"The European Medicines Agency (EMA) has launched a review of the six direct-acting antivirals approved for use in the European Union for treating chronic hepatitis C virus infection, the agency said today.
They are daclatasvir (Dak"...
Pegasys Consumer (continued)
Flu-like symptoms (e.g., fever, chills, muscle aches, fatigue, headache, joint pain, nausea, stomach pain, cough) may occur. If instructed to do so, you may take pain/fever-reducing medications (e.g., acetaminophen, ibuprofen) to help with these symptoms. Dry mouth, loss of appetite, weight loss, trouble sleeping, diarrhea, dry skin, or redness/swelling at the injection site may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Tooth and gum problems may sometimes occur during treatment. Having a dry mouth can worsen this side effect. Prevent dry mouth by drinking plenty of water or using a saliva substitute. Brush your teeth well at least twice a day and have regular dental exams. If you experience vomiting during treatment, rinse your mouth afterwards to lessen the chance of tooth and gum problems.
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: persistent sore throat or fever, easy or unusual bleeding/bruising, unusually severe fatigue, unusually slow/fast/pounding heartbeat, severe stomach pain with nausea/vomiting, black/tarry stools, vomit that looks like coffee grounds, yellowing eyes or skin, dark urine, increased thirst/urination, bloody diarrhea, numbness/tingling of arms/legs.
Get medical help right away if you have any very serious side effects, including: chest pain, vision changes (such as blurred vision, partial loss of vision), seizures, slurred speech, weakness on one side of the body.
This drug may cause you to develop serious mental/mood changes that may get worse during treatment or after your last dose. Tell your doctor right away if you have symptoms such as confusion, depression, suicidal thoughts, unusual irritability, or aggressive behavior. If this occurs, psychiatric therapy and monitoring is recommended during and after treatment with this medication.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Pegasys (peginterferon alfa-2a) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before using peginterferon alfa-2a, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol (PEG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before taking this medication, tell your doctor or pharmacist your medical history, especially of: other liver problems (e.g., autoimmune hepatitis), mental/mood disorders (e.g., depression), low blood counts (e.g., red cells, white cells, or platelets), heart disease, thyroid problems, autoimmune disease (e.g., rheumatoid arthritis, lupus, psoriasis), eye problems, kidney disease, lung disease (e.g., COPD, asthma, pneumonia), history of cancer, intestinal disease ( e.g., colitis), pancreatitis, history of drug/alcohol abuse, diabetes, other infections (e.g., HIV, hepatitis B, chickenpox), high blood triglyceride levels, history of organ transplant.
Do not have immunizations/vaccinations without the consent of your doctor.
Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised, or injured.
This drug may make you drowsy or dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
This medicine may cause stomach bleeding. Daily use of alcohol and this medicine may increase your risk for stomach bleeding.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Children may be more sensitive to the side effects of this drug, especially mental/mood changes (such as severe depression, thoughts/attempts of suicide). Peginterferon and ribavirin may also slow down a child's rate of growth. Normal weight gain and rate of growth usually return after treatment is completed but the final adult height may be lower than expected. Monitor your child's height and weight periodically during treatment.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.
Peginterferon alfa-2a is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control.
Peginterferon alfa-2a, when used in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may cause harm to an unborn baby. Two reliable forms of birth control (such as condoms, birth control pills) must be used whenever at least one sexual partner is using these medicines together, and for at least 6 months after stopping treatment. If you or your partner become pregnant, or if you think you or your partner may be pregnant, tell your doctor immediately.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Additional Pegasys Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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