Temsirolimus
Temsirolimus is a kinase inhibitor given by intravenous infusion to treat advanced renal cell carcinoma (a type of kidney cancer).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Temsirolimus (Torisel) is a weekly IV infusion for advanced renal cell carcinoma, a kidney cancer, that slows tumor growth by blocking mTOR, a cell-growth protein; on the market since about 2007 and available generically, it is now used less often than newer immunotherapy options. It is a demanding treatment, with tiredness, rash, mouth sores and nausea common and blood tests often showing higher sugar and cholesterol. The first infusion needs the closest watch, since a potentially life-threatening allergic-type reaction (flushing, chest pain, trouble breathing) can start early. Between doses, report new cough, belly pain or fever promptly; lung inflammation, a hole in the bowel and infection are real risks.
Clinical pearls
- Tell your team about every medicine and supplement, since clarithromycin, voriconazole, rifampin, St. John’s Wort and grapefruit juice shift levels.
- Let any surgeon know you get temsirolimus well before a planned operation, because it can slow wound healing.
- Skip live vaccines during treatment and avoid close contact with people who have just had one.
- On a blood thinner or with a brain tumor, report any sudden severe headache at once, as brain bleeding can occur.
Patient information guide A plain-language walkthrough of Temsirolimus, written from its FDA label.
What Temsirolimus is used for
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Temsirolimus treats one cancer type across the supported products.
- Advanced renal cell carcinoma (kidney cancer): Torisel and temsirolimus injection are each labeled for this use.
How Temsirolimus works
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Temsirolimus is an mTOR inhibitor. It binds to a protein inside cells called FKBP-12, and this combination blocks mTOR, which controls cell division. Blocking mTOR stops tumor cells from progressing through their growth cycle (G1 growth arrest).
In lab studies of kidney cancer cells, it also lowered levels of HIF-1, HIF-2 alpha and vascular endothelial growth factor, which tumors use to grow.
Temsirolimus dosage
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Temsirolimus is given by a healthcare professional as an IV infusion over about 30 to 60 minutes, once a week. Treatment continues until the disease progresses or side effects become unacceptable.
- An IV antihistamine is given about 30 minutes before each dose.
- Doses may be held or adjusted for low blood counts, side effects, liver problems, or certain interacting drugs.
- The vial is diluted first with the enclosed diluent, then in sodium chloride solution, before infusion.
Because it is given in a clinic, you do not manage doses at home. Follow your prescriber's schedule.
Dosing details from the FDA-approved label
From the Temsirolimus prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Advanced Renal Cell Carcinoma
- 25 mg administered as an intravenous infusion over a 30–60 minute period once a week
- Treatment should continue until disease progression or unacceptable toxicity occurs
- Premedicate with prophylactic intravenous diphenhydramine 25 to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose
- Mild hepatic impairment
- Reduce the dose of TORISEL to 15 mg/week
- Contraindicated in patients with bilirubin >1.5×ULN
- Concomitant strong CYP3A4 inhibitors (if co-administration is necessary)
- A TORISEL dose reduction to 12.5 mg/week should be considered
- If the strong inhibitor is discontinued, allow a washout period of approximately 1 week before the dose is adjusted back to the dose used prior to the inhibitor
- Concomitant strong CYP3A4 inducers (if co-administration is necessary)
- A TORISEL dose increase from 25 mg/week up to 50 mg/week should be considered
- Maximum: 50 mg/week
- If the strong inducer is discontinued, the temsirolimus dose should be returned to the dose used prior to the inducer
