Azacitidine

Azacitidine Manufacturers

• Dr. Reddy’s Laboratories Inc.
  

  ×

  Azacitidine | Dr. Reddy's Laboratories Inc.

  

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  2.1 First Treatment Cycle

  The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days.  Patients should be premedicated for nausea and vomiting.

  Complete blood counts, liver chemistries and serum creatinine should be obtained prior to first dose.

  2.2  Subsequent Treatment Cycles

  Cycles should be repeated every 4 weeks.  The dose may be increased to 100 mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred.  It is recommended that patients be treated for a minimum of 4 to 6 cycles. However, complete or partial response may require additional treatment cycles.  Treatment may be continued as long as the patient continues to benefit.

  Patients should be monitored for hematologic responseand renal toxicities [see Warnings and Precautions (5.3)], and dosage delay or reduction as described belowmay be necessary.[see Warnings and Precautions(5.3)], and dosage delay or reduction as described belowmay be necessary., and dosage delay or reduction as described belowmay be necessary.

  2.3  Dosage Adjustment Based on Hematology Laboratory Values

  For patients with baseline (start oftreatment) WBC ≥3 x109/L,ANC ≥1.5 x109/L and platelets ≥75 x109/L, adjust the dose as follows, based on nadir counts for any given cycle:

  Nadir Counts % Dose in the Next Course ANC (x109/L)
  <0.5
  0.5 –1.5
  >1.5 Platelets (x109/L)
  <25
  25-50
  >50 50%
  67%
  100%

   

  For patients whose baseline counts are WBC <3 x109/L, ANC<1.5 x109/L, or platelets <75 x109/L, dose adjustments should be based on nadir counts and bone marrow biopsy cellularity at the time of the nadir as noted below, unless there is clear improvement in differentiation (percentage of mature granulocytes is higher and ANC is higher than at onset of that course) at the time of the next cycle, in which case the dose of the current treatment should be continued.

  WBC or PlateletNadir% decrease in countsfrom baseline Bone MarrowBiopsy Cellularity
  at Time of Nadir(%) 30-60 15-30 <15 % Dose in the Next Course 50-75 100 50 33 >75 75 50 33

  If a nadir as defined in the table above has occurred, the next course of treatment should be given 28 days after the start of the preceding course, provided that both the WBC and the platelet counts are >25% above the nadir and rising.  If a >25% increase above the nadir is not seen by day 28, counts should be reassessed every 7 days.  If a 25% increase is not seen by day 42, then the patient should be treated with 50% of the scheduled dose.

  2.4 Dosage Adjustment Based on Serum Electrolytes and Renal Toxicity

  If unexplained reductions in serum bicarbonate levels to <20 mEq/L occur, the dosage should be reduced by 50% on the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50% on the next treatment course [see Warnings and Precautions (5.3)].

  2.5  Use in Geriatric Patients

  Azacitidine 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 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5)].

  2.6  Preparation of Azacitidine For Injection

  Azacitidine for injection is a cytotoxic drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing azacitidine for injection suspensions [see How Supplied/Storage and Handling (16)]. 

  If reconstituted azacitidine for injection comes into contact with the skin, immediately and thoroughly wash with soap and water.  If it comes into contact with mucous membranes, flush thoroughly with water. 

  The azacitidine for injection vial is single-use and does not contain any preservatives.  Unused portions of each vial should be discarded properly [see How Supplied/Storage and Handling (16)]. Do not save any unused portions for later administration.

  2.7  Instructions for Subcutaneous Administration

  Azacitidine for injection should be reconstituted aseptically with 4 mL sterile water for injection.  The diluent should be injected slowly into the vial.  Vigorously shake or roll the vial until a uniform suspension is achieved.  The suspension will be cloudy.  The resulting suspension will contain azacitidine 25 mg/mL. Do not filter the suspension after reconstitution. Doing so could remove the active substance.

  Preparation for Immediate Subcutaneous Administration: Doses greater than 4 mL should be divided equally into 2 syringes. The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution. 

