Intron A

The recommended dose and dosing schedule of interferon alfa-2b varies according to the specific condition being treated, the response to therapy, the side effects experienced, and the other medications or treatments being used. The dose administered is also based on body size. It is usually injected under the skin (subcutaneous or SC) or into a muscle (intramuscular or IM).

If you are giving yourself injections, it is very important that you carefully follow the doctor's instructions and the instructions included with the medication. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject Intron A (Interferon-alfa-2b) on your own until you completely understand how to inject a dose.

Do not change the way that you are using the medication without consulting your doctor.

It is important to use Intron A (Interferon-alfa-2b) exactly as prescribed by your doctor. If you miss a dose of Intron A (Interferon-alfa-2b), use it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. 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.

Store Intron A (Interferon-alfa-2b) in the refrigerator at 2°C to 8°C, do not allow it to freeze, and keep it out of the reach of children.

If necessary, the powder form of Intron A (Interferon-alfa-2b) can be kept at room temperature (up to 25°C) for up to 4 weeks before using. After 4 weeks, it cannot be put back in the refrigerator for a new storage period and should be discarded.

If the powder form is mixed with bacteriostatic water for injection (preserved with benzyl alcohol), it can be stored in the refrigerator (2°C to 8°C) for up to 30 days or at room temperature (15°C to 30°C) for up to 14 days. After these time periods, discard any unused portion. If the powder form of Intron A (Interferon-alfa-2b) is mixed with sterile water for injection, it should be used as soon as possible within 3 hours.

The 10M unit vial solution for injection should be stored in the refrigerator at 2°C to 8°C for up to 7 days after the first use.

The 18M unit and 25M unit solution vials should be stored in the refrigerator at 2°C to 8°C for up to 4 weeks after the first use. The vials can be stored at room temperature (up to 25°C) for a period of 7 days before use and can be put back in the refrigerator at any time during this 7-day period. If the product is not used during the 7-day period, it cannot be put back in the refrigerator for a new storage period and should be discarded.

The multi-dose pens should be stored in the refrigerator at 2°C to 8°C. Each pen is intended for a maximum 4-week use period and then must be discarded. A new needle must be used for each dose. After each use, the needle should be discarded safely, and the pen must be returned to the refrigerator immediately. If the pen is accidentally left at temperature (15°C to 25°C), a maximum total of 48 hours (2 days) of exposure at room temperature is allowed over the 4-week use period.

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.

Lyophilized powder with diluent

10M unit
Each vial contains 10M units of interferon alfa-2b, aminoacetic acid, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and human Albumin, and 1 vial of 1 mL sterile water for injection.

18M unit
Each vial contains 18M units of interferon alfa-2b, aminoacetic acid, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and human albumin, and 1 vial of 1 mL sterile water for injection.

Ready-to-use solution vial

10M and 25M unit
Each vial contains 10M units or 25M units of interferon alfa-2b, in which each mL contains 10M units of interferon alfa-2b. Nonmedicinal ingredients: edetate disodium, m-cresol, polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and water for injection. This product does not contain human albumin.

18M unit
Each vial contains 18M units of interferon alfa-2b, in which each mL contains 6M units of interferon alfa-2b. Nonmedicinal ingredients: edetate disodium, m-cresol, polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and water for injection. This product does not contain human albumin.

Solution for injection, multi-dose pen

18M units
Each glass carpoule contains 18 M units (15M units/mL) of interferon alfa-2b. Nonmedicinal ingredients: edetate disodium, m-cresol, polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and water for injection. This product does not contain human albumin.

30M units
Each glass carpoule contains 30M units (25M units/mL) of interferon alfa-2b. Nonmedicinal ingredients: edetate disodium, m-cresol, polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and water for injection. This product does not contain human albumin.

60M units
Each glass carpoule contains 60M units (50M units/mL) of interferon alfa-2b. Nonmedicinal ingredients: edetate disodium, m-cresol, polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and water for injection. This product does not contain human albumin.

