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Torpenz (Everolimus): Uses, Side Effects and Dosage

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Prescription (Rx)
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5 mg, 2.5 mg, 7.5 mg, 10 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Torpenz

What is the most important information I should know about TORPENZ tablets?

TORPENZ tablets can cause serious side effects, including:

  1. 1. You may develop lung or breathing problems.In some people lung or breathing problems may be severe and can lead to death. Tell your healthcare provider right away if you have any of these symptoms:
  • New or worsening cough
  • Shortness of breath
  • Chest pain
  • Difficulty breathing or wheezing
  1. 2. You may be more likely to develop an infection,such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people (including adults and children) these infections may be severe and can lead to death. You may need to be treated as soon as possible.

Tell your healthcare provider right away if you have a temperature of 100.5°F or above, chills, or do not feel well.

Symptoms of hepatitis B or infection may include the following:

  • Fever
  • Chills
  • Skin rash
  • Joint pain and swelling
  • Tiredness
  • Loss of appetite
  • Nausea
  • Pale stools or dark urine
  • Yellowing of the skin
  • Pain in the upper right side of the stomach
  1. 3. Severe allergic reactions.Call your healthcare provider or get medical help right away if you get signs and symptoms of a severe allergic reaction, including: rash, itching, hives, flushing, trouble breathing or swallowing, chest pain or dizziness
  2. 4. Possible increased risk for a type of allergic reaction called angioedema,in people who take an Angiotensin-Converting Enzyme (ACE) inhibitor medicine during treatment with TORPENZ tablets. Talk with your healthcare provider before taking TORPENZ tablets if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with TORPENZ tablets.
  3. 5. Mouth ulcers and sores.Mouth ulcers and sores are common during treatment with TORPENZ tablets but can also be severe. When you start treatment with TORPENZ tablets, your healthcare provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your healthcare provider's instructions on how to use this prescription mouthwash. If you develop pain, discomfort, or open sores in your mouth, tell your healthcare provider. Your healthcare provider may tell you to restart this mouthwash or to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme.
  4. 6. You may develop kidney failure.In some people this may be severe and can lead to death. Your healthcare provider should do tests to check your kidney function before and during your treatment with TORPENZ tablets.

If you have any of the serious side effects listed above, you may need to stop taking TORPENZ tablets for a while or use a lower dose. Follow your healthcare provider's instructions.

What are TORPENZ tablets?

TORPENZ tablets are a prescription medicine used to treat:

  • advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer.
  • TORPENZ tablets are not for use in people with carcinoid tumors that actively produce hormones.

  • people with the following types of tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC):

    • adults with a kidney tumor called angiomyolipoma, when their kidney tumor does not require surgery right away.
    • adults and children 1 year of age and older with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.

It is not known if TORPENZ tablets are safe and effective in children to treat:

  • hormone receptor-positive, HER-2 negative breast cancer
  • a kidney tumor called angiomyolipoma, that can happen in children with a genetic condition called tuberous sclerosis complex (TSC).

Do not take TORPENZ tabletsif you have had a severe allergic reaction to everolimus.

Talk to your healthcare provider before taking this medicine if you are allergic to:

  • a medicine that contains sirolimus
  • a medicine that contains temsirolimus

Ask your healthcare provider if you do not know.

Before taking TORPENZ tablets, tell your healthcare provider about all of your medical conditions, including if you:

  • Have or have had kidney problems
  • Have or have had liver problems
  • Have diabetes or high blood sugar
  • Have high blood cholesterol levels
  • Have any infections
  • Previously had hepatitis B
  • Are scheduled to receive any vaccinations. You should not receive a "live vaccine" or be around people who have recently received a "live vaccine" during your treatment with TORPENZ tablets. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. For children with TSC and SEGA, work with your healthcare provider to complete the recommended childhood series of vaccines before your child starts treatment with TORPENZ tablets.