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dose of Temsirolimus injection is 25 mg administered as an intravenous infusion over a 30-60 minute period once a week. Treat until disease progression or unacceptable toxicity. ( 2.1 ) Antihistamine pre-treatment is recommended. ( 2.2 ) Dose reduction is required in patients with mild hepatic impairment. ( 2.4 ) Temsirolimus injection vial contents must first be diluted with the enclosed diluent before diluting the resultant solution with 250 mL of 0.9% Sodium Chloride Injection. ( 2.5 ) 2.1 Advanced Renal Cell Carcinoma The recommended dose of Temsirolimus injection for advanced renal cell carcinoma is 25 mg administered as an intravenous infusion over a 30 – 60 minute period once a week. Treatment should continue until disease progression or unacceptable toxicity occurs. 2.2 Premedication Patients should receive prophylactic intravenous diphenhydramine 25 to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose of Temsirolimus injection [see Warnings and Precautions ( 5.1 )] . 2.3 Dosage Interruption/Adjustment Temsirolimus injection should be held for absolute neutrophil count (ANC) <1,000/mm 3 , platelet count <75,000/mm 3 , or NCI CTCAE grade 3 or greater adverse reactions. Once toxicities have resolved to grade 2 or less, Temsirolimus injection may be restarted with the dose reduced by 5 mg/week to a dose no lower than 15 mg/week. 2.4 Dose Modification Guidelines Hepatic Impairment : Use caution when treating patients with hepatic impairment. If Temsirolimus injection must be given in patients with mild hepatic impairment (bilirubin >1 - 1.5xULN or AST >ULN but bilirubin ≤ULN), reduce the dose of Temsirolimus injection to 15 mg/week. Temsirolimus injection is contraindicated in patients with bilirubin >1.5×ULN [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.7 )]. Concomitant Strong CYP3A4 Inhibitors : The concomitant use of strong CYP3A4 inhibitors should be avoided (e.g. ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole). Grapefruit juice may also increase plasma concentrations of sirolimus (a major metabolite of temsirolimus) and should be avoided.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Temsirolimus side effects
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The most common side effects (in at least 30% of people) include:
Common side effects
- Rash
- Weakness or tiredness (asthenia)
- Mouth sores (mucositis)
- Nausea
- Swelling (edema)
- Loss of appetite
- High blood sugar and high cholesterol or triglycerides (found on blood tests)
- Low blood counts such as anemia (found on blood tests)
When to get medical help
- Get help right away for flushing, chest pain, trouble breathing, dizziness or fainting during or after an infusion. These can be signs of a serious allergic reaction.
- Call your doctor promptly for new or worsening cough, shortness of breath or fever. These can signal lung inflammation (interstitial lung disease) or an infection.
- Report new or worsening belly pain, fever or blood in your stool right away. Bowel perforation (a hole in the bowel) has occurred, and some cases were fatal.
- Tell your doctor about excessive thirst or more frequent or larger amounts of urination. These can be signs of high blood sugar.
- Report signs of kidney problems or foamy or protein-rich urine. Kidney failure, sometimes fatal, and nephrotic syndrome (a kidney condition causing protein loss in urine) have occurred.
- Report signs of infection. The drug can weaken your immune system.
- Report sudden severe headache or neurologic changes right away. People with brain tumors or on blood thinners may be at higher risk of bleeding in the brain.
Blood tests commonly show anemia, high blood sugar, high cholesterol and triglycerides, and low white cell, lymphocyte and platelet counts. Report breathing problems, severe belly pain, bloody stools, signs of infection or allergic reactions right away.
Temsirolimus warnings and precautions
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- Infusion reactions: can be life-threatening, especially during the first infusion. The infusion is stopped if one occurs.
- Liver problems: people with high bilirubin had more toxicity and deaths. It is contraindicated above 1.5 times normal, and the dose is reduced for mild impairment.
- High blood sugar and lipids: very common and may need treatment.
- Infections: the drug suppresses the immune system. Serious pneumonia (PJP) has occurred.
- Lung disease: interstitial lung disease, some fatal. Baseline and periodic chest imaging is recommended.
- Bowel perforation and kidney failure: some cases were fatal.
- Wound healing and brain bleeding: use caution around surgery, and in people with brain tumors or on blood thinners.
- Proteinuria: urine protein is monitored, and the drug is stopped if nephrotic syndrome develops.
Temsirolimus interactions
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Several medicines and foods can change the level of temsirolimus's active byproduct, sirolimus.
- Strong CYP3A4 inhibitors (such as ketoconazole, clarithromycin, ritonavir): raise sirolimus levels. Avoid, or the dose may be lowered.
