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Avgemsi Dosage

Generic name: GEMCITABINE HYDROCHLORIDE 38mg in 1mL
Dosage form: injection, solution
Drug class: Antimetabolites

Medically reviewed by Drugs.com. Last updated on Jul 20, 2025.

Ovarian Cancer

Recommended Dose and Schedule

The recommended dosage of AVGEMSI is 1,000 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 administered intravenously on Day 1 after AVGEMSI administration. Refer to carboplatin prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for AVGEMSI for myelosuppression are described in Tables 1 and 2. Refer to the recommended dosage modifications for non-hematologic adverse reactions.

Table 1: Recommended Dosage Modifications for AVGEMSI for Myelosuppression on Day of Treatment in Ovarian Cancer
Treatment Day

Absolute Neutrophil Count

(x 106/L)

Platelet Count

(x 106/L)

Dosage Modification
Day 1 Greater than or equal to 1,500 And Greater than or equal to 100,000 None
Less than 1,500 Or Less than 100,000 Delay Treatment Cycle
Day 8 Greater than or equal to 1,500 And Greater than or equal to 100,000 None
1,000 to 1,499 Or 75,000 to 99,999 50% of full dose
Less than 1,000 Or Less than 75,000 Hold
Table 2: Recommended Dosage Modifications for AVGEMSI for Myelosuppression in Previous Cycle in Ovarian Cancer
Occurrence Myelosuppression During Treatment Cycle Dosage Modification
Initial Occurrence
  • Absolute neutrophil count less than 500 x 106/L for more than 5 days or
  • Absolute neutrophil count less than 100 x 106/L for more than 3 days or
  • Febrile neutropenia or
  • Platelets less than 25,000 x 106/L
  • Cycle delay for more than one week due to toxicity
Permanently reduce AVGEMSI to 800 mg/m2 on Days 1 and 8
Subsequent
Occurrence
If any of the above toxicities occur after the initial dose reduction Permanently reduce AVGEMSI to 800 mg/m2 on Days 1 only

Breast Cancer

Recommended Dose and Schedule

The recommended dosage of AVGEMSI is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with paclitaxel 175 mg/m2 on Day 1 before AVGEMSI administration. Refer to paclitaxel prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for AVGEMSI for myelosuppression are described in Table 3. Refer to the recommended dosage modifications for non-hematologic adverse reactions.

Table 3: Recommended Dosage Modifications for AVGEMSI for Myelosuppression on Day of Treatment in Breast Cancer

Treatment Day

Absolute Neutrophil Count

(x 106/L)

Platelet Count
(x 106/L)
Dosage Modification
Day 1 Greater than or equal to 1,500 And Greater than or equal to 100,000 None
Less than 1,500 Or Less than 100,000 Hold
Day 8 Greater than or equal to 1,200 And Greater than 75,000 None
1,000 to 1,199 Or 50,000 to 75,000 75% of full dose
700 to 999 And Greater than or equal to 50,000 50% of full dose
Less than 700 Or Less than 50,000 Hold

Non-Small Cell Lung Cancer

Recommended Dose and Schedule

28-day schedule

The recommended dosage of AVGEMSI is 1,000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 of each 28-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after AVGEMSI administration.

21-day schedule

The recommended dosage of AVGEMSI is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after AVGEMSI administration.

Refer to cisplatin prescribing information for additional information.

Dosage Modifications

Recommended dosage modifications for AVGEMSI myelosuppression are described in Table 4. Refer to the recommended dosage modifications for non-hematologic adverse reactions.

Pancreatic Cancer

Recommended Dose and Schedule

The recommended dosage of AVGEMSI is 1,000 mg/m2 intravenously over 30 minutes. The recommended treatment schedule is as follows:

  • Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one-week rest.
  • After week 8: weekly dosing on Days 1, 8, and 15 of each 28-day cycle.

Dosage Modifications

Recommended dosage modifications for AVGEMSI for myelosuppression are described in Table 4. Refer to the recommended dosage modifications for non-hematologic adverse reactions.

Table 4: Recommended Dosage Modifications for AVGEMSI for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer
Absolute Neutrophil Count (x 106/L) Platelet Count

(x 106/L)

Dosage Modification
Greater than or equal to 1,000 And Greater than or equal to 100,000 None
500 to 999 Or 50,000 to 99,999 75% of full dose
Less than 500 Or Less than 50,000 Hold

Dosage Modifications for Non-Hematologic Adverse Reactions

Permanently discontinue AVGEMSI for any of the following:

  • Severe Cutaneous Adverse Reactions (SCARs)
  • Unexplained dyspnea or evidence of severe pulmonary toxicity
  • Hemolytic uremic syndrome (HUS) or severe renal impairment
  • Severe hepatic toxicity
  • Capillary leak syndrome (CLS)
  • Posterior reversible encephalopathy syndrome (PRES)

Withhold AVGEMSI or reduce dose by 50% for other Grade 3 or 4 non-hematological adverse reactions until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

Preparation

AVGEMSI is a hazardous drug. Follow applicable special handling and disposal procedures.1 Exercise caution and wear gloves when preparing AVGEMSI solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if AVGEMSI contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.

After first use, store the partially used multiple-dose vial in the original carton, refrigerated at 2°C to 8°C (36ºF to 46°F) for up to 14 days. Discard unused portion of the multiple-dose vial after 14 days.

Preparation for Intravenous Infusion Administration

  • Withdraw the calculated dose from the vial.
  • Prior to administration, dilute the appropriate amount of drug with 0.9% Sodium Chloride Injection, USP to a minimum final concentration of at least 0.1 mg/mL.
  • Store diluted AVGEMSI solution for no more than 24 hours at controlled room temperature of 20°C to 25°C (68°F to 77°F). Discard AVGEMSI solution if not used within 24 hours after dilution.
  • Visually inspect for particulate matter or discoloration prior to administration and discard if particulate matter or discoloration is observed.
  • No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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Frequently asked questions

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Further information

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