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Ifosfamide 50 mg/mL Injection — NDC 00143-9530-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ifosfamide 50 mg/mL Injection — NDC 0143-9530-01 (Billing 00143-9530-01)

by Hikma Pharmaceuticals USA Inc. · 1 VIAL in 1 BOX / 60 mL in 1 VIAL

This is a package of Ifosfamide 50 mg/mL Injection from Hikma Pharmaceuticals USA Inc., marketed since Jun 2017 and currently FDA-listed. It is this product's only package size.

NDC 00143-9530-01
🏷️ FDA NDC (as labeled) 0143-9530-01 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⚠ On shortage ⇄ 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0143-9530-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0143 labeler · 9530 product · 01 package
Package marketed since
Jun 10, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0143953001 5
Medicaid fills, this package
34 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Active FDA shortage. Ifosfamide Injection is currently reported in shortage by the FDA (Demand increase for the drug). Unavailable Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0143-9530-01
Product NDC 0143-9530
11-digit billing NDC 00143953001
NCPDP billing unit ML — per mL (volume)
RxCUI 1791597, 1791599
UNII UM20QQM95Y
Application # ANDA076619
SPL Set ID c90ab05f-8fe5-437e-a1c0-8b11ef63291e
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 2017-06-10
Route INTRAVENOUS
Dosage form INJECTION
Substance IFOSFAMIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 21101025002030
GPI class Ifosfamide
GCN Seq No 062947
GCN 98710
HICL code 004570
Ingredient (HICL) Ifosfamide
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 IFOSFAMIDE 3 GM/60 ML VIAL
FDB brand name Ifosfamide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 062947
  • GCN: 98710
  • GPI-14 (Medi-Span): 21101025002030
  • HICL (First Databank): 004570
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1791597
Why two NDCs? The FDA registers this code as 0143-9530-01 — a 4-4-2 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 labeler segment → 00143-9530-01. 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) Nitrogen mustard analogues
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 IFOSFAMIDE 3 GM/60 ML VIAL Ingredient Ifosfamide
📗 Our plain-language guide HelloPharmacist
  • It is used with other cancer medicines as third-line chemotherapy for germ cell testicular cancer. That means it is used after earlier treatments. It is always paired with mesna to...
  • It is given through an IV by your care team, as a slow infusion lasting at least 30 minutes. This is usually once a day for 5 days, repeated about every 3 weeks if your blood count...
  • Common ones are hair loss, nausea and vomiting, low blood counts, anemia, and blood in the urine. Infections and brain effects like drowsiness or confusion can also happen. Tell yo...
  • Call right away for fever or signs of infection, confusion, hallucinations, or seizures. Also call for bloody urine, chest pain, irregular heartbeat, breathing trouble, or signs of...
📖 Read our full Ifosfamide Injection guide →
4
Nutrient depletion considerations

Ifosfamide may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ifosfamide 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $1.42 $1.42 / 1 vial
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9208 $27.613 / J9208 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)0143-9530-01
11-digit billing NDC00143-9530-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ9208
DescriptorINJECTION, IFOSFAMIDE, 1 GRAM
Billing units / pkg0.05 units
How the units are derivedThis package is 60 ML; the HCPCS unit is 1 GM, so one package = 0.05 billing units.
Medicare Part B spend (2026 (Q1))$11,857 · 115 claims · $103.10 per claim (all NDCs under J9208)
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
00143-9530-01 You're viewing this Main listing 1 VIAL in 1 BOX / 60 mL in 1 VIAL 2017-06-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ifosfamide 50 mg/mLthis 00143-9530-01 Hikma 1 vial — AP FDA listed —
Ifosfamide 50 mg/mL 00143-9531-01 Hikma 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

🏛️
2017
On the market since
Jun 2017
📍
2026
Currently FDA-listed
9 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.

🧪 Avoiding an ingredient? See Ifosfamide Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 3.55 mg / 1 mL UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • 1.035 mg / 1 mL UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA076619 (ANDA)
Labeler code00143
First marketedJun 2017
Product typeHuman Prescription Drug
Portfolio726 products on file

More NDCs from Hikma Pharmaceuticals USA Inc. labeler code 00143

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 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 137 words ▾

WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY WARNING: MYELOSUPPRESSION, NEUROTOXICITY, AND UROTOXICITY Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death.

Monitor for CNS toxicity and discontinue treatment for encephalopathy. Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna. [see Warnings and Precautions ( 5.1 to 5.3) ] WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY See full prescribing information for complete boxed warning • Myelosuppression can be severe and lead to fatal infections (5.1) • CNS toxicities can be severe and result in encephalopathy and death (5.2) • Nephrotoxicity can be severe and result in renal failure.

Hemorrhagic cystitis can be severe. (5.3)

🎯 Indications and Usage 77 words ▾

1 INDICATIONS AND USAGE Ifosfamide Injection is indicated for use in combination with certain other approved antineoplastic agentsfor third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. Ifosfamide Injection is an alkylating drug indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.

It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. (1)

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Ifosfamide Injection should be administered intravenously at a dose of 1.2 grams per m 2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity. In order to prevent bladder toxicity, ifosfamide injection should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day.

Mesna should be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Studies of ifosfamide injection in patients with hepatic or renal impairment have not been conducted [see Use in Specifi c Populations ( 8.6 , 8.7 )] .

