Interferon alfa-2b (Injection)

Interferon alfa-2b (Injection) is used to treat hepatitis B and C, lymphoma (lymph node cancer), malignant melanoma (skin cancer), genital warts, hairy cell leukemia (blood cell cancer), and Kaposi sarcoma (AIDS-related tumor). Interferons are substances made by cells in the body to help fight infections and tumors. Interferon alfa-2b is a synthetic (man-made) version of these substances.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to look for unwanted effects.

Using interferon alfa-2b (Injection) with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using them when his partner becomes pregnant. If you become pregnant while using these medicines, tell your doctor right away.

Women of childbearing age must have a negative pregnancy test before starting combination therapy with interferon alfa-2b (Injection) and ribavirin. Female patients and female partners of male patients must use 2 forms of birth control during therapy and for 6 months after therapy ends. Female patients must have regular pregnancy tests during combination therapy.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat.

Interferon alfa-2b (Injection) can temporarily lower your white blood cell count, increasing the risk of infection. It can also lower your platelet count, which is necessary for proper blood clotting. If this happens, there are certain precautions you can take to reduce the risk of infection or bleeding, especially when your blood count is low:

• If possible, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in your urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Check with your doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or situations where bruising or injury could happen.

This medicine can increase thoughts of suicide in people with or without a history of mental illness. It may also cause relapse in people with a history of substance abuse. Tell your doctor right away if you start to feel more depressed or show aggressive behavior. Also tell your doctor right away if you have thoughts of hurting yourself or others. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act recklessly. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects during treatment and up to 6 months after treatment, tell your doctor right away.

The powder form of this medicine contains albumin, which comes from human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Both human donors and donated blood are tested for viruses to keep the transmission risk low. Discuss this risk with your doctor if you have questions.

Check with your doctor if you experience blurred vision, decreased vision, or any other change in vision during your treatment. Your doctor may want you to see an ophthalmologist (eye doctor).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may make you tired or unable to concentrate. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Interferon alfa-2b (Injection) and ribavirin combination may cause a dry mouth. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Some patients who have used this medicine with ribavirin have experienced vomiting. If you vomit during or after your treatment, rinse your mouth out with water. This may also help prevent damage to your teeth and gums.

Children who use interferon alfa-2b and ribavirin combination may experience weight loss and slowed growth. Most children have a growth spurt and gain weight after therapy ends. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks versus the benefits of the medicine. Here are some important points to think about:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

Studies so far have not shown any specific problems in children aged 1 to 17 years with hepatitis B or children aged 3 to 16 years with hepatitis C that would limit the use of interferon alfa-2b (Injection).

However, studies have not been done to understand how age affects the use of interferon alfa-2b (Injection) in children with lymphoma, malignant melanoma, genital warts, hairy cell leukemia, and Kaposi sarcoma. Safety and effectiveness have not been established for these conditions.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the use of interferon alfa-2b (Injection). However, elderly patients may have age-related issues with the liver, kidneys, bone marrow, or heart, which could require careful monitoring and possible dose adjustments while using interferon alfa-2b (Injection).

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together with caution. If you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant and may not include all possible interactions.

Using this medicine with the following medicine is not recommended. Your doctor may choose not to treat you with this medication or may change some of your other medicines.

• Fezolinetant

Using this medicine with the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Bendamustine
• Clozapine
• Pirfenidone
• Triclabendazole

Using this medicine with the following medicine may increase the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed, your doctor may change the dose or frequency of one or both of the medicines.

• Ribavirin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Autoimmune disorders (e.g., psoriasis, Raynaud disease, rhabdomyolysis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, or vasculitis) or
• Blood clotting problems (e.g., pulmonary embolism, thrombophlebitis) or
• Bone marrow problems or
• Bowel problems (e.g., colitis) or
• Depression or mental illness, history of or
• Diabetes or
• Diabetic retinopathy (diabetic eye problem) or
• Eye or vision problems (e.g., retinopathy, optic neuritis) or
• Heart attack, history of or
• Heart or blood vessel disease, history of or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertensive retinopathy (eye problem caused by high blood pressure) or
• Hypertriglyceridemia (high triglycerides in the blood) or
• Hypotension (low blood pressure) or
• Severe liver disease (including cirrhosis) or
• History of lung disease or other breathing problems (e.g., COPD) or
• Stroke, history of or
• Thyroid problems—Use with caution. May worsen these conditions.

• Autoimmune hepatitis (liver inflammation) or
• Human immunodeficiency virus (HIV) infection or
• Severe kidney disease or
• Liver or other organ transplant or
• Sickle cell anemia (red blood cell disorder) or
• Thalassemia major (genetic blood disorder) or
• Weakened immune system—Should not be used in these patients.