Do not use Intron A (Interferon-alfa-2b) if you:

• are allergic to interferon or any ingredients of Intron A (Interferon-alfa-2b)
• have autoimmune hepatitis (hepatitis caused by your immune system attacking your liver)
• have severely reduced kidney function and are taking ribavirin
• have unstable liver disease

There may be an interaction between interferon alfa-2b and any of the following:

• anticancer medications (e.g., Methotrexate, Doxorubicin, Vincristine)
• BCG
• Clozapine
• dipyrone
• Methadone
• ribavirin
• telbivudine
• theophyllines (e.g., Aminophylline, oxtryphylline, Theophylline)
• Tizanidine
• 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 Intron A (Interferon-alfa-2b). 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 Intron A (Interferon-alfa-2b).

Autoimmune conditions: Intron A (Interferon-alfa-2b) may cause or worsen autoimmune conditions (e.g., thyroiditis, systemic Lupus erythematosus). If you develop any new or worsening symptoms while using Intron A (Interferon-alfa-2b), contact your doctor.

Blood glucose (sugar): Intron A (Interferon-alfa-2b) can cause high blood sugar. If you have Diabetes, discuss with your doctor how Intron A (Interferon-alfa-2b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Intron A (Interferon-alfa-2b), and whether any special monitoring is needed.

If you experience symptoms of high blood sugar (increased thirst, hunger, weakness, drowsiness, blurred vision, weight loss) while taking Intron A (Interferon-alfa-2b), contact your doctor.

Colon disorders: Intron A (Interferon-alfa-2b) may cause certain types of colitis. Report any stomach or abdominal pain, bloody diarrhea, or fever to your doctor immediately.

Depression and other mental health disorders: If you have or have had depression or any other mental health issue (e.g., Schizophrenia, Obsessive Compulsive Disorder, substance abuse), your doctor should closely monitor your condition while you are using Intron A (Interferon-alfa-2b). If you develop severe depression or experience other mood or behaviour changes, stop using Intron A (Interferon-alfa-2b) and contact your doctor immediately. If you have thoughts or feelings about harming yourself, get immediate medical attention.

Dental health: If you are taking ribavirin and are using Intron A (Interferon-alfa-2b), you may be more likely to have dental health issues. It is important to brush your teeth thoroughly twice a day and have regular dental exams if you are taking ribavirin and Intron A (Interferon-alfa-2b). If you vomit, rinse your mouth out thoroughly to reduce damage to teeth.

Diabetes: Intron A (Interferon-alfa-2b) can cause changes in blood sugar levels. If you have diabetes, discuss with your doctor how Intron A (Interferon-alfa-2b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Intron A (Interferon-alfa-2b), and whether any special monitoring is required.

Drowsiness, fatigue or confusion: Since Intron A (Interferon-alfa-2b) can cause side effects such as drowsiness, fatigue and confusion, you should not drive or operate machinery until you know that Intron A (Interferon-alfa-2b) does not affect your ability to do these activities safely.

Eye disorders: Certain eye disorders have been observed in people using Intron A (Interferon-alfa-2b). You should have an eye examination before starting Intron A (Interferon-alfa-2b) and periodically during treatment. If you experience any changes in vision (e.g., vision loss, blurred vision) while using Intron A (Interferon-alfa-2b), contact your doctor.

Fever and flu-like symptoms: Intron A (Interferon-alfa-2b) can cause fever and other flu-like symptoms such as chills and headache. If you have heart disease (e.g., unstable Angina, uncontrolled heart failure), lung disease (e.g., chronic Bronchitis, emphysema) or have unstable diabetes, discuss with your doctor how Intron A (Interferon-alfa-2b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Intron A (Interferon-alfa-2b), and whether any special monitoring is needed. Your doctor may suggest that you take Acetaminophen if you develop these symptoms.

