Product Information & Dosing

Product Information

Alymsys® 25 mg/mL concentrate for intravenous infusion is available in the same pack sizes as Avastin®:1,2

  • 100mg/4 mL single-dose vials
  • 400 mg/16 mL single-dose vials

Alymsys® is a clear to slightly opalescent, colorless to pale brown solution in a single-dose vial.

References:
1. Avastin® full Prescribing Information
2. Alymsys® full Prescribing Information

Ordering Information

Alymsys is available through wholesalers and directly from Amneal.

Dosage Strength Unit of Sale NDC Inner NDC Unit of Sale
100 mg/4 mL (25 mg/mL) 70121-1754-1 70121-1754-1 1 Vial
100 mg/4 mL (25 mg/mL) 70121-1754-7 70121-1754-1 10 Vials
400 mg/16 mL (25 mg/mL) 70121-1755-1 70121-1755-1 1 Vial
400 mg/16 mL (25 mg/mL) 70121-1755-7 70121-1755-1 10 Vials
Dosage Strength 100 mg/4 mL (25 mg/mL)
Unit of Sale NDC 70121-1754-1
Inner NDC 70121-1754-1
Unit of Sale 1 Vial
Dosage Strength 100 mg/4 mL (25 mg/mL)
Unit of Sale NDC 70121-1754-7
Inner NDC 70121-1754-1
Unit of Sale 10 Vials
Dosage Strength 400 mg/16 mL (25 mg/mL)
Unit of Sale NDC 70121-1755-1
Inner NDC 70121-1755-1
Unit of Sale 1 Vial
Dosage Strength 400 mg/16 mL (25 mg/mL)
Unit of Sale NDC 70121-1755-7
Inner NDC 70121-1755-1
Unit of Sale 10 Vials

Contact Sales@amneal.com or call (866) 525-7270 for more information.

Coding Information

Coding
HCPCS
(Temporary Code)		 C9142 Injection, bevacizumab-maly, biosimilar, (alymsys),
10 mg (effective 10/1 - 12/31/2022)
HCPCS Code Q5126 Injection, bevacizumab-maly, biosimilar, (alymsys),
10 mg (effective starting 1/1/2023
OPPS Status G Indicates pass-through payment
Coding HCPCS
(Temporary Code)
C9142
Injection, bevacizumab-maly, biosimilar, (alymsys),
10 mg (effective 10/1 - 12/31/2022)
Coding HCPCS Code
Q5126
Injection, bevacizumab-maly, biosimilar, (alymsys),
10 mg (effective starting 1/1/2023
Coding OPPS Status
G
Indicates pass-through payment
Coding per Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Recommendations; Third Quarter, 2022 HCPCS Coding Cycle

Supply & Storage

  • Keep in original carton and protect from light. Do not freeze or shake the vial or carton
  • Alymsys has an extended shelf life up to 30 months vs 24 months for Avastin. 1,2
  • In-use stability of diluted solution of Alymsys has been demonstrated up to 12 hours when stored at 2°C to 8°C (36°F to 46°F), versus 8 hours reported for diluted Avastin solution.



The expiration date is printed on each dispensing pack and vial label.

References:
1. Alymsys full Prescribing Information
2. Avastin full Prescribing Information

Dosing

Alymsys® has the same dosing and administration schedule as Avastin® for the approved indications.

Indication

Dosage (per kilogram of body weight)

Metastatic Colorectal Cancer (mCRC) in combination with fluorouracil-based chemotherapy for first line treatment, and in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for second-line treatment

5 mg/kg or 10 mg/kg every 2 weeks.
5 mg/kg every 2 weeks or 7.5 mg/kg once every 3 weeks.

First-Line Non-Squamous Non-small Cell Lung Cancer (NSCLC) in combination with carboplatin and paclitaxel

15 mg/kg every 3 weeks

Recurrent Glioblastoma (GBM)

10 mg/kg every 2 weeks

Metastatic Renal Cell Cancer (mRCC) in combination with interferon

10 mg/kg every 2 weeks

Persistent, Recurrent, or Metastatic Cervical Cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan

15 mg/kg every 3 weeks

Platinum-resistant Recurrent Epithelial Ovarian, Fallopian tube, or Primary Peritoneal Cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan

10 mg/kg every 2 weeks
15 mg/kg every 3 weeks

Withhold for at least 28 days prior to elective surgery. Do not administer Alymsys® until at least 28 days following major surgery and until adequate wound healing.

This is an abbreviated summary of the approved indications and dosing schedule. See full Prescribing Information for Important Dosing Considerations.

Dosage Modifications for Adverse Reactions

Adverse Reaction Severity Dosage Modification
Gastrointestinal Perforations and Fistulae
  • Gastrointestinal perforation, any grade
  • Tracheoesophageal fistula, any grade
  • Fistula, Grade 4
  • Fistula formation involving any internal organ
Discontinue Alymsys
Wound Healing Complications
  • Any
  • Necrotizing fasciitis
  • Withhold Alymsys until adequate wound healing. The safety of resuming bevacizumab after resolution of wound healing complications has not been established.
  • Discontinue Alymsys
Hemorrhage
  • Grade 3 or 4
  • Recent history of hemoptysis of 1/2 teaspoon (2.5 mL) or more
  • Discontinue Alymsys
  • Withhold Alymsys
Thromboembolic Events
  • Arterial thromboembolism, severe
  • Venous thromboembolism, Grade 4
  • Discontinue Alymsys
  • Discontinue Alymsys
Hypertension
  • Hypertensive crisis
  • Hypertensive encephalopathy
  • Hypertension, severe
  • Discontinue Alymsys
  • Withhold Alymsys if not controlled with medical management; resume once controlled
Posterior Reversible Encephalopathy Syndrome (PRES)
  • Any
  • Discontinue Alymsys
Renal Injury and Proteinuria [see Warnings and Precautions (5.8)].
  • Nephrotic syndrome
  • Proteinuria greater than or equal to 2 grams per 24 hours in absence of nephrotic syndrome
  • Discontinue Alymsys
  • Withhold Alymsys until proteinuria less than 2 grams per 24 hours
Infusion-Related Reactions
  • Severe
  • Clinically significant
  • Mild, clinically insignificant
  • Discontinue Alymsys
  • Interrupt infusion; resume at a decreased rate of infusion after symptoms resolve
  • Decrease infusion rate
Congestive Heart Failure
  • Any
  • Discontinue Alymsys
References:
1. Alymsys full Prescribing Information
2. Avastin full Prescribing Information