Preparation for Intravenous Administration/Stability Solutions of ifosfamide injection may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids: 5% Dextrose Injection 0.9% Sodium Chloride Injection Lactated Ringer’s Injections Sterile Water for Injection Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.

Further diluted solutions of ifosfamide injection should be refrigerated and used within 24 hours. Benzyl alcohol-containing solutions can reduce the stability of ifosfamide injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dosage and duration of treatment and/or treatment intervals depend on the scheme of combination therapy, the patient’s general state of health and organ function, and the results of laboratory monitoring. (2) • Ifosfamide injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes at a dose of 1.2 grams per m2 per day for 5 consecutive days. (2) • Treatment is repeated every 3 weeks or after recovery from hematologic toxicity.

(2) • To prevent bladder toxicity, ifosfamide injection should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fl uid per day. (2, 5.3 ) • Mesna should be used to reduce the incidence of hemorrhagic cystitis. (2)

💊 Dosage Forms and Strengths 26 words ▾

3 DOSAGE FORMS AND STRENGTHS 1 g/20 mL single-dose vial 3 g/60 mL single-dose vial • Single dose vials: 1 g/20 mL, 3 g/60 mL (3)

⛔ Contraindications 32 words ▾

4 CONTRAINDICATIONS Ifosfamide is contraindicated in patients with: • Known hypersensitivity to administration of ifosfamide. • Urinary outflow obstruction. • Known hypersensitivity to administration of ifosfamide. (4) • Urinary outflow obstruction. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Myelosuppression: Can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after treatment. (5.1) • Neurotoxicity: Severe and fatal neurotoxicity can occur.

Carefully monitor the patient for CNS toxicity and other neurotoxic effects. Discontinue therapy should encephalopathy develop. (5.2) • Urotoxicity: Severe nephrotoxicity with renal failure and death can occur.

Monitor for nephrotoxicity with serum and urine chemistries. Mesna should be used to reduce hemorrhagic cystitis. (5.3) • Cardiotoxicity: Arrhythmias, other ECG changes, and cardiomyopathy can occur and result in death.

Use with caution in patients with cardiac risk factors and in patients with preexisting cardiac disease. The risk of cardiotoxicity is dose dependent. (5.4) • Pulmonary toxicity: Interstitial pneumonitis, pulmonary fi brosis, and other forms of pulmonary toxicity with fatal outcomes can occur.

Monitor for signs and symptoms of pulmonary toxicity and treat as clinically indicated (5.5) • Secondary malignancies as late sequelae have occurred. (5.6) • Pregnancy: Can cause fetal harm. Women should not become pregnant and men should not father a child during therapy.

(5.8) • Anaphylactic/anaphylactoid reactions have been reported. (5.10)

5.1Myelosuppression, Immunosuppression, and Infections Treatment with ifosfamide may cause myelosuppression and significant suppression of immune responses, which can lead to severe infections. Fatal outcomes of ifosfamide-associated myelosuppression have been reported. Ifosfamide-induced myelosuppression can cause leukopenia, neutropenia, thrombocytopenia (associated with a higher risk of bleeding events), and anemia.

The nadir of the leukocyte count tends to be reached approximately during the second week after administration. When ifosfamide is given in combination with other chemotherapeutic/hematotoxic agents and/or radiation therapy, severe myelosuppression is frequently observed. The risk of myelosuppression is dose-dependent and is increased with administration of a single high dose compared with fractionated administration.

The risk of myelosuppression is also increased in patients with reduced renal function. Severe immunosuppression has led to serious, sometimes fatal, infections. Sepsis and septic shock also have been reported.

Infections reported with ifosfamide include pneumonias, as well as other bacterial, fungal, viral, and parasitic infections. Latent infections can be reactivated. In patients treated with ifosfamide, reactivation has been reported for various viral infections.

Infections must be treated appropriately. Antimicrobial prophylaxis may be indicated in certain cases of neutropenia at the discretion of the managing physician. In case of neutropenic fever, antibiotics and/or antimycotics must be given.

Close hematologic monitoring is recommended. White blood cell (WBC) count, platelet count and hemoglobin should be obtained prior to each administration and at appropriate intervals after administration. Unless clinically essential, ifosfamide should not be given to patients with a WBC count below 2000/μL and/or a platelet count below 50,000/μL.

Ifosfamide should be given cautiously, if at all, to patients with presence of an infection, severe immunosuppression or compromised bone marrow reserve, as indicated by leukopenia, granulocytopenia, extensive bone marrow metastases, prior radiation therapy, or prior therapy with other cytotoxic agents.

5.2Central Nervous System Toxicity, Neurotoxicity Administration of ifosfamide can cause CNS toxicity and other neurotoxic effects. The risk of CNS toxicity and other neurotoxic effects necessitates careful monitoring of the patient. Neurologic manifestations consisting of somnolence, confusion, hallucinations, blurred vision, psychotic behavior, extrapyramidal symptoms, urinary incontinence, seizures, and in some instances, coma, have been reported following ifosfamide therapy.

There have al… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS In clinical trials of ifosfamide monotherapy, the most common (≥ 10%) adverse reactions were alopecia, nausea/vomiting, leukopenia, anemia, CNS toxicity, hematuria, and infection. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Adverse Reactions from Clinical Trials Because clinical trials are conducted from 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 clinical practice. The adverse reactions and frequencies below are based on 30 publications describing clinical experience with fractionated administration of ifosfamide as monotherapy with a total dose of 4 to 12 g/m 2 per course.