  Preparation for Delayed Subcutaneous Administration: The reconstituted product may be kept in the vial or drawn into a syringe. Doses greater than 4 mL should be divided equally into 2 syringes.  The product must be refrigerated immediately. When azacitidine for injection is reconstituted using water for injection that has not been refrigerated, the reconstituted product may be held under refrigerated conditions (2ºC -8ºC, 36ºF -46ºF) for up to 8 hours. When azacitidine for injection is reconstituted using refrigerated (2ºC -8ºC, 36ºF -46ºF) water for injection, the reconstituted product may be stored under refrigerated conditions (2ºC -8ºC, 36ºF -46ºF) for up to 22 hours.  After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration. 

  Subcutaneous Administration

  To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.

  Azacitidine for injection suspension is administered subcutaneously. Doses greater than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites.  Rotate sites for each injection (thigh, abdomen, or upper arm).  New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, red, or hard. 

  Suspension Stability:  Azacitidine for injection reconstituted with non-refrigerated water for injection for subcutaneous administration may be stored for up to 1 hour at 25°C (77°F) or for up to 8 hours between 2°C and 8°C (36°F and 46°F); when reconstituted with refrigerated (2ºC -8ºC, 36ºF -46ºF) water for injection, it may be stored for 22 hours between 2°C and 8°C (36°F and 46°F).

  2.8  Instructions for Intravenous Administration

  Reconstitute the appropriate number of azacitidine for injection vials to achieve the desired dose.  Reconstitute each vial with 10 mL sterile water for injection. Vigorously shake or roll the vial until all solids are dissolved.  The resulting solution will contain azacitidine 10 mg/mL.  The solution should be clear.  Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 

  Withdraw the required amount of azacitidine for injection solution to deliver the desired dose and inject into a 50 to 100 mL infusion bag of either 0.9% Sodium Chloride Injection or Lactated Ringer’s Injection.

  Intravenous Solution Incompatibility

  Azacitidine for injection is incompatible with 5% Dextrose solutions, Hespan, or solutions that contain bicarbonate.  These solutions have the potential to increase the rate of degradation of azacitidine for injection and should therefore be avoided.

  Intravenous Administration

  Azacitidine for injection solution is administered intravenously.  Administer the total dose over a period of 10 to 40 minutes.  The administration must be completed within 1 hour of reconstitution of the azacitidine for injection vial. 

  Solution Stability: Azacitidine for injection reconstituted for intravenous administration may be stored at 25°C (77°F), but administration must be completed within 1 hour of reconstitution.

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• Dr. Reddy’s Laboratories Inc.
  

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  Azacitidine | West-ward Pharmaceutical Corp

  

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Adults
  The recommended adult intravenous dosage of ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron.

  Pediatrics
  For pediatric patients 6 months through 18 years of age, the intravenous dosage of ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2, 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults
  The recommended adult intravenous dosage of ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics
  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron.

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although ondansetron injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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• Sandoz Inc
  

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  Azacitidine | Sandoz Inc

  

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  2.1 First Treatment Cycle

  The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days. Patients should be premedicated for nausea and vomiting.

  Complete blood counts, liver chemistries and serum creatinine should be obtained prior to first dose.

  2.2 Subsequent Treatment Cycles

  Cycles should be repeated every 4 weeks. The dose may be increased to 100 mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 to 6 cycles. However, complete or partial response may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit.

  Patients should be monitored for hematologic response and renal toxicities [see Warnings and Precautions (5.3)], and dosage delay or reduction as described below may be necessary.

