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. mAbxience Research SL. Periodic Safety Update Report (PSUR) for Alymsys (bevacizumab-maly). PSUR No. PSUSA/00000403/202202. April 22, 2022.
2. ALYMSYS. Prescribing information. Valorum Biologics Pharmaceuticals LLC; 2026.

Ordering Information

ALYMSYS is available through Valorum’s authorized wholesalers and specialty distributors.

Dosage Strength1 Unit of Sale NDC1 Inner NDC1 Unit of Sale1
100 mg/4 mL (25 mg/mL) 85006-1754-01 85006-1754-01 1 Vial
400 mg/16 mL (25 mg/mL) 85006-1755-01 85006-1755-01 1 Vial
Dosage Strength1 100 mg/4 mL (25 mg/mL)
Unit of Sale NDC1 85006-1754-01
Inner NDC1 85006-1754-01
Unit of Sale1 1 Vial
Dosage Strength1 400 mg/16 mL (25 mg/mL)
Unit of Sale NDC1 85006-1755-01
Inner NDC1 85006-1755-01
Unit of Sale1 1 Vial

Contact ValorumCS@icsconnect.com or call (866) 650-6789 for more information.

Reference: 1. ALYMSYS. Prescribing information. Valorum Biologics Pharmaceuticals LLC; 2026.

Coding Information

Coding1,2
HCPCS Code Q5126 Injection, bevacizumab-maly, biosimilar, (ALYMSYS), 10 mg
OPPS Status G Indicates pass-through payment
Coding1,2 HCPCS Code
Q5126
Injection, bevacizumab-maly, biosimilar, (ALYMSYS), 10 mg
Coding1,2 OPPS Status
G
Indicates pass-through payment
Indication ICD-10-CM Code Range Descriptor ICD-10-CM Code Range
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen Limitations of use: ALYMSYS is not indicated for adjuvant treatment of colon cancer3 Metastatic colorectal cancer C18.0-C18.9; C19; C204
Unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment3 Metastatic nonsquamous non-small cell lung cancer C34.00-C34.925
Recurrent glioblastoma in adults3 Glioblastoma C71.0-C71.96
Metastatic renal cell carcinoma in combination with interferon alfa3 Metastatic renal cell carcinoma C64.1-C64.9; C65.1-C65.97
Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan3 Persistent, recurrent, or metastatic cervical cancer C53, C530.0, C53.1, C53.8, C53.98
Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease in patients who received no more than 2 prior chemotherapy regimens3 Epithelial ovarian, fallopian tube, or primary peritoneal cancer C48.0-C48.8; C56.1-C56.9; C57.00-C57.22; C57.3-C57.89
Indication Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen Limitations of use: ALYMSYS is not indicated for adjuvant treatment of colon cancer3
ICD-10-CM Code Range Descriptor Metastatic colorectal cancer
ICD-10-CM Code Range C18.0-C18.9; C19; C204
Indication Unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment3
ICD-10-CM Code Range Descriptor Metastatic nonsquamous non-small cell lung cancer
ICD-10-CM Code Range C34.00-C34.925
Indication Recurrent glioblastoma in adults3
ICD-10-CM Code Range Descriptor Glioblastoma
ICD-10-CM Code Range C71.0-C71.96
Indication Metastatic renal cell carcinoma in combination with interferon alfa3
ICD-10-CM Code Range Descriptor Metastatic renal cell carcinoma
ICD-10-CM Code Range C64.1-C64.9; C65.1-C65.97
Indication Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan3
ICD-10-CM Code Range Descriptor Persistent, recurrent, or metastatic cervical cancer
ICD-10-CM Code Range C53, C530.0, C53.1, C53.8, C53.98
Indication Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease in patients who received no more than 2 prior chemotherapy regimens3
ICD-10-CM Code Range Descriptor Epithelial ovarian, fallopian tube, or primary peritoneal cancer
ICD-10-CM Code Range C48.0-C48.8; C56.1-C56.9; C57.00-C57.22; C57.3-C57.89
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

References:
1. Centers for Medicare & Medicaid Services. Billing and coding: Bevacizumab and biosimilars. Accessed May 21, 2026.
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleld=52370&ver=128
2. Healthcare Common Procedure Coding System Transaction Report. July 2026. Accessed May 21, 2026 https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system/quarterly-update
3. ALYMSYS. Prescribing information. Valorum Biologics Pharmaceuticals LLC; 2026.
4. NCDHHS. Bevacizumab-maly Injection, for intravenous use (Alymsys®) HCPCS Code J9999: Billing Guidelines. Updated November 22, 2022. Accessed May 21, 2026. https://medicaid.ncdhhs.gov/blog/2022/11/22/bevacizumab-maly-injection-intravenous-use-alymsysr-cpcs-code-j9999-billing-guidelines
5. AAPC Knowledge Center. Lung cancer: ICD-10-CM coding. Accessed May 21, 2026. https://www.aapc.com/blog/41198-lung-cancer-icd-10-cm-coding/?srs|tid=AfmBOor59p1ryl.5qd/JIGxI_blAVe8%252%2580%25A6
6. Unbound Medicine. C71.9-Malignant neoplasm of brain, unspecified. Accessed May 21, 2026.
https://www.unboundmedicine.com/icd/view/ICD-10-CM/885384/all/C719%2520Malignant_neoplasm_of_
brain%252%2580%25A6
7. ICDcodes.ai. ICD-10 coding for metastatic renal cell carcinoma. Accessed May 21, 2026.
https://icdcodes.ai/diagnosis/metastatic-renal-cell-carcinoma/documentation
8. Coding & Billing Solutions, LLC. Cervical cancer CD 10 codes. Accessed May 21, 2026. https://codingbillingsolutions.
com/blogs/cervical-cancer-icd-10-codes/
9. Centers for Medicare & Medicaid Services. Billing and coding: Paclitaxel (e.g., Taxol®/Abraxane ™). Accessed May 21, 2026.
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleld=52450&ver=80

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
  • 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.1-3



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

References:
1. mAbxience Research SL. Periodic Safety Update Report (PSUR) for Alymsys (bevacizumab-maly). PSUR No. PSUSA/00000403/202202. April 22, 2022.
2. ALYMSYS. Prescribing information. Valorum Biologics Pharmaceuticals LLC; 2026.
3. Avastin full Prescribing Information.

Dosing1,2

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 or second-line treatment, and in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for second-line treatment for those who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: ALYMSYS is not indicated for adjuvant treatment of colon cancer1

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.

Unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment1

15 mg/kg every 3 weeks

Recurrent Glioblastoma (GBM) in adults1

10 mg/kg every 2 weeks

Metastatic Renal Cell Carcinoma (mRCC) in combination with interferon alpha1

10 mg/kg every 2 weeks

Persistent, Recurrent, or Metastatic Cervical Cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan1

15 mg/kg every 3 weeks

Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease in patients who received no more than 2 prior chemotherapy regimens1

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

Important Administration Information for all ALYMSYS Indications

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.1

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

Dosage Modifications for Adverse Reactions1

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. Prescribing information. Valorum Biologics Pharmaceuticals LLC; 2026.
2. Avastin full Prescribing Information, 2022.