System Organ Class (SOC) Adverse Reaction Percentage (Ratio) INFECTIONS AND INFESTATIONS Infection 9.9% (112/1128) BLOOD AND LYMPHATIC SYSTEM DISORDERS Leukopenia 1 (any) Leukopenia <1 x 10 3 /µL 43.5% (267/614) Thrombocytopenia 2 (any) Thrombocytopenia 50 x 10 3 /µL 4.8% (35/729) Anemia 3 37.9% (202/533) METABOLISM AND NUTRITION DISORDERS Anorexia 1.1% (15/1317) NERVOUS SYSTEM DISORDERS Central nervous system toxicity 4,5 15.4% (154/1001) Peripheral neuropathy 0.4% (5/1317) CARDIAC DISORDERS Cardiotoxicity 6 0.5% (7/1317) VASCULAR DISORDERS Hypotention 7 0.3% (4/1317) GASTROINTESTINAL DISORDERS Nausea/Vomiting 46.8% (443/964) Diarrhea 0.7% (9/1317) Stomatitis 0.3% (4/1317) HEPATOBILIARY DISORDERS Hepatotoxicity 8 1.8% (22/1190) SKIN AND SUBCUTANEOUS TISSUES DISORDERS Alopecia 89.6% (540/603) Dermatitis 0.08% (1/1317) Papular rash 0.08% (1/1317) RENAL AND URINARY DISORDERS Hemorrhagic cystitis 9 Hematuria - without mesna 44.1% (282/640) - with mesna 21.3% (33/155) Macrohematuria - without mesna 11.1% (66/594) - with mesna 5.2% (5/97) Renal dysfunction 10 -- Renal structural damage -- GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS Phlebitis 11 2.8% (37/1317) Neutropenic fever 12 1% (13/1317) Fatigue 0.3% (4/1317) Malaise Unable to calculate 1 The following adverse reaction terms have been reported for leukopenia: neutropenia, granulocytopenia, lymphopenia, and pancytopenia.

For neutropenic fever, see below. 2 Thrombocytopenia may also be complicated by bleeding. Bleeding with fatal outcome has been reported.

3 Includes cases reported as anemia and decrease in hemoglobin/hematocrit. 4 Encephalopathy with coma and death has been reported. 5 Central nervous system toxicity was reported to be manifested by the following signs and symptoms: Abnormal behavior, Affect lability Aggression, Agitation, Anxiety, Aphasia, Asthenia, Ataxia, Cerebellar syndrome, Cerebral function defi ciency, Cognitive disorder, Coma, Confusional state, Convulsions, Cranial nerve dysfunction, Depressed state of consciousness, Depression, Disorientation, Dizziness, Electroencephalogram abnormal, Encephalopathy, Flat affect.

Hallucinations, Headache, Ideation, Lethargy, Memory impairment, Mood change, Motor dysfunction, Muscle spasms, Myoclonus, Progressive loss of brainstem reflexes, Psychotic reaction, Restlessness, Somnolence, Tremor, Urinary incontinence. 6 Cardiotoxicity was reported as congestive heart failure, tachycardia, pulmonary edema. Fatal outcome has been reported.

7 Hypotension leading to shock and fatal outcome has been reported. 8 Hepatotoxicity was reported as increases in liver enzymes, i.e., serum alanine aminotransferase, serum aspartate aminotransferase, alkaline phosphatase, gamma-glutamyltransferase and lactate dehydrogenase, increased bilirubin, jaundice, hepatorenal syndrome. 9 Reported symptoms of hemorrhagic cystitis included dysuria and pollakiuria.

See also Post-marketing Adverse Reactions (6.2). 10 Renal dysfunction was reported to be manifested as: Renal failure (including acute renal failure, irreversible renal failure; fatal outcomes have been reported), Se… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 215 words ▾

7 DRUG INTERACTIONS Ifosfamide is a substrate for both CYP3A4 and CYP2B6. • CYP3A4 Inducers: monitor for increased toxicity when used in combination with CYP3A4 inducers. (7.1) • CYP3A4 Inhibitors: use in combination with CYP3A4 inhibitors could decrease the effectiveness of ifosfamide. (7.2)

7.1Inducers of CYP3A4 CYP3A4 inducers (e.g., carbamazepine, phenytoin, fosphenytoin, phenobarbital, rifampin, St. John Wort) may increase the metabolism of ifosfamide to its active alkylating metabolites. CYP3A4 inducers may increase the formation of the neurotoxic/nephrotoxic ifosfamide metabolite, chloroacetaldehyde. Closely monitor patients taking ifosfamide with CYP3A4 inducers for toxicities and consider dose adjustment.

7.2Inhibitors of CYP3A4 CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, itraconazole, sorafenib, aprepitant, fosaprepitant, grapefruit, grapefruit juice) may decrease the metabolism of ifosfamide to its active alkylating metabolites, perhaps decreasing the effectiveness of ifosfamide treatment.

