3 million IU / 0.5 ml solution for injection or infusion, interferon alfa-2b solution
1. What IntronA is and what it is used for
IntronA ( interferon alfa-2b) affects and helps the body’s immune system in the fight against infections and serious diseases.
IntronA is used in adult patients to treat certain diseases that affect the blood, bone marrow, lymph nodes, or skin and that can spread in the body. These include hairy cell leukemia, chronic myeloid leukemia, multiple myeloma, follicular lymphoma, carcinoids, and malignant melanoma.
IntronA is also used in adult patients to treat chronic hepatitis B or C, which are viral infections of the liver.
IntronA is used in combination with ribavirin in children 3 years of age and older and adolescents with untreated chronic hepatitis C.
2. What you need to know before you use IntronA
Do not use IntronA
- if you are allergic to interferon or any of the other ingredients of this medicine (listed in section 6).
- if you have any serious heart disease.
- if you have impaired kidney or liver function.
- if you have advanced decompensated (uncontrolled) liver disease.
- if you have hepatitis and have recently been treated with medicines that reduce the immune system (with the exception of short-term treatment with cortisone-type medicines).
- if you have had seizures (convulsions).
- if you have had an autoimmune disease or have had an organ transplant and are taking medicines that reduce your immune system (your immune system helps protect you against infection ).
- if you have a thyroid disease that is not well controlled.
- if you are being treated with telbivudine (see section “Other medicines and IntronA”).
Children and adolescents:
- If you have had severe mental disorders or disorders of the central nervous system , such as severe depression or suicidal thoughts.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using IntronA
- if you are pregnant or planning to become pregnant (see section “Pregnancy and breast-feeding”).
- if you are being treated for a mental illness or have been previously treated for another mental disorder or disorder of the central nervous system , including depression (such as feelings of heaviness, depression) or suicidal or murderous behavior (see section 4, “Possible side effects”). Interferon alfa-2b must not be used in children and adolescents who have or have had severe mental illness (see section “Do not use IntronA”).
- if you have cirrhosis or other liver problems (other than hepatitis B or C).
- if you have psoriasis , it may worsen during treatment with IntronA.
- when you use IntronA you may be at a higher risk of getting an infection . Tell your doctor if you think you are getting an infection .
- If you develop symptoms associated with a cold or other respiratory infections, such as fever, cough, or difficulty breathing, tell your doctor.
- If you notice an abnormal tendency for bleeding or bruising, tell your doctor immediately.
- If you develop symptoms of a severe allergic reaction (such as difficulty breathing, wheezing or hives) while taking this medicine, seek medical attention immediately.
- if you are also being treated for HIV (see section “Other medicines and IntronA”).
- if you have or have had hepatitis B, as your doctor may want to monitor you more closely.
- If you have had an organ transplant, either kidney or liver, interferon therapy may increase the risk of organ rejection. Discuss this with your doctor.
Dental and gum problems that can lead to tooth loss have been reported in patients receiving IntronA and ribavirin as combination therapy. In addition, dry mouth can have a detrimental effect on the teeth and oral mucosa during long-term treatment with the combination of IntronA and ribavirin. You should brush your teeth thoroughly twice daily and go for regular dental checkups. In addition, some patients may vomit. If you do, rinse your mouth thoroughly afterward.
Tell your doctor if you have ever had a heart attack or heart problem if you have had irregular breathing or pneumonia, problems with blood coagulation, liver problems, thyroid problems, diabetes, or high or low blood pressure.
Tell your doctor if you have ever been treated for depression or any other psychiatric illness, confusion or unconsciousness, thoughts of suicide, or if you have attempted suicide or been addicted (eg alcohol and drugs).
Tell your doctor if you are taking the Chinese herbal medicine shosaikoto.
Other medicines and IntronA
IntronA enhances the effect of substances that impair your ability to react and can cause drowsiness. Therefore, check with your doctor or pharmacist regarding the consumption of alcoholic beverages, sleeping pills, sedatives, or strong painkillers.
Tell your doctor if you are taking theophylline or aminophylline for asthma and if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as the dose of one of the certain medicines may need to be adjusted while you are being treated with IntronA.
Patients who are also HIV- infected: Lactic acidosis and worsening liver function are side effects associated with high-activity antiretroviral therapy (HAART), an HIV treatment. If you are receiving HAART treatment, the addition of IntronA and ribavirin may increase the risk of lactic acidosis and liver failure. Your doctor will monitor you for signs and symptoms of these conditions (also read the ribavirin package leaflet). In addition, patients treated with IntronA and ribavirin in combination with zidovudine may be at increased risk of developing anemia (low red blood cell count ).
