Rheumatrex); mitoxantrone (Novantrone); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisolone, and prednisone (Deltasone); sirolimus (Rapamune); and tacrolimus (Prograf). Your doctor may tell you that you should not use natalizumab injection.
You may need to have a magnetic resonance imaging scan (MRI; a scan that shows pictures of the inside of the body) before you begin treatment with natalizumab.
A program called the TOUCH program has been set up to help manage the risks of natalizumab treatment. You can only receive natalizumab injection if you are registered with the TOUCH program, if natalizumab is prescribed for you by a doctor who is registered with the program, and if you receive the medication at an infusion center that is registered with the program. Your doctor will give you more information about the program, will have you sign an enrollment form, and will answer any questions you have about the program and your treatment with natalizumab injection.
As part of the TOUCH program, your doctor or nurse will give you a copy of the Medication Guide before you begin treatment with natalizumab injection and before you receive each infusion. Read this information very carefully each time you receive it and ask your doctor or nurse if you have any questions.
Also as part of the TOUCH program, your doctor will need to see you every 3 months at the beginning of your treatment and then at least every 6 months to decide whether you should continue using natalizumab. You will also need to answer some questions before you receive each infusion to be sure that natalizumab is still right for you
Call your doctor immediately if you develop any new or worsening medical problems during your treatment. Be especially sure to call your doctor if you experience any of the following symptoms: weakness on one side of the body that worsens over time; clumsiness of the arms or legs; changes in your thinking, walking, balance, speech, eyesight, or strength that last several days; headaches; seizures; confusion; or personality changes.
If your treatment with natalizumab injection is stopped because you have PML, you may develop another condition called immune reconstitution inflammatory syndrome (IRIS; swelling and worsening of symptoms that may occur as the immune system begins to work again after certain medications that affect it are started or stopped), especially if you receive a treatment to remove natalizumab from your blood more quickly. Your doctor will watch you carefully for signs of IRIS and will treat these symptoms if they occur.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with infliximab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Tell all the doctors who treat you that you are receiving natalizumab injection.
Talk to your doctor about the risks of receiving natalizumab injection.
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Why is this medication prescribed?

Natalizumab is used to prevent episodes of symptoms and slow the worsening of disability in patients with relapsing forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Natalizumab is usually used by people who were not helped by other medications for MS or who cannot take these medications. Natalizumab is also used to treat and prevent episodes of symptoms in people who have Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) who have not been helped by other medications or who cannot take other medications. Natalizumab is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from reaching the brain and spinal cord and causing damage.

How should this medicine be used?

Natalizumab comes as a concentrated solution (liquid) to be diluted and injected slowly into a vein by a doctor or nurse. It is usually given once every 4 weeks in a registered infusion center. It will take about 1 hour for you to receive your entire dose of natalizumab.
Natalizumab may cause serious allergic reactions that are most likely to happen within 2 hours after the beginning of an infusion, but may happen at any time during your treatment. You will have to stay at the infusion center for 1 hour after your infusion is finished. A doctor or nurse will monitor you during this time to see if you are having a serious reaction to the medication. Tell your doctor or nurse if you experience any unusual symptoms such as those listed in the SIDE EFFECTS section, especially if they occur within 2 hours after the start of your infusion.
Natalizumab controls the symptoms of MS, but does not cure the condition. Keep all appointments to receive natalizumab even if you feel well.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using natalizumab,
  • tell your doctor and pharmacist if you are allergic to natalizumab or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had any of the conditions listed in the IMPORTANT WARNING section. Before you receive each infusion of natalizumab, tell your doctor if you have a fever or any type of infection, including infections that last for a long time such as shingles (a rash that may occur from time to time in people who have had chickenpox in the past).
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using natalizumab, call your doctor.
  • do not have any vaccinations without talking to your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If you miss an appointment to receive a natalizumab infusion, call your doctor as soon as possible.

What side effects can this medication cause?

Natalizumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • headache
  • extreme tiredness
  • joint pain or swelling
  • pain in arms or legs
  • swelling of the arms, hands, feet, ankles, or lower legs
  • muscle cramps
  • stomach pain
  • diarrhea
  • heartburn
  • constipation
  • gas
  • weight gain or loss
  • depression
  • night sweats
  • painful, irregular, or missed menstruation (period)
  • swelling, redness, burning, or itching of the vagina
  • white vaginal discharge
  • frequent or painful urination
  • sudden need to urinate right away
  • difficulty controlling urination
  • tooth pain
  • cold sores

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:
  • sore throat, fever, cough or other signs of infection
  • rash
  • hives
  • itching
  • difficulty breathing
  • chest pain
  • dizziness
  • chills
  • flushing
  • yellowing of the skin or eyes
  • nausea
  • vomiting
  • unusual darkening of the urine

Natalizumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What other information should I know?

Keep all appointments with your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

American Society of Health-System Pharmacists, Disclaimer

                                                                                    

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004927/

Further information

Image th-ms10.jpgThis PubMed Clinical Q&A was reviewed by Susan Carson, MPH.
For the full report and evidence tables, please see:
Smith B, Carson S, Fu R, et al. Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis: Final Update 1 Report [Internet]. Portland (OR): Oregon Health & Science University; 2010 Aug. Available at:
http://www.ncbi.nlm.nih.gov/books/NBK50570/.
Logo of National Center for Biotechnology Information (US)
 
I was on Copaxone for the first few years that I was diagnosed.  Although a lot of people don't like the idea of having an injection every day, I preferred it because it was less to remember.  If there's an injection every day, there is no need to remember on which day the injection was.  However, after a couple of years, my doctor felt that I had more relapses than was acceptable to him.  There were also more new lesions showing up on my MRIs.
 
Because of this, my doctor felt that it was necessary to switch my medication.  I started taking Rebif.  As you can see from the information above, Rebif and Avonex are the same medication.  The difference is the dosage.  Rebif is a stronger dose of Avonex.
 
This medication was successful for a couple of years, until I had my last relapse...the worse one that I've had.  I blogged about my relapse when it was happening, in Jan/Feb '09.  After a treatment for the relapse finally worked, my doctor decided to switch my medication once again.  I am currently on Tysabri, which involves a monthly infusion.  Unbelievably, I haven't had a relapse in 2 1/2 years.

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