  2.3 Dosage Adjustment Based on Hematology Laboratory Values • For patients with baseline (start of treatment) WBC ≥3.0 x10 9/L, ANC ≥1.5 x10 9/L, and platelets ≥75.0 x10 9/L, adjust the dose as follows, based on nadir counts for any given cycle:

  Nadir Counts

  % Dose in the Next Course

  ANC (x109/L)
  <0.5
  0.5 - 1.5
  >1.5

  Platelets (x109/L)
  <25.0
  25.0 - 50.0
  >50.0

  
  50%
  67%
  100%

  • For patients whose baseline counts are WBC <3.0 x10 9/L, ANC<1.5 x10 9/L, or platelets <75.0 x10 9/L, dose adjustments should be based on nadir counts and bone marrow biopsy cellularity at the time of the nadir as noted below, unless there is clear improvement in differentiation (percentage of mature granulocytes is higher and ANC is higher than at onset of that course) at the time of the next cycle, in which case the dose of the current treatment should be continued.

  WBC or Platelet Nadir
  % decrease in counts
  from baseline

  Bone Marrow
  Biopsy Cellularity at Time of Nadir (%)

  30 - 60

  15 - 30

  <15

  % Dose in the Next Course

  50 - 75

  100

  50

  33

  >75

  75

  50

  33

  If a nadir as defined in the table above has occurred, the next course of treatment should be given 28 days after the start of the preceding course, provided that both the WBC and the platelet counts are >25% above the nadir and rising. If a >25% increase above the nadir is not seen by day 28, counts should be reassessed every 7 days. If a 25% increase is not seen by day 42, then the patient should be treated with 50% of the scheduled dose.

  2.4 Dosage Adjustment Based on Serum Electrolytes and Renal Toxicity

  If unexplained reductions in serum bicarbonate levels to <20 mEq/L occur, the dosage should be reduced by 50% on the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50% on the next treatment course [see Warnings and Precautions (5.3)].

  2.5 Use in Geriatric Patients

  Azacitidine 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 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5)].

  2.6 Preparation of Azacitidine for Injection

  Azacitidine for Injection is a cytotoxic drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing Azacitidine for Injection suspensions [see How Supplied/Storage and Handling (16)].

  If reconstituted Azacitidine for Injection comes into contact with the skin, immediately and thoroughly wash with soap and water. If it comes into contact with mucous membranes, flush thoroughly with water.

  The Azacitidine for Injection vial is single-use and does not contain any preservatives. Unused portions of each vial should be discarded properly [see How Supplied/Storage and Handling (16)]. Do not save any unused portions for later administration.

  2.7 Instructions for Subcutaneous Administration

  Azacitidine for Injection should be reconstituted aseptically with 4 mL sterile water for injection. The diluent should be injected slowly into the vial. Vigorously shake or roll the vial until a uniform suspension is achieved. The suspension will be cloudy. The resulting suspension will contain azacitidine 25 mg/mL. Do not filter the suspension after reconstitution. Doing so could remove the active substance.

  Preparation for Immediate Subcutaneous Administration: Doses greater than 4 mL should be divided equally into 2 syringes. The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution.

  Preparation for Delayed Subcutaneous Administration: The reconstituted product may be kept in the vial or drawn into a syringe. Doses greater than 4 mL should be divided equally into 2 syringes. The product must be refrigerated immediately. When Azacitidine for Injection is reconstituted using water for injection that has not been refrigerated, the reconstituted product may be held under refrigerated conditions (2ºC - 8ºC, 36ºF - 46ºF) for up to 8 hours. When Azacitidine for Injection is reconstituted using refrigerated (2ºC - 8ºC, 36ºF - 46ºF) water for injection, the reconstituted product may be stored under refrigerated conditions (2ºC - 8ºC, 36ºF - 46ºF) for up to 22 hours. After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration.

  Subcutaneous Administration

  To provide a homogeneous suspension, the contents of the dosing syringe must be re-suspended immediately prior to administration. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.

  Azacitidine for Injection suspension is administered subcutaneously. Doses greater than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites. Rotate sites for each injection (thigh, abdomen, or upper arm). New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, red, or hard.

