Thiotepa 15mg Inj, 1 Vial

Thiotepa is an alkylating agent. It forms DNA interstrand cross-links and DNA-protein cross-links, leading to inhibition of DNA synthesis and cell death. It is cell-cycle phase non-specific.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained or enlarging bruises, or uncontrollable bleeding.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes.
Weakness on one side of the body, speech or thought difficulties, balance changes, facial drooping, or blurred vision.
Missed menstrual period.
Mouth irritation or sores.
Difficulty urinating.
Blood in the urine.
Changes in vision, eye pain, or severe eye irritation.
Severe brain problems, including excessive sleepiness, confusion, changes in behavior, hallucinations (seeing or hearing things that aren't there), memory issues, seizures, movement difficulties, or severe headaches.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no or mild side effects, others may have more significant issues. If you're concerned about any of the following side effects or if they persist or worsen, contact your doctor:

Hair loss.
Dizziness, fatigue, or weakness.
Headache.
Stomach pain.
Irritation at the injection site.
* Diarrhea, vomiting, stomach upset, and decreased appetite are common side effects. If you experience these, discuss ways to manage them with your doctor. If they bother you, don't improve, or become severe, seek medical attention.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Certain medications, such as those used to treat HIV, infections, or seizures, can interact with this drug.
If you are breastfeeding or plan to breastfeed. You should not breastfeed while taking this medication, and you may need to avoid breastfeeding for a period after your last dose. Consult with your doctor to determine the necessary timeframe for avoiding breastfeeding after your last dose.

Please note that this is not an exhaustive list of all potential interactions or health problems that may affect the safety of taking this medication. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition.

Before receiving any vaccinations, consult with your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.

You may experience an increased risk of bleeding, so it is crucial to be cautious and avoid injuries. To minimize this risk, use a soft toothbrush and an electric razor for shaving.

Your risk of developing an infection may also be higher. To reduce this risk, practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.

This medication may cause skin reactions, such as changes in skin color, itching, blisters, or peeling, particularly in areas like the groin, armpits, skin folds, neck, and under bandages or dressings. Follow your doctor's instructions for showering or bathing, changing dressings, and cleaning the affected skin. Additionally, change your bed sheets daily while taking this medication.

This medication may affect menstrual cycles and sperm production. If you have concerns, discuss them with your doctor.

Fertility may also be impacted, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, consult with your doctor before starting this medication.

This medication can harm an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you may become pregnant, use effective birth control during treatment and for six months after the final dose. If you become pregnant, notify your doctor immediately.

If your partner may become pregnant, use birth control during treatment and for one year after the final dose. If your partner becomes pregnant, inform the doctor right away.

• Live vaccines (risk of severe infection due to immunosuppression)
• Other myelosuppressive agents (additive myelosuppression)
• Drugs metabolized by CYP2B6 or CYP3A4 (potential for altered thiotepa/TEPA levels or altered levels of co-administered drug)
• Phenytoin (decreased thiotepa levels, increased phenytoin toxicity)
• Busulfan (increased risk of VOD and mucositis when used in conditioning regimens)
• Cyclophosphamide (increased risk of VOD and mucositis when used in conditioning regimens)

• Warfarin (potential for altered INR, monitor closely)
• Cimetidine (may inhibit thiotepa metabolism, increasing toxicity)
• Allopurinol (may increase myelosuppression)
• Nephrotoxic drugs (increased risk of renal toxicity)
• Hepatotoxic drugs (increased risk of hepatic toxicity, especially VOD)

• Not available

• Fever (sign of infection due to neutropenia)
• Unusual bleeding or bruising (sign of thrombocytopenia)
• Fatigue, weakness, pallor (sign of anemia)
• Nausea, vomiting, diarrhea, mucositis (common GI toxicities)
• Skin rash, redness, peeling (skin toxicity)
• Confusion, lethargy, seizures (CNS toxicity, especially with high doses)
• Yellowing of skin/eyes, dark urine, abdominal pain (signs of hepatotoxicity/VOD)
• Pain or burning during urination, blood in urine (intravesical irritation)

Thiotepa can cause fetal harm when administered to a pregnant woman. It is a Category D drug. Advise pregnant women of the potential risk to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during treatment and for at least 6 months after the last dose. Men should use effective contraception during treatment and for at least 6 months after the last dose.

It is not known whether thiotepa is excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment with thiotepa and for at least 1 week after the last dose.

Thiotepa is used in pediatric patients, primarily in high-dose conditioning regimens for hematopoietic stem cell transplantation. Dosing is typically weight or BSA-based. Pediatric patients may be more susceptible to certain toxicities, such as neurotoxicity and veno-occlusive disease, especially at high doses. Close monitoring is essential.

No specific dose adjustments are generally recommended based solely on age. However, elderly patients may have decreased renal or hepatic function, or more comorbidities, which could increase the risk of toxicity. Close monitoring of hematologic, renal, and hepatic function is advised. Start at the lower end of the dosing range and titrate carefully.

• Thiotepa is highly lipophilic and readily crosses the blood-brain barrier, which contributes to its CNS toxicity, especially at high doses.
• The active metabolite, TEPA, has a longer half-life than thiotepa and contributes significantly to the drug's cytotoxic effects and prolonged myelosuppression.
• High-dose thiotepa regimens are associated with severe mucositis and skin toxicity (e.g., desquamation, blistering), particularly in areas of prior radiation. Meticulous skin care is crucial.
• Intravesical administration for bladder cancer requires careful instillation and retention time. Patients should be instructed to empty their bladder before instillation and retain the solution for 2 hours.
• Due to its vesicant properties, thiotepa should be administered via a central venous catheter for IV infusions, especially high-dose regimens, to prevent extravasation.

• Cyclophosphamide (another alkylating agent)
• Ifosfamide (another alkylating agent)
• Busulfan (another alkylating agent, often used in conditioning regimens)
• Melphalan (another alkylating agent)
• Cisplatin (platinum-based agent, used in bladder cancer)
• Gemcitabine (antimetabolite, used in bladder cancer)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. Instead, consult with your pharmacist to determine the best disposal method. Many communities have drug take-back programs that provide a safe and environmentally responsible way to dispose of unwanted medications.

Some medications may have additional patient information leaflets available. If you have questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare professionals provide the most effective treatment.