7.1Inducers of CYP3A4 CYP3A4 inducers (e.g., carbamazepine, phenytoin, fosphenytoin, phenobarbital, rifampin, St. John Wort) may increase the metabolism of ifosfamide to its active alkylating metabolites. CYP3A4 inducers may increase the formation of the neurotoxic/nephrotoxic ifosfamide metabolite, chloroacetaldehyde. Closely monitor patients taking ifosfamide with CYP3A4 inducers for toxicities and consider dose adjustment.

7.2Inhibitors of CYP3A4 CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, itraconazole, sorafenib, aprepitant, fosaprepitant, grapefruit, grapefruit juice) may decrease the metabolism of ifosfamide to its active alkylating metabolites, perhaps decreasing the effectiveness of ifosfamide treatment.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: fetal growth retardation and neonatal anemia. (8.1) • Geriatric use: dose selection should be cautious. (8.5) • Patients with renal impairment: monitor for toxicity and consider dose reduction as needed ( 8.6)

8.1Pregnancy Ifosfamide can cause fetal harm when administered to a pregnant woman. Fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide-containing chemotherapy regimens during pregnancy. Animal studies indicate that ifosfamide is capable of causing gene mutations and chromosomal damage in vivo .

In pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m 2 dose of ifosfamide was administered on day 11 of gestation. Embryo-lethal effects were observed in rats following the administration of 54 mg/m 2 doses of ifosfamide from the 6th through the 15th day of gestation and embryotoxic effects were apparent after dams received 18 mg/m 2 doses over the same dosing period. Ifosfamide is embryotoxic to rabbits receiving 88 mg/m2/day doses from the 6th through the 18th day after mating.

The number of anomalies was also significantly increased over the control group. Women should not become pregnant and men should not father a child during therapy with ifosfamide. Further, men should not father a child for up to 6 months after the end of therapy.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug or after treatment, the patient should be apprised of the potential hazard to a fetus.

8.3Nursing Mothers Ifosfamide is excreted in breast milk. Because of the potential for serious adverse events and the tumorigenicity shown for ifosfamide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Women must not breastfeed during treatment with ifosfamide.

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, refl ecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. A study of patients 40 to 71 years of age indicated that elimination half-life appears to increase with advancing age [see Pharmacokinetics (12.3) ] . This apparent increase in half-life appeared to be related to increases in volume of distribution of ifosfamide with age.

No signifi cant changes in total plasma clearance or renal or non-renal clearance with age were reported. Ifosfamide and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Use in Patients with Renal Impairment No formal studies were conducted in patients with renal impairment. Ifosfamide and its metabolites are known to be excreted by the kidneys and may accumulate in plasma with decreased renal function. Patients with renal impairment should be closely monitored for toxicity and dose reduction may be considered. Ifosfamide and its metabolites are dialyzable.

8.7Use in Patients with Hepatic Impairment No formal studies were conducted in patients with hepatic impairment. Ifosfamide is extensively metabolized in the liver and forms both efficacious and toxic metabolites. Ifosfamide should be given cautiously to patients with impaired hepatic function.

8.6Use in Patients with Renal Impairment No formal studies were conducted in patients with renal impairment. Ifosfamide and its metabolites are known to be excreted by the kidneys and may accumulate in plasma with decreased renal function. Patients with renal impairment should be closely monitored for toxicit… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 211 words ▾

8.1Pregnancy Ifosfamide can cause fetal harm when administered to a pregnant woman. Fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide-containing chemotherapy regimens during pregnancy. Animal studies indicate that ifosfamide is capable of causing gene mutations and chromosomal damage in vivo .

In pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m 2 dose of ifosfamide was administered on day 11 of gestation. Embryo-lethal effects were observed in rats following the administration of 54 mg/m 2 doses of ifosfamide from the 6th through the 15th day of gestation and embryotoxic effects were apparent after dams received 18 mg/m 2 doses over the same dosing period. Ifosfamide is embryotoxic to rabbits receiving 88 mg/m2/day doses from the 6th through the 18th day after mating.

The number of anomalies was also significantly increased over the control group. Women should not become pregnant and men should not father a child during therapy with ifosfamide. Further, men should not father a child for up to 6 months after the end of therapy.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug or after treatment, the patient should be apprised of the potential hazard to a fetus.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.

🧓 Geriatric Use 153 words ▾

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, refl ecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. A study of patients 40 to 71 years of age indicated that elimination half-life appears to increase with advancing age [see Pharmacokinetics (12.3) ] . This apparent increase in half-life appeared to be related to increases in volume of distribution of ifosfamide with age.

No signifi cant changes in total plasma clearance or renal or non-renal clearance with age were reported. Ifosfamide and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 101 words ▾

10 OVERDOSAGE No specific antidote for ifosfamide is known. Patients who receive an overdose should be closely monitored for the development of toxicities. Serious consequences of overdosage include manifestations of dose-dependent toxicities such as CNS toxicity, nephrotoxicity, myelosuppression, and mucositis [see Warnings and Precautions (5)] .