If you have a persistent fever while using Intron A (Interferon-alfa-2b), contact your doctor.

Heart disease: Interferon alfa-2b can cause chest pain, high blood pressure, an abnormal heart rhythm, or a heart attack. If you have severe heart disease, or have had severe heart disease in the last 6 months, you should not use Intron A (Interferon-alfa-2b).

If you have heart disease (e.g., heart failure, heart attack, or an abnormal heart rhythm) or have AIDS-related sarcoma, discuss with your doctor how Intron A (Interferon-alfa-2b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Intron A (Interferon-alfa-2b), and whether any special monitoring is needed.

If you experience symptoms of heart problems such as chest pain, an abnormal heart rhythm, shortness of breath, dizziness or fainting while using Intron A (Interferon-alfa-2b), contact your doctor immediately or get immediate medical attention.

Infection: Intron A (Interferon-alfa-2b) can reduce the number of cells that fight infection in the body (white blood cells). Your doctor will monitor your white blood cell counts while you are using Intron A (Interferon-alfa-2b), especially if your immune system is suppressed (e.g., if you have an immune system problem or are taking medication that suppresses the immune system). Avoid contact with people with contagious infections and tell your doctor if you begin to notice signs of an infection, such as fever or chills.

Kidney function: Kidney Disease or reduced kidney function may cause Intron A (Interferon-alfa-2b) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Intron A (Interferon-alfa-2b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Intron A (Interferon-alfa-2b), and whether any special monitoring is needed.

If you have severely reduced kidney function, your doctor will regularly monitor your kidney function with blood tests.

Liver disorders: Intron A (Interferon-alfa-2b) may affect your liver function. If you have chronic hepatitis B, discuss with your doctor how Intron A (Interferon-alfa-2b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Intron A (Interferon-alfa-2b), and whether any special monitoring is needed.

If you have unstable liver disease, you should not use Intron A (Interferon-alfa-2b).

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking Intron A (Interferon-alfa-2b). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking interferon alfa-2B contact your doctor immediately.

Pancreatitis (inflammation of the pancreas): Intron A (Interferon-alfa-2b) can cause pancreatitis, which may be fatal. If you develop symptoms of pancreatitis (e.g., severe abdominal with or without vomiting), get immediate medical attention.

Skin problems: Intron A (Interferon-alfa-2b) may worsen psoriasis or sarcoidosis. If you have these conditions, discuss with your doctor how Intron A (Interferon-alfa-2b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Intron A (Interferon-alfa-2b), and whether any special monitoring is needed.

Stroke: Intron A (Interferon-alfa-2b) has been associated with strokes. If you experience symptoms of a stroke (e.g., sudden and severe headache, sudden weakness or numbness in the arms or legs, sudden vision changes, sudden dizziness, or sudden difficulty talking or walking), get immediate medical attention.

Thyroid disorders: Intron A (Interferon-alfa-2b) can cause or worsen hypothyroidism (low thyroid) or Hyperthyroidism (high thyroid). If you have a thyroid condition, discuss with your doctor how Intron A (Interferon-alfa-2b) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Intron A (Interferon-alfa-2b), and whether any special monitoring is needed.

Transplants: The safety and effectiveness of using Intron A (Interferon-alfa-2b) have not been established for people who have had a liver or other organ transplant.

Triglycerides: Intron A (Interferon-alfa-2b) may increase the triglyceride (a type of fat) levels in your blood. Your doctor will monitor for this with blood tests.

Pregnancy: Intron A (Interferon-alfa-2b) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Intron A (Interferon-alfa-2b), contact your doctor immediately. If you may become pregnant, you should use an effective method of birth control while you are using Intron A (Interferon-alfa-2b).

Breast-feeding: It is not known if interferon alfa-2b passes into breast milk. If you are a breast-feeding mother and are using Intron A (Interferon-alfa-2b), 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 Intron A (Interferon-alfa-2b) have not been established for children and adolescents less than 18 years of age.