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Thiotepa 100 mg Injection, Powder, For Solution, 1 vial — NDC 71288-0157-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Thiotepa 100 mg Injection, Powder, For Solution, 1 vial — NDC 71288-157-10 (Billing 71288-0157-10)

by Meitheal Pharmaceuticals Inc · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of Thiotepa 100 mg Injection, Powder, For Solution from Meitheal Pharmaceuticals Inc, marketed since Dec 2023 and currently FDA-listed. It is this product's only package size.

NDC 71288-0157-10
🏷️ FDA NDC (as labeled) 71288-157-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71288-157-10
Product NDC 71288-157
11-digit billing NDC 71288015710
NCPDP billing unit EA — each (per item)
RxCUI 1660004, 1660009
UNII 905Z5W3GKH
Application # ANDA216037
SPL Set ID 4b4725eb-95f1-45cc-852f-152beb5f1e2c
Established class (EPC) Alkylating Drug
Mechanism of action Alkylating Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-26
Route INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance THIOTEPA
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21100040002150
GCN Seq No 066744
GCN 29119
HICL code 003898
Ingredient (HICL) Thiotepa
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1A
Therapeutic class — specific (HIC3) Antineoplastic - Alkylating Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name THIOTEPA 100 MG VIAL
FDB brand name Thiotepa
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066744
  • GCN: 29119
  • GPI-14 (Medi-Span): 21100040002150
  • HICL (First Databank): 003898
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1660004
Why two NDCs? The FDA registers this code as 71288-157-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71288-0157-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Ethylene imines
How it works Alkylating Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name THIOTEPA 100 MG VIAL Ingredient Thiotepa
📗 Our plain-language guide HelloPharmacist
  • It is a chemotherapy medicine. Tepadina is used before stem cell transplant in children with class 3 beta-thalassemia. It is also used for breast or ovarian adenocarcinoma, cancer-...
  • A healthcare team gives it to you. Depending on the use, it goes into a vein, into a body cavity, or into your bladder through a catheter. Your team decides the schedule and checks...
  • Low blood counts are very common. You may also get mouth sores, diarrhea, rash, bleeding, blood in the urine, nausea and tiredness. Call right away for fever, signs of infection, u...
  • Thiotepa can leave your body partly through the skin and cause discoloration, itching, blistering or peeling. The label advises bathing at least twice daily through 48 hours after...
📖 Read our full Thiotepa Injection guide →
1
Nutrient depletion considerations

Thiotepa may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Thiotepa nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9342 $4.931 / J9342 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)71288-157-10
11-digit billing NDC71288-0157-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9342
DescriptorINJECTION, THIOTEPA, NOT OTHERWISE SPECIFIED, 1 MG
Billing units / pkg100 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 1 MG, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$17,876 · 32 claims · $558.64 per claim (all NDCs under J9342)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71288-0157-10 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2023-12-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Thiotepa 100 mg 00143-9292-01 Hikma 1 vial — AP FDA listed —
Thiotepa 100 mg 43598-0171-11 Dr.Reddy's 1 vial — AP FDA listed —
Thiotepa 100 mg 65219-0029-20 Fresenius 1 vial — AP FDA listed —
Thiotepa 100 mg 68083-0503-01 Gland 1 vial — AP FDA listed —
Tepadina 100 mg 70121-1631-01 Amneal 1 vial — AP FDA listed —
Thiotepa 100 mgthis 71288-0157-10 Meitheal 1 vial — AP FDA listed —
Thiotepa 100 mg 72205-0046-01 Novadoz 1 vial — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMeitheal Pharmaceuticals Inc
Application holderMEITHEAL PHARMACEUTICALS INC
FDA applicationANDA216037 (ANDA)
Labeler code71288
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio16 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 116 words ▾

WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY Thiotepa may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Hematopoietic progenitor (stem) cell transplantation (HSCT) is required to prevent potentially fatal complications of the prolonged myelosuppression after high doses of thiotepa [see Warnings and Precautions (5.1) ] .

Thiotepa should be considered potentially carcinogenic in humans [see Warnings and Precautions (5.7) ] . WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY See full prescribing information for complete boxed warning. May cause severe marrow suppression or ablation with resulting infection or bleeding.

Monitor hematologic laboratory parameters [see Warnings and Precautions (5.1) ] . Potentially carcinogenic in humans [see Warnings and Precautions (5.7) ] .

🎯 Indications and Usage 151 words ▾

1 INDICATIONS AND USAGE Thiotepa for Injection is an alkylating drug indicated: For treatment of adenocarcinoma of the breast or ovary. ( 1.2 ) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. ( 1.3 ) For treatment of superficial papillary carcinoma of the urinary bladder. ( 1.4 )

1.2Adenocarcinoma of the Breast or Ovary Thiotepa for Injection is indicated for treatment of adenocarcinoma of the breast or ovary.

1.3Malignant Effusions Thiotepa for Injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.