If you take telbivudine with pegylated interferonalfa-2a or any type of injectable interferon product, you have a higher risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensation in the arms and/or legs). These side effects can also be more serious. Therefore, the combination of IntronA with telbivudine should not be used.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
IntronA with food, drink and alcohol
During treatment with IntronA, your doctor may want you to drink extra fluids to counteract low blood pressure.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. In studies in pregnant animals, interferon er has in some cases caused the miscarriage. The effect on pregnant women is unknown.
If you have been prescribed IntronA in combination with ribavirin, ribavirin can be very harmful to an unborn baby, therefore both female and male patients must take special precautions in their sexual intercourse if there is a risk of becoming pregnant:
– if you are a girl or woman of childbearing potential, you must show a negative pregnancy test before treatment, every month during treatment, and for 4 months after the end of treatment. You must use an effective contraceptive during the time you take ribavirin and for 4 months after stopping treatment. You can discuss this with your doctor.
– if you are a man taking ribavirin, you should not have sex with a pregnant woman unless you are using a condom. This reduces the risk of ribavirin remaining in the woman’s body. If your female partner is not pregnant now but is of childbearing potential, she must have a pregnancy test every month during treatment and for 7 months after treatment has ended. You can discuss this with your doctor. If you are a male patient, you or your partner must use an effective contraceptive during the time you take ribavirin and for 7 months after stopping treatment. You can discuss this with your doctor.
It is not known if this medicine is excreted in human milk. Therefore, you should not breastfeed your baby if you are taking IntronA. In combination with ribavirin, you should take into account what is stated in the information text for medicines containing ribavirin.
Driving and using machines
Do not drive or use any tools or machines if you become drowsy, tired, or confused by this medicine.
IntronA contains sodium
IntronA contains less than 1 mmol sodium (23 mg) per 0.5 ml, ie essentially ‘sodium-free’ . is essentially “sodium-free”.
3. How to use IntronA
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor has prescribed IntronA specifically for you and your current condition. Do not share this medicine with anyone else.
Your doctor has determined the correct dosage of IntronA according to your personal needs. Dosage one will vary depending on the disease you are being treated for.
If you are injecting IntronA yourself, make sure that the dose you have been prescribed is clearly stated on the medicine pack that you receive. Dosage to be given 3 times a week is best given every other day.
The normal starting dose for each condition is as follows, however, individual doses may vary and your doctor may change your dose based on your specific needs:
Chronic hepatitis B: 5 to 10 million IU 3 times a week (every other day) injected subcutaneously (under the skin).
Chronic hepatitis C: Adults – 3 million IU 3 times a week (every other day) injected subcutaneously (under the skin) in combination with ribavirin or as the sole treatment. Children 3 years of age or older and adolescents – 3 million IU / m 2 3 times a week (every other day) injected subcutaneously (under the skin) in combination with ribavirin (see also ribavirin package leaflet).
Hair cell leukemia: 2 million IU / m² 3 times a week (every other day) injected subcutaneously (under the skin).
Chronic myeloid leukemia: 4-5 million IU / m² daily injected subcutaneously (under the skin).
Multiple myeloma: 3 million IU / m² 3 times a week (every other day) injected subcutaneously (under the skin).
Follicular lymphoma: In addition to chemotherapy 5 million IU 3 times a week (every other day) injected subcutaneously (under the skin).
Carcinoid tumor: 5 million IU 3 times a week (every other day) injected subcutaneously (under the skin).
Malignant melanoma: Initial treatment: 20 million IU / m² is given daily intravenously 5 days a week for a 4-week period. Maintenance treatment: 10 million IU / m² 3 times a week (every other day) injected subcutaneously (under the skin).
Your doctor may prescribe another dose of IntronA alone or in combination with other medicines (eg cytarabine, ribavirin). If you are being prescribed IntronA in combination with another medicine, read the package leaflet for the medicine you are taking in combination for more information. Your doctor will determine the exact dosing schedule based on your needs. If you have the impression that the effect of IntronA is too strong or too weak, talk to your doctor or pharmacist.
Subcutaneous use:
IntronA is usually for subcutaneous use. This means that IntronA is injected with a short injection needle into the adipose tissue just under the skin. If you inject this medicine yourself, you will be given instructions on how to prepare and inject one. Detailed instructions for subcutaneous administration are included in this leaflet (see section “HOW TO INJECT INTRONA YOURSELF” at the end of this leaflet).
Intravenous infusion:
Infusion should be reconstituted immediately before use. Any size of the vial can be used to measure the calculated dose. However, the final dose of interferon in sodium chloride solution for infusion should not be less than 0.3 million IU / ml. The appropriate dose of IntronA is withdrawn from the vial (s) and added to 50 ml of sodium chloride 9 mg/ml (0.9%) solution for injection in a PVC bag or glass vial for intravenous use and given for 20 minutes.
