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Cyramza

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Cyramza

Indications
Dosage
How Supplied

INDICATIONS

Gastric Cancer

CYRAMZA® as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine-or platinum-containing chemotherapy.

DOSAGE AND ADMINISTRATION

Do not administer CYRAMZA as an intravenous push or bolus.

Recommended Dose And Schedule

  • The recommended dose of CYRAMZA either as a single agent or in combination with weekly paclitaxel is 8 mg/kg every 2 weeks administered as an intravenous infusion over 60 minutes. Continue CYRAMZA until disease progression or unacceptable toxicity.
  • When given in combination, administer CYRAMZA prior to administration of paclitaxel.

Premedication

  • Prior to each CYRAMZA infusion, premedicate all patients with an intravenous histamine H1 antagonist (e.g., diphenhydramine hydrochloride).
  • For patients who have experienced a Grade 1 or 2 infusion reaction, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion [see Dose Modifications].

Dose Modifications

Infusion-Related Reactions (IRR)
  • Reduce the infusion rate of CYRAMZA by 50% for Grade 1 or 2 IRRs.
  • Permanently discontinue CYRAMZA for Grade 3 or 4 IRRs [see Premedication and WARNINGS AND PRECAUTIONS].
Hypertension
  • Interrupt CYRAMZA for severe hypertension until controlled with medical management.
  • Permanently discontinue CYRAMZA for severe hypertension that cannot be controlled with antihypertensive therapy [see WARNINGS AND PRECAUTIONS].
Proteinuria
  • Interrupt CYRAMZA for urine protein levels ≥ 2 g/24 hours. Reinitiate treatment at a reduced dose of 6 mg/kg every 2 weeks once the urine protein level returns to < 2 g/24 hours. If the protein level ≥ 2 g/24 hours reoccurs, interrupt CYRAMZA and reduce the dose to 5 mg/kg every 2 weeks once the urine protein level returns to < 2 g/24 hours.
  • Permanently discontinue CYRAMZA for urine protein level > 3 g/24 hours or in the setting of nephrotic syndrome [see ADVERSE REACTIONS].
Wound Healing Complications
  • Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed [see WARNINGS AND PRECAUTIONS].
Arterial Thromboembolic Events, Gastrointestinal Perforation, or Grade 3 or 4 Bleeding
  • Permanently discontinue CYRAMZA [see WARNINGS AND PRECAUTIONS].

For toxicities related to paclitaxel, refer to the current prescribing information.

Preparation For Administration

Inspect vial contents for particulate matter and discoloration prior to dilution [see DESCRIPTION]. Discard the vial, if particulate matter or discolorations are identified. Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use. Keep the vial in the outer carton in order to protect from light.

  • Calculate the dose and the required volume of CYRAMZA needed to prepare the infusion solution. Vials contain either 100 mg/10 mL or 500 mg/50 mL at a concentration of 10 mg/mL solution of CYRAMZA.
  • Withdraw the required volume of CYRAMZA and further dilute with only 0.9% Sodium Chloride Injection in an intravenous infusion container to a final volume of 250 mL. Do not use dextrose containing solutions.
  • Gently invert the container to ensure adequate mixing.
  • DO NOT FREEZE OR SHAKE the infusion solution. DO NOT dilute with other solutions or co-infuse with other electrolytes or medications.
  • Store diluted infusion for no more than 24 hours at 2°C to 8°C (36°F to 46°F) or 4 hours at room temperature (below 25°C [77°F]).
  • Discard vial with any unused portion of CYRAMZA.

Administration

  • Visually inspect the diluted solution for particulate matter and discoloration prior to administration. If particulate matter or discolorations are identified, discard the solution.
  • Administer diluted CYRAMZA infusion via infusion pump over 60 minutes through a separate infusion line. Use of a protein sparing 0.22 micron filter is recommended. Flush the line with sterile sodium chloride (0.9%) solution for injection at the end of the infusion.

HOW SUPPLIED

Dosage Forms And Strengths

  • 100 mg/10 mL (10 mg per mL) solution, single-dose vial
  • 500 mg/50 mL (10 mg per mL) solution, single-dose vial

CYRAMZA is supplied in single-dose vials as a sterile, preservative-free solution.

NDC 0002-7669-01 100 mg/10 mL (10 mg/mL), individually packaged in a carton
NDC 0002-7678-01 500 mg/50 mL (10 mg/mL), individually packaged in a carton

Storage And Handling

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use. Keep the vial in the outer carton in order to protect from light. DO NOT FREEZE OR SHAKE the vial.

For product diluted in 0.9% sodium chloride, the chemical and physical stability have been demonstrated for up to 24 hours at 2°C to 8°C (36°F to 46°F) or for 4 hours at room temperature (below 25°C [77°F]). DO NOT FREEZE OR SHAKE the diluted product.

Eli Lilly and Company, Indianapolis, IN 46285, USA. Revised: November 2014

Last reviewed on RxList: 11/12/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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