Decitex

Each 20-mL single-dose vial also contains monobasic potassium phosphate (potassium dihydrogen phosphate) 68 mg and sodium hydroxide 11.6 mg.

Decitex contains Decitabine (5-aza-2'-deoxycytidine), an analogue of the natural nucleoside 2'-deoxycytidine. Molecular formula of C₈H₁₂N₄O₄ and a molecular weight of 228.21.

Decitex is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one.

It is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO).

Decitex (Decitex injection) is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

Decitex (Decitex) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Decitex is used to treat myelodysplastic syndromes (certain types of blood or bone marrow cancer).

Decitex may also be used for purposes not listed in this medication guide.

There are two regimens for Decitex (Decitex injection) administration. With either regimen it is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles.

Complete blood counts and platelet counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each cycle. Liver chemistries and serum creatinine should be obtained prior to initiation of treatment.

Treatment Regimen – Option 1

Decitex (Decitex injection) is administered at a dose of 15 mg/m² by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. This cycle should be repeated every 6 weeks. Patients may be premedicated with standard anti-emetic therapy.

If hematologic recovery (ANC ≥ 1,000/μL and platelets ≥ 50,000/μL) from a previous Decitex (Decitex injection) treatment cycle requires more than 6 weeks, then the next cycle of Decitex (Decitex injection) therapy should be delayed and dosing temporarily reduced by following this algorithm:

• Recovery requiring more than 6, but less than 8 weeks-Decitex (Decitex injection) dosing to be delayed for up to 2 weeks and the dose temporarily reduced to 11 mg/m² every 8 hours (33 mg/m²/day, 99 mg/m²/cycle) upon restarting therapy.
• Recovery requiring more than 8, but less than 10 weeks-Patient should be assessed for disease progression (by bone marrow aspirates); in the absence of progression, the Decitex (Decitex injection) dose should be delayed up to 2 more weeks and the dose reduced to 11 mg/m² every 8 hours (33 mg/m²/day, 99 mg/m²/cycle) upon restarting therapy, then maintained or increased in subsequent cycles as clinically indicated.

Treatment Regimen – Option 2

Decitex (Decitex injection) is administered at a dose of 20 mg/m² by continuous intravenous infusion over 1 hour repeated daily for 5 days. This cycle should be repeated every 4 weeks. Patients may be premedicated with standard anti-emetic therapy.

If myelosuppression is present, subsequent treatment cycles of Decitex (Decitex injection) should be delayed until there is hematologic recovery (ANC ≥ 1,000/μL platelets ≥ 50,000/μL ).

Patients with Non-hematologic Toxicity

Following the first cycle of Decitex (Decitex injection) treatment, if any of the following non-hematologic toxicities are present, Decitex (Decitex injection) treatment should not be restarted until the toxicity is resolved: 1) serum creatinine ≥ 2 mg/dL; 2) SGPT, total bilirubin ≥ 2 times ULN; 3) and active or uncontrolled infection.

Instructions for

Intravenous Administration

Decitex (Decitex injection) is a cytotoxic drug and caution should be exercised when handling and preparing Decitex (Decitex injection). Procedures for proper handling and disposal of antineoplastic drugs should be applied. Several guidances on this subject have been published..

Decitex (Decitex injection) should be aseptically reconstituted with 10 mL of Sterile Water for Injection (USP); upon reconstitution, each mL contains approximately 5.0 mg of Decitex at pH 6.7-7.3. Immediately after reconstitution, the solution should be further diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer's Injection to a final drug concentration of 0.1 - 1.0 mg/mL. Unless used within 15 minutes of reconstitution, the diluted solution must be prepared using cold (2°C - 8°C) infusion fluids and stored at 2°C - 8°C (36°F - 46°F) for up to a maximum of 7 hours until administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if there is evidence of particulate matter or discoloration.

How supplied

Dosage Forms And Strengths

Decitex (Decitex) for Injection is supplied as a sterile, lyophilized white to almost white powder, in a single-dose vial, packaged in cartons of 1 vial. Each vial contains 50 mg of Decitex.

Storage And Handling

NDC 62856-600-01, 50 mg single-dose vial individually packaged in a carton.

Storage

Store vials at 25°C (77°F); excursions permitted to 15-30°C (5986°F).

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.html3. 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). Chemotherapy and biotherapy guidelines and recommendations for practice (2nd ed.) 2005. Pittsburgh, PA: Oncology Nursing Society.

Manufactured by Pharmachemie B.V. Haarlem, The Netherlands. Manufactured for Eisai Inc., Woodcliff Lake, NJ 07677. Revised: 03/2010

See also:
What is the most important information I should know about Decitex?

Before receiving this medication, tell your doctor if you have liver or kidney disease.

Do not use Decitex if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 2 months after you stop receiving Decitex.