1.4Superficial Papillary Carcinoma of the Urinary Bladder Thiotepa for Injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder. Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection. However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of thiotepa for injection for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously. ( 2.1 ) The recommended dose of thiotepa for injection for treatment of malignant effusions is 0.6 to 0.8 mg/kg intracavitary. ( 2.1 ) The recommended dose of thiotepa for injection for treatment of superficial papillary carcinoma of the urinary bladder is 60 mg in 30 to 60 mL of Sodium Chloride Injection into the bladder by catheter.

( 2.1 )

2.1Recommended Dosage Adenocarcinoma of the Breast or Ovary The recommended dose of thiotepa for injection for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously. Doses should be given at 1 to 4 week intervals. Initially the higher dose in the given range is commonly administered.

The maintenance dose should be adjusted weekly on the basis of pretreatment control blood counts and subsequent blood counts. Maintenance doses should not be administered more frequently than weekly. Malignant Effusions The recommended dose of thiotepa for injection for treatment of malignant effusions is 0.6 to 0.8 mg/kg intracavitary.

Administration is usually effected through the same tubing which is used to remove the fluid from the cavity involved. Doses should be given at 1 to 4 week intervals. Initially the higher dose in the given range is commonly administered.

The maintenance dose should be adjusted weekly on the basis of pretreatment control blood counts and subsequent blood counts. Maintenance doses should not be administered more frequently than weekly. Superficial Papillary Carcinoma of the Urinary Bladder The recommended dose of thiotepa for injection for treatment of superficial papillary carcinoma of the urinary bladder is 60 mg in 30 to 60 mL of Sodium Chloride Injection into the bladder by catheter.

The solution should be retained for 2 hours. If the patient finds it impossible to retain 60 mL for 2 hours, the dose may be given in a volume of 30 mL. The patient may be repositioned every 15 minutes for maximum area contact.

The usual course of treatment is once a week for 4 weeks. The course may be repeated if necessary, but second and third courses must be given with caution since bone-marrow depression may be increased. Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection.

However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

2.2Preparation Instructions Thiotepa for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures 1 . Reconstitution Reconstitute thiotepa for injection 15 mg with 1.5 mL of sterile water for injection.

Using a syringe fitted with a needle, aseptically withdraw 1.5 mL of sterile water for injection. Inject the content of the syringe into the vial through the rubber stopper. Remove the syringe and needle, and mix manually by repeated inversions.

Reconstitute thiotepa for injection 100 mg with 10 mL of sterile water for injection. Using a syringe fitted with a needle, aseptically withdraw 10 mL of sterile water for injection. Inject the content of the syringe into the vial through the rubber stopper.

Remove the syringe and needle, and mix manually by repeated inversions. The reconstituted solution is hypotonic and must be diluted in saline prior to administration. Reconstituted solutions, free of visible particulate matter, may occasionally show opalescence; such solutions can still be used for further dilution.

If not used immediately after reconstitution, the product is stable for 8 hours when stored at 2° to 8°C (36° to 46°F). Dilution in the Infusion Bag Prior to administration, dilute the reconstituted solution further with an appropriate volume of sodium chloride 0.9% solution for injection to obtain a final thiotepa for injection concentration between 0.5 and 1 mg per mL. Dilute thiotepa for injection as recommended in Table 2 .

Table 2: Dilu… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 75 words ▾

3 DOSAGE FORMS AND STRENGTHS Thiotepa for Injection, USP, 15 mg, white lyophilized powder or lyophilized cake in single-dose vial for reconstitution Thiotepa for Injection, USP, 100 mg, white lyophilized powder or lyophilized cake in single-dose vial for reconstitution For injection: 15 mg, white lyophilized powder or lyophilized cake in single-dose vial for reconstitution. ( 3 ) For injection: 100 mg, white lyophilized powder or lyophilized cake in single-dose vial for reconstitution. ( 3 )

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS Thiotepa is contraindicated in: Patients with severe hypersensitivity to thiotepa [see Warnings and Precautions (5.2) ] Concomitant use with live or attenuated vaccines [see Warnings and Precautions (5.4) ] Hypersensitivity to the active substance. ( 4 ) Concomitant use with live or attenuated vaccines. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cutaneous toxicity: Cleanse skin at least twice daily through 48 hours after the last dose of thiotepa. ( 5.3 ) Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy. ( 5.8 )

5.1Myelosuppression The consequence of treatment with high doses of thiotepa together with other chemotherapy is profound myelosuppression occurring in all patients. Monitor complete blood counts, and provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery. For patients receiving thiotepa for treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder, if the bone marrow has been compromised by prior irradiation or chemotherapy, or is recovering from chemotherapy, the risk of severe myelosuppression with thiotepa may be increased.

Perform periodic complete blood counts during the course of treatment with thiotepa. Provide supportive care for infections, bleeding, and symptomatic anemia [see Adverse Reactions (6.1) ] . Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection.