• Kidney disease—Use with caution. The effects may be stronger due to slower elimination of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Depression
• difficult or labored breathing
• swelling or puffiness of the face
• tightness in the chest
• weight loss

Less common

• Back, leg, or stomach pains
• bleeding, tender, or enlarged gums
• bloody, black, or tarry stools
• bloody nose
• bloody or cloudy urine
• blurred vision
• change in personality
• changes in behavior
• chest pain, discomfort, or heaviness
• chills
• clay-colored stools
• confusion as to time, place, or person
• constipation
• cough producing mucus
• coughing or spitting up blood
• dark urine
• decreased urination
• diarrhea
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fainting
• fast, slow, pounding, irregular, or racing heartbeat or pulse
• feeling, seeing, or hearing things that are not there
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• fever
• hallucinations
• headache
• hearing loss
• heavier menstrual periods
• hives or rash
• hoarseness or husky voice
• inability to speak
• increased thirst
• increased urination
• indigestion
• irritability
• itching, pain, redness, or swelling of the skin
• light-colored stools
• lightheadedness
• loss of appetite
• loss of consciousness
• loss of hearing
• lower back or side pain
• metallic taste
• muscle aches or cramps
• nausea or vomiting
• pale skin
• passing of gas
• pinpoint red spots on the skin
• seizures
• severe mood or mental changes
• severe stomach pain with nausea and vomiting
• slow speech
• sneezing
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stiffness of the limbs
• stomach cramps, tenderness, or discomfort
• stomach pain, continuing
• stomach upset
• sweating
• swelling around the eyes
• swelling of the face, fingers, hands, ankles, feet, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• thoughts of hurting or killing oneself
• trouble sleeping
• unusual behavior
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain
• yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• bleeding gums
• blistering, crusting, irritation, itching, or reddening of the skin
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste, or bad, unusual, or unpleasant (after) taste
• cracked, dry, or scaly skin
• hair loss or thinning of the hair
• irritation in the mouth
• joint pain
• lack or loss of strength
• loss of memory
• muscle or bone pain
• pain or tenderness around the eyes and cheekbones
• poor concentration
• problems with memory
• redness and swelling of the gums
• stuffy or runny nose
• swollen joints

Less common

• Abnormal ejaculation
• absent, missed, or irregular menstrual periods
• bleeding, burning, inflammation, itching, or pain at the injection site
• bone deformity
• burning, itching, and pain in the hairy areas, pus at the root of the hair
• burning, numbness, pain, or tingling in all fingers except smallest finger
• cold and clammy skin
• decrease in height
• decreased interest in sexual intercourse
• degenerative disease of the joint
• difficulty with moving or walking
• discoloration of the skin
• inability to have or keep an erection
• increased clear or white vaginal discharge
• increased sensitivity of the skin to sunlight
• itching or pain of the genital area
• leg cramps
• longer menstrual periods
• loss in sexual ability, desire, drive, or performance
• multiple swollen and inflamed skin lesions
• pain in the ankles or knees
• pain in the ribs
• pain, inflammation, or swelling in the calves, shoulders, or hands
• painful, red lumps under the skin, mostly on the legs
• pelvic pain
• rash with flat lesions or small raised lesions on the skin
• red or irritated eyes
• redness or swelling in the arms or legs
• redness, tenderness, itching, burning, or peeling of the skin
• severe sunburn
• shivering
• skin rash, encrusted, scaly, and oozing small lumps under the skin
• small lumps under the skin
• soreness of the muscles
• stopping of menstrual bleeding
• swelling or redness in the joints
• tanning or blue-gray discoloration of the skin
• tearing of the eyes
• underactive reflexes
• unexpected menstrual bleeding

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Intron A

Pharmacologic Class: Interferon, Alfa (class)

A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin, into a muscle or vein, or directly into a skin lesion.

If you are injecting interferon alfa-2b yourself, use it exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve your condition.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

This medicine comes in a vial (glass container) or prefilled syringe. You might not use all of the medicine in each vial or syringe. Use them only one time and do not save an open vial or syringe. If the medicine has changed color or has particles in it, do not use it.

The solution in the vial or prefilled syringe should be allowed to warm to room temperature before injecting it.

Use a new needle and syringe each time you inject your medicine.

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

This medicine comes with a Medication Guide. Read this information carefully and make sure you understand:

• How to prepare the injection.
• The proper use of disposable syringes.
• How to give the injection.
• How long the injection is stable.

If you have any questions about any of this information, talk with your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.