Management of overdosage would include general supportive measures to sustain the patient through any period of toxicity that might occur, including appropriate state-of-the-art treatment for any concurrent infection, myelosuppression, or other toxicity. Ifosfamide as well as ifosfamide metabolites are dialyzable. Cystitis prophylaxis with mesna may be helpful in preventing or limiting urotoxic effects with overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ifosfamide is a prodrug that requires metabolic activation by hepatic cytochrome P450 isoenzymes to exert its cytotoxic activity. Activation occurs by hydroxylation at the ring carbon atom forming the unstable intermediate 4-hydroxyifosfamide and its ring-opened aldo tautomer, which decomposes to yield the cytotoxic and urotoxic compound acrolein and an alkylating isophosphoramide mustard as well as multiple other nontoxic products. The exact mechanism of action of ifosfamide has not been determined, but its cytotoxic action is primarily through DNA crosslinks caused by alkylation by the isophosphoramide mustard at guanine N-7 positions.

The formation of inter- and intra-strand cross-links in the DNA results in cell death.

12.3Pharmacokinetics Ifosfamide exhibits dose-dependent pharmacokinetics in humans. At single doses of 3.8 to 5 g/m2, the plasma concentrations decay biphasically and themean terminal elimination half-life is about 15 hours. At doses of 1.6 to 2.4 g/m2/day, the plasma decay is monoexponential and the terminal elimination half-life is about 7 hours.

Ifosfamide exhibits time-dependent pharmacokinetics in humans. Following intravenous administration of 1.5 g/m 2 over 0.5 hour once daily for 5 days to 15 patients with neoplastic disease, a decrease in the median elimination half-life from 7.2 hours on Day 1 to 4.6 hours on Day 5 occurred with a concomitant increase in the median clearance from 66 mL/min on Day 1 to 115 mL/min on Day 5. There was no significant change in the volume of distribution on Day 5 compared with Day 1.

Distribution Ifosfamide volume of distribution (Vd) approximates the total body water volume, suggesting that distribution takes place with minimal tissue binding. Following intravenous administration of 1.5 g/m 2 over 0.5 hour once daily for 5 days to 15 patients with neoplastic disease, the median Vd of ifosfamide was

0.64 L/kg on Day 1 and

0.72L/kg on Day 5. Ifosfamide shows little plasma protein binding. Ifosfamide and its active metabolites are extensively bound by red blood cells.

Ifosfamide is not a substrate for P-glycoprotein. Metabolism Ifosfamide is extensively metabolized in humans through two metabolic pathways: ring oxidation (“activation”) to form the active metabolite, 4-hydroxy-ifosfamide and side-chain oxidation to form the inactive metabolites, 3-dechloro-ethylifosfamide or 2-dechloroethylifosfamide with liberation of the toxic metabolite, chloroacetaldehyde. Small quantities (nmol/mL) of ifosfamide mustard and 4-hydroxyifosfamide are detectable in human plasma.

Metabolism of ifosfamide is required for the generation of the biologically active species and while metabolism is extensive, it is also quite variable among patients. Excretion After administration of doses of 5 g/m 2 of 14C-labeled ifosfamide, from 70% to 86% of the dosed radioactivity was recovered in urine as metabolites, with about 61% of the dose excreted as parent compound. At doses of 1.6 to 2.4 g/m 2 only 12% to 18% of the dose was excreted in the urine as unchanged drug within 72 hours.

Two different dechloroethylated derivatives of ifosfamide, 4-carboxyifosfamide, thiodiacetic acid and cysteine conjugates of chloroacetic acid have been identifi ed as the major urinary metabolites of ifosfamide in humans and only small amounts of 4-hydroxyifosfamide and acrolein are present. Pediatrics Population PK analysis was performed on plasma data from 32 pediatric patients various malignant diseases aged between 1 and 18 years. Patients received a total of 45 courses of ifosfamide at doses of 1.2, 2 and 3 g/m 2 given intravenously over 1 or 3 hours on 1, 2, or 3 days.

The mean ± standard error population estimates for the initial clearance and volume of distribution of ifosfamide were 2.4±0.33 L/h/m 2 and 21±1.6 L/m 2 with an interindividual variability of 43% and 32%, respectively. Effect of Age A study of 20 patients between 40 to 71 years of age receiving 1.5… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 108 words ▾

12.1Mechanism of Action Ifosfamide is a prodrug that requires metabolic activation by hepatic cytochrome P450 isoenzymes to exert its cytotoxic activity. Activation occurs by hydroxylation at the ring carbon atom forming the unstable intermediate 4-hydroxyifosfamide and its ring-opened aldo tautomer, which decomposes to yield the cytotoxic and urotoxic compound acrolein and an alkylating isophosphoramide mustard as well as multiple other nontoxic products. The exact mechanism of action of ifosfamide has not been determined, but its cytotoxic action is primarily through DNA crosslinks caused by alkylation by the isophosphoramide mustard at guanine N-7 positions.

The formation of inter- and intra-strand cross-links in the DNA results in cell death.

📦 How Supplied / Storage and Handling 138 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ifosfamide Injection is available in single-dose vials as follows: NDC 0143-9531-01 – 1 g/20 mL Single Dose Vial of ifosfamide; individually-boxed. NDC 0143-9530-01 – 3 g/60 mL Single Dose Vial of ifosfamide; individually-boxed. Store in a refrigerator 2°C to 8°C (36°F to 46°F).

See USP. Exercise caution when handling ifosfamide. The handling and preparation of ifosfamide should always be in accordance with current guidelines on safe handling of cytotoxic agents.

Several guidelines on this subject have been published. 1-4 Skin reactions associated with accidental exposure to ifosfamide may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing ifosfamide.

If ifosfamide solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.