However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

5.2Hypersensitivity Clinically significant hypersensitivity reactions, including anaphylaxis, have occurred following administration of thiotepa. If anaphylactic or other clinically significant allergic reaction occurs, discontinue treatment with thiotepa, initiate appropriate therapy, and monitor until signs and symptoms resolve [see Contraindications (4) , Adverse Reactions (6.1) ] .

5.3Cutaneous Toxicity Thiotepa and/or its active metabolites may be excreted in part via skin patients receiving high-dose therapy. Treatment with thiotepa may cause skin discoloration, pruritus, blistering, desquamation, and peeling that may be more severe in the groin, axillae, skin folds, in the neck area, and under dressings. Instruct patients to shower or bathe with water at least twice daily through 48 hours after administration of thiotepa.

Change occlusive dressing and clean the covered skin at least twice daily through 48 hours after administration of thiotepa. Change bed sheets daily during treatment. Skin reactions associated with accidental exposure to thiotepa may also occur.

Wash the skin thoroughly with soap and water in case thiotepa solution contacts the skin. Flush mucous membranes in case of thiotepa contact with mucous membranes.

5.4Concomitant Use of Live and Attenuated Vaccines Do not administer live or attenuated viral or bacterial vaccines to a patient treated with thiotepa until the immunosuppressive effects have resolved.

5.5Hepatic Veno-Occlusive Disease Hepatic veno-occlusive disease may occur in patients who have received high-dose thiotepa in conjunction with busulfan and cyclophosphamide. Monitor by physical examination, serum transaminases and bilirubin and provide supportive care to patients who develop hepatic veno-occlusive disease. Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection.

However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

5.6Central Nervous System Toxicity Fatal encephalopathy has occurred in patients treated with high doses of thiotepa. Other central nervous system toxicities, such as headache, apathy, psychomotor retardation, disorientation, confusion, amnesia, hallucinations, drowsiness, somnolence, seizures, coma, inappropriate behaviour 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 thiotepa.

If severe or life-threatening central nervous system toxicity occurs, discontinue administration of thiotepa and provide supportiv… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 ) ] Infection [see Warnings and Precautions ( 5.1 ) ] Hypersensitivity [see Warnings and Precautions ( 5.2 )] Cutaneous Toxicity [see Warnings and Precautions ( 5.3 )] Hepatic Veno-Occlusive Disease [see Warnings and Precautions ( 5.5 )] Central Nervous System Toxicity [see Warnings and Precautions ( 5.6 )] Carcinogenicity [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (incidence greater than 10%) were neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions with Treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder Gastrointestinal : Nausea, vomiting, abdominal pain, anorexia.

General : Fatigue, weakness. Febrile reaction and discharge from a subcutaneous lesion may occur as the result of breakdown of tumor tissue. Hypersensitivity Reactions : Allergic reactions - rash, urticaria, laryngeal edema, asthma, anaphylactic shock, wheezing.

Local Reactions : Contact dermatitis, pain at the injection site. Neurologic : Dizziness, headache, blurred vision. Renal : Dysuria, urinary retention, chemical cystitis or hemorrhagic cystitis.

Reproductive : Amenorrhea, interference with spermatogenesis. Respiratory : Prolonged apnea has been reported when succinylcholine was administered prior to surgery, following combined use of thiotepa and other anticancer agents. It was theorized that this was caused by decrease of pseudocholinesterase activity caused by the anticancer drugs.

Skin : Dermatitis, alopecia. Skin depigmentation has been reported following topical use. Special Senses : Conjunctivitis.

Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection. However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

6.2Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of thiotepa in preparative regimens prior to allogeneic or autologous hematopoietic progenitor (stem) cell transplantation (HSCT) in patients. Blood and lymphatic system disorders : Febrile bone marrow aplasia.

Cardiac disorders : Bradycardia, cardiac failure congestive, cardio-respiratory arrest, pericardial effusion, pericarditis, right ventricular hypertrophy. Congenital, familial and genetic disorders : Aplasia. Ear and labyrinth disorders : Deafness.

Eye disorders : Blindness, eyelid ptosis, papilledema, strabismus. Gastrointestinal disorders : Ascites, dysphagia, enterocolitis, gastritis, palatal disorder. General disorders and administration site conditions : Device related infection, gait disturbance, malaise, multi-organ failure, pain.

Hepatobiliary disorders : Hepatomegaly. Immune system disorders : Bone marrow transplant rejection, immunosuppression. Infections and infestations : Acute sinusitis, bronchopulmonary aspergillosis, candida sepsis, enterococcal infection, Epstein-Barr virus infection, Escherichia sepsis, Fusarium infection… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 209 words ▾

7 DRUG INTERACTIONS

7.1Effect of Cytochrome CYP3A Inhibitors and Inducers In vitro studies suggest that thiotepa is metabolized by CYP3A4 and CYP2B6 to its active metabolite TEPA. Avoid coadministration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with thiotepa due to the potential effects on efficacy and toxicity [see Clinical Pharmacology (12.2) ] . Consider alternative medications with no or minimal potential to inhibit or induce CYP3A4.