No other drugs may be infused concomitantly with IntronA.
One dose of IntronA is given every set day. IntronA is given either daily (5 or 7 times a week) or three times a week, every other day, for example on Monday, Wednesday, and Friday. Interferons can cause unusual fatigue. If you inject yourself or give it to a child, do it at bedtime.
Always use IntronA exactly as your doctor has told you. Do not exceed the recommended dosage and use IntronA for as long as prescribed.
If you use more IntronA than you should
Tell your doctor or healthcare professional as soon as possible.
If you forget to use IntronA
If you are administering the treatment yourself or if you are helping a child to take IntronA in combination with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual. Do not take a double dose to compensate for a missed dose. If you are prescribed to inject this medicine every day and you accidentally miss a full daily dose, continue treatment with the usual dose the following day. If necessary, contact your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Although not all of these side effects occur, they may require medical attention if they do occur
| Mental disorders and central nervous system: Some people become depressed when taking IntronA, either alone or in combination with ribavirin, and in some cases, people have had thoughts of threatening others with life, suicidal thoughts, or aggressive behavior (sometimes directed at others). Some patients have committed suicide. Be sure to seek emergency care if you notice that you are depressed or have suicidal thoughts or that your behavior is changing. You may want to consider asking a family member or close friend for help in drawing attention to signs of depression or changes in your behavior. Children and adolescents are particularly prone to developing depression during treatment with IntronA and ribavirin. Contact a doctor immediately or seek emergency treatment if the child shows unusual behavioral symptoms, feels depressed, or has a feeling of wanting to harm themselves or others. |
| Growth and development (children and young people): During the one-year treatment with IntronA in combination with ribavirin, some children and adolescents did not grow or gain as much weight as expected. Some children did not reach the estimated length within 10‑12 years after completion of treatment. |
If any of the following side effects occur, stop taking IntronA and tell your doctor immediately or go to the emergency department of the nearest hospital:
- swelling of the hands, feet, ankles, face, lips, mouth or throat and which may cause difficulty in swallowing or breathing; hives, fainting.
They are all very serious side effects. If you get them, you may have had a severe allergic reaction to IntronA. You may need urgent medical attention or hospitalization. These very serious side effects are very rare.
Tell your doctor immediately if any of the following side effects occur:
- chest pain or persistent and severe cough, irregular or rapid heartbeat, shortness of breath, confusion, difficulty staying alert, numbness or tingling sensation or pain in hands or feet, seizures, difficulty sleeping, thinking or concentrating, altered state of mind, suicidal ideation, suicide attempts, altered behavior or aggressive behavior (sometimes directed at others), hallucinations, severe abdominal pain, black or tar-like stools, blood in stools or urine, heavy nosebleeds, wax-like pallor of the skin, high blood sugar, fever or chills that occur after several weeks of treatment , pain in the lower back or side, difficult urination, problems with your eyes, your vision or hearing, hearing loss, severe or painful rednessare or sores on the skin or mucous membranes.
These side effects can be a signal of serious side effects that may require urgent medical attention. Your doctor will take blood samples to make sure that the number of your white blood cells (cells that protect against infection ) and red blood cells (cells that carry iron and oxygen), platelets (cells that coagulate the blood), and other laboratory values are at acceptable levels. Moderate and usually transient decrease in all three blood cells ( white blood cells, red blood cells, and platelets ) has been reported.
At the beginning of IntronA treatment, you may experience flu-like symptoms with fever, fatigue, headache, muscle aches, joint pain, and chills/stiffness. Your doctor may recommend that you take paracetamol if you develop these symptoms.
Any side effects listed below are broken down by frequency:
| Very common | (occurs in more than 1 in 10 users) |
| Usual | (affects 1 to 10 users in 100) |
| Less common | (affects 1 to 10 users in 1,000) |
| Rare | (affects 1 to 10 users in 10,000) |
| Very rare | (occurs in less than 1 in 10,000 users) |
| No known frequency | (cannot be calculated from available data) |
The following side effects have been reported:
Very common side effects reported:
pain, swelling, and redness or skin damage at the injection site, hair loss, dizziness, changes in appetite, abdominal or abdominal pain, diarrhea, nausea (feeling sick), viral infection, depression, emotional instability, insomnia, anxiety, sore throat and pain when swallowing, fatigue, chills. , fever, flu-like reaction, general discomfort, headache, weight loss, vomiting, irritation, weakness, mood swings, cough (sometimes severe), shortness of breath, itching, dry skin, rash, sudden and severe muscle pain, joint pain, musculoskeletal pain, changes in laboratory blood counts including decreased white blood cell count. Some children have had a decrease in growth rate (height and weight).