📋 Description 93 words ▾

11 DESCRIPTION Ifosfamide injection is presented in sterile, single-dose vials for administration by intravenous infusion. Each mL contains ifosfamide, 50 mg, monobasic sodium phosphate monohydrate, 1.035 mg, dibasic sodium phosphate, 3.55 mg and water for injection, q.s.. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog cyclophosphamide.

Ifosfamide is 3-(2-ChloroethyI)-2-[(2-chloroethyl) amino]tetrahydro-2 H -1,3,2- oxazaphosphorine 2-oxide. Its structural formula is: C 7 H 15 C l2 N 2 O 2 P M. W. = 261.09 Ifosfamide is a white crystalline powder that is soluble in water.

Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Myelosuppression, Immunosuppression, and Infections Advise patients that treatment with ifosfamide injection may cause myelosuppression which can be severe and lead to infections and fatal outcomes. Inform patients of the risks associated with the use of ifosfamide injection and plan for regular blood monitoring during therapy [see Boxed Warning, Warnings and Precautions (5.1) ] Inform patients to report fever or other symptoms of an infection [see Boxed Warning, Warnings and Precautions (5.1) , Adverse Reactions (6.2) ].

Advise patients on the risks of bleeding and anemia [see Warnings and Precautions (5.1, 5.8 ), Adverse Reactions (6.2 )], Use in Specific Populations (8.1) ]. Central Nervous System Toxicity, Neurotoxicity Advise patients on the risk of CNS toxicity and other neurotoxic effects with fatal outcome [see Boxed Warning, Warnings and Precautions (5.2) ]. Renal and Urothelial Toxicity and Effects Advise patients on the risk of bladder and kidney toxicity.

Advise patients of the need to increase fluid intake and frequent voiding to prevent accumulation in the bladder [see Warnings and Precautions (5.3) ]. Cardiotoxicity Advise patients on the risk of cardiotoxicity and fatal outcome. Advise patients to report preexisting cardiac disease and manifestations of cardiotoxicity [see Warnings and Precautions (5.4 ), Adverse Reactions (6.2) ].

Pulmonary Toxicity Advise patients on the risk of pulmonary toxicity leading to respiratory failure with fatal outcome. Inform patients to report signs and symptoms of pulmonary toxicity [see Warnings and Precautions (5.5) ]. Secondary Malignancies Advise patients on the risk of secondary malignancies due to therapy [see Warnings and Precautions (5.6) ].

Veno-occlusive Liver Disease Advise patients on the risk of veno-occlusive liver disease [see Warnings and Precautions (5.7) ]. Pregnancy Advise patients on the potential hazard to a fetus if a patient becomes pregnant or fathers a child during therapy and for up to 6 months after therapy. Advise patients to use effective contraception during therapy and for up to 6 months after therapy [see Warnings and Precautions (5.8) , Adverse Reactions (6.2)] .

Lactation Advise patients on the potential for serious adverse reactions and tumorigenicity when children are breastfed during therapy [see Use in Specific Populations (8.3) ]. Reproductive System Disorders Advise patients on the risk of amenorrhea, premature menopause, and sterility [see Warnings and Precautions (5.9), Adverse Reactions (6.2) ]. Skin and Subcutaneous Tissue Disorders Advise patients on the risk of alopecia, wound healing, and other serious skin and subcutaneous tissue disorders [see Warnings and Precautions (5.11) , Adverse Reactions (6.2 )].

Gastrointestinal Disorders Advise patients that the therapy may cause gastrointestinal disorders and alcohol may increase nausea and vomiting [see Adverse Reactions (6.2) ]. Advise patients on the risk of stomatitis and the importance of proper oral hygiene [see Adverse Reactions (6.2) ]. Eye Disorders Advise patients on the risk of eye disorders such as visual impairment, blurred vision, and eye irritation [see Adverse Reactions (6.2) ].

Ear and Labyrinth Disorders Advise patients on the risk of ear and labyrinth disorders such as deafness, vertigo, and tinnitus [see Adverse Reactions (6.2)] . Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised June 2020 127.207.010/03

🍼 Nursing Mothers 59 words ▾

8.3Nursing Mothers Ifosfamide is excreted in breast milk. Because of the potential for serious adverse events and the tumorigenicity shown for ifosfamide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Women must not breastfeed during treatment with ifosfamide.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Ifosfamide exhibits dose-dependent pharmacokinetics in humans. At single doses of 3.8 to 5 g/m2, the plasma concentrations decay biphasically and themean terminal elimination half-life is about 15 hours. At doses of 1.6 to 2.4 g/m2/day, the plasma decay is monoexponential and the terminal elimination half-life is about 7 hours.

Ifosfamide exhibits time-dependent pharmacokinetics in humans. Following intravenous administration of 1.5 g/m 2 over 0.5 hour once daily for 5 days to 15 patients with neoplastic disease, a decrease in the median elimination half-life from 7.2 hours on Day 1 to 4.6 hours on Day 5 occurred with a concomitant increase in the median clearance from 66 mL/min on Day 1 to 115 mL/min on Day 5. There was no significant change in the volume of distribution on Day 5 compared with Day 1.