If concomitant use of strong CYP3A4 modulators cannot be avoided, closely monitor for adverse drug reactions.

7.2Effect of Thiotepa on Cytochrome CYP2B6 Substrates In vitro studies suggest that thiotepa inhibits CYP2B6. Thiotepa may increase the exposure of drugs that are substrates of CYP2B6 in patients; however, the clinical relevance of this in vitro interaction is unknown [see Clinical Pharmacology (12.2) ] . The administration of thiotepa with cyclophosphamide in patients reduces the conversion of cyclophosphamide to the active metabolite, 4-hydroxycyclophosphamide; the effect appears sequence dependent with a greater reduction in the conversion to 4-hydroxycyclophosphamide when thiotepa is administered 1.5 hours prior to the intravenous administration of cyclophosphamide compared to administration of thiotepa after intravenous cyclophosphamide [see Clinical Pharmacology (12.2) ] .

The reduction in 4-hydroxycyclophosphamide levels may potentially reduce efficacy of cyclophosphamide treatment.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended. ( 8.2 ) Moderate or severe renal impairment: Monitor patients more frequently for toxicity. ( 8.6 , 12.2 ) Moderate or severe hepatic impairment: Monitor patients more frequently for toxicity.

( 8.7 , 12.2 ) Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection. However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

8.1Pregnancy Risk Summary Thiotepa can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [see Clinical Pharmacology (12.1) ] . Limited available data with thiotepa use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. In animal reproduction studies, administration of thiotepa to pregnant mice and rats during organogenesis produced teratogenic effects (neural tube defects and malformations of the skeletal system of the fetus) at doses approximately 0.125 and 1 times, respectively, the maximum recommended human daily dose on a mg/m 2 basis.

Thiotepa was lethal to rabbit fetuses at approximately 2 times the maximum recommended human therapeutic dose based on body-surface area [see Data ] . Consider the benefits and risks of thiotepa for the mother and possible risks to the fetus when prescribing thiotepa to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Thiotepa given by the IP route in mice at doses ≥ 1 mg/kg (3.2 mg/m 2 ), approximately 8-fold less than the maximum recommended human therapeutic dose based on body-surface area, and in rats at doses ≥ 3 mg/kg (21 mg/m 2 ), approximately equal to the maximum recommended human therapeutic dose based on body-surface area, resulted in various malformations including neural tube defects, omphalocele, renal agenesis, atresia ani, limb and digit defects, cleft palate, micrognathia, other skeletal anomalies in the skull, vertebrae and ribs, and reduced skeletal ossification.

Thiotepa was lethal to rabbit fetuses at a dose of 3 mg/kg (41 mg/m 2 ), approximately 2 times the maximum recommended human therapeutic dose based on body-surface area.

8.2Lactation Risk Summary There is no information regarding the presence of thiotepa in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions, including the potential for tumorigenicity shown for thiotepa in animal studies, advise patients not to breastfeed during thiotepa treatment.

8.3Females and Males of Reproductive Potential Pregnancy Testing Thiotepa can cause fetal harm when administered to a pregnant female. Verify the pregnancy status of females of reproductive potential prior to initiating thiotepa therapy. Contraception Females Advise females of reproductive potential to avoid pregnancy during thiotepa treatment and for at least 6 months after the final dose of thiotepa.

Advise females to immediately report pregnancy [see Use in Specific Populations (8.1) ] . Males Thiotepa may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during thiotepa treatment and for at least 1 year after the final dose of thiotepa [see Nonclinical Toxicology (13.1) ] .

Infertility Based on nonclinical findings, male and female fertility may be compromised by treatment with thiotepa. Inform male patients about the possibility of sperm conservation before the start of therapy [see Nonclinical Toxicology (13.1 )] .

8.4Pediatric Use Safety and effectiveness of thiotepa in neonates… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Thiotepa can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [see Clinical Pharmacology (12.1) ] . Limited available data with thiotepa use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. In animal reproduction studies, administration of thiotepa to pregnant mice and rats during organogenesis produced teratogenic effects (neural tube defects and malformations of the skeletal system of the fetus) at doses approximately 0.125 and 1 times, respectively, the maximum recommended human daily dose on a mg/m 2 basis.

Thiotepa was lethal to rabbit fetuses at approximately 2 times the maximum recommended human therapeutic dose based on body-surface area [see Data ] . Consider the benefits and risks of thiotepa for the mother and possible risks to the fetus when prescribing thiotepa to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Thiotepa given by the IP route in mice at doses ≥ 1 mg/kg (3.2 mg/m 2 ), approximately 8-fold less than the maximum recommended human therapeutic dose based on body-surface area, and in rats at doses ≥ 3 mg/kg (21 mg/m 2 ), approximately equal to the maximum recommended human therapeutic dose based on body-surface area, resulted in various malformations including neural tube defects, omphalocele, renal agenesis, atresia ani, limb and digit defects, cleft palate, micrognathia, other skeletal anomalies in the skull, vertebrae and ribs, and reduced skeletal ossification.

