Temsirolimus is a cancer medication. It slows the growth and spread of cancer cells in the body.
Temsirolimus is used to treat cancer of the kidneys, also called renal cell carcinoma.
Temsirolimus may also be used for other purposes not listed in this medication guide.
FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive temsirolimus without telling your doctor if you are pregnant. Use an effective form of birth control while you are using this medication and for at least 3 months after your treatment ends.
If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 3 months after you stop using temsirolimus.
Temsirolimus can lower the blood cells that help your body fight infections. Avoid contact with people who have colds, the flu, or other contagious illnesses. Do not receive any vaccines. Contact your doctor immediately if you develop signs of infection.
You should not use this medication if you are allergic to temsirolimus.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive temsirolimus without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication and for at least 3 months after your treatment ends.
high cholesterol or triglycerides;
a history of head injury, stroke, or brain tumor; or
if you are allergic to sirolimus (Rapamune).
If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 3 months after you stop using temsirolimus.It is not known whether temsirolimus passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
Temsirolimus is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 1 hour to complete.
Temsirolimus is usually given once each week unless your cancer progresses or you have serious side effects from the medication.
You may receive other medications before your temsirolimus infusion. These medications will help prevent certain side effects.
Temsirolimus can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor.If you need to have any type of surgery, tell the surgeon ahead of time that you are using temsirolimus. This medication can make it harder for wounds to heal, and you may need to stop using the medicine for a short time.
Call your doctor if you miss an appointment for your temsirolimus injection.
Seek emergency medical attention if you think you have received too much of this medicine.
Overdose symptoms may include black or bloody stools, severe stomach pain, confusion, unusual thoughts or behavior, sudden numbness or weakness, sudden headache, problems with vision or speech, pain or swelling in one or both legs, or seizure (convulsions).
Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with temsirolimus, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.
Grapefruit and grapefruit juice may interact with temsirolimus and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
cough, feeling short of breath;
warmth, redness, or tingly feeling under your skin;
increased thirst, hunger, or urination;
black, bloody, or tarry stools;
fever, severe stomach pain;
urinating less than usual or not at all;
drowsiness, confusion, mood changes, loss of appetite, nausea and vomiting;
swelling, weight gain; or
pale skin, easy bruising or bleeding, weakness.
Less serious side effects include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Renal Cell Carcinoma:
Initial dose: 25 mg infused over a 30 to 60 minute period once a week
Treatment may continue until disease progression or unacceptable toxicity.
Before receiving temsirolimus, tell your doctor if you are using any of the following drugs:
dexamethasone (Decadron, Hexadrol);
rifampin (Rifadin, Rimactane, Rifater);
St. John's wort;
a blood thinner such as warfarin (Coumadin);
insulin or diabetes medications you take by mouth;
an antibiotic such as clarithromycin (Biaxin), telithromycin (Ketek), and others;
an antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
HIV/AIDS medicine such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), or saquinavir (Invirase, Fortovase); or
seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton).
This list is not complete and there may be other drugs not listed that can affect temsirolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
- Your pharmacist can provide more information about temsirolimus.
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