Distribution Ifosfamide volume of distribution (Vd) approximates the total body water volume, suggesting that distribution takes place with minimal tissue binding. Following intravenous administration of 1.5 g/m 2 over 0.5 hour once daily for 5 days to 15 patients with neoplastic disease, the median Vd of ifosfamide was

0.64 L/kg on Day 1 and

0.72L/kg on Day 5. Ifosfamide shows little plasma protein binding. Ifosfamide and its active metabolites are extensively bound by red blood cells.

Ifosfamide is not a substrate for P-glycoprotein. Metabolism Ifosfamide is extensively metabolized in humans through two metabolic pathways: ring oxidation (“activation”) to form the active metabolite, 4-hydroxy-ifosfamide and side-chain oxidation to form the inactive metabolites, 3-dechloro-ethylifosfamide or 2-dechloroethylifosfamide with liberation of the toxic metabolite, chloroacetaldehyde. Small quantities (nmol/mL) of ifosfamide mustard and 4-hydroxyifosfamide are detectable in human plasma.

Metabolism of ifosfamide is required for the generation of the biologically active species and while metabolism is extensive, it is also quite variable among patients. Excretion After administration of doses of 5 g/m 2 of 14C-labeled ifosfamide, from 70% to 86% of the dosed radioactivity was recovered in urine as metabolites, with about 61% of the dose excreted as parent compound. At doses of 1.6 to 2.4 g/m 2 only 12% to 18% of the dose was excreted in the urine as unchanged drug within 72 hours.

Two different dechloroethylated derivatives of ifosfamide, 4-carboxyifosfamide, thiodiacetic acid and cysteine conjugates of chloroacetic acid have been identifi ed as the major urinary metabolites of ifosfamide in humans and only small amounts of 4-hydroxyifosfamide and acrolein are present. Pediatrics Population PK analysis was performed on plasma data from 32 pediatric patients various malignant diseases aged between 1 and 18 years. Patients received a total of 45 courses of ifosfamide at doses of 1.2, 2 and 3 g/m 2 given intravenously over 1 or 3 hours on 1, 2, or 3 days.

The mean ± standard error population estimates for the initial clearance and volume of distribution of ifosfamide were 2.4±0.33 L/h/m 2 and 21±1.6 L/m 2 with an interindividual variability of 43% and 32%, respectively. Effect of Age A study of 20 patients between 40 to 71 years of age receiving 1.5 g/m 2 of ifosfamide daily for 3 or 5 days indicated that elimination half-life appears to increase with age. The elimination half-life increase appeared to be related to the increase in ifosfamide volume of distribution with age.

No significant changes in total plasma clearance or renal clearance with age were reported.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Patients with refractory testicular cancer (n=59) received a combination of ifosfamide, cisplatin, and either etoposide (VePesid®) or vinblastine (VIP) as third-line therapy or later. The selection of etoposide or vinblastine (“V” in the VIP regimen) was guided by the therapeutic effect achieved with prior regimens. The contribution of ifosfamide to the VIP combination was determined in patients treated with cisplatin-etoposide prior to ifosfamide-cisplatin-etoposide or those who received cisplatin-vinblastine prior to ifosfamide-cisplatin-vinblastine.

A total of 59 patients received a third-line salvage regimen which consisted of ifosfamide 1.2 g/m 2 /day intravenously on days 1 to 5, cisplatin 20 mg/m2/day intravenously on days 1 to 5, and either etoposide 75 mg/m 2 /day intravenously on days 1 to 5 or vinblastine 0.22 mg/kg intravenously on day 1. Efficacy results with the VIP regimen were compared to data pooled from six single agent phase II trials conducted between August 1980 and October 1985 including a total of 90 patients of whom 65 were eligible as controls of this study.

Twenty-three patients in the VIP regimen became free of disease with VIP alone or VIP plus surgery, whereas a single patient in the historical control group achieved complete response. The median survival time exceeded two years in the VIP group versus less than one year in the control group. Performance status ≥ 80, embryonal carcinoma and minimal disease were favorable prognostic factors for survival.

In all prognostic categories, the difference between VIP and historical controls remained highly significant. Number. (%) of Patients p-value VIP Control Total Patients 59 (100) 65 (100) Disease-free 23 (39) 1 (2) < 0.001 Chemotherapy alone 15 (25) 1 (2) < 0.001 Chemotherapy plus surgery 8 (14) 0 Overall Response 32 (54) 2 (3) < 0.001 Time to progression (weeks) Median 19 4 < 0.001a Range 1 to 205+ 1 to 29 Disease-free interval (weeks) Median 114 29 Range 13 to 205+ -- Survival (weeks) Median 53 10 < 0.001a Range 1 to 205+ 1 to 123+ a: Gehan-Breslow and Mantel-Cox tests In a study, 50 fully evaluable patients with germ cell testicular cancer were treated with ifosfamide in combination with cisplatin and either vinblastine or etoposide after failing (47 of 50 patients) at least two prior chemotherapy regimens consisting of cisplatin/vinblastine/bleomycin, (PVB), cisplatin/vinblastine/actinomycin D/bleomycin/cyclophosphamide, (VAB6), or the combination of cisplatin and etoposide.

Patients were selected for remaining cisplatin sensitivity because they had previously responded to a cisplatin containing regimen and had not progressed while on the cisplatin containing regimen or within 3 weeks of stopping it. Patients served as their own control based on the premise that long term complete responses could not be achieved by retreatment with a regimen to which they had previously responded and subsequently relapsed. Ten of 50 fully evaluable patients were still alive 2 to 5 years after treatment.

