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Tepylute

Generic name: thiotepa
Brand name: Tepylute
Dosage form: intravenous injection (15 mg/1.5 mL)
Drug class: Alkylating agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Jul 1, 2024.

What is Tepylute?

Tepylute (thiotepa) is used to treat a type of breast cancer or ovarian cancer called adenocarcinoma. Tepylute is a chemotherapy medication from a group of medicines called alkylating agents.

Tepylute is given as an intravenous infusion every 1 to 4 weeks. It is a ready-to-dilute formulation that is easier to prepare than other lyophilized powder formulations. 

Tepylute became an FDA-approved medicine on June 25, 2024, to treat adults with adenocarcinoma of the breast or ovary.

Tepylute side effects

Common Tepylute side effects 

Common Tepylute side effects may include low blood cell counts, signs of infection (fever, chills, sore throat, muscle aches), diarrhea, rash blood in your urine, bleeding, mouth sores, abnormal liver function tests, and cytomegalovirus infection.

Serious Tepylute side effects

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; or swelling of your face, lips, tongue, or throat.

Tepylute may cause other serious side effects. Call your doctor at once if you have:

Also see the Warning Section below.

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 the FDA at 1-800-FDA-1088

Warnings

Hypersensitivity Reactions: Anaphylaxis and other hypersensitivity reactions have occurred with this medication.

Skin Toxicity (Cutaneous Toxicity): Cleanse skin at least twice daily through 48 hours after the last dose of Tepylute.

Polyethylene Glycol 400 Toxicity: Consider the PEG 400 load from concomitant medications.

Embryo-Fetal Toxicity: Females should not use Tepylute while pregnant and for 6 months before becoming pregnant. Males of reproductive potential should use effective contraception during and after treatment with this medicine for 1 year after therapy.

Myelosuppression is when bone marrow activity is decreased, so there are fewer red blood cells, white blood cells, and platelets. The risk of myelosuppression is increased if the bone marrow has been affected by irradiation or chemotherapy or is recovering from chemotherapy. Periodic complete blood counts should be completed during treatment with Tepylute. Provide supportive care for infections, bleeding, and symptomatic anemia. 

Hepatic Veno-Occlusive Disease Monitor by physical examination, serum transaminases, and bilirubin, and provide supportive care to patients who develop hepatic veno-occlusive disease. 

Central Nervous System Toxicity Fatal encephalopathy has occurred in patients treated with high doses of this medicine. Other central nervous systems toxicities, such as headache, apathy, psychomotor retardation, disorientation, confusion, amnesia, hallucinations, drowsiness, sleepiness, seizures, coma, inappropriate behavior, and forgetfulness, have been reported to occur in a dose-dependent manner during or shortly after administration of high-dose thiotepa. Do not exceed the recommended dose of Tepylute. If severe or life-threatening central nervous system toxicity occurs, discontinue administration of this medicine and provide supportive care.

Carcinogenicity There is an increased risk of a secondary malignancy with the use of this medicine.

Who should not use Tepylute?

You should not use this medicine if you have hypersensitivity to the active substance thiotepa, and it should not be used with live or attenuated vaccines. 

Before taking this medicine

Tell your doctor if you have ever had:

Tell your doctor about all other cancer treatments you have recently received, including chemotherapy and radiation.

You should not be treated with Tepylute if you are allergic to ithe active ingredient or if you have recently received a live or attenuated vaccine.

Using Tepylute may increase your risk of developing other cancers, such as leukemia. Ask your doctor about this risk.

Pregnancy

Tepylute is a potential risk to a fetus.
Females of reproductive potential should have a negative pregnancy test before receiving treatment with Tepylute.

Females should not use this medicine while pregnant and for 6 months before becoming pregnant.

Females of reproductive potential are advised to use highly effective contraception during treatment with this medicine and for 6 months after therapy. 

Males of reproductive potential should use effective contraception during and after treatment with this medicine for 1 year after therapy.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using thiotepa.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because thiotepa can harm an unborn baby.

Breastfeeding

Patients should not breastfeed during Tepylute treatment and for 1 week after the last dose.

How is Tepylute given?

Tepylute is diluted and given as an intravenous infusion into a vein (intravenous infusion).

This medicine can increase your risk of bleeding or infection. You will need frequent medical tests.

This medicine can be dangerous if it gets in your mouth, eyes, or nose, or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water.

Tepylute treatment may cause itching, blistering, peeling, or discoloration (especially in the skin folds of your groin, underarms, or neck). Bathe or shower and wash your skin with soap and water at least 2 times per day for at least 48 hours after each time you receive this medicine.

If you cover the skin with any bandaging, change the dressing and clean the covered skin 2 times per day for 48 hours after each time you receive this medicine.

Change your bed sheets every day during treatment.

What should I avoid while receiving Tepylute?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a live or attenuated vaccine while using thiotepa, or you could develop a serious infection.

What other drugs will affect Tepylute?

Sometimes, it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect Tepylute, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

Manufacturer

Manufactured by: AqVida GmbH, Dassow, Germany

Distributed by: Shorla Oncology Inc., Cambridge, MA 02142, USA

References

  1. Tepylute Package Insert FDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer