Avsola (Infliximab)

Generic Name

Infliximab

Brand Names

Avsola, Zymfentra, Remicade, Renflexis, Inflectra

FDA approval date: August 24, 1998

Classification: Tumor Necrosis Factor Blocker

Form: Injection, Kit

What is Avsola (Infliximab)?

ZYMFENTRA is a tumor necrosis factor blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn’s disease following treatment with an infliximab products administered intraneously. ZYMFENTRA is indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn's disease following treatment with an infliximab product administered intravetnously.

Approved To Treat

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Brand Information

AVSOLA (infliximab-axxq)

1DOSAGE FORMS AND STRENGTHS

For injection: 100 mg of infliximab-axxq as a white to slightly yellow lyophilized powder in a single-dose vial for reconstitution and dilution.

2CONTRAINDICATIONS

The use of AVSOLA at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure

AVSOLA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of AVSOLA or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness]

3OVERDOSAGE

Single doses up to 20 mg/kg have been administered without any direct toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects

4DESCRIPTION

Infliximab-axxq, a tumor necrosis factor (TNF) blocker, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab-axxq is produced in a recombinant Chinese Hamster Ovary (CHO) cell line.

AVSOLA (infliximab-axxq) for injection is supplied as a sterile, preservative-free, white to slightly yellow, lyophilized powder for intravenous infusion after reconstitution and dilution. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the final concentration is 10 mg/mL and the resulting pH is approximately 7.2. Each single-dose vial contains 100 mg infliximab-axxq, dibasic sodium phosphate, anhydrous (4.9 mg), monobasic sodium phosphate, monohydrate (2.2 mg), polysorbate 80 (0.5 mg), and sucrose (500 mg).

5REFERENCES

Turner D, Otley AR, Mack D, et al. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: A prospective multicenter study.

6PATIENT COUNSELING INFORMATION

Advise the patient or their caregiver to read the FDA-approved patient labeling (Medication Guide).

Patients or their caregivers should be advised of the potential benefits and risks of AVSOLA. Healthcare providers should instruct their patients or their caregivers to read the Medication Guide before starting AVSOLA therapy and to reread it each time they receive an infusion.

7PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton Label

100

AMGEN

NDC 55513-670-01

AVSOLA

100 mg/vial

For Intravenous infusion only

Single-Dose Vial. Discard unused portion.

Contents: Each carton contains one 100 mg AVSOLA Single-Dose Vial.

Rx Only

PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton Label