Zolbetuximab Dosage

Medically reviewed by Drugs.com. Last updated on Jan 7, 2025.

Usual Adult Dose for Liver Metastasis in Adenocarcinoma

First dose: 800 mg/m2 IV infusion
Maintenance dose: 600 mg/m2 IV infusion every 3 weeks or 400 mg/m2 IV infusion every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer antiemetics before each infusion to prevent nausea and vomiting.
• This drug is used in combination with fluoropyrimidine- and platinum-containing chemotherapy.
• The manufacturer product information should be consulted for infusion rates.

Use: For the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dose reduction is not recommended. Manage adverse reactions by slowing the infusion, interrupting it, withholding the dose, or permanently discontinuing the drug.

Recommended Dose Modifications for Hypersensitivity or Infusion-related reactions:

• Grade 2 severity: Stop the infusion until it resolves to grade 1 or lower, then resume at a slower rate. Consider premedicating before administering next infusion. The manufacturer product information should be consulted for infusion rates.
• Grade 3 or 4 severity or anaphylaxis: Immediately stop the infusion and permanently discontinue this drug.
• Grade 3 infusion-related nausea and vomiting: Stop the infusion until it resolves to grade 1 or lower, then resume at a slower rate. Premedicate before administering next infusion. The manufacturer product information should be consulted for infusion rates.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Select patients for treatment based on the presence of a moderate to strong membranous claudin 18.2 immunohistochemical staining using an approved US FDA test.
• If nausea and/or vomiting occur before administering this drug, resolve symptoms to grade 1 or less first.
• To prevent nausea and vomiting premedicate with antiemetics prior to each infusion.
• When this drug and chemotherapy (fluoropyrimidine and platinum) are given on the same day, administer this drug first.
• Inspect reconstituted solution for particulate matter and discoloration. Discard any vial with visible particles or discoloration. Do not shake the vial.
• Administer as an intravenous infusion only. Do not administer as an intravenous push or bolus.
• Use in-line filters (0.2 micrometer pore size) made from the recommended materials during administration.
• Do not co-administer other drugs through the same infusion line.
• To reduce the risk of adverse reactions, initiate infusion at a slower rate for 30 to 60 minutes. If tolerated, gradually increase the rate of infusion.
• If the infusion time exceeds the recommended storage time, the infusion bag must be discarded and a new infusion bag prepared to continue the infusion.

Storage requirements:

• Refrigerate vials at 2C to 8C (36F to 46F) in the original carton. Do not freeze. Do not shake.
• Reconstituted vial(s): Store at room temperature 15C to 30C (59F to 86F) for up to 5 hours if not used immediately.
• Prepared infusion bag:
• Store at room temperature 15C to 30C (59F to 86F) for no longer than 6 hours from the end of the preparation of the infusion bag to the completion of the infusion.
• Store refrigerated at 2C to 8C (36F to 46F) for no longer than 16 hours from the end of the preparation of the infusion bag to the completion of the infusion. Do not freeze.

Reconstitution/preparation techniques:

• The recommended dose should be calculated based on the patient's body surface area.
• Do not shake the vial.
• The manufacturer product information should be consulted.

IV compatibility:

• No incompatibilities have been reported with closed system transfer devices composed of PP, PE, stainless steel, silicone (rubber/oil/resin), polyisoprene, PVC with TOTM plasticizer, acrylonitrile-butadiene-styrene (ABS) copolymer, methyl methacrylate-ABS copolymer, thermoplastic elastomer, polytetrafluoroethylene, polycarbonate, PES, acrylic copolymer, polybutylene terephthalate, PB, or EVA copolymer and central ports composed of silicone rubber, titanium alloy or PVC with TOTM plasticizer.

General:

• This product does not contain preservative.
• Report suspected adverse reactions to Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Monitoring:

• Hypersensitivity: Hypersensitivity reactions, signs and symptoms of anaphylaxis, infusion-related reactions (nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough and hypertension)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• If hypersensitivity or infusion-related reactions occur during or after administration, consult your healthcare provider.
• Contact your healthcare provider immediately if you experience persistent or worsening nausea or vomiting.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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