Thiotepa was lethal to rabbit fetuses at a dose of 3 mg/kg (41 mg/m 2 ), approximately 2 times the maximum recommended human therapeutic dose based on body-surface area.

🧒 Pediatric Use 76 words ▾

8.4Pediatric Use Safety and effectiveness of thiotepa in neonates have not been established. Safety and effectiveness of thiotepa for treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder in pediatric patients have not been established. Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection.

However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

🧓 Geriatric Use 106 words ▾

8.5Geriatric Use Clinical studies of thiotepa for treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreasing hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 51 words ▾

10 OVERDOSE There is no experience with overdoses of thiotepa. The most important adverse reactions expected in case of overdose are myeloablation and pancytopenia [ see Nonclinical Toxicology (13.2) ] . There is no known antidote for thiotepa. Monitor the hematological status closely and provide vigorous supportive measures as medically indicated.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Thiotepa is a cytotoxic agent of the polyfunctional type, related chemically and pharmacologically to the nitrogen mustard. The radiomimetic action of thiotepa is believed to occur through the release of ethyleneimine radicals which, like irradiation, disrupt the bonds of DNA. One of the principle bond disruptions is initiated by alkylation of guanine at the N-7 position, which severs the linkage between the purine base and the sugar and liberates alkylated guanines.

12.2Pharmacokinetics Absorption Thiotepa reached maximal concentrations close to the end infusion following an intravenous infusion. Distribution The binding of thiotepa to plasma proteins is approximately 10% to 20%. In adults administered intravenous thiotepa between 20 mg to 250 mg/m 2 as an intravenous bolus or infusion up to 4 hours, the mean volume of distribution of thiotepa ranged from

1.0 L/kg (30%) to

1.9L/kg (17%). Elimination In adults administered intravenous thiotepa between 20 mg to 250 mg/m 2 as an intravenous bolus or infusion up to 4 hours, the mean thiotepa clearance ranged from

14.6 L/hr/m 2 (23%) to

27.9L/hr/m 2 (69%). In adult population, the mean terminal elimination half-life ranged from 1.4 hours (7%) to 3.7 hours (14%) for thiotepa and from 4.9 hours to 17.6 hours (20%) for TEPA. Metabolism Thiotepa undergoes hepatic metabolism.

In vitro data suggests that CYP3A4 and CYP2B6 may be responsible for the metabolism of thiotepa to TEPA, a major active metabolite. Excretion In adult patients, urinary excretion of thiotepa accounted for less than 2% of the dose and TEPA accounted for 11% or less of the dose. Specific Populations Hepatic Impairment The exposure (as measured by area under the curve (AUC)) of thiotepa increased by 1.6-fold and 1.8-fold following administration of multiple thiotepa doses of 7 mg/kg administered every 2 days with cyclophosphamide in two adult patients who had liver metastases with moderate hepatic impairment compared to the exposure observed in one patient with normal hepatic function.

The effect of severe hepatic impairment on thiotepa exposure is unknown. Renal Impairment The exposure (as measured by AUC) of thiotepa increased by 1.4-fold and TEPA increased by 2.6-fold following administration of multiple doses of 120 mg/m 2 /day in one patient with moderate renal impairment (CLcr = 38 mL/min) administered cyclophosphamide plus thiotepa plus carboplatin, compared to exposure of thiotepa in patients with normal renal function. The effects of severe renal impairment or end-stage renal disease on thiotepa exposure are unknown.

Drug Interactions The clinical relevance of in vitro inhibition of the cytochrome P450 enzymes described below is unknown, but it cannot be excluded that the systemic exposure of thiotepa or medicinal products that are substrates for these enzymes may be affected with concomitant administration with thiotepa. Effect of Cytochrome P450 Modulators on Thiotepa In vitro data demonstrates that CYP3A4 and CYP2B6 inhibitors decrease the metabolism of thiotepa [see Drug Interactions (7.1) ] . Effect of Thiotepa on Cytochrome P450 2B6 In vitro data demonstrates that thiotepa inhibits CYP2B6.

Effect of Thiotepa on Cyclophosphamide The administration of thiotepa 1.5 hours prior to intravenous cyclophosphamide in patients administered cyclophosphamide plus thiotepa plus carboplatin decreased the AUC of 4-hydroxycyclophosphamide by 26% and maximal concentrations of 4­-hydroxycyclophosphamide by 62%, compared to administration of cyclophosphamide prior to thiotepa. Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection. However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

🧬 Mechanism of Action 75 words ▾

12.1Mechanism of Action Thiotepa is a cytotoxic agent of the polyfunctional type, related chemically and pharmacologically to the nitrogen mustard. The radiomimetic action of thiotepa is believed to occur through the release of ethyleneimine radicals which, like irradiation, disrupt the bonds of DNA. One of the principle bond disruptions is initiated by alkylation of guanine at the N-7 position, which severs the linkage between the purine base and the sugar and liberates alkylated guanines.