You should not breast-feed while you are receiving Decitex.

Decitex can lower blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury. Your blood may need to be tested often. Visit your doctor regularly.

Use Decitex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Decitex is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Decitex at home, a health care provider will teach you how to use it. Be sure you understand how to use Decitex. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Decitex if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• If you miss a dose of Decitex, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Decitex.

Use: Labeled Indications

Myelodysplastic syndromes: Treatment of myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups

Off Label Uses

Acute myeloid leukemia

Data from a multicenter phase II study and a multicenter open-label phase III trial in older patients with acute myeloid leukemia (AML) support the use of Decitex for the treatment of newly diagnosed AML.

See also:
What other drugs will affect Decitex?

Drug interaction studies with Decitex have not been conducted. In vitro studies in human liver microsomes suggest that Decitex is unlikely to inhibit or induce cytochrome P-450 enzymes. In vitro metabolism studies have suggested that Decitex is not a substrate for the human liver cytochrome P-450 enzymes. As plasma protein-binding of Decitex is negligible (<1%), interactions due to displacement of more highly protein-bound drugs from plasma proteins are not expected.

See also:
What are the possible side effects of Decitex?

Most Commonly Occurring: Neutropenia, thrombocytopenia, anemia, fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea and hyperglycemia.

Most Frequently (≥1%) Occurring Resulting in Clinical Intervention in the Phase 3 Trial in the Decitex Arm: Discontinuation: Thrombocytopenia, neutropenia, pneumonia, Mycobacterium avium complex infection, cardiorespiratory arrest, increased blood bilirubin, intracranial hemorrhage, abnormal liver function tests.

Delayed Dose: Neutropenia, pulmonary edema, atrial fibrillation, central line infection, febrile neutropenia.

Reduced Dose: Neutropenia, thrombocytopenia, anemia, lethargy, edema, tachycardia, depression, pharyngitis.

Decitex was studied in 2 single-arm phase 2 studies (N=66, N=98) and 1 controlled phase 3 (supportive care) study (N=83 exposed to Decitex). The data described as follows reflect exposure to Decitex in 83 patients in the phase 3 MDS trial. In the phase 3 trial, patients received 15 mg/m² IV every 8 hrs for 3 days every 6 weeks. The median number of Decitex cycles was 3 (range 0-9).

Table 4 presents all adverse events regardless of causality occurring in at least 5% of patients in the Decitex group and at a rate greater than supportive care.

Clinically Important Adverse Reactions: In the phase 3 trial, the highest incidences of Grade 3 or Grade 4 adverse events in the Decitex arm were neutropenia (87%), thrombocytopenia (85%), febrile neutropenia (23%) and leukopenia (22%). Bone marrow suppression was the most frequent cause of dose reduction, delay and discontinuation. Six patients had fatal events associated with their underlying disease and myelosuppression (anemia, neutropenia and thrombocytopenia) that were considered at least possibly related to drug treatment. Of the 83 Decitex-treated patients, 8 permanently discontinued therapy for adverse events; compared to 1 of 81 patients in the supportive care arm.

No overall difference in safety was detected between patients >65 years and younger patients in these myelodysplasia trials. No significant gender differences in safety or efficacy were detected. Patients with renal or hepatic dysfunction were not studied. Insufficient numbers of non-White patients were available to draw conclusions in these clinical trials.

Serious Adverse Events that occurred in patients receiving Decitex regardless of causality, not previously reported in Table 4 include: Blood and Lymphatic System Disorders: Myelosuppression, splenomegaly.

Cardiac Disorders: Myocardial infarction, congestive cardiac failure, cardiorespiratory arrest, cardiomyopathy, atrial fibrillation, supraventricular tachycardia.

Gastrointestinal Disorders: Gingival pain, upper gastrointestinal hemorrhage.

General Disorders and Administration Site Conditions: Chest pain, asthenia, mucosal inflammation, catheter site hemorrhage.

Hepatobiliary Disorders: Cholecystitis.

Infections and Infestations: Fungal infection, sepsis, upper respiratory tract infection, bronchopulmonary aspergillosis, peridiverticular abscess, respiratory tract infection, pseudomonal lung infection, Mycobacterium avium complex infection.

Injury, Poisoning and Procedural Complications: Post-procedural pain and hemorrhage.

Nervous System Disorders: Intracranial hemorrhage.

Psychiatric Disorders: Mental status changes.

Renal and Urinary Disorders: Renal failure, urethral hemorrhage.

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, hemoptysis, lung infiltration, pulmonary embolism, respiratory arrest, pulmonary mass.

Allergic Reaction: Hypersensitivity (anaphylactic reaction) to Decitex has been reported in a phase 2 trial.

Post-Marketing Data: No additional adverse reactions were identified in the analysis of the post-marketing safety database.