- Strong CYP3A4 inducers (such as rifampin, phenytoin, carbamazepine, dexamethasone): lower sirolimus levels. Avoid, or the dose may be raised.
- Grapefruit juice: may raise sirolimus levels.
- St. John's Wort: unpredictably lowers levels. Do not use.
- Sunitinib: combination caused dose-limiting toxicity.
- ACE inhibitors and calcium channel blockers: possible angioedema (swelling).
- Live vaccines: avoid them.
- Drugs that block or are moved by P-glycoprotein: levels may rise, so caution is needed.
Interactions listed in the FDA-approved label
From the Temsirolimus prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inducers (e.g., rifampin): Rifampin had no significant effect on temsirolimus Cmax and AUC but decreased sirolimus Cmax by 65% and AUC by 56% compared to TORISEL alone. Avoid concomitant use; if it cannot be avoided, a dose increase from 25 mg/week up to 50 mg/week should be considered.
- Strong CYP3A4 inhibitors (e.g., ketoconazole): Ketoconazole had no significant effect on temsirolimus Cmax or AUC, but sirolimus AUC increased 3.1-fold and Cmax increased 2.2-fold compared to TORISEL alone. Avoid concomitant use; if it cannot be avoided, a dose reduction to 12.5 mg/week should be considered.
- Grapefruit juice: May increase plasma concentrations of sirolimus (a major metabolite of temsirolimus). Should be avoided.
- ACE inhibitors (e.g., ramipril) and calcium channel blockers (e.g., amlodipine): Angioedema has been reported in patients taking mTOR inhibitors in combination with ramipril and/or amlodipine. Monitor patients for signs and symptoms of angioedema.
- CYP2D6 or CYP3A substrates (e.g., desipramine): Desipramine concentration was unaffected when 25 mg of temsirolimus was co-administered; no clinically significant effect is anticipated with agents metabolized by CYP2D6 or CYP3A.
Read the label’s full interactions text
7 DRUG INTERACTIONS Strong inducers of CYP3A4/5 and inhibitors of CYP3A4 may affect concentrations of the primary metabolite of Temsirolimus injection. If alternatives cannot be used, dose modifications of Temsirolimus injection are recommended. ( 7.1 , 7.2 , 7.3 ) 7.1 Agents Inducing CYP3A Metabolism Co-administration of Temsirolimus injection with rifampin, a potent CYP3A4/5 inducer, had no significant effect on temsirolimus C max (maximum concentration) and AUC (area under the concentration versus the time curve) after intravenous administration, but decreased sirolimus C max by 65% and AUC by 56% compared to Temsirolimus injection treatment alone. If alternative treatment cannot be administered, a dose adjustment should be considered [see Dosage and Administration ( 2.4 )] . 7.2 Agents Inhibiting CYP3A Metabolism Co-administration of Temsirolimus injection with ketoconazole, a potent CYP3A4 inhibitor, had no significant effect on temsirolimus C max or AUC; however, sirolimus AUC increased 3.1-fold, and C max increased 2.2-fold compared to Temsirolimus injection alone. If alternative treatment cannot be administered, a dose adjustment should be considered [see Dosage and Administration ( 2.4 )] . 7.3 Angioedema with ACE inhibitors and Calcium Channel Blockers Angioedema has been reported in patients taking mammalian target of rapamycin (mTOR) inhibitors in combination with ramipril and/or amlodipine. Monitor patients for signs and symptoms of angioedema when temsirolimus is given concomitantly with an angiotensin converting enzyme (ACE) inhibitors (e.g., ramipril) or calcium channel blockers (CCB) (e.g., amlodipine).
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Temsirolimus
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- Not for people with bilirubin above 1.5 times normal.
- Mild liver impairment: caution and a lower dose.
- Known allergy to temsirolimus, sirolimus, polysorbate 80 or antihistamines.
- Pregnancy: can harm a fetus. Use effective contraception during treatment and for 3 months after the last dose (women and men).
- Breastfeeding: do not breastfeed during treatment and for 3 weeks after the last dose.
- Fertility may be affected.
- Kidney impairment: no dose adjustment is recommended.
- Older adults: more likely to have diarrhea, swelling and pneumonia.
