Temsirolimus (Intravenous route)
Uses of This Medicine:
Temsirolimus injection is used to treat advanced kidney cancer. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Temsirolimus is an antineoplastic (cancer medicine).
This medicine is to be given only by or under the direct supervision of a doctor.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of temsirolimus injection in children.
Appropriate studies on the relationship of age to the effects of temsirolimus injection have not been performed in the geriatric population. However, elderly patients are more likely to have diarrhea, edema (swelling), and pneumonia, which may require caution in patients receiving temsirolimus injection.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This Medicine:
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
You will receive a medicine to prevent allergic reactions (eg, diphenhydramine, Benadryl®) before you receive this medicine.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Men and women should use an effective form of birth control during treatment with temsirolimus and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Temsirolimus may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection.
This medicine may cause flushing, headaches, and lightheadedness or faintness, while you are receiving the injection or within 24 hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.
This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or urination. Your doctor may give you insulin or other medicines that can lower the amount of sugar in your blood.
While you are being treated with temsirolimus, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Temsirolimus may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, other persons living in your household should not get live vaccines (eg, nasal flu virus vaccine, measles, mumps, or rubella vaccine, oral polio vaccine, BCG, yellow fever vaccine, varicella vaccine, or TY21a typhoid vaccine). Try to avoid being around persons who have received live vaccines. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Treatment with temsirolimus may also increase the chance of getting other infections. If you can, avoid people with colds or other infections. If you think you are getting a cold or other infection, check with your doctor.
This medicine may cause a serious lung problem. Check with your doctor immediately if you are having tightness in the chest, shortness of breath, difficulty with breathing, or wheezing.
Temsirolimus may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats.
Check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; diarrhea; fever; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.
This medicine may increase your chance of having acute kidney disease that is not related to the worsening of your kidney cancer. Talk to your doctor about this risk.
This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several weeks before and after having surgery.
Grapefruit and grapefruit juice may increase the effects of temsirolimus by increasing the amount of medicine in your blood. You should not eat grapefruit or drink grapefruit juice while receiving this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's Wort) or vitamin supplements.
Side Effects of This Medicine:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 4/4/2014
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