Pronunciation:

tem-sir-OH-li-mus

Brand Names:

• Torisel

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

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:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of temsirolimus injection in children.

Older adults—

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 some unwanted effects, which may require caution in patients receiving temsirolimus injection.

Breast-feeding—

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.

Other medicines—

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Levoketoconazole

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.

• Adagrasib
• Asciminib
• Atazanavir
• Avacopan
• Belzutifan
• Berotralstat
• Carbamazepine
• Ceritinib
• Clarithromycin
• Cobicistat
• Conivaptan
• Crizotinib
• Dabrafenib
• Duvelisib
• Eluxadoline
• Enzalutamide
• Erdafitinib
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ketoconazole
• Lanreotide
• Larotrectinib
• Lefamulin
• Lenacapavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mitapivat
• Mitotane
• Mobocertinib
• Nefazodone
• Nelfinavir
• Netupitant
• Octreotide
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Palbociclib
• Phenobarbital
• Phenytoin
• Pirtobrutinib
• Primidone
• Ribociclib
• Rifampin
• Ritlecitinib
• Ritonavir
• Saquinavir
• Selpercatinib
• Sotorasib
• St John's Wort
• Taurursodiol
• Telithromycin
• Tocilizumab
• Trofinetide
• Tucatinib
• Verapamil
• Voriconazole
• Voxelotor

Other interactions—

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.

• Grapefruit Juice

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:

• Bleeding problems or
• Brain tumor—Use with caution. May cause side effects to become worse.

• Bowel pain or
• Diabetes or
• Hyperglycemia (high blood glucose) or
• Hyperlipidemia (high blood cholesterol) or
• Infection or
• Kidney disease or
• Lung disease (eg, interstitial lung disease)—Use with caution. May make these conditions worse.

• Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Should not be used in patients with this condition.

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 in a medical facility. A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must be injected slowly, so the needle will have to stay in place for at least 30 minutes once a week.

You will receive an allergy medicine (eg, diphenhydramine, Benadryl®) 30 minutes before receiving the injection.

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 and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if it is used by the father when his sexual partner becomes pregnant. Men and women should use effective birth control during treatment and for at least 3 months after the last dose. Tell your doctor right away if pregnancy occurs while you are using this medicine.

Temsirolimus may cause serious types of allergic reactions, including anaphylaxis, which 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 breathing, or chest pain after 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. Diabetic patients should check their blood sugar more frequently with this medicine.

While you are being treated with temsirolimus, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Temsirolimus may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Temsirolimus may increase the risk of getting infections, including an infection called Pneumocystis jiroveci pneumonia or PJP. Try to avoid people with colds or other infections. If you think you are getting an infection, check with your doctor right away.

This medicine may cause a serious lung problem. Check with your doctor right away if you have tightness in the chest or difficulty with breathing.

Temsirolimus may increase your cholesterol and fats in the blood. If this occurs, your doctor may give you a medicine to lower your blood cholesterol levels.

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 kidney disease (including kidney failure, proteinuria, nephrotic syndrome) that is not related to 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.

This medicine may increase your risk of developing bleeding in the brain, which may be life-threatening. Talk to your doctor if you have concerns about this risk.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

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:

More common

Bladder pain

bloody nose

bloody or cloudy urine

body aches or pain

blurred vision

chest pain

chills

congestion

cough

cracked lips

diarrhea

difficult or labored breathing

difficult, burning, or painful urination

difficulty with swallowing

dizziness

dryness or soreness of the throat

ear congestion

fever

frequent urge to urinate

headache

hoarseness

joint or muscle pain

lack or loss of strength

loss of voice

lower back or side pain

nasal congestion

nausea

nervousness

numbness or tingling of the face, hands, or feet

pounding in the ears

runny nose

skin rash

slow or fast heartbeat

sneezing

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

sore throat

stomach pain

stuffy or runny nose

swelling of the hands, ankles, feet, or lower legs

swelling or puffiness of the face

tender, swollen glands in the neck

tightness in the chest

voice changes

vomiting

Less common

Black, tarry stools

bloody stools

changes in skin color

delayed wound healing

pain, tenderness, or swelling of the foot or leg

seizures

severe vomiting, sometimes with blood

stomach cramp

vomiting of blood or material that looks like coffee grounds

Incidence not known

Blistering, peeling, or loosening of the skin

dark-colored urine

itching

muscle cramps, spasms, or stiffness

pain or redness at the injection site

pale skin at injection site

red skin lesions, often with a purple center

red, irritated eyes

unusual tiredness or weakness

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:

More common

Back pain

blemishes on the skin

burning, dry, or itching eyes

change in taste

difficulty having a bowel movement

difficulty with moving

discharge or excessive tearing

discoloration of the fingernails or toenails

dry skin

loss of appetite

loss of taste

pimples

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

swollen joints

trouble sleeping

weight loss

Less common

Discouragement

feeling sad or empty

irritability

loss of interest or pleasure

tiredness

trouble concentrating

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.