  • Are pregnant, can become pregnant, or have a partner who can become pregnant. TORPENZ tablets can cause harm to your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider will give you a pregnancy test before you start treatment with TORPENZ tablets.
    • You should use effective birth control during treatment and for 8 weeks after your last dose of TORPENZ tablets.

Maleswith a female partner, you should use effective birth control during treatment and for 4 weeks after your last dose of TORPENZ tablets.

  • Talk to your healthcare provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your healthcare provider right away.

  • Are breastfeeding or plan to breastfeed. It is not known if everolimus passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of TORPENZ tablets.

  • Are planning to have surgery or if you have had a recent surgery. You should stop taking TORPENZ tablets at least 1 week before planned surgery. See " What are the possible side effects of TORPENZ tablets?"
  • Have received radiation therapy or are planning to receive radiation therapy in the future. See " What are the possible side effects of TORPENZ tablets?"

Tell your healthcare provider about all of the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TORPENZ tablets may affect the way other medicines work, and other medicines can affect how TORPENZ tablets work. Taking TORPENZ tablets with other medicines can cause serious side effects.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Especially tell your healthcare provider if you take:

  • St. John's Wort ( Hypericum perforatum)

  • Medicine for:

    • Fungal infections
    • Bacterial infections
    • Tuberculosis
    • Seizures
    • HIV-AIDS
    • Heart conditions or high blood pressure
  • Medicines that weaken your immune system (your body's ability to fight infections and other problems)

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. If you are taking any medicines for the conditions listed above, your healthcare provider might need to prescribe a different medicine or your dose of TORPENZ tablets may need to be changed. You should also tell your healthcare provider before you start taking any new medicine.

How should I take TORPENZ tablets?

  • Your healthcare provider will prescribe the dose of TORPENZ tablets that is right for you.
  • Take TORPENZ tablets exactly as your healthcare provider tells you to.
  • Your healthcare provider may change your dose of TORPENZ Tablets or tell you to temporarily interrupt dosing, if needed.
  • Take only TORPENZ tablets or AFINITOR DISPERZ. Do not mix TORPENZ tablets and AFINITOR DISPERZ together.

TORPENZ tablets:

  • Use scissors to open the blister pack.
  • Take TORPENZ tablets 1 time each day at about the same time.
  • Take TORPENZ tablets the same way each time, either with food or without food.
  • If you take too much TORPENZ tablets, contact your healthcare provider or go to the nearest hospital emergency room right away. Take the bottle of everolimus tablets with you.
  • If you miss a dose of TORPENZ tablets, you may take it if it is less than 6 hoursafter the time you normally take it. If it is more than 6 hoursafter you normally take your TORPENZ tablets, skip the dose for that day. The next day, take TORPENZ tablets at your usual time. Do not take 2 doses to make up for a missed dose. If you are not sure about what to do, call your healthcare provider.
  • You should have blood tests before you start TORPENZ tablets and as needed during your treatment. These will include tests to check your blood cell count, kidney and liver function, cholesterol, and blood sugar levels.
  • If you take TORPENZ tablets to treat SEGA, you will also need to have blood tests regularly to measure how much medicine is in your blood. This will help your healthcare provider decide how much TORPENZ tablets you need to take.

TORPENZ tablets:

  • Swallow TORPENZ tablets whole with a glass of water. Do not take any tablet that is broken or crushed.

What should I avoid while taking TORPENZ tablets?

You should not drink grapefruit juice or eat grapefruit during your treatment with TORPENZ tablets. It may make the amount of everolimus in your blood increase to a harmful level.

What are the possible side effects of TORPENZ tablets?

TORPENZ tablets can cause serious side effects, including:

  • See " What is the most important information I should know about TORPENZ tablets?" for more information.

  • Risk of wound healing problems.Wounds may not heal properly during TORPENZ tablets treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with TORPENZ tablets.

