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
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.
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 |
Occurrence | Myelosuppression During Treatment Cycle | Dosage Modification |
Initial Occurrence |
|
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
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.
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
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
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.
Recommended dosage modifications for AVGEMSI for myelosuppression are described in Table 4. Refer to the recommended dosage modifications for non-hematologic adverse reactions.
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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