"The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
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Paraplatin Consumer (continued)
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: numbness or tingling in the hands/feet, mouth sores, yellowing eyes/skin, dark urine, unusual tiredness, change in the amount of urine, pain/swelling/redness at the injection site, hearing problems (e.g., ringing in the ears, hearing loss), easy bruising/bleeding, blood in the urine, black/bloody stools, fast/irregular heartbeat.
Rarely, temporary vision loss may occur with high doses of carboplatin. Normal vision usually returns within several weeks after the end of treatment. Consult your doctor or pharmacist for more details and report this side effect immediately if it occurs.
This medication can lower your body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.
A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: 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 Paraplatin (carboplatin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using carboplatin, tell your doctor or pharmacist if you are allergic to it, or to cisplatin; 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, mineral imbalance (low blood levels of sodium, potassium, magnesium, calcium).
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.
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.
Wash your hands well to prevent the spread of infections.
The elderly may be more sensitive to the side effects of this drug, especially to bleeding problems and numbness/tingling of the hands/feet.
Children may be at greater risk for hearing loss when carboplatin is used at higher-than-recommended doses in combination with other medications that may affect hearing.
This medication can affect sperm production in men. Therefore, men should use a reliable form of birth control during treatment and for some time afterwards. Consult your doctor for more details.
This medication is not recommended for use during pregnancy. It may cause harm to an unborn baby. Women of childbearing age should use reliable form(s) of birth control during treatment and for some time afterwards. Consult your doctor for more details.
It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Additional Paraplatin Information
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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