  Suspension Stability: Azacitidine for Injection reconstituted with non-refrigerated water for injection for subcutaneous administration may be stored for up to 1 hour at 25°C (77°F) or for up to 8 hours between 2°C and 8°C (36°F and 46°F); when reconstituted with refrigerated (2ºC - 8ºC, 36ºF - 46ºF) water for injection, it may be stored for 22 hours between 2°C and 8°C (36°F and 46°F).

  2.8 Instructions for Intravenous Administration

  Reconstitute the appropriate number of Azacitidine for Injection vials to achieve the desired dose. Reconstitute each vial with 10 mL sterile water for injection. Vigorously shake or roll the vial until all solids are dissolved. The resulting solution will contain azacitidine 10 mg/mL. The solution should be clear. Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Withdraw the required amount of Azacitidine for Injection solution to deliver the desired dose and inject into a 50 - 100 mL infusion bag of either 0.9% Sodium Chloride Injection or Lactated Ringer's Injection.

  Intravenous Solution Incompatibility

  Azacitidine for Injection is incompatible with 5% Dextrose solutions, Hespan, or solutions that contain bicarbonate. These solutions have the potential to increase the rate of degradation of Azacitidine for Injection and should therefore be avoided.

  Intravenous Administration

  Azacitidine for Injection solution is administered intravenously. Administer the total dose over a period of 10 - 40 minutes. The administration must be completed within 1 hour of reconstitution of the Azacitidine for Injection vial.

  Solution Stability: Azacitidine for Injection reconstituted for intravenous administration may be stored at 25°C (77°F), but administration must be completed within 1 hour of reconstitution.

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• Sandoz Inc
  

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  Azacitidine | Sandoz Inc

  

  ---

  2.1 First Treatment Cycle

  The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days. Patients should be premedicated for nausea and vomiting.

  Complete blood counts, liver chemistries and serum creatinine should be obtained prior to first dose.

  2.2 Subsequent Treatment Cycles

  Cycles should be repeated every 4 weeks. The dose may be increased to 100 mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 to 6 cycles. However, complete or partial response may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit.

  Patients should be monitored for hematologic response and renal toxicities [see Warnings and Precautions (5.3)], and dosage delay or reduction as described below may be necessary.

  2.3 Dosage Adjustment Based on Hematology Laboratory Values • For patients with baseline (start of treatment) WBC ≥3.0 x10 9/L, ANC ≥1.5 x10 9/L, and platelets ≥75.0 x10 9/L, adjust the dose as follows, based on nadir counts for any given cycle:

  Nadir Counts

  % Dose in the Next Course

  ANC (x109/L)
  <0.5
  0.5 - 1.5
  >1.5

  Platelets (x109/L)
  <25.0
  25.0 - 50.0
  >50.0

  
  50%
  67%
  100%

  • For patients whose baseline counts are WBC <3.0 x10 9/L, ANC<1.5 x10 9/L, or platelets <75.0 x10 9/L, dose adjustments should be based on nadir counts and bone marrow biopsy cellularity at the time of the nadir as noted below, unless there is clear improvement in differentiation (percentage of mature granulocytes is higher and ANC is higher than at onset of that course) at the time of the next cycle, in which case the dose of the current treatment should be continued.

  WBC or Platelet Nadir
  % decrease in counts
  from baseline

  Bone Marrow
  Biopsy Cellularity at Time of Nadir (%)

  30 - 60

  15 - 30

  <15

  % Dose in the Next Course

  50 - 75

  100

  50

  33

  >75

  75

  50

  33

  If a nadir as defined in the table above has occurred, the next course of treatment should be given 28 days after the start of the preceding course, provided that both the WBC and the platelet counts are >25% above the nadir and rising. If a >25% increase above the nadir is not seen by day 28, counts should be reassessed every 7 days. If a 25% increase is not seen by day 42, then the patient should be treated with 50% of the scheduled dose.

  2.4 Dosage Adjustment Based on Serum Electrolytes and Renal Toxicity

  If unexplained reductions in serum bicarbonate levels to <20 mEq/L occur, the dosage should be reduced by 50% on the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50% on the next treatment course [see Warnings and Precautions (5.3)].