    • You should stop taking TORPENZ tablets at least 1 week before planned surgery.
    • Your healthcare provider should tell you when you may start taking TORPENZ tablets again after surgery.
  • Increased blood sugar and fat (cholesterol and triglyceride) levels in the blood.Your healthcare provider should do blood tests to check your fasting blood sugar, cholesterol, and triglyceride levels in the blood before you start and during treatment with TORPENZ tablets.
  • Decreased blood cell counts.TORPENZ tablets can cause you to have decreased red blood cells, white blood cells, and platelets. Your healthcare provider should do blood tests to check your blood cell counts before you start and during treatment with TORPENZ tablets.
  • Worsening side effects from radiation treatment,that can sometimes be severe. Tell your healthcare provider if you have had or are planning to receive radiation therapy.

The most common side effects of TORPENZ tablets in people with advanced hormone receptor-positive and HER2-negative breast cancer include:

  • Infections
  • Rash
  • Feeling weak or tired
  • Diarrhea
  • Swelling of arms, hands, feet, ankles, face or other parts of the body
  • Stomach-area (abdominal) pain
  • Nausea
  • Fever
  • Cough
  • Headache
  • Decreased appetite

The most common side effects of TORPENZ in people who have SEGA or, renal angiomyolipoma, includerespiratory tract infections.

Other side effects that may occur with TORPENZ tablets:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your healthcare provider if this happens.
  • TORPENZ tablets may affect fertility in females and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.
  • TORPENZ tablets may affect fertility in males and may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of TORPENZ tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TORPENZ tablets?

  • Store TORPENZ tablets at room temperature, between 68° to 77°F (20° to 25°C).
  • Keep TORPENZ tablets in the pack they come in.
  • Open the blister pack just before taking TORPENZ tablets.
  • Keep TORPENZ tablets dry and away from light.
  • Do not use TORPENZ tablets that are out of date or no longer needed.

Keep TORPENZ tablets and all medicines out of the reach of children.

General information about the safe and effective use of TORPENZ tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TORPENZ tablets for a condition for which they were not prescribed. Do not give TORPENZ tablets to other people, even if they have the same problem you have. They may harm them. This leaflet summarizes the most important information about TORPENZ tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information written for healthcare professionals.

What are the ingredients in TORPENZ tablets?

Active ingredient: everolimus.

Inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate and magnesium stearate.

Manufactured for: UPSHER-SMITH LABORATORIES, LLC, Maple Grove, MN 55369

TORPENZ is a registered trademark of Upsher-Smith Laboratories, LLC.

All other trademarks are property of their respective owners.

For more information, go to www.upsher-smith.com or call UPSHER-SMITH LABORATORIES, LLC at 1-888-650-3789.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for

UPSHER-SMITH LABORATORIES, LLC.

Maple Grove, MN 55369

Revised:3/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 214182 · View the label on DailyMed

Revision date stated in the text: March 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Torpenz

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Kinase Inhibitor, mTOR Inhibitor Immunosuppressant
Active ingredient Everolimus
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) BIOCON PHARMA
FDA approval ANDA 214182Abbreviated New Drug Application (ANDA) – generic drug Approved February 11, 2021
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Afinitor, Everolimus, Yulithira, Zortress with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
5 mg – 30 in 1 bottle NDC 0245-0823-30
5 mg – 1 in 1 blister pack / 28 in 1 carton NDC 0245-0823-89
2.5 mg – 30 in 1 bottle NDC 0245-0822-30
2.5 mg – 1 in 1 blister pack / 28 in 1 carton NDC 0245-0822-89
7.5 mg – 30 in 1 bottle NDC 0245-0824-30
7.5 mg – 1 in 1 blister pack / 28 in 1 carton NDC 0245-0824-89
10 mg – 30 in 1 bottle NDC 0245-0825-30
10 mg – 1 in 1 blister pack / 28 in 1 carton NDC 0245-0825-89

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.