📦 How Supplied / Storage and Handling 122 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Thiotepa for Injection, USP, a white lyophilized powder or lyophilized cake, is supplied in a Type I clear glass vial with a chlorobutyl rubber stopper as follows: NDC Thiotepa for Injection, USP Package Factor 71288- 156 -05 71288- 157 -10 15 mg Single-Dose Vial 100 mg Single-Dose Vial 1 vial per carton 1 vial per carton

16.2Storage and Handling Thiotepa for Injection, USP vials must be stored and transported refrigerated at 2° to 8°C (36° to 46°F). Do not freeze. Discard unused portion. Thiotepa for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures 1 . Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

📦 Storage and Handling 58 words ▾

16.2Storage and Handling Thiotepa for Injection, USP vials must be stored and transported refrigerated at 2° to 8°C (36° to 46°F). Do not freeze. Discard unused portion. Thiotepa for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures 1 . Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

📋 Description 173 words ▾

11 DESCRIPTION Thiotepa for Injection, USP is an alkylating agent. Thiotepa for Injection, USP is supplied as a nonpyrogenic, sterile, white lyophilized powder or lyophilized cake for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for Injection, USP is available in a single-dose vial containing: 15 mg thiotepa.

After reconstitution with 1.5 mL of water for injection, each mL contains 10 mg thiotepa. 100 mg thiotepa. After reconstitution with 10 mL of water for injection, each mL contains 10 mg thiotepa.

Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula: Thiotepa has the molecular formula C 6 H 12 N 3 PS, and a molecular weight of 189.22, and it appears as fine, white crystalline flakes, with a melting range of 52° to 57°C.

It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium. structural formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Counsel patients on the signs and symptoms of hypersensitivity and to seek immediate emergency assistance if they develop any of these signs and symptoms [see Warnings and Precautions (5.2) ] . Myelosuppression Inform patients of the possibility of developing low blood cell counts and the need for hematopoietic progenitor cell infusion. Instruct patients to immediately report to their healthcare provider if bleeding or fever occurs [see Warnings and Precautions (5.1) ] .

Females and Males of Reproductive Potential Thiotepa can cause fetal harm. Advise females receiving thiotepa to avoid pregnancy during thiotepa treatment and for at least 6 months after the final dose of thiotepa [see Warnings and Precautions (5.8) ] . Advise males with female sexual partners of reproductive potential to use effective contraception during thiotepa treatment and for at least 1 year after the final dose of thiotepa [see Use in Specific Populations (8.3) ] .

Advise females to report pregnancy immediately [see Warnings and Precautions (5.8) ] . Advise patients that thiotepa can produce infertility. Inform male patients about the possibility of sperm conservation before the start of therapy [see Use in Specific Populations (8.3) ] .

Lactation Advise patients to avoid breastfeeding while receiving thiotepa [see Use in Specific Populations (8.2) ] . Secondary malignancies Inform patients that thiotepa can increase the risk of secondary malignancy [see Warnings and Precautions (5.7) ] . Brands listed are the trademarks of their respective owners. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2023 Meitheal Pharmaceuticals Inc.

Mfd. by Kindos Pharmaceuticals Co., Ltd. Chengdu, China 611731 February 2023 LB-381-V1

🧬 Pharmacokinetics ~2 min read ▾

12.2Pharmacokinetics Absorption Thiotepa reached maximal concentrations close to the end infusion following an intravenous infusion. Distribution The binding of thiotepa to plasma proteins is approximately 10% to 20%. In adults administered intravenous thiotepa between 20 mg to 250 mg/m 2 as an intravenous bolus or infusion up to 4 hours, the mean volume of distribution of thiotepa ranged from

1.0 L/kg (30%) to

1.9L/kg (17%). Elimination In adults administered intravenous thiotepa between 20 mg to 250 mg/m 2 as an intravenous bolus or infusion up to 4 hours, the mean thiotepa clearance ranged from

14.6 L/hr/m 2 (23%) to

27.9L/hr/m 2 (69%). In adult population, the mean terminal elimination half-life ranged from 1.4 hours (7%) to 3.7 hours (14%) for thiotepa and from 4.9 hours to 17.6 hours (20%) for TEPA. Metabolism Thiotepa undergoes hepatic metabolism.