- Children: effectiveness has not been established.
Temsirolimus overdose
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There is no specific treatment for an intravenous overdose of temsirolimus. Doses above the recommended amount raise the risk of serious problems, including blood clots (thrombosis), bowel perforation, interstitial lung disease, seizure and psychosis.
What Temsirolimus does in the body
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At the recommended dose, temsirolimus did not cause clinically relevant changes in the QT interval, a measure of heart rhythm, in a study of healthy volunteers. In patients given doses up to 175 mg, none had a dangerous QTcF increase or a value above 500 ms.
How your body processes Temsirolimus
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After an IV infusion, blood levels of temsirolimus peak at the end of the infusion. The body breaks it down mainly through the CYP3A4 enzyme, producing sirolimus, an active byproduct that lasts longer in the body. The average half-life is about 17 hours for temsirolimus and about 55 hours for sirolimus.
Most of the drug leaves through the stool (about 78% of the dose), and very little through urine. Age and gender did not appear to affect drug levels.
How to store Temsirolimus
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stored at 2° to 8°C (36° to 46°F). Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Temsirolimus
169 supplements and herbal products have documented interactions with Temsirolimus in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 135
- Minor · 30
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Temsirolimus: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Temsirolimus — the kind of thing our pharmacy team would talk through with you at the counter.
What is temsirolimus for?
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How will I get it, and how often?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I take my other medicines and supplements with it?
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Is it safe in pregnancy?
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Is Temsirolimus available over the counter?
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When was Temsirolimus first available?
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Who makes Temsirolimus?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Temsirolimus on HelloPharmacist
Temsirolimus forms and strengths (how it comes)
Temsirolimus is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Temsirolimus inactive ingredients by manufacturer.
Injection
How this form is used
- Temsirolimus injection is used to treat advanced renal cell carcinoma.
- Temsirolimus injection is given as an IV infusion over about 30 to 60 minutes once a week.
- Temsirolimus injection vial contents are first diluted with the enclosed diluent, then further diluted in sodium chloride solution before infusion.
- An antihistamine is given by IV about 30 minutes before each temsirolimus injection dose.
Temsirolimus on the U.S. market: products, makers and brands
How Temsirolimus appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
5 companies list 5 Temsirolimus product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2007. Brand names on the directory include Torisel; the rest are generics.
Also listed with the FDA, not a patient dose form: Kit (10) · Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Temsirolimus is used (Medicaid data)
A general measure of how commonly Temsirolimus is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Temsirolimus is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Temsirolimus prescribed? Of the 1,601 medications we measure, Temsirolimus ranks #1,514 by Medicaid prescriptions — more than 5% of them.
Utilization by Temsirolimus product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1.2 ML temsirolimus 25 MG/ML Injection
Summed across the 1 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 722289
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Temsirolimus, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 11 listed Temsirolimus NDCs with Medicaid activity.
Compare Temsirolimus products
A representative set of FDA-listed product records for Temsirolimus — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|
| 💊Kits | |||
| — | Accord Healthcare Inc. | ANDA | View NDC → |
| — | Almaject, Inc. | ANDA | View NDC → |
| Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| — | Gland Pharma Limited | ANDA | View NDC → |
| — | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Temsirolimus NDCs →
Temsirolimus side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Temsirolimus — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Temsirolimus in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Temsirolimus FDA approval history
How Temsirolimus went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Temsirolimus recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Temsirolimus recalls since July 2021.
✅No Temsirolimus recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 657797 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1724304In current FDA listingsClinical drug / strength (SCD) 1.2 ML temsirolimus 25 MG/MLRxCUI 722289
Look up RxCUI 657797 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Temsirolimus supply and shortage status
Whether Temsirolimus is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Temsirolimus brand names
Temsirolimus is sold under one brand name in the FDA directory — Torisel. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Temsirolimus: manufacturers and labelers
5 companies list Temsirolimus products with the FDA. By number of product records, the largest are Accord Healthcare Inc., Almaject, Inc., Fresenius Kabi USA, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Temsirolimus drug class (RxNorm)
Temsirolimus belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Temsirolimus page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →