Eflornithine Injection (Ornidil) – 200 mg/mL

      13.5% Eflornithine Cream

11.5% Eflornithine Cream

 

                             

Side Effect Profile of Eflornithine: Key Insights from the Eflornithine Drug Profile

The side effects of Eflornithine vary based on its form (topical or injectable) and the condition being treated.

For Topical Cream (Vaniqa):

• Common: Skin irritation, redness, or burning sensation at the application site.
• Rare but Serious: Severe skin reactions like blistering or peeling, or allergic reactions such as swelling or difficulty breathing.

For Injectable Form (Ornidyl or Eflon):

• Common: Fatigue, headache, nausea, vomiting, and blood abnormalities like low white blood cell count.
• Severe: Seek immediate medical attention if serious reactions occur.

How to Use Eflornithine

• Topical Use for Hirsutism:

  Apply a thin layer of Vaniqa cream to the affected area twice daily. Avoid contact with eyes, mouth, and mucous membranes. Refrain from waxing or plucking hair from treated areas for at least two hours before and after application.

• Injectable Use for Sleeping Sickness:

  Administered under medical supervision in a hospital setting, often combined with nifurtimox for enhanced effectiveness in advanced cases.

Availability of Eflornithine

Eflornithine is widely available in regions where sleeping sickness is prevalent, particularly in Africa, and in Western countries for treating hirsutism.

• In the U.S., Eflornithine is sold as Vaniqa for hirsutism.
• It is distributed under brands like Ornidyl and Eflon in Africa for sleeping sickness treatment.

Frequently Asked Questions (FAQs) with regards to Eflornithine Drug Profile

1. What is Eflornithine?

Eflornithine, also known as difluoromethylornithine (DFMO), is a medication that inhibits the enzyme ornithine decarboxylase, which is involved in cell growth. It is used in treatments for neuroblastoma, African trypanosomiasis, and pseudofolliculitis barbae (shaving bumps). Eflornithine also shows potential in cancer prevention and skin conditions.

2. Is Eflornithine Safe During Pregnancy?

Eflornithine is not recommended during pregnancy unless absolutely necessary. The drug is classified as Pregnancy Category C, meaning animal studies suggest potential risks, but human studies are limited. Always consult a doctor before use if you are pregnant or planning to become pregnant.

3. Is Eflornithine Over-the-Counter or Prescription Only?

Eflornithine is a prescription-only medication. Whether it’s the topical cream for skin conditions or the oral form for cancer treatment, you’ll need a prescription from a healthcare provider.

4. What is the Cost of Eflornithine?

The cost of topical eflornithine (15% hydrochloride cream) ranges from $200 to $300 without insurance, depending on your location. Oral DFMO is usually covered by insurance for medical treatments but can be expensive without coverage.

5. What Safety Precautions Should I Follow?

When using eflornithine, keep these safety tips in mind:

• Topical Use: Avoid applying eflornithine to broken or irritated skin.
• Oral Use: Regular monitoring is required for liver function, especially when used for cancer treatments.
• Allergic Reactions: If you experience a rash, swelling, or difficulty breathing, seek immediate medical help.

6. Can Eflornithine Be Used in Children?

Topical eflornithine can be used in children for pseudofolliculitis barbae, but only under a doctor’s supervision. Oral DFMO is used in pediatric cancer treatment but requires careful dosing and monitoring.

7. How Does Eflornithine Work in Cancer and Trypanosomiasis?

Eflornithine blocks ornithine decarboxylase (ODC), slowing tumor growth and helping treat neuroblastoma and African trypanosomiasis (sleeping sickness) by interfering with the parasites’ ability to survive.

8. What If I Miss a Dose of Eflornithine?

• Topical: If you miss an application, apply it as soon as you remember unless it’s almost time for your next dose.
• Oral: If you miss a dose, take it as soon as possible but don’t double the dose to make up for it.

9. Can Eflornithine Be Used Long-Term?

Long-term use of eflornithine is generally safe under a doctor’s supervision. For topical eflornithine, long-term use is common for cosmetic purposes. Oral DFMO may be used long-term for specific medical conditions like cancer but requires regular health monitoring.

Conclusion
The eflornithine drug profile continues to evolve with its expanding uses, from treating shaving bumps to fighting serious conditions like neuroblastoma and trypanosomiasis. Always consult a healthcare provider to determine the appropriate use and dosage for your specific condition.

Latest Research on Eflornithine that You need to know under Eflornithine drug profile

Eflornithine Drug Profile: Key Objectives, Findings, and Status of Clinical Trials

Eflornithine, also known as DFMO (difluoromethylornithine), has been extensively studied for its potential across a wide range of medical conditions, including cancer prevention, treatment of parasitic diseases, and dermatological uses. The following trials provide insights into its diverse applications and ongoing research. Here’s a look at the objectives, key findings, and current status of these clinical studies.

1. Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Objective: This trial aimed to evaluate the combination of eflornithine and etoposide in treating relapsed or refractory neuroblastoma, a challenging childhood cancer.

Key Findings: Early-phase results indicated potential efficacy in improving treatment outcomes when used alongside etoposide.

Status: Ongoing – The trial is still recruiting participants to confirm these early results in a larger cohort.

2. Topical Eflornithine for Pseudofolliculitis Barbae

Objective: To assess the effectiveness of topical eflornithine in treating pseudofolliculitis barbae (shaving bumps), commonly affecting African American men.

Key Findings: Eflornithine was shown to reduce inflammation and improve skin appearance by inhibiting hair growth in affected areas.

Status: Completed – The trial has concluded, with positive results supporting eflornithine as an effective treatment for this condition.

3. Chemoprevention of Gastric Carcinogenesis

Objective: Investigating the role of eflornithine in preventing gastric cancer, particularly in individuals with precancerous gastric lesions.

Key Findings: Preliminary results suggest eflornithine may reduce the progression of gastric carcinogenesis by inhibiting polyamine synthesis.

Status: Ongoing – Further studies are needed to determine long-term effectiveness in high-risk populations.

4. DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma

Objective: To evaluate eflornithine (DFMO) as a maintenance therapy for patients with high-risk or relapsed medulloblastoma.

Key Findings: Initial results show that DFMO may help in preventing relapse by targeting molecular pathways involved in cancer recurrence.

Status: Ongoing – The study is still recruiting and monitoring long-term survival outcomes.

5. Eflornithine to Prevent Cancer in Patients with Barrett’s Esophagus

Objective: This trial aims to prevent esophageal cancer in patients with Barrett’s esophagus, a condition that increases cancer risk.

Key Findings: While early results are promising, showing a reduction in markers of cancer progression, additional data is needed to confirm these outcomes.

Status: Ongoing – The trial continues to monitor participants to assess long-term benefits.

6. Neuroblastoma Maintenance Therapy Trial S0820

Objective: To explore maintenance therapies for neuroblastoma survivors, improving survival and reducing recurrence.

Key Findings: The addition of eflornithine as a maintenance therapy showed some improvement in preventing relapse.

Status: Completed – Findings are being analyzed, with results indicating that eflornithine could be beneficial in high-risk neuroblastoma patients.

7. Adenoma and Second Primary Prevention Trial

Objective: Evaluating eflornithine as a preventive treatment for adenomas (precancerous polyps) and second primary cancers in colorectal cancer survivors.

Key Findings: Preliminary findings suggest that eflornithine may reduce the recurrence of adenomas, potentially lowering the risk of secondary cancers.

Status: Ongoing – The study is continuing to track the long-term effects of eflornithine on polyp recurrence and secondary cancer prevention.

8. Eflornithine in Treating Patients with Bladder Cancer

Objective: To determine if eflornithine can prevent recurrence in patients who have undergone initial treatment for bladder cancer.

Key Findings: Early trials suggest a reduction in recurrence rates, though more research is needed for conclusive evidence.

Status: Ongoing – Further trials are being conducted to refine dosing and confirm results.

9. Eflornithine to Prevent Skin Cancer in Patients with Previously Treated Early Stage Skin Cancer

Objective: Testing eflornithine as a chemopreventive agent for patients at high risk of developing skin cancer following treatment for early-stage skin cancers.

Key Findings: Initial findings show a potential protective effect, but additional data is necessary to confirm these outcomes.

Status: Ongoing – The trial is still collecting data on the long-term benefits for skin cancer prevention.

10. Eflornithine to Prevent Cervical Cancer in Patients with Cervical Intraepithelial Neoplasia

Objective: Investigating eflornithine as a preventive treatment for cervical cancer in women with precancerous lesions (CIN).

Key Findings: Preliminary results indicate that eflornithine may slow the progression of CIN, reducing the risk of cervical cancer.

Status: Ongoing – The study is continuing, with results expected in the coming years.

11. Eflornithine in Treating Patients at High Risk of Developing Prostate Cancer

Objective: To evaluate eflornithine in reducing the risk of prostate cancer in men with a family history or other risk factors.

Key Findings: Early-stage data show a potential for eflornithine to lower prostate cancer risk, though further validation is needed.

Status: Ongoing – Recruitment is underway, and long-term monitoring is required.

12. Evaluation of Eflornithine on Facial and Forearm Skin

Objective: This trial tests the effects of eflornithine on improving skin health, specifically targeting facial and forearm skin.

Key Findings: Eflornithine showed promise in improving skin texture and reducing visible signs of aging.

Status: Completed – Results indicate a favorable outcome for skin health, though more studies are needed for broader application.

13. Intermediate Expanded Use Trial of DFMO

Objective: To assess the expanded use of DFMO in broader populations for cancer prevention.

Key Findings: Early findings are promising, particularly in the context of preventing colorectal and skin cancers.

Status: Ongoing – The trial is in its later stages, with results expected to guide future use of DFMO in chemoprevention.

14. Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects with a History of Skin Cancer

Objective: This study compares the effects of topical diclofenac and DFMO in preventing skin cancer recurrence.

Key Findings: Results indicate that topical DFMO may offer additional protection against skin cancer recurrence compared to diclofenac.

Status: Completed – Findings are positive and suggest a role for DFMO in skin cancer prevention.

15. Trial of Eflornithine Plus Sulindac in Patients with Familial Adenomatous Polyposis (FAP)

Objective: To assess whether the combination of eflornithine and sulindac can reduce the risk of colorectal cancer in FAP patients.

Key Findings: Early-stage results suggest that the combination therapy may be effective in reducing polyp growth, a precursor to colorectal cancer.

Status: Ongoing – The study is still being monitored to determine long-term efficacy.

16. Efficacy and Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine Alone in Human African Trypanosomiasis

Objective: To compare the combination therapy of eflornithine and nifurtimox against eflornithine alone in treating sleeping sickness.

Key Findings: Combination therapy showed higher efficacy and reduced relapse rates compared to eflornithine alone.

Status: Completed – Findings support the use of the combination for treating African trypanosomiasis.

17. DFMO Chemoprevention of Skin Cancer in Organ Transplant Recipients

Objective: To investigate whether DFMO can prevent skin cancer in organ transplant recipients, who are at high risk due to immunosuppressive therapy.

Key Findings: DFMO showed promise in reducing the incidence of skin cancers in this high-risk group.

Status: Ongoing – The trial is still evaluating long-term outcomes.

18. Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA)

Objective: To compare eflornithine plus lomustine with lomustine alone in patients with recurrent anaplastic astrocytoma, an aggressive brain cancer.

Key Findings: The combination of eflornithine and lomustine showed a potential improvement in progression-free survival.

Status: Ongoing – The study is currently gathering data to validate these preliminary findings.

19. Evaluation of Eflornithine Plus Temozolomide in Patients with Newly Diagnosed Glioblastoma

Objective: This trial examines whether eflornithine can enhance the effects of temozolomide in patients with newly diagnosed glioblastoma, a highly aggressive brain tumor.

Key Findings: Early results indicate that the combination may improve survival outcomes, though more data is needed.

Status: Ongoing – The study is in progress, with results expected shortly.

20. Study of Difluoromethylornithine (DFMO) in Combination With Bortezomib for Relapsed or Refractory Neuroblastoma

Objective: Investigate the efficacy of DFMO combined with bortezomib for treating relapsed or refractory neuroblastoma.

Key Findings: DFMO plus bortezomib demonstrated enhanced activity against neuroblastoma cells.

Status: Ongoing – Further studies are required to confirm clinical benefits.

21. Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer

Objective: Evaluate the combination of acetylsalicylic acid (ASA) and eflornithine in colorectal cancer prevention in high-risk patients.

Key Findings: The combination showed potential in reducing colorectal cancer incidence in high-risk individuals.

Status: Ongoing – Additional data is being collected.

22. Targeting Type 1 Diabetes Using Polyamines (TADPOL)

Objective: Explore the use of polyamines, including DFMO, in preventing the progression of type 1 diabetes.

Key Findings: Initial findings suggest DFMO could delay autoimmune destruction of pancreatic beta-cells.

Status: Ongoing – Continued research is needed to confirm these results.

23. Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis

Objective: Test the combination of celecoxib and eflornithine in preventing colorectal cancer in FAP patients.

Key Findings: The combination may help reduce polyp formation, lowering colorectal cancer risk.

Status: Ongoing – Long-term data is still being collected.

24. Clinical Study to Assess the Tolerability, Feasibility, and Effectiveness of Nifurtimox and Eflornithine (NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Phase

Objective: Assess the safety and effectiveness of nifurtimox and eflornithine in treating advanced HAT in the central nervous system phase.

Key Findings: NECT has been shown to be a tolerable and effective treatment for late-stage HAT.

Status: Completed – This combination is now a standard treatment for advanced HAT.

25. Eflornithine + Nifurtimox in Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda

Objective: Investigate the efficacy of DFMO and nifurtimox in treating late-stage HAT in Uganda.

Key Findings: The combination showed improved efficacy and reduced relapse rates in patients.

Status: Ongoing – Data is being collected on its long-term effectiveness.

26. Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

Objective: Study the combination of eflornithine and sulindac for preventing colorectal cancer in patients with colon polyps.

Key Findings: Eflornithine and sulindac together appear to reduce polyp formation and colorectal cancer risk.

Status: Ongoing – The study is monitoring long-term outcomes.

27. Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

Objective: Test the combination of irinotecan, temozolomide, and dinutuximab with or without eflornithine in neuroblastoma treatment.

Key Findings: Eflornithine enhanced the effects of this multi-drug regimen in controlling tumor growth and reducing relapse.

Status: Ongoing – Further trials are in progress.

28. Treatment With Topical Eflornithine After Laser Treatment in Women With Facial Hirsutism

Objective: Evaluate the use of topical eflornithine to reduce hair regrowth after laser treatment in women with facial hirsutism.

Key Findings: Topical eflornithine effectively reduced hair regrowth, improving the results of laser hair removal.

Status: Completed – The trial concluded successfully, confirming eflornithine’s effectiveness.

29. Preventative Trial of Difluoromethylornithine (DFMO) in High-Risk Patients With Neuroblastoma That is in Remission

Objective: Investigate DFMO as a preventive treatment in high-risk neuroblastoma patients in remission.

Key Findings: Early results suggest DFMO may help prevent neuroblastoma relapse.

Status: Ongoing – The study is still being conducted.

30. DFMO in Children With Type 1 Diabetes

Objective: Assess DFMO’s role in protecting children with type 1 diabetes from beta-cell destruction.

Key Findings: Preliminary studies suggest DFMO may slow the progression of type 1 diabetes.

Status: Ongoing – Additional trials are underway to confirm these findings.

31. Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin

Objective: Evaluate the effectiveness of eflornithine and diclofenac in treating sun-damaged skin, potentially preventing skin cancer.

Key Findings: Eflornithine showed potential in improving skin health, while diclofenac reduced inflammation and damage markers.

Status: Ongoing – The study is continuing to evaluate the combination’s effects.

32.  Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy

Objective: Compare the effectiveness of eflornithine and bicalutamide, alone or in combination, as neoadjuvant therapy for prostate cancer.

Key Findings: The combination of eflornithine and bicalutamide may improve treatment outcomes by reducing tumor growth.

Status: Ongoing – The trial is in progress, with further data to be analyzed.

33. A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)

Objective: Study the combination of low-dose sulindac and eflornithine in preventing colorectal cancer in FAP patients.

Key Findings: Early results suggest the combination may reduce new polyp formation.

Status: Ongoing – The trial is still ongoing, monitoring long-term effects.

34. Urinary Biomarker Study With Sulindac and Difluoromethylornithine

Objective: Investigate the combined effect of sulindac and DFMO in reducing urinary biomarkers linked to colorectal cancer.

Key Findings: The combination showed a reduction in biomarkers associated with colorectal cancer, indicating potential for chemoprevention.

Status: Ongoing – Further data is being collected to assess clinical relevance.

35. Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC (DFMO)

Objective: Explore the use of DFMO in targeting ornithine decarboxylase (ODC) in NSCLC with STK11/LKB1 mutations.

Key Findings: DFMO has shown promise in inhibiting cancer cell growth by targeting ODC.

Status: Ongoing – The trial continues to evaluate long-term benefits.

36. Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae

Objective: Test the effectiveness of 15% eflornithine cream in treating pseudofolliculitis barbae (shaving bumps) in African-American males.

Key Findings: Eflornithine cream significantly reduced hair regrowth and skin irritation in affected areas.

Status: Completed – The trial concluded successfully, confirming eflornithine’s benefits for this condition.

37. Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

Objective: Assess the efficacy of fexinidazole in treating late-stage human African trypanosomiasis (HAT).

Key Findings: Fexinidazole has shown efficacy in treating late-stage HAT, improving survival rates.

Status: Completed – The treatment is being considered for broader use in endemic regions.

38. Difluoromethylornithine (DFMO) and AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas

Objective: Evaluate the combination of DFMO and AMXT-1501 in treating neuroblastoma, CNS tumors, and sarcomas, particularly relapsed cases.

Key Findings: Early data suggests that the combination could improve treatment outcomes by targeting key metabolic pathways in tumors.

Status: Ongoing – Further research is required to confirm these initial findings.

39. Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis

Objective: Test the effectiveness of eflornithine, with or without triamcinolone, in preventing nonmelanoma skin cancers in actinic keratosis patients.

Key Findings: Eflornithine may reduce the incidence of skin cancers, especially when combined with triamcinolone.

Status: Ongoing – This trial is still recruiting and observing long-term effects.

Key Insights from the Eflornithine Drug Profile

• Topical eflornithine (13.9% cream) is used for hirsutism and shaving bumps.
• Injectable eflornithine is for late-stage HAT, with 100 mg/kg body weight IV twice daily for 7 days.
• Experimental uses for colorectal cancer prevention and type 1 diabetes vary depending on study protocols.
• Topical finasteride (finasteride cream) and flutamide (topical antiandrogen) are under investigation as treatments for unwanted hair growth.

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