"The U.S. Food and Drug Administration approved the cancer drug Afinitor (everolimus) on Friday to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), a rare genetic disorder. This approval was f"...
Zortress Consumer (continued)
Constipation, headache, nausea, and sores in the mouth/throat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor right away if you have any serious side effects, including: swelling hands/ankles/feet, wound problems (such as infection, slow wound healing, opening of wound), decreased sexual ability (in men), chest pain/pressure, shortness of breath, unusual bruising/bleeding.
This medication may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur: clumsiness, loss of coordination, weakness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving your muscles, problems with speech, seizure, vision changes.
This medication has caused very serious (rarely fatal) lung problems. Tell your doctor right away if you have symptoms of lung problems, such as shortness of breath, chest pain.
Everolimus may cause your cholesterol/triglycerides or blood sugar to increase. You may be required to have your cholesterol/triglycerides or blood sugar checked periodically. You may need medication to control your cholesterol/triglycerides or blood sugar. Tell your doctor or pharmacist if you experience symptoms of high blood sugar, including increased thirst/hunger, frequent urination.
This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.
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 Zortress (everolimus) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before taking everolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus or temsirolimus; 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 using this medication, tell your doctor or pharmacist your medical history, especially of: high cholesterol/triglyceride levels, any recent/current infections, diabetes, liver disease, certain hereditary enzyme problems (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption).
Everolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Since this medication may increase your risk of skin cancer, avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication and for 8 weeks after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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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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