Common side effects reported:
thirst, dehydration, high blood pressure, migraine, swollen glands, swelling, menstrual problems, decreased sexual drive, vaginal problems, chest pain, testicular pain, thyroid problems, red gums, dry mouth, red or sore mouth or tongue, toothache, or toothache, herpes simplex (fever blisters), taste change, upset stomach, indigestion (heartburn), constipation, liver enlargement (liver problems, sometimes severe), loose stools, bedwetting in children, sinusitis, bronchitis, eye pain, tear duct problems, conjunctivitis(“Red eyes”), anxiety, drowsiness, sleepwalking, behavior problems/problems, nervousness, stuffy or runny nose, sneezing, rapid breathing, pale or reddened skin, bruising, skin or nail problems, psoriasis (onset or worsening), increased sweating, increased need to urinate, tremors, decreased sensitivity to touch, arthritis.
Uncommon side effects reported:
bacterial infection, numbness and tingling sensation, and pericarditis (pericarditis).
Rarely reported side effects:
pneumonia
Very rarely reported side effects:
low blood pressure, swelling of the face, diabetes, calf cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anemia. Lack of red blood cells, a condition in which the body stops or reduces the production of red blood cells, has been reported. This can cause severe anemia with symptoms that may include unusual tiredness and lack of energy.
In very rare cases, sarcoidosis has been reported (a disease characterized by persistent fever, weight loss, joint pain and swelling, skin changes, and swollen glands ). Unconsciousness has occurred in very rare cases, in most cases in elderly patients treated with high doses. Cases of stroke (cerebrovascular events) have been reported. Tell your doctor immediately if you have any of these symptoms.
No known frequency of side effects:
The disease of the tooth root (gums are attacked) and dental problems, discoloration of the tongue, altered state of mind, loss of consciousness, acute hypersensitivity reaction including urticaria (hives), angioedema (swollen hands, feet, ankles, face, lips, mouth or throat, which can lead to swallowing or breathing), bronchoconstriction and anaphylaxis (a severe allergic reaction affecting the whole body) have been reported, but it is unknown how common they are.
In addition, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disease that affects the eyes, skin, and membranes of the ears, brain, and spinal cord), thoughts of threatening others to live, manic states (excessive or unfounded enthusiasm), bipolar disorder (mood changes) characterized by alternation between depression and mood), congestive heart failure, pericardial effusion (a fluid that occurs between the pericardium and the heart itself), pulmonary fibrosis (scarring of the lungs) and reactivation of hepatitis B patients co-infected with HCV / HBV (relapse of hepatitis B) reported using IntronA.
Pulmonary arterial hypertension – a disease with severe narrowing of the blood vessels of the lungs that leads to high blood pressure in the blood vessels that transport blood from the heart to the lungs. This may in particular occur in patients with risk factors such as HIV – infection or serious liver problems ( cirrhosis ). Side effects can develop at different times during treatment, usually several months after starting treatment with IntronA.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store IntronA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
During short trips, the liquid can be stored outside the refrigerator at or below 25 ° C for up to seven days before use. IntronA can be returned to the refrigerator at any time during this seven-day period. If the medicine is not used during this seven-day period, it should be discarded.
Do not use this medicine if you notice any change in the appearance of IntronA.
Any remaining medicine must be discarded after a dose has been withdrawn.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is recombinant interferon alfa-2b. One vial contains 3 million IU in 0.5 ml solution.
- The other ingredients are anhydrous disodium phosphate, sodium dihydrogen phosphate monohydrate, sodium edetate, sodium chloride, m-cresol, polysorbate 80 and water for injections.
What the medicine looks like and contents of the pack
IntronA is available as a solution for injection or infusion solution
The clear and colorless solution is available in a glass vial.
IntronA is available in four-pack sizes:
- Pack of 1 vial
- Pack of 1 vial , 1 syringe (1 ml), 1 needle and 1 cleaning cloth
- Pack of 6 vials, 6 syringes (1 ml), 6 syringes and 6 cleaning wipes
- Pack of 12 vials, 12 syringes (1 ml), 12 syringes and 12 cleaning wipes
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
| Marketing Authorization Holder: Merck Sharp & Dohme BVWaarderweg 392031 BN Haarlem Netherlands | Manufacturer :SP Labo NVIndustrial Park 30B-2220 Heist-op-den-BergBelgium |
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgique / België / BelgienMSD BelgiumTel: +32 (0) 27766211dpoc_belux@merck.com | LithuaniaUAB Merck Sharp & DohmeTel .: +370 5 278 02 47msd_lietuva@merck.com |
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| GermanyMSD Sharp & Dohme GmbHTel: 0800 673 673 673 (+49 (0) 89 4561 2612)email@msd.de | The NetherlandsMerck Sharp & Dohme BVTel: 0800 9999000 (+31 23 5153153)medicalinfo.nl@merck.com |
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