Four of the 10 long term survivors were rendered free of cancer by surgical resection after treatment with the ifosfamide regimen; median survival for the entire group of 50 fully evaluable patients was 53 weeks.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Ifosfamide has been shown to be carcinogenic in rats when administered by intraperitoneal injection at 6 mg/kg (37 mg/m 2 , or about 3% of the daily human dose on a mg/m 2 basis) 3 times a week for 52 weeks. Female rats had a signifi cantly higher incidence of uterine leiomyosarcomas and mammary fibroadenomas than vehicle controls. The mutagenic potential of ifosfamide has been documented in bacterial systems in vitro and mammalian cells in vivo .

In vivo , ifosfamide has induced mutagenic effects in mice and Drosophila melanogaster germ cells, and has induced a significant increase in dominant lethal mutations in male mice as well as recessive sex-linked lethal mutations in Drosophila. Ifosfamide was administered to male and female beagle dogs at doses of 1 or 4.64 mg/kg/day (20 or 93 mg/m 2 ) orally 6 days a week for 26 weeks. Male dogs at 4.64 mg/kg (about 7.7% of the daily clinical dose on a mg/m 2 basis) had testicular atrophy with degeneration of the seminiferous tubular epithelium.

In a second study, male and female rats were given 0, 25, 50, or 100 mg/kg (0, 150, 300, or 600 mg/m 2 ) ifosfamide intraperitoneally once every 3 weeks for 6 months. Decreased spermatogenesis was observed in most male rats given 100 mg/kg (about half the daily clinical dose on a mg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Ifosfamide has been shown to be carcinogenic in rats when administered by intraperitoneal injection at 6 mg/kg (37 mg/m 2 , or about 3% of the daily human dose on a mg/m 2 basis) 3 times a week for 52 weeks. Female rats had a signifi cantly higher incidence of uterine leiomyosarcomas and mammary fibroadenomas than vehicle controls. The mutagenic potential of ifosfamide has been documented in bacterial systems in vitro and mammalian cells in vivo .

In vivo , ifosfamide has induced mutagenic effects in mice and Drosophila melanogaster germ cells, and has induced a significant increase in dominant lethal mutations in male mice as well as recessive sex-linked lethal mutations in Drosophila. Ifosfamide was administered to male and female beagle dogs at doses of 1 or 4.64 mg/kg/day (20 or 93 mg/m 2 ) orally 6 days a week for 26 weeks. Male dogs at 4.64 mg/kg (about 7.7% of the daily clinical dose on a mg/m 2 basis) had testicular atrophy with degeneration of the seminiferous tubular epithelium.

In a second study, male and female rats were given 0, 25, 50, or 100 mg/kg (0, 150, 300, or 600 mg/m 2 ) ifosfamide intraperitoneally once every 3 weeks for 6 months. Decreased spermatogenesis was observed in most male rats given 100 mg/kg (about half the daily clinical dose on a mg/m 2 basis).

📚 References 108 words ▾

15 REFERENCES 1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004.

U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure to hazardous drugs.

OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html 3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs.

Am J Health-Syst Pharm . 2006; 63:1172-1193. 4.

Polovich M, White JM, Kelleher LO, (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. (2nd ed.) Pittsburgh, PA: Oncology Nursing Society.

📄 Package Label / Principal Display Panel 114 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0143- 9531 -01 Rx only Ifosfamide Injection 1 g per 20 mL (50 mg/mL) For Intravenous use Cytotoxic Agent 20 mL Sterile Single Dose Vial NDC 0143- 9531 -01 Rx only Ifosfamide Injection 1 g per 20 mL (50 mg/mL) For Intravenous use Cytotoxic Agent 1 Sterile Single Dose Vial vial carton

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0143- 9530 -01 Rx only Ifosfamide Injection 3 g per 60 mL (50 mg/mL) For Intravenous use Cytotoxic Agent 60 mL Sterile Single Dose Vial NDC 0143- 9530 -01 Rx only Ifosfamide Injection 3 g per 60 mL (50 mg/mL) For Intravenous use Cytotoxic Agent 1 Sterile Single Dose Vial vial carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
34
Units reimbursed last 4 qtrs
2K
Gross reimbursed last 4 qtrs
$2.9K
Avg / prescription
$84.96
Avg / unit
$1.4159
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
53% FFS 47% MCO
Fee-for-service · 18 Rx Managed care · 16 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 960 units · 30.1 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,080 units · 2.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.830.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nevada 30.1 /100k
2 California 2.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Ifosfamide — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ifosfamide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$2.6K
Claims incl. refills
12
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$213.71
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for IFOSFAMIDE — the ingredient across all brands.

Top reported reactions

Febrile Neutropenia2,756
Disease Progression2,135
Neutropenia1,910
Thrombocytopenia1,553
Anaemia1,263
Pyrexia1,011
Sepsis886

Reporter sex

21,571 reports
Male · 58%
Female · 41%
Unknown · 1%

Serious outcomes

Hospitalization6,659
Death4,442
Life-threatening1,775
Disabling268
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,275 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

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 Hikma Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA 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.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9208 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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
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.
← 00143-9529-01 · Hikma 00143-9531-01 · Hikma →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.