In vitro data suggests that CYP3A4 and CYP2B6 may be responsible for the metabolism of thiotepa to TEPA, a major active metabolite. Excretion In adult patients, urinary excretion of thiotepa accounted for less than 2% of the dose and TEPA accounted for 11% or less of the dose. Specific Populations Hepatic Impairment The exposure (as measured by area under the curve (AUC)) of thiotepa increased by 1.6-fold and 1.8-fold following administration of multiple thiotepa doses of 7 mg/kg administered every 2 days with cyclophosphamide in two adult patients who had liver metastases with moderate hepatic impairment compared to the exposure observed in one patient with normal hepatic function.

The effect of severe hepatic impairment on thiotepa exposure is unknown. Renal Impairment The exposure (as measured by AUC) of thiotepa increased by 1.4-fold and TEPA increased by 2.6-fold following administration of multiple doses of 120 mg/m 2 /day in one patient with moderate renal impairment (CLcr = 38 mL/min) administered cyclophosphamide plus thiotepa plus carboplatin, compared to exposure of thiotepa in patients with normal renal function. The effects of severe renal impairment or end-stage renal disease on thiotepa exposure are unknown.

Drug Interactions The clinical relevance of in vitro inhibition of the cytochrome P450 enzymes described below is unknown, but it cannot be excluded that the systemic exposure of thiotepa or medicinal products that are substrates for these enzymes may be affected with concomitant administration with thiotepa. Effect of Cytochrome P450 Modulators on Thiotepa In vitro data demonstrates that CYP3A4 and CYP2B6 inhibitors decrease the metabolism of thiotepa [see Drug Interactions (7.1) ] . Effect of Thiotepa on Cytochrome P450 2B6 In vitro data demonstrates that thiotepa inhibits CYP2B6.

Effect of Thiotepa on Cyclophosphamide The administration of thiotepa 1.5 hours prior to intravenous cyclophosphamide in patients administered cyclophosphamide plus thiotepa plus carboplatin decreased the AUC of 4-hydroxycyclophosphamide by 26% and maximal concentrations of 4­-hydroxycyclophosphamide by 62%, compared to administration of cyclophosphamide prior to thiotepa. Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection. However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

🔬 Clinical Studies 32 words ▾

14 CLINICAL STUDIES Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection. However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In mice, repeated intraperitoneal (IP) administration of thiotepa (1.15 or 2.3 mg/kg three times per week for 52 or 43 weeks, respectively) produced a significant increase in the combined incidence of squamous-cell carcinomas of the skin, preputial gland, and ear canal, and combined incidence of lymphoma and lymphocytic leukemia. In other studies in mice, repeated IP administration of thiotepa (4 or 8 mg/kg three times per week for 4 weeks followed by a 20 week observation period or 1.8 mg/kg three times per week for 4 weeks followed by a 35 week observation period) resulted in an increased incidence of lung tumors.

In rats, repeated IP administration of thiotepa (0.7 or 1.4 mg/kg three times per week for 52 or 34 weeks, respectively) produced significant increases in the incidence of squamous-cell carcinomas of the skin or ear canal, combined hematopoietic neoplasms, and uterine adenocarcinomas. Thiotepa given intravenously (IV) to rats (1 mg/kg once per week for 52 weeks) produced an increased incidence of malignant tumors (abdominal cavity sarcoma, lymphosarcoma myelosis, seminoma, fibrosarcoma, salivary gland hemangioendothelioma, mammary sarcoma, pheochromocytoma) and benign tumors.

The lowest reported carcinogenic dose in mice (1.15 mg/kg, 3.68 mg/m 2 ) is approximately 7-fold less than the maximum recommended human therapeutic dose based on body-surface area. The lowest reported carcinogenic dose in rats (0.7 mg/kg, 4.9 mg/m 2 ) is approximately 6-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa was mutagenic in in vitro assays in Salmonella typhimurium, E coli , Chinese hamster lung and human lymphocytes.

Chromosomal aberrations and sister chromatid exchanges were observed in vitro with thiotepa in bean root tips, human lymphocytes, Chinese hamster lung, and monkey lymphocytes. Mutations were observed with oral thiotepa in mouse at doses > 2.5 mg/kg (8 mg/m 2 ). The mouse micronucleus test was positive with intraperitoneal administration of > 1 mg/kg (3.2 mg/m 2 ).

Other positive in vivo chromosomal aberration or mutation assays included Drosophila melanogaster , Chinese hamster marrow, murine marrow, monkey lymphocyte, and murine germ cell. Thiotepa impaired fertility in male mice at oral or intraperitoneal doses ≥ 0.7 mg/kg (2.24 mg/m 2 ), approximately 12-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa (0.5 mg) inhibited implantation in female rats when instilled into the uterine cavity.