  2.5 Use in Geriatric Patients

  Azacitidine 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 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5)].

  2.6 Preparation of Azacitidine for Injection

  Azacitidine for Injection is a cytotoxic drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing Azacitidine for Injection suspensions [see How Supplied/Storage and Handling (16)].

  If reconstituted Azacitidine for Injection comes into contact with the skin, immediately and thoroughly wash with soap and water. If it comes into contact with mucous membranes, flush thoroughly with water.

  The Azacitidine for Injection vial is single-use and does not contain any preservatives. Unused portions of each vial should be discarded properly [see How Supplied/Storage and Handling (16)]. Do not save any unused portions for later administration.

  2.7 Instructions for Subcutaneous Administration

  Azacitidine for Injection should be reconstituted aseptically with 4 mL sterile water for injection. The diluent should be injected slowly into the vial. Vigorously shake or roll the vial until a uniform suspension is achieved. The suspension will be cloudy. The resulting suspension will contain azacitidine 25 mg/mL. Do not filter the suspension after reconstitution. Doing so could remove the active substance.

  Preparation for Immediate Subcutaneous Administration: Doses greater than 4 mL should be divided equally into 2 syringes. The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution.

  Preparation for Delayed Subcutaneous Administration: The reconstituted product may be kept in the vial or drawn into a syringe. Doses greater than 4 mL should be divided equally into 2 syringes. The product must be refrigerated immediately. When Azacitidine for Injection is reconstituted using water for injection that has not been refrigerated, the reconstituted product may be held under refrigerated conditions (2ºC - 8ºC, 36ºF - 46ºF) for up to 8 hours. When Azacitidine for Injection is reconstituted using refrigerated (2ºC - 8ºC, 36ºF - 46ºF) water for injection, the reconstituted product may be stored under refrigerated conditions (2ºC - 8ºC, 36ºF - 46ºF) for up to 22 hours. After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration.

  Subcutaneous Administration

  To provide a homogeneous suspension, the contents of the dosing syringe must be re-suspended immediately prior to administration. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.

  Azacitidine for Injection suspension is administered subcutaneously. Doses greater than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites. Rotate sites for each injection (thigh, abdomen, or upper arm). New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, red, or hard.

  Suspension Stability: Azacitidine for Injection reconstituted with non-refrigerated water for injection for subcutaneous administration may be stored for up to 1 hour at 25°C (77°F) or for up to 8 hours between 2°C and 8°C (36°F and 46°F); when reconstituted with refrigerated (2ºC - 8ºC, 36ºF - 46ºF) water for injection, it may be stored for 22 hours between 2°C and 8°C (36°F and 46°F).

  2.8 Instructions for Intravenous Administration

  Reconstitute the appropriate number of Azacitidine for Injection vials to achieve the desired dose. Reconstitute each vial with 10 mL sterile water for injection. Vigorously shake or roll the vial until all solids are dissolved. The resulting solution will contain azacitidine 10 mg/mL. The solution should be clear. Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Withdraw the required amount of Azacitidine for Injection solution to deliver the desired dose and inject into a 50 - 100 mL infusion bag of either 0.9% Sodium Chloride Injection or Lactated Ringer's Injection.

  Intravenous Solution Incompatibility

  Azacitidine for Injection is incompatible with 5% Dextrose solutions, Hespan, or solutions that contain bicarbonate. These solutions have the potential to increase the rate of degradation of Azacitidine for Injection and should therefore be avoided.

  Intravenous Administration

  Azacitidine for Injection solution is administered intravenously. Administer the total dose over a period of 10 - 40 minutes. The administration must be completed within 1 hour of reconstitution of the Azacitidine for Injection vial.

  Solution Stability: Azacitidine for Injection reconstituted for intravenous administration may be stored at 25°C (77°F), but administration must be completed within 1 hour of reconstitution.

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