Extavia

The recommended adult dose of interferon beta-1b is 0.25 mg (8 MIU) injected subcutaneously (under the skin) every other day. In some cases, the doctor may prescribe a lower dose to start, and gradually increase the dose until the recommended adult dose has been reached.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Interferon beta-1b is used with the guidance and supervision of a doctor. Your doctor or nurse may ask you to inject the medication at home once they have instructed you and are certain that you won't have any problems with doing it at home. Do not attempt to prepare or inject Extavia (Interferon-beta-1b) on your own until you completely understand how to mix and inject a dose.

Use a different injection site for each dose. You should avoid injecting Extavia (Interferon-beta-1b) into an area of skin that is sore, red, infected, or otherwise damaged. If you are having difficulty giving yourself injections, talk to your health care provider.

It is important that Extavia (Interferon-beta-1b) be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible. Your next injection should be given about 48 hours after the first dose. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

See the package insert for instructions on choosing the injection site, preparing the injection, and injecting the medication. Before mixing, interferon beta-1b should be kept at temperatures between 2°C and 25°C. Excursions between 25°C and 30°C are permitted as long as they do not exceed a maximum of 30 days. Do not freeze. After mixing, the vial or syringe containing the medication should be kept in a refrigerator and used within 3 hours.

Protect Extavia (Interferon-beta-1b) from light, moisture, freezing and high temperatures. Keep Extavia (Interferon-beta-1b) out of reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea or constipation, depending on the person; it may cause unusual tiredness; it may cause flu-like symptoms; it may cause redness and swelling at the injection site. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each single-use vial of lyophilized powder contains 0.3 mg (9.6 MIU) interferon beta-1b. Nonmedicinal ingredients: 15 mg Albumin human USP and 15 mg mannitol USP. Each prefilled diluent syringe contains sodium chloride 0.54%.

Do not use interferon beta-1b if you:

• are allergic to interferon beta-1b or any ingredients of the medication
• are or may be pregnant
• have severe Depression or ideas of self harm
• have severe liver disease

Do not give Extavia (Interferon-beta-1b) to children and adolescents less than 18 years of age.

There may be an interaction between interferon beta-1b and any of the following:

• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• zidovudine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Extavia (Interferon-beta-1b). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Extavia (Interferon-beta-1b).

Blood counts: Extavia (Interferon-beta-1b) can decrease the number of neutrophils (a type of white blood cell that helps fight infection) and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, contact your doctor immediately.

Depression: Depression has been reported by some people taking interferon medications. If you have a history of depression, discuss with your doctor how Extavia (Interferon-beta-1b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Extavia (Interferon-beta-1b), and whether any special monitoring is needed.

If you have depression you should be closely monitored by your doctor. If symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or thoughts of suicide occur while taking Extavia (Interferon-beta-1b) contact your doctor as soon as possible. If you notice any of these symptoms in a family member who is taking Extavia (Interferon-beta-1b) contact your doctor as soon as possible.

Heart problems: Extavia (Interferon-beta-1b) may worsen symptoms of heart disease. If you have heart disease such as Angina, Congestive Heart Failure, or arrhythmia, discuss with your doctor how Extavia (Interferon-beta-1b) may affect the medical condition, how the medical condition may affect the dosing and effectiveness of Extavia (Interferon-beta-1b), and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Kidney function: Interferon beta 1-b can cause changes to kidney function. If you have decreased kidney function, discuss with your doctor how Extavia (Interferon-beta-1b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Extavia (Interferon-beta-1b), and whether any special monitoring is needed.

If you experience puffy hands, face or feet, high blood pressure, unusual muscle cramping, or darkened urine, contact your doctor as soon as possible.

Liver function: Extavia (Interferon-beta-1b) may cause severe liver damage. Although rare, this side effect can be very serious. If you have a history of poor liver function, alcohol abuse, or active liver disease, discuss with your doctor how Extavia (Interferon-beta-1b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Extavia (Interferon-beta-1b), and whether any special monitoring is needed.

Your doctor will test your liver function regularly while you are taking Extavia (Interferon-beta-1b). Contact your doctor as soon as possible if you notice any of the signs of liver damage, including yellow eyes or skin, easy bruising of the skin, nausea and vomiting, itching, or abdominal pain.

Pancreatitis: Extavia (Interferon-beta-1b) may cause inflammation of the pancreas (pancreatitis). If you have a history of pancreatitis or are at risk for developing pancreatitis, discuss with your doctor how Extavia (Interferon-beta-1b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Extavia (Interferon-beta-1b), and whether any special monitoring is needed. If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.

Seizures: Some people have had seizures while taking Extavia (Interferon-beta-1b), including patients who have never had seizures before. It is not known whether the seizures were related to the effects of their MS, to the medication, or to the combination of both. If you have a seizure disorder, discuss with your doctor how Extavia (Interferon-beta-1b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Extavia (Interferon-beta-1b), and whether any special monitoring is needed. If you have a seizure while taking Extavia (Interferon-beta-1b), you should call your doctor right away.

Thyroid problems: Some people taking Extavia (Interferon-beta-1b) develop changes in the function of their thyroid. Symptoms of these changes include feeling cold or hot all the time, a change in weight (gain or loss) without a change in your diet or amount of exercise you get, or feeling emotional. Contact your doctor if you experience these symptoms.

Pregnancy: Extavia (Interferon-beta-1b) should not be used during pregnancy. If you become pregnant while taking Extavia (Interferon-beta-1b), contact your doctor immediately. Women who may become pregnant should use effective contraception while taking Extavia (Interferon-beta-1b).

Breast-feeding: It is not known if interferon beta-1b passes into breast milk. If you are a breast-feeding mother and are taking Extavia (Interferon-beta-1b), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of using Extavia (Interferon-beta-1b) have not been established for children and adolescents less than 18 years of age.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. Use this medication regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this. If you drink alcohol, a moderate consumption is recommended. Talk to your health care professional to find out exactly how much alcohol you can drink.