Thiotepa interfered with spermatogenesis in mice at IP doses ≥ 0.5 mg/kg (1.6 mg/m 2 ), approximately 17-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa interfered with spermatogenesis in hamsters at an IP dose of 1 mg/kg (4.1 mg/m 2 ), approximately 7-fold less than the maximum recommended human therapeutic dose based on body-surface area.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In mice, repeated intraperitoneal (IP) administration of thiotepa (1.15 or 2.3 mg/kg three times per week for 52 or 43 weeks, respectively) produced a significant increase in the combined incidence of squamous-cell carcinomas of the skin, preputial gland, and ear canal, and combined incidence of lymphoma and lymphocytic leukemia. In other studies in mice, repeated IP administration of thiotepa (4 or 8 mg/kg three times per week for 4 weeks followed by a 20 week observation period or 1.8 mg/kg three times per week for 4 weeks followed by a 35 week observation period) resulted in an increased incidence of lung tumors.

In rats, repeated IP administration of thiotepa (0.7 or 1.4 mg/kg three times per week for 52 or 34 weeks, respectively) produced significant increases in the incidence of squamous-cell carcinomas of the skin or ear canal, combined hematopoietic neoplasms, and uterine adenocarcinomas. Thiotepa given intravenously (IV) to rats (1 mg/kg once per week for 52 weeks) produced an increased incidence of malignant tumors (abdominal cavity sarcoma, lymphosarcoma myelosis, seminoma, fibrosarcoma, salivary gland hemangioendothelioma, mammary sarcoma, pheochromocytoma) and benign tumors.

The lowest reported carcinogenic dose in mice (1.15 mg/kg, 3.68 mg/m 2 ) is approximately 7-fold less than the maximum recommended human therapeutic dose based on body-surface area. The lowest reported carcinogenic dose in rats (0.7 mg/kg, 4.9 mg/m 2 ) is approximately 6-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa was mutagenic in in vitro assays in Salmonella typhimurium, E coli , Chinese hamster lung and human lymphocytes.

Chromosomal aberrations and sister chromatid exchanges were observed in vitro with thiotepa in bean root tips, human lymphocytes, Chinese hamster lung, and monkey lymphocytes. Mutations were observed with oral thiotepa in mouse at doses > 2.5 mg/kg (8 mg/m 2 ). The mouse micronucleus test was positive with intraperitoneal administration of > 1 mg/kg (3.2 mg/m 2 ).

Other positive in vivo chromosomal aberration or mutation assays included Drosophila melanogaster , Chinese hamster marrow, murine marrow, monkey lymphocyte, and murine germ cell. Thiotepa impaired fertility in male mice at oral or intraperitoneal doses ≥ 0.7 mg/kg (2.24 mg/m 2 ), approximately 12-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa (0.5 mg) inhibited implantation in female rats when instilled into the uterine cavity.

Thiotepa interfered with spermatogenesis in mice at IP doses ≥ 0.5 mg/kg (1.6 mg/m 2 ), approximately 17-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa interfered with spermatogenesis in hamsters at an IP dose of 1 mg/kg (4.1 mg/m 2 ), approximately 7-fold less than the maximum recommended human therapeutic dose based on body-surface area.

📚 References 9 words ▾

15 REFERENCES OSHA Hazardous Drugs. OSHA. [Accessed from http://www.osha.gov/SLTC/hazardousdrugs/index.html].

📄 Package Label / Principal Display Panel 196 words ▾

PRINCIPAL DISPLAY PANEL – Thiotepa for Injection, USP 15 mg Vial Label NDC 71288- 156 -05 Rx Only Caution: Cytotoxic Agent Thiotepa for Injection, USP 15 mg per vial For Intravenous, Intracavitary, or Intravesical Use Single-Dose Vial PRINCIPAL DISPLAY PANEL – Thiotepa for Injection, USP 15 mg Vial Label

PRINCIPAL DISPLAY PANEL – Thiotepa for Injection, USP 15 mg Carton NDC 71288- 156 -05 Rx Only Thiotepa for Injection, USP 15 mg per vial For Intravenous, Intracavitary, or Intravesical Use Caution: Cytotoxic Agent 1 Single-Dose Vial Sterile PRINCIPAL DISPLAY PANEL – Thiotepa for Injection, USP 15 mg Carton

PRINCIPAL DISPLAY PANEL – Thiotepa for Injection, USP 100 mg Vial Label NDC 71288- 157 -10 Rx Only Caution: Cytotoxic Agent Thiotepa for Injection, USP 100 mg per vial For Intravenous, Intracavitary, or Intravesical Use Single-Dose Vial PRINCIPAL DISPLAY PANEL – Thiotepa for Injection, USP 100 mg Vial Label

PRINCIPAL DISPLAY PANEL – Thiotepa for Injection, USP 100 mg Carton NDC 71288- 157 -10 Rx Only Thiotepa for Injection, USP 100 mg per vial For Intravenous, Intracavitary, or Intravesical Use Caution: Cytotoxic Agent 1 Single-Dose Vial Sterile PRINCIPAL DISPLAY PANEL – Thiotepa for Injection, USP 100 mg Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Meitheal Pharmaceuticals Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Meitheal Pharmaceuticals Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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Yes — this NDC cross-references HCPCS code J9342 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71288-0156-05 · Meitheal 71288-0158-96 · Meitheal →
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